Betaferon zasosuvannya. Betaferon

Betaferon is an immunomodulator, which can become stagnant in case of rosy sclerosis.

Form vipusk and warehouse

Release Betaferon from the viglyad lyophilizate for preparing the gap, designated for the pediatric introduction. The name is a masu white color... It is sold in glass bottles, and it is additionally equipped with a razchinnik.

The Betaferon store contains recombinant interferon beta-1b. In 1 ml, there are 8 million MOUs, in one bottle - 9.6 million MOUs.

Shown to sucking

From the instruction to Betaferon, a drug of indications for the treatment of clinically isolated syndrome (KIS), which is one of the most important ones in the process of demilisation, allowing the patient to allow an alternative to an obvious ignition process, Scho is the sign of the GKS to be assigned to the assistant professor. Meta therapy - trusting the transition of the whole camp to clinically significant development of sclerosis (CDRS) in ailments with a high risk of development. With a lot of varto it means that the understanding of the high rhiziku not іsnuє. It is worth noting that, up to such a group, there are patients from mono-focal KIS (tobto key manifestations only one headquarters in the central nervous systems) І T2-vignes, which appear behind the MRI, or vignisches, to accumulate contrasting speech. Patients with a multi-focus KIS (so that in some of the most clinically manifested more than one head in the central nervous system), they are referred to the group of increased risk of development of KDRS just from the number of diagnostics.

Also Betaferon, for instructions, should be used for drinking:

Remіttіruyuschego rozsіyanogo sclerosis - s metoyu zmenshennya tyazhkostі i frequency now zagostrennya zahvoryuvannya in ambulatory patsієntіv (tobto zdatnih peresuvatisya samostіyno without storonnoї dopomoga) at nayavnostі in їh anamnezі yak mіnіmum dvoh epіzodіv zagostrennya hvorobi protyagom ostannіh 2 rokіv i for minds away Povny abo nepovnogo vіdnovlennya neurological symptoms;
Suddenly, a progressive rosy sclerosis, which is characterized by an active breakdown, sharpened or deteriorated in neurological functions, the improvement of 2 remaining rocky

Prototype

Annotation before the drug, the consumption of Betaferon is shown to be:

Pid hour of vaginosti;
Bustle;
If there is a history of increased sensitivity to interferon-beta (recombinant or natural) or human albumin.

I mean a medication, albeit with special protection for children and adolescents up to 18 years of age (through the availability of sufficient money about the safety of Betaferon's supply from the whole group of children), as well as for patients from:

Engulfed in heart, incl. from the heart lack of II-IV functional class for NYHA classification and cardiomyopathy;
anemia;
thrombocytopenia;
Depression and suicidal symptoms / thoughts in anamnesis;
Epileptic seizures in history;
Damaged functions of the stove.

How to save and add

Therapy with Betaferon is guilty of being carried out under the control of a doctor, which can lead to the diagnosis of rosy sclerosis.

If for the cause of the patient, having missed the Chergov іn'єktsіyu, he is guilty of the death immediately, as only because of the guess, and I will step - in 48 years, etc., as well as see the new hour introduced.

The triviality of treatment in a specific skin type is due to a specific drug, some of the food about the triviality of therapy with Betaferon does not become nonvirusin. In the classroom pre-adolescents, children are treated with secondary progressive and remitting rosy sclerosis in some cases, it reached 3 and 5 rocky in all cases.

Pobichna diya

With the stasis of Betaferon, for the help of the patients, a great deal of development side effects.

Flu-like symptoms often occur - chills, head bill, Likhomanka, more in myazah, increase in the appearance, however, the frequency of these manifestations decreases with an hour. Until then, the symptoms can be alleviated by refining the refinery.

Also, it is often the case that there are miscellaneous reactions, such as hyperemia, heat, local swelling, blistering, necrosis in the masses. Over the years, the frequency will drop.

Ridko, including okremі vipadki, a lot of development of such side-by-side Betaferon, yak:

Beat at the breasts, zagalne nezduzhannya;
Anemia, thrombocytopenia, leukopenia, lymphadenopathy;
Arterial hypertension, tachycardia, cardiomyopathy, heart disease, vasodilatation;
damaged function thyroid gland, Hypothyroidism, hyperthyroidism;
M'yazovy hypertonicity, sudomi, depression, anxiety, confusion of testimony, emotional labiality, impairment, anorexia, suicidal problems;
Zadishka, bronchospasm;
Nudota, bloating, diarrhea, pancreatitis, hepatitis, adiposity of bilirubin, activity of AST, ALT and GGT;
Arthralgia, mialgia;
ruin menstrual cycle, Menoragia;
Anaphylactic reactions;
Adjustment of triglycerides;
Kropivyanka, alopecia, sverbіzh і visip, zmіna koloru shkіri.

analogs

The same by speech vipuskayut preparations Interferon beta-1b, Infibeta, Ronbetali Ekstavia.

For a subset of mechanisms for analogs of Betaferon, it is possible to use Avoneks, Altevir, Alfarona, Alfaferon, Viferon, Genferon, Giaferon, Diaferon, Ingarol, Interferon, Interferon human, human recombinant

Terms and conditions

The term of the attachment of Betaferon is 2 rocky. It can be obtained at temperatures below 25 ºС.

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In 1 bottle interferon beta-1b - 0.30 mg (or 9.6 million MO). Human Album and Manitol - as an additional speech.

Vipusku form

Lyophilizate for preparation of a bottle or a suspension of 9.6 million OD per bottle.

Pharmacological diya

Immunomodulatory.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Speech is active interferon beta-1b I’m against the level of the immune system. Mechanism of yogo diya is not residually established, but it seems that the dressing is due to the interaction with singing receptors. The connection with the cimi receptors is the induction of the expression of the speech, which appeared in the blood of the ailments, as the drug was taken away. Beta-interferon the suppressor effect of mononuclear blood cells.

For patients with a secondary progressive form RS Zasosuvannya to the drug will override the progress of illness and disability to one fate. results MRI the brain is ailing to positive dynamics: the change in the adoption of new vognisch. No further toxicity and carcinogenicity of the drug was carried out. Clinical transformation test carried out in vitro , Without revealing a carcinogenic effect.

Pharmacokinetics

When administered in a pediatric dose of 1 ml (0.25 mg) concentration beta-interferon in the blood of low blood does not appear, to that there is no information about pharmacokinetics. With the introduction of 0.5 mg, the maximum concentration appears in 1-8 years. Bioavailability 50%. When the drug is administered internally, the period of time is 5 years.

Introduced pіdshkіrno every other day is not a wedge of increasing concentration in the blood. In case of a child's consumption every other day at a dose of 0.25 mg, the indicators of markers in biological form appear to change significantly after 6-12 years after the first dose, reach a peak in 40-125 years and become too small for 168 years.

