RECOFERON« GAMMA - MEDICINAL PRODUCT FOR VETERINARY USE
Designer and manufacturer:
INDICATIONS FOR USE:
- infectious diseases;
- oncological diseases;
- In order to immunorehabilitation;
- disease of the adaptation;
- postoperative complications.
MAIN CHARACTERISTICS OF RECOFERON« GAMMA:
- Preparation created biotechnologically (recombinant, no leukocyte), that making it absolutely safety;
- The active ingredient of the drug RECOFERON« GAMMA is a recombinant interferon gamma, which is also the basis Ingaron« drug successfully used in the treatment of infectious diseases in humans;
- RECOFERON« GAMMA - the only Russian drug interferon gamma for the animals;
- REKOFERON« GAMMA has a strong combined effect of: etiotropic (antiviral) broad-spectrum and potent immunomodulatory (immunostimulatory and inducing non-specific protection), and antiproliferative activity;
- Increases the resistance of animals to infectious agents of viral etiology;
- It activates cellular immunity;
- Increases non-specific resistance of the animal organism;
- RECOFERON« GAMMA apply cats and dogs of all ages as immunocorrector for the treatment and prevention of infectious diseases of viral origin (herpesvirus, calicivirus, parvovirus enteritis, etc.), Immunosuppressive conditions, as well as for leveling the adverse effects of stress factors;
- RECOFERON« GAMMA is recommended as replacement therapy in the treatment of acute infection, both during the initial stage of the disease, and during the development of the disease.
Dosage form ľ lyophilisates for solution for intravenous and intramuscular introduction.
One RECOFERON« GAMMA ampoule contains as active ingredient the recombinant human gamma interferon 100000, 250000, 500000 and 1000000 and IU. Excipients: dextran, potassium phosphate monobasic, potassium phosphate dibasic trihydrate, potassium hydroxide.
In appearance, the lyophilized formulation is a porous mass of white to white and gray.
The shelf life of the drug when stored - 2 years from the date of issue. After opening the ampoule RECOFERON« GAMMA must not be stored. The drug is prohibited to use beyond the expiration date.
Product form. The drug release packaged in glass ampules of 2 ml with a specific activity of 100,000, 250,000, 500,000 and 1,000,000 IU. The ampoules are packaged in blisters, blisters in a pack. Every unit of consumer packaging is provided with instructions for use.
Storage conditions. Store the medication in the original container in a dry, dark place, away from food and feed, at a temperature of 2 ░ C to 8 ░ C.
RECOFERON« GAMMA should be stored out of the reach of children.
Unused drug utilized in accordance with the requirements of the legislation.
Conditions of supply: Without prescription.
Pharmacotherapeutic group:immunomodulating agents..
RECOFERON« GAMMA - recombinant interferon gamma (IFN-y), has a pronounced antiviral efficacy, refers to regulatory immunomodulators. Interferon gamma is a regulatory cytokine which is a producer of natural killer cells, CD4, Th1 cells and cytotoxic CD8 suppressor cells.Interferon gamma receptors belongs to macrophages, neutrophils, natural killer cells, cytotoxic T-lymphocytes. Interferon gamma activates the effector functions of these cells, in particular their microbicidal, cytotoxicity, cytokine production, and nitroxide superoxide radicals. Interferon gamma blockes viral DNA replication and RNA synthesis of viral proteins and assembly of mature virus particles. Shows a cytotoxic effect on virus-infected cells.
Antiproliferative effect of interferon gamma is in inhibiting cell growth by inhibiting the synthesis of RNA and proteins, as well as the inhibition of growth factors stimulate cell proliferation.
According to the degree of exposure to the body interferon gamma is "low-hazard substances".
Pharmacokinetics and pharmacodynamics: Pharmacokinetics of interferon gamma depends on the method of its application.
When it is introduced intravenously, its maximum serum concentration reached after 15 - 20 minutes, 1.5 - 2 hours found only traces of (4 - 8 IU). In the application of interferon gamma intramuscularly or subcutaneously reaches its maximum concentration after 8 hours. The half-life depends on the characteristics of the body and is in the range 4 - 12 hours.
When intravaginal or rectal interferon is readily absorbed through mucous membranes, flows into surrounding tissues and the lymphatic system. Rectal use of interferon enhances prolonged circulation in the blood..
he blood-brain barrier is a major barrier to the penetration of interferons in the cerebrospinal fluid, including, and brain.
In clinical trials, the drug RECOFERON« GAMMA:
- assigned to Class V is practically non-toxic drugs;
- when it is introduced intramuscularly to experimental animals (rats and dogs) it has almost no local irritant effect;
- does not have allergenic effects;
- lacks reproductive toxicity (no effect on spermatogenesis rats, not mutagenic, no effect on mature follicles in the ovaries, of ovulation, fertilization, and results in dysmorphogenesis fetus).
