Translation of the instruction Mose

LAFEROMAKS suppositories 1000000 MO, suppositories 3000000 MO

Instruction

On medical use of medicine

Laferomaks

(laferomax)

Ingredients:

Active ingredient: interferon alfa-2b

contains 1 suppository: interferon alpha 2b recombinant the person — 1,000,000 ME or 3,000,000 ME;

excipients: tocopherol of acetate of 5% Solutio oleosa, ascorbic acid, solid fat.

Dosage form.

Suppositories.

Main physical and chemical properties: suppositories of a bullet form of yellow-white color of uniform consistence.

Pharmacotherapeutic group.

Immunostimulyatora's

. interferona. interferon alpha 2b. code atkh l03a b05.

Pharmacological properties.

Pharmacodynamics.

Interferon alpha 2b recombinant possesses the significant anti-virus, anti-proliferative and immunomodulatory action. Active ingredient of Laferomaks medicine — interferon alpha 2b recombinant has immunomodulatory effect on T - and V-lymphocytes, immunoglobulin E content normalizes, has anti-virus activity. The antibodies neutralizing anti-virus activity of interferon alpha 2b recombinant, even at its use for 2 years are not formed, functioning of an endogenous system is normalized.

Pharmacokinetics.

Pharmacokinetic properties of medicine were not studied by

.

Clinical characteristics.

Indication.

For adults:

• in human papillomavirus infections (vulgar warts, peaked condylomas);
• in urogenital multi-infections which are transmitted sexually;
• in pretumor diseases of a neck of the uterus.

Contraindication.

Hypersensitivity to medicament components; existence at the patient of dysfunction of a thyroid gland; existence of heavy visceral disturbances at patients with Kaposi sarcoma; serious cardiovascular illness; psoriasis; profound abnormal liver functions and/or kidneys; epilepsy and other diseases of central nervous system (including functional); chronic hepatitis against the background of the progressing or dekompensirovanny cirrhosis; chronic hepatitis at the patients who are receiving or recently receiving therapy by immunodepressants (except a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in the anamnesis. oppression of a myeloid sprout of a hemopoiesis.

Interaction with other medicines and other types of interactions.

With care should use medicament along with opioid medicines, analgetics, somnolent and sedative (potentially render myelosuppressive effect).

At simultaneous use with medicaments which are metabolized by oxidation (including with xanthine derivatives — Aminophyllinum and theophylline) should consider a possibility of influence of Laferomaks on oxidizing metabolic processes. Concentration of theophylline in blood serum needs to be controlled and if necessary — to adjust the dosing mode.

At use of medicament in a combination with chemotherapeutic medicaments (Cytarabinum, doxorubicine, tenipozid, cyclophosphamide) risk of development of life-threatening toxic effects (their weights and duration) increases.

At simultaneous use with a zidovudine the risk of development of a neutropenia increases.

Feature of use.

Treatment laferomaksy should be carried out by

under observation of the doctor.

alcohol intake has to be excluded by

At medicament treatment.

to

Before prescribing of medicament to a long time recommends a research of function of a thyroid gland. To begin to use medicament provided that the level of thyroid stimulating hormone (TSH) is in norm limits. If any changes of level of thyroid stimulating hormone are found, it is necessary to carry out the corresponding treatment and to begin therapy by Laferomaks only when the content of thyroid stimulating hormone manages to be supported at the normal level. In the course of treatment it is reasonable to control the level of thyroid stimulating hormone.

function of a thyroid gland broken as a result of administration of medicament is not restored by

After the therapy termination.

to All patients before the beginning and regularly during treatment recommends to carry out

developed analysis of peripheral blood with an obligatory qualitative and quantitative research of indicators of blood and also biochemical analysis of blood, including determination of content of electrolytes, calcium, hepatic enzymes and creatinine.

periodic control of function of kidneys is necessary for

In a multiple myeloma.

At all patients receiving medicament also the prothrombin time is recommended to control carefully albumine level in blood serum.

by

With care to appoint medicament in the presence in the anamnesis of such diseases as diabetes with episodes of ketoacidosis and chronic obstructive diseases of lungs, at disturbances of blood clotting (including thrombophlebitises of a pulmonary artery), in the profound myelosuppression.

needs to provide to

At medicament treatment adequate hydration of an organism; at manifestations of fever it is necessary to exclude other reasons of its emergence.

recommends to use

medicament against the background of antihistaminic and febrifugal therapy.

At development of reaction of immediate hypersensitivity (urticaria, a Quincke's disease, a bronchospasm, an anaphylaxis) medicament should cancel and take the appropriate measures immediately.