Shown to sucking

Isolation syndrome we rotate the ignition process, with a є supply for the internal combustion corticosteroids , With confidence in the transition to a reliable RS ... Call the chain of pacinti with key manifestations of more than one in CNS ;
relapsing MS (With a decrease in the frequency of hypersensitivity in the presence of 2 or more hypersensitivity for 2 times with incomparable changes in the neurological status);
secondary progressive RS I will be active in perebig iz sharpened for 2 fate and in the reduction of the neurological status (with the change of frequency and increase in the improvement of progress).

Prototype

sensitivity is adjusted;
breastfeeding.

I will protect myself when heart failure III-IV stages, anemia , leukopenia and deterioration of the function of the stove.

Pobichna diya

Often there are reactions:

reactions in the conference hyperemia , Zapalennya,);
flu-like symptoms (chills, mіalgії ).

Reactions are rare:

nezduzhannya, chest pain;
anemia , leukopenia ;
reduction of vagi or reduction;
abo;
hypertonicity m'yaziv;
sudomi , Zbujennya, suicidal probi, emotional labileness;
, Pidvischennya;
і bronchospasm ;
mіalgіya і arthralgia ;
tediousness of blues;
, Anaphylactic reactions;
, Sverbіzh, visip;
damage to the menstrual cycle.

The reactions are even more rare:

vasodilation ;
menoragia .

Betaferon

The drug is administered pediatric. For powdering beta-interferon in the bottle, inject 1.2 ml of the bottle. Powder without crushing is good. Yaksh є є

Betaferon at rosy sclerosis inject every other day, 1 ml (0.25 mg beta-interferon ). If I miss the pass, I will be victorious at once, and I will start to viroblyayut, as I will be in 48 years. The triviality of the rate of viznacha likar, with key advances, reached from 3 to 5 years.

Overdose

With the introduction of the drug intravenously, 5.5 mg of three do not mean significant unnecessary reactions.

vzaєmodiya

No previous interactions with other drugs were carried out. glucocorticosteroids , Scho zastosovovatsya one hour at zagostrennyah, good to be transferred. Zasosuvannya Betaferon with іnshi immunomodulators not screwed in. After taking care of the condition when it is recognized that it is spilo from the LZ, the clearing of which to lay down from the system P450 (Antidepressants, antiepileptic drugs), as well as drugs that are injected into the blood. It is not possible to use drugs in one syringe.

Mind the sale

For the recipe.

Umovi zberigannya

Temperature up to 25 ° C.

Term of attachment

analogues of Betaferon

Zbigi for the ATC code of the 4th rivnya:

Інфібета , Ronbetal , Ekstavia .

Powder of lyophilization for preparation of rosters for ін'єкцій - 1 vial. interferon beta-1b - 0.3 mg (form 9.6 million IU) additional speech: human albumin; mannitol 0.25 mg (8 million IU) of recombinant interferon beta-1b in 1 ml of the prepared solution. vials of alcoholic servetka without any bottom; in a box 5 or 15 sets.

Description of licarsky form

Lyophilizate: lyophilized mass of white color. Rozchinnik: prosorium, vilny from the part of rozchin. Razchin innovations: razchin from slightly opalescent to opalescent, barless or light-colored color.

Pharmacokinetics

For subcutaneous administration in a dose, 0.25 mg concentration of interferon beta-1b in the blood is low, or it does not appear. After subcutaneous administration of 0.5 mg of Betaferon® to healthy volunteers, Cmax in plasma becomes close to 40 IU / ml after 1-8 years of writing. In general, the absolute bioavailability of Betaferon® with subcutaneous administration is approximately 50%. In case of intravenous injection of clearence and T 1/2 to the preparation from syrovat - in the middle 30 ml / hv / kg and 5 years as appropriate. The introduction of Betaferon® every other day should not be administered until the preparation is adjusted in the blood plasma; its pharmacokinetic parameters will not change during the course of therapy. With subcutaneous intake of Betaferon® at a dose of 0.25 mg every other day in healthy volunteers with biologic markers (neopterin, beta2-microglobulin and immunosuppressive cytokine IL-10) were significantly dose the drug. Cmax reached 40-124 years later and was moved by a stretch of 7-day (168 h) period until the end of the day.

Pharmacodynamics

Active speech for the drug Betaferon® (interferon beta-1b) can be anti-virus and immunoregulatory activity. Mechanism for interferon beta-1b in case of rosular sclerosis is not residually established. However, it seems that the biological effect of beta-1b interferon is outdone by its interaction with specific receptors, which appear on the surface of human cells. The connection to interferon beta-1b with multiple receptors and induction expression is low, as it is seen in the capacity of mediators in biological effects to interferon beta-1b. Zmіst of the people from the cich speeches were started in the syrovattsі and fractions of the blood cells of the ailments, as they eliminated interferon beta-1b. Interferon beta-1b reduces the intensity and expression of receptors to gamma-interferon, when the response is low. In addition, interferon beta-1b increases the suppressor activity of mononuclear cells of the peripheral blood.

clinical pharmacology

Yak in case of remitting and secondary progressive sclerosis of the disease Betaferon ® decreases the frequency (by 30%) and the severity of clinical ailments, the number of hospitalizations and the need for treatment, as well as three steroids. In ailments with secondary progressive sclerosis of the disease, Betaferon ® allows you to take away the progress of illness and illness, incl. important (so that if there are ailments, you will always be able to use an invalid cruise) for a term of up to 12 months. The main effect is to promote the presence of ailments as a result of acute illnesses, as well as without a warning, as well as with an index of indiscrimination (in the past, the children took part in the rating from 3.0 to 6.0 in the range of 6.5 to 6.0 The results of the MRI scan of the brain with remitting and secondary progressive sclerosis against the background of Betaferon ® therapy confirm a significant positive injection of the drug on the severity of the pathological process, as well as the decrease in the approval of new active ones.

Shown to zasosuvannya Betaferon

klіnіchno іzolovany syndrome (KІS) (єdiny klіnіchny epіzod demyelination scho dozvolyaє pripustiti rozsіyany sclerosis, alternatively of minds viklyuchennya dіagnozіv) of dostatnoyu for priznachennya vnutrіshnovennih kortikosteroїdіv viraznіstyu Process ignition - for a transition upovіlnennya klіnіchno dostovіrny rozsіyany sclerosis (KDRS) of at patsієntіv with a high rizik yogo rozvitku. Zagalnoprimyannya visnachennya temple riziku is not. According to the dosage, up to a group of high risk, the development of KDRS is carried out by patients with mono-focal KIS (key manifestations of 1 head in the central nervous system) і> = 9 T2-signals on the MRI and / or accumulate in contrast to the speech. Patients with multifocal KIS (key manifestations> 1 head in the central nervous system) are brought to a group of high risk development of KDRS just from the number of heads on MRI; remitting sclerosis (RRS) - for a decrease in the frequency and severity of an aggravation in outpatient ailments (for patients who walk without outside help) with a history of at least 2 Secondary progressive development of sclerosis with an active transition to a disease, which is characterized by acute deterioration of neurological functions by extending the remaining two rocks - to change the frequency of the stage of such severe disease

Prototype shown prior to delivery of Betaferon

hypersensitivity to natural abo recombinant beta-interferon or human albumin in history; vagіtnіst; lactation. I am safe with such ailments: heart failure, waking heart lack of III-IV stage (for NYHA classification), cardiomyopathy; depression і / abo suicidal thoughts (including in anamnesis), epileptic seizures in anamnesis; monoclonal gammapathy; anemia, thrombocytopenia, leukopenia; deterioration of the function of the liver; up to 18 rockets (at the close of the day there is ample supply of money).