APPLICATION FEATURES OF RECOFERON« GAMMA
RECOFERON« GAMMA is applied for cats and dogs of all ages as an immunomodulator for the treatment and prevention of infectious diseases of viral origin (herpesvirus, calicivirus, parvovirus enteritis, etc.) immunosuppressive conditions and under the influence of stress factors.
It is not recommended to use the drug RECOFERON« GAMMA after vaccination of animals within 10 days.
Contraindications to the use of the drug RECOFERON« GAMMA is the individual animal's increased sensitivity to interferon (including history), severe allergic and autoimmune diseases.
RECOFERON« GAMMA is administered intravenously or intramuscularly..For intravenous administration, the contents of one ampoule is dissolved in - 3 ml of 0.9% sodium chloride solution for intramuscular administration of the drug allowed dilution with water for injection.
When respiratory viral diseases of the drug may be administered intranasally. Dilute the contents of the ampoule in 5 ml of 0.9% sodium chloride solution or water for injection and instilled into the nasal cavity of the animals at the rate of body weight: 5 kg to use ampoule 100,000 IU; from 5 to 25 kg - 250,000 IU; over 25 kg - 500 000 IU. Bury two drops in each nostril at least 3 - 5 times a day for 5 - 7 days.
Symptoms of overdose when using the drug have been identified. Features of the medicinal product in the primary and course application or cancellation has not been established.
The drug RECOFERON« GAMMA may be used in dogs and cats during pregnancy if the benefits of the drug exceeds the risk to the fetus.
Special measures for the admission of reception of one or more doses of the drug are not provided, the treatment may be continued. The pattern of use must be strictly enforced, infraction may reduce its therapeutic effectiveness.
In some cases, in the application of the drug is possible a transient increase of body temperature, which is relieved by drugs, flu syndrome, anxiety, lethargy, drowsiness, allergic reactions, sometimes vomiting, and injection site reactions (redness, local pain). Soreness is usually held immediately after injection, and the redness and induration - 24 - 48 hours. For animals with severe liver and kidney failure, with severe cardiovascular disease the drug should be used under the supervision of a veterinarian.
COMPATIBILITY WITH OTHER DRUGS
RECOFERON« GAMMA may be used in conjunction with any pharmacological and immunobiological preparations (sera and immunoglobulins), but its application should observe the following rules:
- is not allowed to enter RECOFERON« GAMMA in the same syringe with other drugs and biological products;
- should not be used together with inducers of endogenous interferon.
REGIMEN RECOFERON« GAMMA IN ANIMALS
This section is a compilation of the experience of the clinical use of the drug RECOFERON« GAMMA in dogs, cats and rodents.
RECOFERON« GAMMA is used for the treatment and prevention of infectious diseases of viral origin of dogs (adenovirus, herpes virus infection, infectious hepatitis, coronavirus and parvovirus enteritis, plague, etc..), cats (panleukopenia, calicivirus and herpesvirus infections, infectious peritonitis, rotavirus enteritis and others. ), rodents and other animals. In addition to viral infections the drug is effective against bacterial infections, chlamydia, mycoplasmosis and mixed infections.
For the treatment of infectious diseases RECOFERON« GAMMA drug is administered intravenously, intramuscularly or intranasally in doses of 10 000 - 20 000 IU / kg (dosage depends on the severity of the animal's condition), with an interval of 24 - 48 hours. The course of treatment is 3 - 14 days depending on the severity of the disease, in combination with antibiotics, immunoglobulins and antisera, in accordance with instructions of their use.
Inclusion drug RECOFERON« GAMMA in complex therapy of infectious diseases causes a significant increase in the blood and tissues of animals organism concentration IFN-y, that blocks replication of viral DNA and RNA synthesis of viral proteins and assembly of mature viral particles in infected cells.
The drug activates effector functions (microbicide, the cytotoxic effect on virus-infected cells, cytokine production, nitroxide and superoxide radicals), macrophages, neutrophils, natural killer kletkok cytotoxic T-lymphocytes having receptors for IFN-y. The drug increases the resistance of normal cells to infection by the virus.
This is accompanied by:
- quick normalization of blood biochemical parameters;
- clinical recovery of animals (reduction of recovery terms);
- favorable course of the disease;
- normalization of antibody titers;
- increases the overall resistance of the organism.
There is an opportunity to vaccinate animals.
