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In 1 bottle of interferon of beta 1b 0,30 mg (or 9,6 million ME). Human albumine and Mannitolum as excipients.
Lyophilisate for preparation of solution or suspension of 9,6 mln units in a bottle.
Pharmacodynamics and pharmacokinetics
Active agent interferon beta 1b has antiviral and immunomodulatory effect. The mechanism of its action is not finalized, but it is known that it is connected with interaction with certain receptors. Linkng with these receptors induces an expression of substances which came to light in blood of the patients receiving this drug. Beta interferon increases suppressor action of mononuclear blood cells.
At patients with the secondary progressing RS form use of drug detains progressing of a disease and disability till one year. Results of MRT of a brain of patients confirm positive dynamics: reduction of formation of the new centers. Research of toxicity and carcinogenicity of drug was not carried out. The test of the cellular transformation which is carried out by in vitro did not reveal cancerogenic action.
At hypodermic introduction in a dose of 1 ml (0,25mg) concentration of beta interferon in blood low or are not defined therefore there are no data on pharmacokinetics. At introduction of 0,5 mg the maximum concentration is defined in 1-8 hours. Bioavailability of 50%. If the drug was administered intravenously, the elimination half-life it is made by 5 hours.
Introduction subcutaneously every other day does not cause increase of concentration in blood. At hypodermic use every other day in a dose of 0,25 mg indicators of markers of the biological answer considerably raise in 6-12 hours after the first dose, reach peak in 40-125 hours and remain raised 168 hours.
Indications to use
- the isolated syndrome with the expressed inflammatory process at which there are indications for use of intravenous corticosteroids, for the purpose of delay of transition to reliable RS. Usually it is patients with clinical manifestations more than one center in TsNS;
- remittiruyushchy RS (for the purpose of reduction of frequency of aggravations in the presence of the 2nd and more aggravations for 2 years with incomplete recovery of the neurologic status);
- the secondary progressing RS having an active current with aggravations for 2 years and the expressed deterioration in the neurologic status (for the purpose of reduction of frequency of aggravations and delay of progressing).
- feeding by a breast.
Often found reactions:
- reactions in the place of an injection (pain, a hyperemia, an inflammation, hypostasis);
- grippopodobny symptoms (fever, fever, headache, mialgiya).
Seldom found reactions:
- indisposition, stethalgias;
- anemia, leukopenia;
- weight reduction or increase;
- hyperthyroidism or hypothyroidism;
- hyper tone of muscles;
- spasms, excitement, suicide attempts, emotional lability;
- tachycardia, increase of the ABP;
- asthma and bronchospasm;
- mialgiya and arthralgia;
- nausea, vomiting;
- alopecia, anaphylactic reactions;
- urticaria, itch, rash;
- disturbances of a menstrual cycle.
Very seldom found reactions:
Betaferon, application instruction (Way and dosage)
The drug is administered subcutaneously. For beta interferon powder dissolution enter 1,2 ml of solvent into a bottle. Powder without stirring is well dissolved. If there are not dissolved particles, solution cannot be applied.
Betaferon at multiple sclerosis enter every other day 1 ml of solution (0,25 mg of beta interferon). In case of the admission of an injection it is carried out at once, and following made, as well as it is necessary in 48 hours. Duration of a course is determined by the doctor, at clinical trials it reached from 3 to 5 flyings.
Even at administration of drug intravenously on 5,5 mg significant undesirable reactions were not noted three times.
Researches of interaction with other drugs were not carried out. The glucocorticosteroids applied at the same time at aggravations are well transferred. Betaferon's use with other immunomodulators was not studied. To be careful at appointment together with HP which clearance depends on system of P450 cytochrome (antidepressants, antiepileptic means) and also drugs which influence a hemopoiesis. It is impossible to mix with medicines in one syringe.
Terms of sale
According to the recipe.
Temperature is up to 25 °C.
Period of validity
Coincidence on the ATH code of the 4th level:
Infibeta, Ronbetal, Ekstavia.
Using immunomodulators — drugs of interferon in treatment of PC will make progress. With the proved efficiency at this disease treat drugs beta interferony (in Russia Betaferon and Rebif are registered). According to tests drug Betaferon reduces the frequency of aggravations by 30% and slows down approach of an invalidism at the progressing course of a disease. However treatment beta interferonami is not shown after the first aggravation and at the minimum changes revealed at MRT. As the remote effects of these immunomodulators are unknown, do not appoint them also to patients till 18 flyings. Analyzing responses of patients, it is possible to draw a conclusion — this drug was appointed at frequent and heavy aggravations (two and more within two years) which could entail increase of an invalidism.
- "… It is necessary to accept Betaferon as was influenced by good results. I accept it six months. Lack of a spring aggravation which was every year and proceeded hard is result of administration of drug. Right at the beginning temperature rose to 39".
- "… Temperature was after the first pricks, and then increased by 0,2 degrees. It is tolerant, I know that this only medicine which will delay disability approach therefore I accept it".
- "… Despite all minuses (temperature, morbidity of the place of pricks, need to constantly receive drug) the frequency of aggravations considerably decreased. I will continue treatment".
- "… Betaferon I accept 1,5 years and even there is a temperature increase now. I feel well".
- "… Drug expensive, suits not everyone. I had a deterioration, it was necessary to refuse".
- "… Stopped reception of this drug because of nothing the forced-down high temperature which kept a long time".
Major factor of risk of exacerbations of this disease are viral infections therefore their prevention is at the same time prevention of aggravations of RS. It is contraindicated at PC interferon - gamma which provoke an aggravation. In this connection it is necessary to treat with care inductors of interferon which strengthen products of gamma interferon.
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Section: Immunity increase
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