Betaferon Zastosuvannya with vaginosti and children

Prototypically indicated for vaginosity. However, it’s unbelievable that the healthy Betaferon® vaccine is posed to the fetus in cases of vaginal women’s abuse, or it’s injected on the reproductive function of people. Among the controllers of the preschool children, the ailments on the development of sclerosis were shown to have symptoms of spontaneous abortion. In rhesus monkeys, human interferon beta-1b has been administered in pre-adolescent rhesus monkeys by administering an embryotoxic dose and in higher doses, in order to increase the frequency of abortions. Women of reproductive health need an hour to get rid of the drug with adequate methods of contraception. At the time of the vagina until the hour of taking Betaferon ® or planning the vagina, it should be recommended to take the drug. Inadvertently, interferon beta-1b is secreted in breast milk. I will look at the potential for the development of serious undesirable reactions in nemovlyat, who are bosomed, breast year bath abo dictate the drug.

Betaferon Pobichnі dії

Lower perceptible diseases, which were diagnosed at a frequency of 2% in food, lower in the placebo group (inactive drug) in patients who in the course of clinical viprobuvan took Betaferon® at a dose of 0.16 mg / m2 a day at a dose of 0.16 / m2 three rock_v. Significant reactions: reaction in the middle of the disease, asthenia (weakness), a complex of flu-like symptoms, headache, increased fever, chills, abdominal pain, chest pain, malignant localization Sertsevo-Sudinna system: Peripheral swelling, vasodilatation, peripheral vascular disease, hypertension, stronger heart rate, tachycardia. Herbal system: nudota, constipation, diarrhea, dyspepsia. shelter i lymphatic system: Lymphocytopenia (= 10%, often - = 1%, inodi - = 0.1%, rarely - = 0.01% and even more rarely -

likarska vzaєmodiya

There were no special preparations for the interaction of Betaferon® with other drugs. Effect of consumption of Betaferon® in doses of 0.25 mg (8 million IU) every other day on metabolism lykarsky zasobiv in ailments on the development of sclerosis of nevidomas. On the basis of the intake of Betaferon®, corticosteroids and ACTH, which are recognized for a term of up to 28 days in case of fever, are well tolerated. Zastosuvannya Betaferon® one hour with other immunomodulators, including corticosteroids or ACTH, was not injected. Interferon reduces the activity of pepine cytochrome P450-fallow enzymes in humans and animals. It is necessary to take care when prescribed in a combination of drugs, as well as a high therapeutic index, which in the meanings of the world lies in the form of the liver system and cytochrome P450 (for example, antipyretic, antibiotic) It is necessary to take care of any medications that are injected into the blood-forming system for one hour.

Dozing Betaferon

S / c, every other day. Lіkuvannya Betaferon ® next to fix it by a visual doctor, which can lead to the diagnosis of rosy sclerosis. In the last hour to become immune to nutrition about the triviality of Betaferon ® therapy. In preschool children, the triviality of treatment in patients with remitting and secondary progressive rosy sclerosis reached 5 or 3 rocky in all cases. The triviality of the course is to start with a doctor. Preparing an interferon beta-lb powder for the preparation, to put the vials and in front of the syringe: for dispensing the lyophilized interferon beta-lb powder for the first use, I use a ready-to-use syringe. B. Packaging for the preparation, where the vials should be placed, in front of the syringes, an adapter for a vial with a bottle of alcohol and alcohol servet: for dispensing lyophilized powder to interferon beta-lb for an adapter for use with a ready-to-use syringe. In a bottle of Betaferon®, inject 1.2 ml of the bottle (sodium chloride 0.54%). The powder is guilty of being broken up without crushing. Before zasosuvannyam slіd look around the ready razchin, with the presence of particles or a change in color, the razchina yogo cannot be zastosovuvati. The recommended dose of Betaferon® is 0.25 mg (8 million IU) in 1 ml of the prepared roschin. If at the right hour the injection is not broken, then it is necessary to inject the drug immediately, as only to eat for a year. I’ll start rocking in 48 hours.

Overdose

With the introduction of Betaferon® i.v. in doses up to 5.5 mg (176 million IU) 3 times per day we will grow to patients cancer patients no serious nebazhany appearances were found.

Betaferon- the first preparation of disintegration, specially for the treatment of rosy sclerosis and repairs only according to the time indicated.

Yak in case of remitting, and in case of secondary progressive sclerosis, treatment with Betaferon reduces the frequency (by 30%) and the severity of clinical ailments, the number of hospitalizations and the need for such repairs, as well as

Among the ailments with secondary-progressive RS, Betaferon allows the progression of ill-treatment and inconvenience, including important ones (so that if ailments are suspicious), they are constantly being turned away by the term. The effect is observed in ailments as a result of sharpened illnesses, as well as without staggering, as well as with an index of indiscrimination (in the past they took part in the evaluation of a scale of 3.0 to 6.5 points for a scale of 3.0 to 6.5 points).

The results of magnetic resonance tomography of the brain of those with remitting and secondary progressive sclerosis on the background of treatment with Betaferon lead to a significant positive injection of the drug on the severity of the pathological process, as well as significant changes in the disease.

Pharmacological authorities

Pharmacodynamics. Active speech to the drug Betaferon (interferon beta-lb) can anti-tier and immunomodulatory activity. Mechanisms for interferon beta-1b in case of rosy sclerosis (MS) have not been established. However, it seems that the biological effect of beta-1b interferon is outdone by its interaction with specific receptors, which appear on the surface of human cells. Zv'yazuvannya іnterferonu beta receptors of tsimi іndukuє ekspresіyu low rechovin, SSMSC rozglyadayutsya in yakostі medіatorіv bіologіchnih efektіv іnterferonu beta-1K Іnstruktsіya on zastosuvannyu: deyakih s Tsikh rechovin viznachali in sirovattsі i fraktsіyah klіtin krovі ailments, SSMSC otrimuvali іnterferon beta-1K Іnterferon beta - lowering the effect of the gamma interferon receptor and promoting internalization and degradation. In addition, interferon beta-1b stimulates the suppressor activity of mononuclear cells of the peripheral blood.

No post-mortem toxicity was carried out. Oskilki gryzuny are insensitive to human interferon beta, the assessment of rhizic was carried out on the basis of the level of toxicity at repeated doses in rhesus monkeys. Transient hyperthermia was promoted, the order of the turn of the hourly increase in the concentration of lymphocytes and the past decrease in platelets and segmented neutrophils.