In viral infections, therapy efficiency increases significantly at complex application RECOFERON« GAMMA with immunomodulators RONKOLEYKIN«. It is recommended to begin treatment of the drug RECOFERON« GAMMA (intravenously, intramuscularly or intranasally twice with an interval of 24 hours), followed by RONKOLEYKIN« (intravenously or subcutaneously, 2 - 5 injections with an interval of 24 - 48 hours), according to the scheme:
- the first day:RECOFERON« GAMMA i/v or i/m at 10 000 - 20 000 IU / kg;
- after 24 hours: simultaneously RECOFERON« GAMMA i/v or i/m at 10 000 - 20 000 IU / kg and RONKOLEYKIN« i/v or s/c at 10 000 - 20 000 IU / kg;
- 24-48 hours: RONKOLEYKIN« i/v or s/c at 10 000 - 20 000 IU / kg;
- after 24-48 hours: RONKOLEYKIN« i/v or s/c in a dose of 10 000 IU / kg.
Also effective is the treatment of infectious diseases, while the use of drugs and RONKOLEYKIN« RECOFERON« GAMMA on the same time in scheme:
- simultaneouslyRECOFERON« GAMMA i/v, i/m i/n at 10 000 - 20 000 IU / kg and RONKOLEYKIN« i/v or s/c at 10 000 - 20 000 IU / kg. The course of treatment 3 - 5 injections (3 - 10 days), depending on the severity of the disease. The interval between administrations 24 - 48 hours.
For the prevention of infectious diseases or drug is administered once or twice in dose of 5,000 - 10,000 IU / kg, at intervals of 24 - 48 hours. Use of the drug optionally in combination with sera and immunoglobulins.
To prevent SARS, when hypothermia or after contact with an infected animal RECOFERON« GAMMA is recommended to administere intranasally. Dilute the contents of the vial in 5 ml of 0.9% sodium chloride solution or water for injection and bury into the nasal cavity of the animals at the rate of body weight: under 5 kg to use ampoule 100,000 IU; from 5 to 25 kg - 250,000 IU; over 25 kg - 500 000 IU. Bury two drops in each nostril at least 3 - 5 times a day for 5 - 7 days. If contact with the infected animal was a single, for the prevention of infection is enough to bury the drug 1 - 2 times.
In applying the drug RECOFERON« GAMMA prophylactic:
- activate effector functions of macrophages, neutrophils, natural killer cells cytotoxic T-lymphocytes;
- increases the resistance of microorganisms cells to infection by viruses and bacteria;
- increases the body's natural resistance.
RECOFERON« GAMMA has a strong anti-tumor, immunomodulatory and antiproliferative effects.
The drug is recommended for use in the treatment of a number of cancers as an immunomodulator in conjunction with surgery to prevent metastasis and occurrence of secondary immunodeficiencies, leading to the emergence of post-operative complications. RECOFERON« GAMMA is also possible to use during or after the passage of chemotherapy and radiotherapy.
The drug is administered intravenously or intramuscularly at a dose of 10 000 - 20 000 IU / kg. Treatments - 5 - 10 injections (duration of treatment is determined individually) with an interval of 24 - 48 hours. After 30 days, repeat the course. Further, depending on the condition of the animal, it is recommended from 4 to 8 courses per year at intervals of 1 - 3 months.
The inclusion of the drug RECOFERON« GAMMA in the complex cancer therapy leads to suppression of cell growth by inhibiting the synthesis of RNA and proteins, as well as the inhibition of growth factors stimulate cell proliferation.
RECOFERON« GAMMA may be used with other immunomodulators, however, to obtain the greatest synergistic effect the drug is recommended in conjunction with immunomodulators RONKOLEYKINOM«. Each of the products is introduced at the rate of 10 000 - 20 000 IU / kg. Treatments - 5 injections with an interval of 24 - 48 hours later to repeat the course of 30 days.. Depending on the condition of the animal is recommended 4 - 8 courses per year at intervals of 1 - 3 months.
When the immunosuppressive drug states RECOFERON« GAMMA administered at a dose of 5000 - 10,000 IU / kg, at intervals of 24 - 48 hours. The course of treatment is 3 - 5 days, without the use of other drugs, the duration of treatment can be increased to achieve a therapeutic effect.
- activated cellular part of the immune response;
- increases the body's natural resistance.
PREVENTION OF DISEASES OF ADAPTATION
To relieve stress at various manipulations, transportation, etc. RECOFERON« GAMMA is administered once or twice in a dose of 5,000 - 10,000 IU / kg at intervals of 24 - 48 hours without the use of other drugs.
- enhanced immune response;
- the animal easier to tolerate various manipulations, transportation, etc.
POSTOPERATIVE CONDITIONS AND COMPLICATIONS
In preparation for elective surgery, and to prevent the occurrence of complications during surgery RECOFERON« GAMMA is administered at a dose of 5,000 - 10,000 IU / kg, before and/or after surgery once or twice every 48 hours.
Application RECOFERONA« GAMMA provides:
- reduce the probability of postoperative complications;
- the presence of postoperative complications - a significant improvement in the general condition of the animals;
- reduction of recovery terms.