Alfarona

Alfarona – recombinant human interferon alpha 2b with immunomodulatory, antimicrobic, antineoplastic, antiviral, antiinflammatory action.

Form of release and structure

Dosage forms:

• Lyophilisate for preparation of solution for injections and topical administration: the porous hydroscopic mass of almost white or white color (in bottles: in a cardboard pack of 1, 5, 10 or 20 bottles; in planimetric strip or cassette planimetric packaging of 1, 5, 10 or 20 bottles, in a cardboard pack 1 packaging);
• Lyophilisate for preparation of solution for intranasal use: the porous mass of light yellow or white color, is hygroscopic; after dissolution – transparent light yellow or colourless liquid without foreign inclusions and a deposit (in bottles, in a cardboard pack of 1 or 5 bottles complete with 1 or 5 bottles or ampoules (on 5 ml) waters for injections).

Active ingredient of Alfarona – interferon alpha 2b human recombinant:

• 1 bottle with lyophilisate for preparation of solution for injections and topical administration: 0,5 million international units (IU), 1 million, 3 million or 5 million ME;
• 1 bottle with lyophilisate for preparation of solution for intranasal introduction: 0,05 million ME.

Auxiliary components: sodium chloride, sodium phosphate disubstituted, Polyglucinum, sodium phosphate monosubstituted 2-water. 

Indications to use

Lyophilisate for preparation of solution for injections and topical administration
As a part of complex therapy at adults:

• Acute long hepatitis B, chronic form of the active hepatitis B or D with symptoms of cirrhosis or without them;
• Average or severe form of an acute viral hepatitis of B – from the moment of emergence of symptoms and till fifth day of jaundice (appointment in later period is less effective, and at a cholestatic current and the developing hepatic coma – at all it is inefficient);
• Chronic form of a viral hepatitis of C;
• Viral conjunctivitis, keratitis, keratoconjunctivitis, keratouveit;
• Meningoentsefalita virus (herpetic, adenoviral, enteroviral, influenzal, parotitis), virus and bacterial and mycoplasmal etiology;
• Malignant tumor of a kidney of the IV stage;
• Primary reticulosis, fungoid mycosis and other malignant lymphoma of skin;
• Planocellular and bazalnokletochny carcinoma cutaneum;
• Kaposha's sarcoma;
• Hairy cell leukosis;
• Keratoacanthoma;
• Histiocytosis of X;
• Chronic form of a myeloleukemia;
• Subleukemic myelosis;
• Multiple sclerosis;
• Essential thrombocytopenia.

Alfarona's use for children as a part of complex therapy:

• Acute lymphoblastoid leukosis – after end of inductive chemotherapy on 4-5 month of the period of remission;
• Respiratory papillomatosis of a throat.

Lyophilisate for preparation of solution for intranasal introduction
Use is shown at adults and children for prevention and treatment of initial stages of flu, the acute respiratory viral infections (ARVI).

Contraindications

• Severe forms of allergic pathologies;
• Individual intolerance of components of drug and other interferon.

Besides, purpose of lyophilisate for preparation of solution for injections and topical administration is contraindicated during pregnancy.

Route of administration and dosage

Lyophilisate for preparation of solution for injections and topical administration
Ready solution of lyophilisate is intended for intramuscular (in oil), hypodermic (п / to), subconjunctival maintaining and introduction under the center or in the defeat center, and also for topical administration.

For preparation of solution for bottle contents before direct use it is necessary to add water for injections in the following proportion: for introduction in oil and introduction to the center – 1 ml, for subconjunctival introduction and topical administration – 5 ml. The period of dissolution should not exceed 4 minutes. The received solution has to have transparent structure without any inclusions.

It is impossible to store divorced drug!

The recommended dosing for in oil and п / to introduction:

• Acute hepatitis of B: on 1 million ME 2 times a day for 5-6 days, then – in the same dose of 1 times a day within 5 days. For achievement of clinical effect the course of treatment can be continued after carrying out biochemical analysis of blood in a dose 1 million ME of 1 times in 3-4 days within 14 days. The course dose should not exceed 15-21 million ME;
• Chronic and acute long active hepatitis B (without symptoms of cirrhosis and delta infection): on 1 million ME of 1 times in 3-4 days within 1-2 months. In case of lack of therapeutic effect after this course of treatment the patient should appoint 2-3 similar courses with a break in 1-6 months or to continue the begun course of treatment up to 3-6 months;
• Chronic active hepatitis D without cirrhosis symptoms: on 0,5-1 million ME a day every 3-4 day within a month. A repeated course – in 1-6 months;
• The chronic active hepatitis B and D with symptoms of cirrhosis: on 0,25-0,5 million ME a day every 3-4 day, a course – 1 month. Repeated courses are appointed at development of signs of a decompensation with an interval of 2 months and more;
• Chronic viral hepatitis of C: adults – on 3 million ME 3 times in 7 days, children – from calculation for 3 million ME on 1 ^sq.m of a body surface, but no more than 3 million ME 3 times in 7 days. A course of treatment – 9 months;
• Malignant tumor of a kidney: on 3 million ME of 1 times a day within 10 days. The course is repeated at an interval of 21 days from 3 to 9 and more times. Total amount of drug – 120-300 million ME and more;
• Hairy cell leukosis: on 3-6 million ME of 1 times a day within 2 months. At achievement of normalization of a gemogramma the dose is reduced to 1-2 million ME a day. A maintenance therapy – on 3 million ME of 1 times in 3-4 days within 1,5 months. A total dose of drug – 420-600 million ME above;
• Acute lymphoblastoid leukosis at children within 4-5 months of the period of remission after end of inductive chemotherapy: in a combination with the supporting chemotherapy – on 1 million ME of 1 times in 7 days within 6 months, then – 1 time in 14 days in the same dose within 24 months;
• Myelosis: on 3 million ME a day or on 6 million ME every other day, a course of treatment – 2,5-6 months;
• Histiocytosis of X: on 3 million ME a day, a therapy course – 1 month. Within 12-36 months the course is repeated every 1-2 month;
• Subleukemic myelosis, essential thrombocytopenia (for the purpose of correction of a hyperthrombocytosis): on 1 million ME of 1 times a day or every other day within 20 days;
• Kaposha's sarcoma, malignant lymphoma: on 3 million ME a day within 10 days in a combination with glucocorticosteroids and cytostatics (Cyclophosphanum, Prospidinum);
• Tumoral stage of fungoid mycosis, reticulum cell sarcomatosis: alternation in oil of introduction in a dose of 3 million ME and intra focal introduction in a dose of 2 million ME, a course of treatment – is reasonable 10 days. At temperature increase it is above 39 °C and an aggravation of a state at patients with fungoid mycosis in an erythrodermic stage Alfarona's introduction should be cancelled. In the absence of desirable effect purpose of a repeated course in 10-14 days is shown. A dose of a maintenance therapy – 3 million ME of 1 times in 7 days within 1,5 months;
• Respiratory papillomatosis of a throat (next day after operation on removal of papillomas): on 0,1-0,15 million ME on 1 kg of weight of the patient a day within 45-50 days, further – in the same dose 3 times in 7 days within a month. The course is repeated by 2 more times with an interval of 2-6 months;
• Multiple sclerosis: at a pyramidal syndrome – on 1 million ME 3 times a day, at a cerebellar syndrome – on 1 million ME 1-3 times a day. A course of treatment – 10 days. Then appoint introduction of the same dose of 1 times in 7 days within 5-6 months. A total dose – 50-60 million ME.