Trivial pre-toxicity tests have not been performed. Pre-treatment of reproductive toxicity in rhesus monkeys has shown toxicity to mothers and an increase in the frequency of spontaneous abortions. Live offspring did not have a tendency to develop. Pre-treatment injected on fertility was not carried out. Chi didn’t sposter if I’m pouring it into the MAVP estral cycle.

In one case, there was no evidence of genotoxicity (Ames test), there were no mutagenic effects. Previous carcinogenicity was not carried out. The test of in vitro clinical transformation does not reveal any carcinogenic potential.

Pharmacokinetics. For the pediatric administration of Betaferon at the recommended dose of 0.25 mg of syrovat concentration, interferon beta-1b is low, or it does not start. In connection with the range of information about the pharmacokinetics of the drug in ailments on the development of sclerosis, which should be treated with Betaferon in a dose, it is recommended that it is not. The maximum concentration in the plasma is reached after 1-8 years for the child's administration of 0.5 mg of Betaferon. The absolute availability of Betaferon when administered to children is close to 50%. With intravenous introduction of beta-1b interferon, the clearing and period of the preparation is stored in the middle 30 ml / hv / kg for 5 years as an indication.

The introduction of Betaferon every other day should not be produced until the concentration of beta-lb interferon in blood plasma is adjusted, and this pharmacokinetics does not change during the course of therapy.

In case of adolescent intake of Betaferon in a dose of 0.25 mg every other day ... The stench reached the peak in 40-124 years and got too much of a stretch of 7-day (168 hours) period until the end of the day.

Shown up until Betaferon's stasis

Klіnіchno іzolovany syndrome (KІS) (єdiny klіnіchny epіzod demyelination scho dozvolyaє pripustiti rozsіyany sclerosis, alternatively of minds viklyuchennya dіagnozіv) of dostatnoyu viraznіstyu ignition Process for priznachennya vnutrіshnovennih kortikosteroїdіv -for upovіlnennya transition in klіnіchno dostovіrny rozsіyany sclerosis (KDRS) of at patsієntіv with a high risik to the development of the KDRS.

Zagalnoprimyannya visnachennya temple riziku is not. For the downgrade to a group of high risk, the development of KDRS is carried out by patients with mono-focal KIS (key manifestations of 1 head in the central nervous system) і> 9 T2-signals on the MRI і / or to accumulate a contrasting speech region. Patients with multifocal KIS (key manifestations> 1 head in the central nervous system) are brought to a group of high risk development of KDRS directly from the number of head on MRI.

Remedy sclerosis (RRS) - for a decrease in the frequency and severity of acute conditions in outpatient ailments (tobto patients who walk without outside help) with a history of at least 2 severe acute conditions

Suddenly, a progressive growth of sclerosis with an active transition to a disease, which is characterized by sharpened or deterioration of neurological functions with a stretch of two rocky ones - to reduce the frequency and stages of such a disease

How to store that dosi

Lіkuvannya Betaferon next to fix it on a visual basis, which can lead to the diagnosis of rosular sclerosis. In the given hour, I will become immune to nutrition about the triviality of Betaferon therapy. In preschool children, the triviality of treatment in patients with remitting and secondary progressive rosy sclerosis reached 5 or 3 rocky in all cases. The triviality of the course is to start with a doctor.

Preparing for the first time

A. Packaging for the preparation, to place the vials and in front of the syringe:

B. Packaging for the preparation, where the bottles should be placed, in front of the syringes, the adapter for the bottle with empty and alcoholic servet: For dispensing the lyophilized powder to interferon beta-1b for the inlet adapter, the bottle can be supplied with a ready-to-use syringe.

In a bottle of Betaferon, inject 1.2 ml of a bottle (sodium chloride 0.54%). The powder is guilty of being broken up without crushing. Before zasosuvannyam slid look around the ready rozchin. With the presence of particles, or a change in color, the size of it cannot be stored. In 1 ml of the finished product, 0.25 mg (8 mln. MO) of interferon beta-lb is provided.

The recommended dose of Betaferon is 0.25 mg (8 million IU), which should be injected into 1 ml of the prepared rosette every other day. If you got a shot at the right hour, then you need to inject your own drug immediately, as long as you guessed it. I’ll start rocking in 48 hours.

special features

Danish drug to take revenge on human albumin vyrusnyh zhvoryuvan... The theoretical risk of transmission of the ailments of Creutzfeldt-Jakob is also used in the region of small families

Laboratory indicators

Krіm standard laboratory analіzіv scho priznachayutsya at vedennі patsієntіv of rozsіyanim sclerosis, before cob terapії Betaseron and takozh regularly pid hour Venue of lіkuvannya rekomenduєtsya provoditi rozgornuty analіz krovі, vklyuchayuchi viznachennya leykotsitarnoї formulas kіlkostі trombotsitіv i bіohіmіchnogo analіzu krovі and takozh perevіryati funktsіyu pechіnki ( for example, the activity of aspartate-aminotransferase (AST), alanin-aminotransferase (ALT) and gama-glutamyltransferase (y-HT)). When patients are diagnosed with anemia, thrombocytopenia, leukopenia (okremo, or in combination), more retinal monitoring of an open blood test, including thrombocytopenia, leukopenia, can be known.

Shlunkovo-intestinal damage

In rare cases on aphids of Betaferon consumption, the development of pancreatitis is promoted, in most cases it is associated with the manifestation of hypertriglyceridemia.

Destruction of the function of the stove and zhovchividnyh shlakhiv

Clinical preliminaries have shown that therapy with Betaferon can often lead to an asymptomatic increase in the activity of "pechink" transaminases, as in a large number of cases it is slightly affected and is of a time-consuming nature. For example, in the case of beta-interferon intake, important liver damage (including liver deficiency) in the presence of Betaferon is very rare. Naybіlsh important vypodki were indicated in patients, who became aware of the infusion of hepatotoxic drugs or drugs, as well as with some fellow patients evil new affirmations metastases, important infections and sepsis, alcohol malignancy).

When detecting with Betaferon, it is necessary to monitor the function of the furnace (including an assessment classic paintings). Increasing the activity of transaminases in the blood of the immune system. With a significant increase in the activity of transaminases in the bloodstream, there is a sign of liver damage (for example, zhovtyanitsi), it is necessary to fix it with the drug. When outside key signs liver control for normalization of the activity of "liver" enzymes can be updated with Betaferon therapy with a visualization of the liver function.

endocrine failure

For patients with thyroid dysfunction, it is recommended to reverse the function of the thyroid zone (thyroid hormone, thyroid stimulating hormone) regularly, and in other vypads - for clinical indications.

Inception of the heart-vascular system

Betaferon needs to be protected from the ailments because of the sickness of the heart, wintry, in case of heart failure of the III-IV stage for the classification of the New York cardiological associations (NYHA), such classifications are not included. As soon as cardiomyopathy develops on aphids with Betaferon and is transmitted, it is linked from the drug intake, then the treatment with Betaferon goes down.

