Realdiron

Active material: interferon alfa-2b, recombinant human
When ATH: L03AB05
CCF: Interferon. Antineoplastic, antiviral and immunomodulatory drugs
ICD-10 codes (testimony): A84, B16, B18.1, B18.2, B21.0, C43, C64, C84.0, C84.1, Q91.4, Q92.1
When CSF: 09.01.05.01
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Pharmaceutical form, composition and packaging

Valium for drug of a solution for i / m and n / introductions as a powder or porous mass of white.

Excipients: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, dextran 60.

Ampoules glass (5) – contour cell package (1) – packs cardboard.

Valium for drug of a solution for i / m and n / introductions as a powder or porous mass of white.

Excipients: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, dextran 60.

Glass Bottles (5) – contour cell package (1) – packs cardboard.

* – interferon alfa-2b, recombinant human cell isolated from Pseudomonas purida, in the genetic apparatus which is integrated gene of human leukocyte interferon alpha-2b. The polypeptide structure of the molecule, biological activity and pharmacological properties of the recombinant protein and of human leukocyte interferon alpha-2b is identical.

Pharmacological action

The drug Realdiron^® It has antiviral, immunomodulatory, the antiproliferative and antineoplastic effect.

Interferon alfa, interact with cognate receptors on the cell surface, It initiates a complex chain of changes within cells. Expected, These processes are associated with the prevention of viral replication in the cell, inhibition of cell proliferation and immunomodulatory effects of interferon. Interferon alpha has the ability to stimulate the phagocytic activity of macrophages, as well as cytotoxic T-cell activity and “natural killer”. These properties are due to interferon and the therapeutic effect of the drug Realdiron^®.

Pharmacokinetics

Data on the pharmacokinetics Realdiron^® not provided.

Testimony

Viral diseases:

- Acute hepatitis B;

- Chronic active hepatitis B;

- Chronic hepatitis C;

- Tick-borne encephalitis.

Oncological diseases:

- Volosatokletochnыy leukemia;

- Chronic myelogenous leukemia;

- Počečno-kletočnaâ cancer;

- Kaposi's sarcoma on the background of AIDS;

- Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome);

- Zlokachestvennaya melanoma.

Dosage regimen

The solution Realdiron^® injected i / m and s / c. Before use, the contents of the vial or ampoule is dissolved in 1 ml water for injection. The drug dissolves quickly, is dose-dependent, contained in a vial or ampule. The solution of the drug is a colorless transparent or slightly opalescent liquid. Realdiron^® It contains no preservatives, Therefore, to avoid bacterial contamination should be used only freshly prepared solution.

Viral diseases

At acute hepatitis B (light, moderate and severe forms) appoint 1 million. ME 2 times / day for 5-6 days, then reduce the dose to 1 million. ME 1 time / day, and is administered for a further 5 days. If necessary, (After biochemical blood test to assess the functional state of the liver) Treatment can be continued for a 2 of the week, during which the drug is administered by 1 million. ME 2 times a week.

In acute hepatitis B drug Realdiron^® It is most effective at the beginning of jaundice period until the 5th day of jaundice. In the appointment at a later date efficacy is reduced. In cholestatic disease course or developing hepatic coma Realdiron^® ineffective.

At chronic active hepatitis B drug Realdiron^® appoint 3-6 million. ME 3 once a week for 24 weeks. If after therapy for 12 Sun. no clinical improvement is observed, improve the blood biochemical parameters and / or disappearance of HBsAg, drug overturned.

At chronic hepatitis C drug Realdiron^® appoint 3 million. ME 3 once a week for 24 Sun. If after drug administration for 4 weeks, there is no reduction in the 50% ALT activity in plasma, the dose was increased to 6 million. ME 3 times a week. If the 12 weeks of treatment, there is no clinical improvement, improve the blood biochemical parameters, the drug should be discontinued.

At meningeal forms Tick-borne encephalitis drug Realdiron^® administered by 1-3 million. ME 2 times / day for 10 days. Then move on to maintenance therapy – 5 injections 1-3 million. IU every 2 day.

