Composition, form of production and packaging
Lyophilizate for the preparation of a solution for w / m and / or injections in the form of a powder or a porous mass of white.
1 amp.
interferon alpha-2b human recombinant * 1 million MU
- "- 3 million MEU
- "- 5 million MEU
- "- 6 million MEU
- "- 9 million MEU
- "- 18 million MEU
[PRING] sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, dextran 60.
Ampoules glass (5) - packings contour mesh (1) - packs cardboard.
Lyophilizate for the preparation of a solution for w / m and / or injections in the form of a powder or a porous mass of white.
1 f.
interferon alpha-2b human recombinant * 1 million MU
- "- 3 million MEU
- "- 5 million MEU
- "- 6 million MEU
- "- 9 million MEU
- "- 18 million MEU
[PRING] sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, dextran 60.
Glass vials (5) - packings contour mesh (1) - packs cardboard.
* - interferon alpha-2b human recombinant is isolated from cells of Pseudomonas purida, in the genetic apparatus of which the human leukocyte interferon alpha-2b gene is built. The polypeptide structure of the molecule, the biological activity and pharmacological properties of the recombinant protein and human leukocyte interferon alpha-2b are identical.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The drug Realdiron В® has antiviral, immunomodulating, antiproliferative and antitumor effect.
Interferon alfa, interacting with related receptors on the cell surface, initiates a complex chain of changes within the cell. It is assumed that these processes are associated with preventing the replication of viruses in the cell, inhibiting the proliferation of cells and immunomodulating action of interferon. Interferon alfa has the ability to stimulate the phagocytic activity of macrophages, as well as the cytotoxic activity of T cells and "natural killers." These properties of interferon and caused the therapeutic effect of the drug Realdiron В® .
PHARMACOKINETICS
Data on the pharmacokinetics of the preparation of Realdiron В® are not available.
INDICATIONS
Viral diseases:
- Acute hepatitis B;
- chronic active hepatitis B;
- chronic hepatitis C;
tick-borne encephalitis.
Oncological diseases:
- hairy cell leukemia;
- chronic myelogenous leukemia;
- Renal cell carcinoma;
- Kaposi's sarcoma on the background of AIDS;
- cutaneous T-cell lymphoma (mushroom mycosis and Cesari syndrome);
- malignant melanoma.
DOSING MODE
Solution of the drug Realdiron В® is administered in / m or s / c. Before use, the contents of the ampoule or vial are dissolved in 1 ml of water for injection. The drug dissolves quickly, regardless of the dose contained in the vial or ampoule. The drug solution is a colorless, transparent or slightly opalescent liquid. Realdiron В® does not contain preservatives, therefore, in order to avoid bacterial contamination, only freshly prepared solution should be used.
Viral diseases
For acute hepatitis B (light, moderate and severe forms), 1 million IU is prescribed 2 times / day for 5-6 days, then the dose is reduced to 1 million IU once / day and injected for another 5 days. If necessary (after controlling biochemical blood tests to assess the functional state of the liver), treatment can continue for another 2 weeks, during which the drug is administered 1 million IU 2 times a week.
In acute hepatitis B, the preparation Realdiron В® is most effective at the beginning of icteric period before the 5th day of jaundice. At the appointment in later terms, the effectiveness of the drug is reduced. With cholestatic flow of the disease or with developing hepatic coma, Realdiron В® is ineffective.
In chronic active hepatitis B, the preparation Realdiron В® is prescribed 3-6 million IU 3 times a week for 24 weeks. If after therapy for 12 weeks. there is no clinical improvement, improvement of biochemical parameters of blood and / or disappearance of HBsAg, the drug is canceled.
In chronic hepatitis C, the preparation Realdiron В® is prescribed 3 million IU 3 times a week for 24 weeks. If after the introduction of the drug for 4 weeks there is no decrease in 50% of the activity of ALT in the blood plasma, the dose of the drug is increased to 6 million IU 3 times a week. If after 12 weeks of therapy there is no clinical improvement, improving the biochemical parameters of the blood, the drug should be discarded.
With meningeal forms of tick-borne encephalitis, the preparation Realdiron В® is administered on 1-3 million IU 2 times / day for 10 days. Then they switch to maintenance therapy - 5 injections of 1-3 million IU every 2 days.
Oncological diseases
The general principle of the use of interferon in cancer is to prescribe the maximum dose that the patient can tolerate for a sufficiently long time (months, years).Because interferon alfa has a cytostatic effect, supporting treatment with the drug Realdiron В® should continue and after achieving a clinical effect - hematological remission, regression of solid tumor sites.