Injury of the nervous system

Ailments need to be overridden about those who, as a side effect of Betaferon, may be depression and suicidal thoughts, if any traces appear, they will inaccurately turn up to the drug. In two monitored clinical preschool children for the participation of +1657 patients with secondary progressive MS, there were no reliable indications of the frequency and development of depression and suicidal placenta in case of stagnation of Betaferon. Protect, we must show safety when we are diagnosed with Betaferon, we are sick with depressive breakdowns and history of suicidal thoughts. If there are any similar appearances on the floor, then you should see the food about the professionalism of Betaferon. Betaferon is required to be safeguarded in patients with a history of court cases.

General destruction and destruction in the mice

Serious allergic reactions may be spontaneous (ridkisny, or even manifest in hospitals and severe forms, such as bronchospasm, anaphylaxis and blood pressure). When there is a sign of the school's worthiness (for example, the birth of the day from the month of the month), the child will turn to the likar persh, he should not continue the display of the test. Patients who were treated for Betaferon were susceptible to necrosis in the event of a necrosis (Div. Rozdil "Pobichni Efekti"). Necrosis can be great and widen on the myazov fascias, as well as fat tissueі, as a heritage, to produce scars to the end. For children, it is necessary to see the dead children, or even more, transplantation of the children. The ignition process can take up to 6 months.

In the event of the appearance of multiple necrosis, the treatment with Betaferon should be pinned to the rest of the sleep of the little ones. With the presence of one sign, as if the necrosis is not great, the vicariousness of Betaferon can be continued, the impressions of the children of the children of the dead child in the city of the beginning of the day became fertile. To reduce the risk of development of the reaction and necrosis in the іn'єktsії, we are ailing further recommend:

carry out ін'єкції, strictly observing the rules of asepsis;
dermal times minty mіsce ін'єкції;
inject the drug suvoro pidshkirno.

Periodically, control over the correctness of the display of self-contained injections, especially when micro reactions appear.

neutralizing antibodies

If you are taking advantage of these drugs, you will be able to take antibodies. In a number of monitored clinical patients, an analysis of skin blood counts was carried out for 3 months to detect antibodies to Betaferon. It has been shown in cich pre-slugs that neutralizing antibodies to beta-lb interferon developed in 23% -41% of patients who were at least two positive laboratory test results. In 43% -55% of the number of patients in the offensive laboratory tests The volume of antibodies to interferon beta-lb is stable.

In pre-adolescents for the participation of patients with clinically isolated syndrome, which allows to prevent the development of sclerosis, as well as neutralize the activity, as the appearance of the skin 6 months, during the period of 16, 2% of the last Neutralization activity was detected at least once in 30% (75) patients with Betaferon; in 23% (17) of them, before it was completed, the status of antibodies once again became negative. In the course of the courtyard period, the development of neutralizing activity was not affected by the decrease in clinical efficiency (in that, an hour before the development of clinically significant developmental sclerosis).

It has not been reported, but the presence of neutralizing antibodies is not significantly infused into key results... With the development of neutralization of activity, be sure side reactions... The decision about the continuation of the therapy is not guilty of guilt based on indicators of clinical activity, and not on the status of neutralizing activity.

immune damage

Stagnation of cytokines in ailments with monoclonal gammapathy and systemic changes in capillary penetration with development of shock and fatal result.

Zasosuvannya in children

Systematic inoculation of the efficiency and safety of Betaferon in children and adults up to 18 years was not carried out.

Inflow to the building of keruvati by car and pratsyuvati with mechanisms

Special preliminaries were not carried out. Negligible appearances on the side of the central nervous system can be infused into the health of the keruvat with a car and machinery with mechanisms. In connection with the cymbals, it is necessary to take care of yourself when you are busy with potentially unsafe types of activity, so that you require additional respect.

Pobichna diya

Lower re-insurance of minor effects, which were diagnosed with a frequency of 2% and less in the placebo group (inactive drug) in patients who in the course of the patients received Betaferon at a dose of 0.16 / m2 to three times a day at a dose of 0.16 / m2 rock_v. Flu-like symptoms can be weakened, stagnant non-steroidal antiapaline drugs. Dosvid zasosuvannya "Betaferon" for the treatment of patients with rosy sclerosis to end up with intercourse, the same, negative reactions, which are found with a low frequency, could not have been discouraged yet. To describe the specific reactions, synonyms and associated with her, the best suitable term from the Medicinal Dictionary for Regulatory Activity (MedDRA) will be chosen.

Significant reactions: Reactions in the center of illness, asthenia (weakness), a complex of flu-like symptoms, headache, increased temperature, chills, peripheral swelling, chest pain, malignancy

Sertsevo-sudinna system: arterial vise.

Herbal system: Beat in the stomach.

Blood and lymphatic system: Lymphocytopenia less than 1500 / mm3, neutropenia less than 1500 / mm3, leukopenia less than 3000 / mm3. Lymphadenopathy.

Metabolic and alimentary damage: Increasing the activity of enzymes in the blood: aspartate aminotransferase (AST) 5 times as cob value, alanaminotransferase (ALT) 5 times as cob value.

Support-arm system: Mіasthenіya, mіalgіya, sudomi in the legs.

Nervous system: Sleeplessness, loss of coordination.

Dichny system: Zadishka.

Shkira: Visip, the battle of the shkira.

Sechostate's system: І operative posivi up to sechovipuskannya, for women - metrorail (acyclic uterine bleeding)

The submissions below are a list of side effects of recordings on the guard for the stagnation of Betaferon when going to the market.

Significant reactions: Even more often: flu-like symptoms (fever, chills, maladies, headache or increased fatigue) *. The frequency of cich symptoms decreases with an hour. Ridko: nezduzhannya zagalne, pain in the breasts, decreased muscle mass, decreased muscle mass.

Miscellaneous reactions: Even more often: reactions in the mésci іn'єktsії (hyperemia, mousseviy embryak), fiery, bil. Often: necrosis in the center of the disease. With the advancement of the disease, the frequency of reactions in the injection of the drug will decrease.

Blood and lymphatic system: Uncommon: anemia, thrombocytopenia, leukopenia. Ridko: lymphadenopathy.

Endocrine disruption: Ridko: impaired function of the thyroid gland, including hyperthyroidism, hypothyroidism.

Metabolic damage: Ridko: adjusting the concentration of triglycerides.

Nervous system: Infrequently: muscle hypertonicity, depression. Ridko: judgment, confusion of evidence, abnormalities, emotional lability, suicidal problems, anorexia, spoilage.

Sertsevo-sudinna system: Uncommon: p_dvischennya arterial vise. Ridko: cardiomyopathy, tachycardia, stronger heart rate. Even worse: vasodilatation.

Organi dikhannya: Ridko: zadishka, bronchospasm.

Shlunkovo-intestinal tract: Uncommon: tediousness and bloating. Ridko: pancreatitis, diarrhea.