Oncological diseases

The general principle of the use of interferon for cancer is to appoint a maximum dose, that can be tolerated, for a sufficiently long time (of the month, years). Unnecessarily. Interferon alpha has a cytostatic effect, maintenance treatment Realdiron^® should continue and after the clinical effect – remission, regression of solid tumor foci.

At hairy cell leukemia administered by 3 million. IU daily. After achieving remission move on to maintenance therapy – by 3 million. ME 3 once a week for 2 months, Further treatment can not continue. When relapse repeat treatment.

At chronic myeloid leukemia appoint 9 million. IU daily. After achieving remission appoint 9 million. ME 3 times a week. The duration of treatment is determined by the attending physician depending on the nature of the disease.

At renal cell carcinoma Realdiron^® administered by 18 million. ME 3 times a week. The clinical effect (complete or partial regression of metastases) observed after 8-12 weeks of treatment Realdiron^® or later. Upon reaching the therapeutic effect or stabilization of the disease continues to support treatment for 18 million. ME 3 times a week. The duration of treatment is determined by the attending physician depending on the nature of the disease. With the progression of drug treatment may be replaced by the attending physician for anti-tumor therapy.

At Kaposi's sarcoma on the background of AIDS prescribed daily 36 million. ME. The drug is used for a long time, except in cases of rapid progression of the disease or severe intolerance to the drug. After reaching the therapeutic effect of maintenance therapy – by 18 million. ME 3 times a week.

At cutaneous T-cell lymphoma (mushroom avium and Sezary syndrome) drug Realdiron^® appoint 18 million. IU daily. The duration of treatment is determined by the attending physician depending on the nature of the disease.

At malignant melanoma drug Realdiron^®appoint 18 million. IU daily. After reaching the clinical effect (complete or partial regression of metastases) switching to maintenance therapy – by 18 million. ME 3 times a week. Adjuvant therapy with Realdiron^® by 18 million. ME 3 times a week, appointed after surgical removal of the primary tumor melanoma stage I-II or metastases to regional lymph nodes, It helps to increase the duration of remission and survival.

Side effect

There are flu-like symptoms: common – chills, fever, feeling tired, slackness, headache, joint pain, myalgia, loss of appetite. These symptoms are partially cropped acetaminophen or paracetamol.

There are slight leukopenia, thrombocytopenia, changes in liver function tests. These side effects disappear with the abolition of the drug Realdiron^® or reducing its dose.

Depending on the individual sensitivity to the drug and prescribed dose treatment possible drowsiness, weakness, fatigue.

Contraindications

- Hypersensitivity to interferon alpha or other ingredients.

Pregnancy and lactation

Pregnant and lactating women drug Realdiron^® prescribed only in cases, when the expected therapeutic effect for the mother clearly outweighs the potential risk of undesirable effects on the fetus (particularly in the first 3 of the month) or child.

Cautions

Precautions should be prescribed the drug Realdiron^® patients with severe heart disease. Patients with a history of instructions diseases of the cardiovascular system in the application of the drug may develop arrhythmia as a side reaction.

If the side effect is not reduced or enhanced, the dose is reduced by 50% or treatment with Realdiron^® stop.

During the period of administration of the drug should be deleted alcohol.

Effects on ability to drive vehicles and management mechanisms

Depending on the individual sensitivity and the prescribed dose of the drug may be a slowing of psychomotor reactions due to the potential for adverse effects – drowsiness, weakness, fatigue. In such cases it is advisable to give up driving and management of any arrangements.

Overdose

Currently, cases of drug overdose Realdiron^® not reported.

Drug Interactions

In appointing the drug Realdiron^® You should tell your doctor about other medicines taken. Drug Interactions drug Realdiron^® with other drugs studied enough.

Precautions should be used drug Realdiron^® simultaneously with opioid analgesics, hypnotics and sedatives, with drugs, providing mielodepressivny effect.

With the simultaneous use of the drug Realdiron^® theophylline is necessary to control the concentration of the serum and adjust the dosing regimen.

Interferons may affect the oxidative metabolic processes. This should be taken into account while applying the drug Realdiron^® with drugs, metabolized by oxidation.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 ° C. Shelf life – 3 year.

The drug is transported in a, that maintain a temperature of 2 ° to 8 ° C.