At high pyrogenic reaction (39 °C and above) Alfarona's introduction are recommended to be accompanied with indometacin use.

At a keratoacanthoma, planocellular and bazalnokletochny cancer the drug is administered under the defeat center (perifokalno) in a dose 1 million ME of 1 times a day within 10 days. Perifocal introduction in 1-2 days is shown to patients with the expressed local inflammatory reactions. In need of a cryolysis it will be out after a course of treatment.

At keratoiridotsiklita and a stromal keratitis on 0,5 ml of solution enter subkonjyunktivalno in a dose 0,06 million ME every other day or daily under local anesthesia of 0,5% of solution of Dicainum. A therapy course – 15-25 injections.

For topical administration lyophilisate dissolve in 5 ml 0,9% of solution of sodium of chloride for injections. For storage solution is placed (with observance of rules of an asepsis and antiseptics) in a sterile bottle and saved in the refrigerator (temperature of 4-10 °C) no more than 12 hours.

At a superficial keratitis and conjunctivitis Alfarona is appointed locally in the form of drawing to a conjunctiva of the affected eye on 2 drops of 6-8 times a day. The number of instillations should be reduced in process of decrease in processes of an inflammation to 3-4 times a day. Treatment duration – 14 days.

Lyophilisate for preparation of solution for intranasal introduction
Ready solution is entered intranazalno into each nasal course.

For preparation of solution for contents of a bottle add 5 ml of water for injections.

It is necessary to begin use at emergence of the first symptoms of flu and diseases of a SARS.

The recommended mode of dosing has age restrictions:

• Adults: on 3 drops of 5-6 times a day (a single dose – 0,003 million ME, daily – 0,015-0,018 million ME);
• Newborns and children till 1 year: on 1 drop of 5 times a day (a single dose – 0,001 million ME, daily – 0,005 million ME);
• Children at the age of 1-3 years: on 2 drops 3-4 times a day (a single dose – 0,002 million ME, daily – 0,006-0,008 million ME);
• Children from 3 to 14 years: on 2 drops of 4-5 times a day (a single dose – 0,002 million ME, daily – 0,008-0,01 million ME).

Duration of treatment is 5 days.

Prevention of a SARS and flu is carried out in a dose of the patient corresponding to age: after contact with the patient and/or overcooling – 2 times a day within 5-7 days; with a seasonal growth of incidence – 1 time (morning) in days, in 1-2 days. At single contact it is possible to be limited to one instillation. Preventive courses can be repeated as required.

For hypodispersion of solution in a nasal cavity wings of a nose should be massaged after an instillation.

Side effects

Lyophilisate for preparation of solution for injections and topical administration

• Parenteral administration: perhaps – fatigue, a fever, temperature increase, a skin itch, rash, a leukopenia, thrombocytopenia;
• Obkalyvaniye of the defeat center: local inflammatory reactions;
• Local drawing on a mucous membrane of an eye: perhaps – a hyperemia mucous eyes, a conjunctival infection, a chemosis of the lower arch.

Lyophilisate for preparation of solution for intranasal introduction
Side effects are not established.

Special instructions

At emergence against the background of parenteral administration of a leukopenia or thrombocytopenia the patient needs to conduct a laboratory blood analysis 2-3 times a week.

Use of drug should be cancelled in case of development of considerable local or cumulative side effects when drawing on a conjunctiva of eyes.

Medicinal interaction

Lyophilisate for preparation of solution for intranasal introduction
Simultaneous use of vasoconstrictive intranasal means as it promotes excessive drying of a mucous surface of the nasal courses is not recommended.

Terms and storage conditions

To protect from children.

To store in the protected from light, dry place at a temperature up to 10 °C.

Period of validity – 2 years.

Ready solution can be stored in the refrigerator up to 10 days, without allowing freezing.