Stove and zhovchivividnі ways: Infrequently: an increase in the activity of AST, ALT. Ridko: adjusting the activity of gamma-glutamyltransferase, concentration of bilirubin, hepatitis.

Shkira and pedagogue klitkovina: Uncommon: alopecia, kropiv'yanka, sverbіzh shkіri, shkіrnі visipannya. Ridko: zmіna koloru shkіri.

Skeleton m'yazi: Uncommon: mіalgії. Ridko: arthralgia.

Juvenile reproductive system: Ridko: damage to the menstrual cycle. Even worse: menorrhagia (trivial menstrual bleeding).

Allergic reactions: Ridko: anaphylactic reactions.

Vzaєmodia with іnshy lіkarskiy zasob

Special preliminaries in the interaction of Betaferon with other drugs were not carried out. The effect of the intake of Betaferon in doses of 0.25 mg (8 million IU) every other day on the metabolism of lycars' patients in patients with developmental sclerosis of nevidomas. On the basis of the intake of Betaferon, glucocorticoid and ACTH, which are recognized for a term of up to 28 days in case of fever, are well tolerated. Zastosuvannya Betaferon immediately with other immunomodulators, except for corticosteroids or ACTH, was not injected. Іnterferoni znizhuyut aktivnіst pechіnkovih cytochrome P450 fallow fermentіv Lyudin y i zhіvotnih.Neobhodіmo dotrimuvatisya oberezhnostі at priznachennі of Betaseron in kombіnatsії lіkarskimi preparations scho mayutsya vuzky іndeks is therapeutic, klіrens yakih in znachnіy mіrі deposits od pechіnkovoї sistemi cytochrome P450 (napriklad, protiepіleptichnі zasobi, antidepressants ). It is also necessary to take care of the preservation in case of a one-hour consumption of any preparations, which are injected into the blood-forming system. Exciting for the daytime for the daytime for the daytime, Denmark lykarskiy zasib do not go overboard with other drugs.

Prototype

Viability.
Lactation.
Hypersensitivity reactions to natural recombinant interferon-beta or human albumin in anamnesis.

Betaferon followed the protection of the children with such ailments:

sickness of the heart, zokrem, heart failure of the III-IV stage for the classification of the New York cardiological association (NYHA), cardiomyopathy;
depression and suicidal thoughts (including in anamnesis), epileptic seizures in anamnesis;
monoclonal gammapathy;
anemia, thrombocytopenia, leukopenia;
deterioration of the function of the stove.

In connection with a sufficient amount of information, protection is necessary in case of stagnation in children younger than 18 years old.

Viability. Inadvertently, the high rate of Betaferon is reduced to a fetus in the presence of vaginal women or injected into the reproductive function of humans. Among the controllers of the preschool children, the ailments on the development of sclerosis were shown to have symptoms of spontaneous abortion. In rhesus monkeys, human interferon beta was given in pre-adult rhesus monkeys by giving an embrotoxic dose and in higher doses, and the frequency of abortions increased. Women of reproductive health in case of elimination with the drug should be treated with superior methods of contraception. At the time of the onset of vaginosity from the hour of treatment with Betaferon or planned vaginosti, it is recommended to take the drug.

Lactation. It is inadvisable to see interferon beta-1b in breast milk. I will look at the theoretical potential for the development of undesirable reactions to Betaferon in people who are not sick, for whom there is a breast, it is necessary to fix a breast or to take the drug.

Prototypically shown in vaginosti (it can be caused by the death of the fetus, or the cause of natural indulgence). For an hour, lіkuvannya slіd pinch the chest vigodovuvannya.

Overdose

With the introduction of Betaferon internally in a dose of up to 5.5 mg (176 million IU) three times per week, patients with oncological illnesses did not develop serious non-essential pests.

Description of licarsky form

lyophilizate: lyophilized mass of white color.

distributor: foresight, vilny from the patch of confusion.

Outline updates: rozchin from slightly opalescent to opalescent, bezbarvny or light-colored color.

Pharmacological diya

Pharmacological diya- immunomodulatory.

Pharmacodynamics

Active speech to the drug Betaferon ® (interferon beta-1b) can be anti-virus and immunoregulatory activity. Mechanism for interferon beta-1b in case of rosular sclerosis is not residually established. However, it seems that the biological effect of beta-1b interferon is outdone by its interaction with specific receptors, which appear on the surface of human cells. The connection to interferon beta-1b with multiple receptors and induction expression is low, as it is seen in the capacity of mediators in biological effects to interferon beta-1b. Zmіst of the people from the cich speeches were started in the syrovattsі and fractions of the blood cells of the ailments, as they eliminated interferon beta-1b. Interferon beta-1b reduces the intensity and expression of receptors to gamma-interferon, when the response is low. In addition, interferon beta-1b stimulates the suppressor activity of mononuclear cells of the peripheral blood.

Pharmacokinetics

For healthy volunteers administered 0.5 mg of Betaferon ® to healthy volunteers, C max in plasma should become close to 40 IU / ml after 1-8 years of writing. In general, the absolute bioavailability of Betaferon ® when administered subcutaneously is approximately 50%. In case of intravenous injection of clearence and T 1/2 to the preparation from syrovat - in the middle 30 ml / hv / kg and 5 years as appropriate.

The introduction of Betaferon® every other day should not be carried out until the preparation is adjusted in blood plasma, its pharmacokinetic parameters will not change during the course of therapy.

With subcutaneous intake of Betaferon® at a dose of 025 mg every other day, healthy volunteers with biologic markers (neopterin, beta 2 -microglobulin and immunosuppressive cytokine IL-10) were significantly increased after 6-12 years. the drug. C max was reached in 40-124 years and was lost by a stretch of 7-day (168 hours) period until the end of the day.

clinical pharmacology

Yak in case of remitting, and in case of secondary progressive sclerosis, treatment with Betaferon ® reduces the frequency (by 30%) and the severity of clinical acute ailments, the number of hospitalizations and demand in people, and three steroids.

In ailments with secondary progressive sclerosis of the disease, Betaferon ® allows you to take the progress of illness and illness further, incl. important (so that if there are ailments, you will always be able to use an invalid cruise) for a term of up to 12 months. The main effect is to promote the presence of ailments as a result of acute illnesses, as well as without a warning, as well as with an index of indiscrimination (in the past, the children took part in the rating from 3.0 to 6.0 in the range of 6.5 to 6.0

The results of the MRI scan of the brain with remitting and secondary progressive sclerosis against the background of Betaferon ® treatment confirm a significant positive injection of the drug on the severity of the pathological process, as well as the decrease in the acceptance of new active ones.

Shown to the drug Betaferon ®

remitting sclerosis (RRS) - for a decrease in the frequency and severity of an aggravation in outpatient ailments (for patients who walk without outside help) with a history of at least 2

Secondary progressive development of sclerosis with an active transition to a disease, which is characterized by acute deterioration of neurological functions by extending the remaining two rocks - to change the frequency of the stage of such severe disease

Prototype

hypersensitivity to natural abo recombinant beta-interferon or human albumin in history;

vagіtnіst;

lactation.