Development of heavy and moderately severe side effects demands dose adjustment, and in certain cases — medicament treatment cancellations.

Use of medicament to stop

in cases: lengthenings of a blood clotting time (at patients with chronic hepatitis), manifestations of a pulmonary syndrome and radiological identification of infiltrate or dysfunction of lungs, emergence or increase in disorders of vision, dysfunction of a thyroid gland (TSH level aberration), decrease in level of albumine in serum of blood and decrease in indicators of a prothrombin time.

use of medicament is inadmissible

After an expiration date. Drug is not subject to repeated quality control and extension of an expiration date.

Use during pregnancy or feeding by a breast.

Data on use of medicament during pregnancy and feeding by a breast are absent.

Ability to influence speed of response at control of motor transport or other mechanisms.

Some adverse effects from central nervous system caused by medicament use can affect ability of patients to run vehicles and to work with potentially dangerous mechanisms.

Route of administration and doses.

For adults:

• in a human papillomavirus infection (vulgar warts, peaked condylomas) medicament is used rektalno on 1,000,000 ME by 2 times a day with a 12-one-hour break. A course of treatment — 10 days. Treatment is carried out, controlling a condition of the patient by means of a cytologic, bacteriological research and watching manifestation of clinical symptoms;
• in urogenital multi-infections which are transmitted sexually and at bacterial, virus and multi-infections medicament is used rektalno on 1,000,000 — 3,000,000 ME by 2 times a day with a 12-one-hour break. A course of treatment — 10 days. Treatment is carried out, controlling a condition of the patient by means of a cytologic, bacteriological research and watching manifestation of clinical symptoms. Treatment is carried out to both sexual partners;
• at pretumor diseases of a neck of the uterus medicament is used rektalno on 1,000,000 ME by 2 times a day with a 12-one-hour break. A course of treatment — 10 days. Further treatment is defined by clinical laboratory indicators.

Children.

is not applied in pediatric practice.

Overdose.

did not describe overdose cases by medicine laferomaks So far. however, as well as at overdose any medicine, recommends symptomatic therapy with monitoring of functions of vitals and careful observation of a condition of the patient.

Side reactions.

All side reactions connected with application of a laferomaks, insignificant or moderately severe. after the end of treatment they usually disappear.

Rectal method of administration of medicine is not followed by the expressed side reactions which are usually observed at parenteral administration of medicines of interferon. In some cases in the first days of treatment there can be grippopodobny symptoms which decrease subsequently and disappear. For their prevention it is possible to use paracetamol medicaments in the corresponding age dosages.

General violations. At Laferomaks's introduction possible grippopodobny symptoms: fever, temperature increase, fatigue, slackness and also headache, muscle, joints pain, perspiration; seldom — vomiting, dizziness, inflows. Emergence of reactions of hypersensitivity to medicament is possible.

Disturbance from the system of blood formation: at prolonged use the leukopenia, thrombocytopenia, anemia, nasal bleedings are possible.

Disturbance from digestive tract, a liver: increase in the ALT and nuclear Heating Plant level, increase in the SF level, loss of appetite. Abnormal liver function.

Endocrine violations: dysfunction of a thyroid gland.

Disturbance from the central and peripheral nervous system: at prolonged use the dizziness, a sleep disorder, confusion of consciousness, alarming and depressions, hyperexcitability, drowsiness, an ataxy, paresthesias are possible.

Disturbance from a cardiovascular system: arterial hypertension or hypotension are possible; seldom — tachycardia.

Disturbance from skin and hypodermic fabrics: allergic reactions, including rash (including herpetic), an itch, hyperaemia, urticaria, an acute anaphylaxis.

Disturbance respiratory systems: cough.

Other: changes in the injection site, disorder of vision, renal failure, violation of electrolytic balance.

Message about side reactions after registration of medicine are important. It the advantage risk of medicine gives the chance of continuous monitoring of a ratio. The request to report to health workers about side reactions by means of national reporting system.

Expiration date.

2 years.

Storage conditions.

to Store

in original packing for protection against influence of light at a temperature from 2 to 8 ºс.

to Store

out of children's reach.

Packing.

On 3 or 5 suppositories in planimetric cell-like packing. on 1 planimetric cell-like packing with 3 either 5 suppositories or 2 planimetric cell-like packs with 5 suppositories in a cardboard box.

Category of a holiday.

According to the prescription.

Producer.

LLC fz «biofarma.

Location of the producer and its address of the place of implementation of activity.

Ukraine, 09100, Kiev Region, white church, st. Kiev, 37.