Аллокин-Альфа Отечественный противовирусный препарат нового поколения для лечения герпеса и папилломавирусной инфекции (ВПЧ) Прощай вирус! Русский языкРУС EnglishEN
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Instructions (EN)

INSTRUCTION
for medical use of the drug
ALLOKIN-ALPHA

Marketing authorisation number: P N002829/01

Proprietary (trade) name: Allokin-alfa

International Nonproprietary Name (INN) or chemical (generic) name:
Hystidyl-glycyl-valyl-seryl-glycyl-hystidyl-glycyl-glutaminyl-hystidyl-glycyl-valyl-hystidyl-glycine

Dosage form:lyophilisate for solution for subcutaneous administration

Composition (for 1 vial): Alloferon [Hystidyl-glycyl-valyl-seryl-glycyl-hystidyl-glycyl-glutaminyl-hystidyl- glycyl-valyl-hystidyl-glycine] 1,0 mg.

Description: White lyophilized powder or porous mass. Hydroscopic.

Pharmacotherapeutic class: antiviral, immunomodulatory agent.

АТС code: [J05AХ, L03A]

Pharmacology
Pharmacodynamics
Alloferon is a polypeptide. Its pharmacological action is similar to that of interferon alpha. Alloferon acts as an effective inducer of endogenous interferon synthesis and as an activator of the system of natural killers. It can stimulate the recognition and lysis of defective cells by cytotoxic lymphocytes. Experiments have demonstrated its high efficiency against infections caused by influenza A and В viruses, hepatitis В and С viruses, herpes type 1 and type 2 viruses and human papilloma viruses (oncogenic types). Alloferon has not been reported to exert systemic toxicity. It does not have allergenic properties or exert mutagenic or cancerogenic action. It has no embryotoxic effect. Its influence on fertility has not been reported.

Pharmacokinetics
Alloferon rapidly penetrates into the blood flow where it interacts with immunocompetent cells after what the determination of Alloferon concentration is hampered due to the close structural similarity of its metabolites with blood serum proteins. Interferon concentration increase was reported 2 hours after the drug administration. The concentration remained increased (2-2.5 folds higher than usual background level) during 6-8 hours reaching initial values by the end of the period of 24 hours. Increased functional activity of natural killers was observed during 7 days after the drug administration.

Indications
Chronic papilloma viral infection caused by oncogenic types of human papilloma viruses. Therapy of chronic herpes recidivicus type 1 and type 2, complex therapy of moderate (jaundiced) form of acute hepatitis B.

Contraindications
Hypersensitivity, pregnancy and breastfeeding (breastfeeding should be stopped during the course of the treatment), severe autoimmune diseases. Pediatric population.

Dosage and directions for use
Alloferon should be injected subcutaneously.
Standard course of the treatment of infections caused by oncogenic types of human papilloma virus includes injections of 1 mg every other day, 6 injections in total over the course of therapy. Standard course of the treatment of herpes recidivicus includes injections of 1 mg every other day, the total course comprises 3 injections.
In case of moderate forms of acute hepatitis В the drug is administered after the diagnosis verification. The dosage used is 1 mg x 3 times a week during 3 weeks (9 injections in total).
When preparing the solution for injections 1 ml of 0.9% NaCl solution to be used as a solvent.

Side effects
In some cases fatigue, dizziness and new bumps emerging (in case of herpes infection) are possible.

Overdosage
Up to date there have been no reported cases of overdosage.

Interactions
When treating chronic herpes genitalis recidivicus Alloferon can be prescribed in combination with acyclovir and its derivatives (these medicines have different modes of action and complement each other in viral infection treatment). For acute hepatitis В treatment the drug is prescribed along with conventional background therapy. No other drug interactions have been established.

Special precautions
In single-agent therapy Allokin-alpha is used for the treatment of papilloma viral infection caused by oncogenic types of the virus in the absence of clinical or subclinical lesions of the uterine cervix or anogenital areas.
In complex therapy it is used for the treatment of clinical or subclinical lesions of the uterine cervix or anogenital areas induced by papilloma viral infection caused by oncogenic types of the virus.
Chronic herpes recidivicus type 1 and type 2 treatment should be started at the onset of the first signs of the disease.
In case of hepatitis В treatment should be started no later than on the 7th day after jaundice development.

Effect on the ability to drive and operate machinery
In case of dizziness avoid driving or using machines.

Presentation
Lyophilisate for solution for subcutaneous administration, 1.0 mg.
Clear flint glass vials containing 1.0 mg of lyophilisate for solution for subcutaneous administration. Blisters containing 1, 2, 3, 5 or 10 vials.
Cardboard boxes containing 1 or 2 blisters along with prescribing information (patient information leaflet).

Storage conditions
Protect from light. Store in a cool place (2 to 8 °C).
Keep out of the reach of children.

Shelf life
2 years. Do not use after expiry date.

Prescription status
Prescription only.

Manufacturers:
Federal State Unitary Enterprise “State Research Institute of Highly Pure Biopreparations” of Federal Medico-Biological Agency
(FSUE “SRIHPB” of FMBA of Russia), Russia
7 “B” Pudozhskaya Street, St.-Petersburg, 197110, Russia

Federal State Budgetary Institution “National Medical Research Centre of Cardiology” (FSBI “NMRC of Cardiology” of the Ministry of Healthcare of Russia), Russia
15A 3rd Cherepkovskaya st., Moscow, 121552, Russia

Enterprises considering customer claims:

FSUE “SRIHPB” of FMBA of Russia
7 “B” Pudozhskaya Street, St.-Petersburg, 197110, Russia
Tel: (812) 499-17-00, fax: (812) 499-16-63.

FSBI “NMRC of Cardiology” of the Ministry of Healthcare of Russia
15A 3rd Cherepkovskaya st., Moscow, 121552, Russia
Tel/fax: (499) 149-02-13.

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