WITH CARE

With such illnesses:

sickness of the heart, withering of the heart lack of III-IV stage (for the classification of NYHA), cardiomyopathy;

depression і / abo suicidal thoughts (including in anamnesis), epileptic seizures in anamnesis;

monoclonal gammapathy;

anemia, thrombocytopenia, leukopenia;

deterioration of the function of the liver;

up to 18 rockets (at the close of the day there is ample supply of money).

Stagnation during vaginosis and breastfeeding

Prototypically indicated for vaginosity. However, it’s unbelievable that the high level of Betaferon® is known to the fetus in cases of vaginal women’s abuse, or to inflict on the reproductive function of people. Among the controllers of the preschool children, the ailments on the development of sclerosis were shown to have symptoms of spontaneous abortion. In rhesus monkeys, human interferon beta-1b has been administered in pre-adolescent rhesus monkeys by administering an embryotoxic dose and in higher doses, in order to increase the frequency of abortions. Women of reproductive health need an hour to get rid of the drug with adequate methods of contraception. At the time of the appointment of the vagina before the hour of treatment with Betaferon ® or the planned treatment, it is recommended to recommend the treatment.

Inadvertently, interferon beta-1b is secreted in breast milk. I will look at the potential for the development of serious non-essential reactions in nemovlyat, who are breastfeeding, then pinch their breasts, or pinch them with the drug.

Pobichna diya

Lower perceptible diseases were diagnosed at a frequency of 2% in food, lower in the placebo group (inactive drug) in patients who were treated with Betaferon ® 2 at a dose of 0.16 / 025 mg during the course of clinical vipovers. rock_v.

General reactions: reaction in the disease, asthenia (weakness), a complex of flu-like symptoms, headache, increased temperature, chills, abdominal pain, chest pain, more severe local disease, disease

Sertsevo-sudinna system: peripheral swelling, vasodilatation, congestion of peripheral vascular disease, hypertension, stronger heart rate, tachycardia.

Herbal system: nudota, constipation, diarrhea, dyspeptic symptoms.

lymphocytopenia (<1500/мм 3), нейтропения (<1500/мм 3 ), лейкопения (<3000/мм 3 ); лимфаденопатия.

Metabolic and alimentary damage: the growth of enzymes in the blood: ACT and ALT - 5 times as of the cob. Zbilshennya masi tila.

Support-rokhov system: mіasthenia, arthralgia, mіalgіya, sudomy in the legs.

Nervous system: hypertonicity, zapamorochennya, sleeplessness, disordered coordination, restlessness, nervousness.

Dichny system: zadishka.

shkira: visip, shkіrnі alopecia, pіdvischenia sweaty, alopecia.

Sechostatev system: Imperative positive up to the second, often the second, in women - metrhagia (acyclic bleeding), menorrhagia (three menstrual bleeding), dysmenorrhea (ailing months), in the cholovikov - early

The submissions below are a list of side effects of recordings on the guard against the stagnation of Betaferon ® when going to the market.

The frequency of side effects is classified as offensive: even more often - ≥10%, often -<10-≥1%, иногда — <1- ≥0,1%, редко — <0,1-≥0,01% и очень редко — <0,01%.

General reactions: even more often - flu-like symptoms (fever, chills, mіalgії, headache or fatigue) *. The frequency of cich symptoms decreases with an hour. Ridko - nezduzhannya zagalne, pain in the breasts, decreased mass.

Miscellaneous reactions: even more often - reactions in the message of ін'єкції (hyperemia, local napryak) *, fired *, bil *. Inodi - necrosis of the shkiri *.

With the advancement of the disease, the frequency of reactions in the injection of the drug will decrease.

Blood and lymphatic system: Inodi - anemia, thrombocytopenia, leukopenia. Ridko - lymphadenopathy.

Endocrine disruption: Ridko - impaired function of the thyroid gland, hyperthyroidism, hypothyroidism.

Metabolic damage: Ridko - adjustment of the triglycerides.

Nervous system: Inodi - myazovy hypertonicity, depression. Ridko - judgment, confusion of evidence, anxiety, emotional lability, suicidal problems, anorexia.

Sertsevo-sudinna system: Inodi - arterial hypertension. Ridko - cardiomyopathy, tachycardia, heart disease.

Organi dihannya: Ridko - zadishka, bronchospasm.

Shlunkovo-intestinal tract: Inodi - boring and bloating. Ridko - pancreatitis.

Stove and zhovchivividnі ways: Inodі - adjusted activity of ACT, ALT. Ridko - adjustment of the activity of gamma-glutamyltranspeptidase, rivnya bilirubin, hepatitis.

Shkira and pedagogical klitkovina: Inodі - alopecia, kropiv'yanka, sverbіzh shkіri, shkіrnі visipannya. Ridko is a change to the color of the shkiri, the taste is adjusted.

Skeleton m'yazi: Inodi - mіalgії.

Juvenile reproductive system: Ridko - damage to the menstrual cycle.

Allergic reactions: Ridko - anaphylactic reactions.

* - the frequency of the diagnosis of side effects is indicated on the presentation of the given clinical reports.

vzaєmodiya

There were no special advances in the interaction of Betaferon ® with other drugs.

The effect of the intake of Betaferon® at a dose of 025 mg (8 million IU) every other day on the metabolism of lycars' patients in patients with developmental sclerosis of nevidomas.

On the basis of Betaferon ® corticosteroids and ACTH, which are recognized for a term of up to 28 days in case of zagostrenia, are well tolerated. Zastosuvannya Betaferon ® immediately with other immunomodulators, except for corticosteroids or ACTH, was not injected.

Interferon reduces the activity of pepine cytochrome P450-fallow enzymes in humans and animals. It is necessary to take care when prescribed in a combination of drugs, as well as a high therapeutic index, which in the meanings of the world lies in the form of the liver system and cytochrome P450 (for example, antipyretic, antibiotic) It is necessary to take care of any medications that are injected into the blood-forming system for one hour.

How to store that dosi

N / a, in one day.

Lіkuvannya Betaferon ® next to fix it for a visual doctor, which can lead to the diagnosis of rosular sclerosis.

In the last hour to become immune to nutrition about the triviality of therapy with Betaferon ®. In preschool children, the triviality of treatment in patients with remitting and secondary progressive rosy sclerosis reached 5 or 3 rocky in all cases. The triviality of the course is to start with a doctor.

Preparing for the first time

A. Packaging for the preparation, to put the bottles in front of the syringe: to dispense the lyophilized interferon beta-lb powder for the first injection, a ready-made syringe is supplied with a dispenser and a cylinder.

B. Packaging for the preparation, where the vials should be placed, in front of the syringes, an adapter for a vial with a bottle of alcohol and alcohol servet: for dispensing lyophilized powder to interferon beta-lb for an adapter for use with a ready-to-use syringe.