With hairy cell leukemia , 3 million IU daily is administered. After achieving hematologic remission go to supportive therapy - 3 million IU 3 times a week for 2 months, then treatment can not continue. When relapse treatment is repeated.
With chronic myelogenous leukemia appoint 9 million IU daily. After achieving hematologic remission, 9 million IU are prescribed 3 times a week. The duration of treatment is determined by the attending physician depending on the nature of the course of the disease.
In renal cell carcinoma, REALDIRONВ® is administered to 18 million IU three times a week. The clinical effect (complete or partial regression of metastases) is observed after 8-12 weeks of treatment with the drug Realdiron В® or later. When the therapeutic effect or stabilization of the course of the disease is achieved, maintenance therapy is continued for 18 million IU three times a week. The duration of treatment is determined by the attending physician depending on the nature of the course of the disease. When the process progresses, the treatment with the drug can be replaced by the attending physician with antitumor therapy.
With Kaposi's sarcoma , 36 million IU are prescribed daily against AIDS . The drug is used for a long time, except for cases of rapid progression of the disease or severe intolerance of the drug. After achieving therapeutic effect, maintenance therapy is prescribed - 18 million IU 3 times a week.
With cutaneous T-cell lymphoma (fungal mycosis and Sesari syndrome), the preparation Realdiron В® appoint 18 million IU daily. The duration of treatment is determined by the attending physician depending on the nature of the course of the disease.
In malignant melanoma, the preparation Realdiron В® is prescribed for 18 million IU daily. After achieving a clinical effect (complete or partial regression of metastases) go on supporting therapy - 18 million IU 3 times a week. Adjuvant therapy with the drug Realdiron В® for 18 million IU 3 times a week, prescribed after surgical removal of the primary tumor of melanoma I-II stage or metastases in the regional lymph nodes, contributes to an increase in the duration of remission and the survival of patients.
SIDE EFFECT
Influenza -like symptoms are possible : most often - chills, fever, fatigue, lethargy, headache, joint pain, myalgia, loss of appetite. These symptoms are partially suppressed by acetaminophen or paracetamol.
Possible minor leukopenia, thrombocytopenia, changes in liver function. These adverse reactions disappear when the preparation Revaldiron В® is discontinued or its dose is reduced.
Depending on the individual sensitivity to the drug and the prescribed dose of treatment, drowsiness, weakness, and increased fatigue are possible.
CONTRAINDICATIONS
- Hypersensitivity to interferon alpha or other components of the drug.
PREGNANCY AND LACTATION
Pregnant women and lactating mothers receive the drug Realdiron В® only in cases where the expected therapeutic effect of the mother clearly exceeds the risk of possible unwanted effects on the fetus (especially in the first 3 months) or the baby.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
There may be changes in liver function indicators that disappear after the abolition of Realdiron or a reduction in its dose.
SPECIAL INSTRUCTIONS
Caution should be given to the drug Realdiron В® in patients with severe heart disease. In patients with a history of cardiovascular disease, the use of the drug may develop arrhythmia as an adverse reaction.
If the side effect does not decrease or increases, the dose of the drug is reduced by 50% or the treatment with the drug Realdiron В® is stopped.
During the intake of the drug should be excluded from drinking alcohol.
Impact on the ability to drive vehicles and manage mechanisms
Depending on the individual sensitivity and the prescribed dose of the drug, the psychomotor reactions may slow down because of the possible development of side effects - drowsiness, weakness, increased fatigue. In such cases it is recommended to abandon the driving of vehicles and the management of any mechanisms.
OVERDOSE
There have been no reports of overdose of the drug Realdiron В® .
DRUG INTERACTION
When prescribing the drug Realdiron В® should inform the doctor about other medications taken. The drug interaction of the drug Realdiron В® with other drugs has not been studied enough.
With caution should be used preparation Realdiron В® simultaneously with opioid analgesics, hypnotics and sedatives, with drugs that have a mielodepressivny effect.
With the simultaneous use of the drug Realdiron В® with theophylline it is necessary to monitor the concentration of the latter in the serum and, if necessary, adjust the dosage regimen.
Interferons can affect oxidative metabolic processes. This should be taken into account when using the drug Realdiron В® with drugs metabolized by oxidation.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C. Shelf life - 3 years.
The preparation is transported under conditions ensuring the maintenance of the temperature from 2 В° to 8 В° C.