In a bottle of Betaferon®, inject 1.2 ml of a bottle (sodium chloride 0.54%). The powder is guilty of being broken up without crushing. Before zasosuvannyam slіd look around the ready razchin, with the presence of particles or a change in color, the razchina yogo cannot be zastosovuvati.

The recommended dose of Betaferon ® is 0.25 mg (8 million IU) in 1 ml of the prepared roschin.

If at the right hour the injection is not broken, then it is necessary to inject the drug immediately, as only to eat for a year. I’ll start rocking in 48 hours.

Overdose

With the introduction of Betaferon® intravenously in doses up to 5.5 mg (176 million IU) 3 times per day, patients with oncological illnesses did not develop any serious malignant diseases.

special requests

Betaferon ® is to take revenge on human albumin, for which there is even an insignificant risk of transmission of foreign illnesses. The theoretical risk of the transmission of the Creutzfeldt-Jakob ailment can also be imposed on the edge of small families.

Variety of laboratory indicators. Krіm standard laboratory analіzіv scho priznachayutsya at vedennі patsієntіv of rozsіyanim sclerosis, before cob terapії Betaseron ®, and takozh regularly pid hour Venue of lіkuvannya rekomenduєtsya provoditi rozgornuty analіz krovі, vklyuchayuchi viznachennya leykotsitarnoї formulas kіlkostі trombotsitіv i bіohіmіchnogo analіzu krovі and takozh perevіryati funktsіyu pechіnki (for example, the activity of ACT, ALT and GGTP). With the management of patients with anemia, thrombocytopenia, leukopenia (single abnormal combination), more retinal monitoring of an open blood analysis, including the value of blood count, leukopenia, can be known.

Shlunkovo-intestinal damage. In rare cases on aphids, the consumption of Betaferon ® has promoted the development of pancreatitis, in most cases it is associated with the manifestation of hypertriglyceridemia.

Destruction of the function of the stove and the young people. Clinical preliminaries have shown that therapy with Betaferon ® can often lead to asymptomatic development of hepatic transaminases, as in a large number of cases it is slightly affected and has a time-consuming character.

For example, in case of treatment with the other beta-interferons, important liver damage (including liver deficiency) in case of consumption of Betaferon ® is very rare. Some of the most important symptoms were indicated in patients who were aware of the infusion of hepatotoxic drugs or drugs, as well as in case of some fellow patients (for example, malignant alcoholism due to metastases).

When using Betaferon ®, it is necessary to monitor the function of the liver (including evaluation of the clinical picture). Advancing the level of transaminases in the syrovatz blood of the medical care and maintenance. If there is a significant increase in transaminases in the bloodstream, there is a sign of liver damage (for example, zhovtyanitsa) should be taken with the drug. When there are clinical signs of liver damage, as well as normalization of liver enzymes, it is possible to renew therapy with Betaferon ® due to the prevention of liver function.

Endocrine disruption. Patients with thyroid dysfunction are advised to reverse the function of the thyroid gland (thyroid hormone hormones, TSH) regularly, and in other cases - for clinical indications.

Zakvoryuvannya heart-vascular system. with caution in sick people from sick hearts, waking up with heart failure of III-IV stages for the classification of NYHA, some of these patients are not included in the clinical reports.

As soon as cardiomyopathy develops on aphids with Betaferon ® and is transmitted, it is linked from the drug intake, then the use of Betaferon ® goes on.

Involvement of the nervous system. Ailments need to be overridden about those who, as a side effect of Betaferon ®, may be depression and suicidal thoughts, if any traces appear, they will inadvertently turn up to the drug.

In the two monitored clinical pre-adolescents for the participation of 1,657 patients with secondary progressive sclerosis, no reliable indications of the frequency of the development of depression and suicidal diseases were revealed. Protect, then, to show safety when signs of Betaferon ® we get sick with depression and suicidal thoughts in anamnesis. If there are any similar appearances on the floor, then you should look at the nutritional status of Betaferon ®.

Betaferon ® is required to be used with caution in ailments with epileptic seizures in anamnesis.

Countryside destruction and country Serious allergic reactions may be spontaneous (ridkisny, or even manifest in hospitals and severe forms, such as bronchospasm, anaphylaxis and blood pressure).

When there is a sign of the school's worthiness (for example, the vitality of the birth from the month of the beginning), the child will turn to the likar persh, he must not continue the display of the Inferno Beta.

Patients who had been treated with Betaferon ® were susceptible to necrosis in the event of a necrosis (div. Rozdil "Pobichni Efekti"). Necrosis can be great and widen on the fascia, and also fatty tissue, like inheritance, to produce scars. In some cases, there is a need for seeing dead children, or even more, transplantation of shkiri. The ignition process can take up to 6 ms.

In the event of the appearance of multiple necrosis, the treatment with Betaferon ® should be pinned to the rest of the sleep of the little ones. With the presence of one sign, as if the necrosis is not great, the vicariousness of Betaferon® can be continued, the impressions of the children of the children of the dead child's birth in the city of іn'єktsії vіdbіvіvana ®.

To reduce the risk of development of the reaction and necrosis in the іn'єktsії, we are ailing further recommend:

Carry out ін'єкції, strictly observing the rules of asepsis;

Skinny times mintya mіsce ін'єкції;

Introduce the drug suvoro pidshkirno.

Periodically, control over the correctness of the display of self-contained injections, especially when micro reactions appear.

Neutralizing antibodies. If you are taking any drugs with the help of a bottle, if you are using Betaferon ®, there is a clear possibility of setting antibodies. In a number of monitored patients, an analysis of the skin blood count was carried out 3 msec to detect the development of antibodies to Betaferon®. It has been shown in cich pre-slugs that neutralizing antibodies to beta-lb interferon developed in 23-41% of patients who were at least two positive laboratory test results. In 43-55% of the number of patients in the onset of laboratory preliminaries, the rate of antibodies to interferon beta-1b was stable.

It has not been reported that the presence of neutralizing antibodies is not significantly injected into clinical results, including MRI data. With the development of neutralization of activity, there are no side reactions.

The decision about the continuation of the therapy is not guilty of guilt based on indicators of clinical activity, and not on the status of neutralizing activity.

Immunity damage. Stagnation of cytokines in ailments with monoclonal gammapathy and systemic changes in capillary penetration with development of shock and fatal result.

Zastosuvannya in children. There was no systematic inoculation of Betaferon ® efficiency and safety in children and children under 18 years of age.

Inflow to the building of keruvati by car and pratsyuvati with mechanisms Special preliminaries were not carried out. Negative appearances on the side of the central nervous system can be infused into the building of a keruvat with a car and with mechanisms, In connection with this, it is necessary to take care when busy with potentially unsafe types of activity, respect.

Vipusku form

Powder of lyophilization for preparing rosters for ін'єкцій. In vials, in a set with a razchinnik in syringes or in vials with alcohol servetki or without them; in a box 5 or 15 sets.