Immunoglobulin complex-lyophilizate.
Information for specialists.
Information for specialists.
This section is intended for medical and pharmaceutical workers only.
The information provided in this section is not intended for self-diagnosis or treatment.
The information provided in this section is not intended for self-diagnosis or treatment.
GENERAL INFORMATION
INSTRUCTIONS
Trade name of the drug: Immunoglobulin complex drug
International nonproprietary name (INN): None.
Pharmaceutical group: MIBP-globulin.
Dosage form: Lyophilizate for the preparation of a solution for oral administration.
Product form: in vials containing 300 mg of protein (one dose). Five vials in a pack with instructions for use.
Dispensed: Dispensed with a doctor's prescription.
International nonproprietary name (INN): None.
Pharmaceutical group: MIBP-globulin.
Dosage form: Lyophilizate for the preparation of a solution for oral administration.
Product form: in vials containing 300 mg of protein (one dose). Five vials in a pack with instructions for use.
Dispensed: Dispensed with a doctor's prescription.
LS-001690-050412
MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF
RUSSIAN FEDERATION
INSTRUCTIONS
according to the use of the drug for medical use Immunoglobulin complex drug name of the drug
TRADE NAME: Immunoglobulin complex preparation
INTERNATIONAL NONPROPRIETARY NAME: No
PHARMACEUTICAL FORM: lyophilisate for solution preparation for intake
THE COMPOSITION FOR ONE DOSE:
ACTIVE SUBSTANCE: Immunoglobulin complex preparation - 300 mg (according to the content of human plasma proteins)
Auxiliary substance: Glycine-100 mg
DESCRIPTION: Amorphous mass of white or bluish color.
PHARMACOTHERAPEUTIC GROUP: MIBP-globulin
ATX CODE: [J06BA]
PHARMACOLOGICAL EFFECT
Immunoglobulin complex drug is a lyophilized protein solution containing IgG, IgA, and IgM immunoglobulins isolated from human blood plasma tested for the absence of antibodies to human immunodeficiency virus HIV-1 and HIV-2, antibodies to hepatitis C virus (HCV) and hepatitis b virus surface antigen (HBsAg). The technology for obtaining the drug provides two special stages of inactivation of possibly present viruses.
The active principle of the drug is an immunologically active fraction of human serum proteins containing immunoglobulins of classes G, A, and M. Immunoglobulins have a high titer of antibodies against a wide range of viruses and bacteria of various classes, which provides an effective therapeutic effect of the drug.
After oral administration, it has a local effect in the lumen of the small and large intestine, blocking the receptors of microbial cells, thereby reducing the adsorption of microbes on the epithelial cells of the intestinal mucosa and inhibiting the reproduction of adsorbed microbial cells, weakening or preventing the development of the infectious process.
PHARMACOKINETICS
Immunoglobulins and their fragments that have retained serological activity are detected both in the contents of the colon and in coprophiltrates within a few days after taking the drug.
INDICATIONS FOR USE
The drug is used as part of complex therapy in the treatment of viral and bacterial intestinal infections in children from 1 month and adults.
CONTRAINDICATIONS FOR USE
Allergic reactions to human immunoglobulins in the anamnesis.
DOSAGE REGIMEN AND METHOD OF ADMINISTRATION
After opening, add 5 ml (1/2 tablespoon) of boiled water at room temperature to the bottle. The drug is dissolved with a light shake.
Apply inside 1-2 doses (bottle) 2-3 times a day, depending on the age of the patient and the severity of the disease for 30 minutes before meals for 5 days. If necessary, repeat the course of treatment.
The drug should not be used if there is no label on the bottle or if there is incomplete information on it, as well as if there are cracks on the bottles.
The SYMPTOMS of OVERDOSE are not described.
POSSIBLE SIDE EFFECTS
Local allergic reactions in the form of rashes are possible. In this case, the drug is continued on the background of Hi-histamine receptor blockers.
INTERACTION WITH OTHER MEDICATIONS
The use of Immunoglobulin complex drug is possible in combination with antibiotics, chemotherapeutic agents and bacteriophages.
USE DURING PREGNANCY AND LACTATION
Studies on the use of the drug in women during pregnancy and breast-feeding have not been conducted, so the drug is prescribed to pregnant and nursing women with caution when the potential benefit to the mother exceeds the potential risk to the child.
INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS:
it has no effect.
FORM RELEASE
Lyophilizate for the preparation of a solution for oral administration is produced in vials containing 300 mg of protein (one dose). Five vials in a pack with instructions for use.
STORAGE CONDITIONS: Store at a temperature of 2 to 8 °C out of the reach of children.
SHELF LIFE: 3 years. Do not use after the expiration date!
RELEASE from PHARMACIES: prescription.
MANUFACTURER
LLC Immuno-Hem, 125212, Moscow, Golovinskoe shosse, 8, building 2A. Tel: (495) 232-61-74, (495) 232-48-95, tel / Fax: (495) 232-61-75 production Address: 610027, Kirov, Krasnoarmeyskaya str., 70, 72
It is recommended to send information about all cases of undesirable effects to the Ministry of health and social development of the Russian Federation and to the manufacturer.
General Director of JSC "Immuno-Hem" A.V. Kharchenko
MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF
RUSSIAN FEDERATION
INSTRUCTIONS
according to the use of the drug for medical use Immunoglobulin complex drug name of the drug
TRADE NAME: Immunoglobulin complex preparation
INTERNATIONAL NONPROPRIETARY NAME: No
PHARMACEUTICAL FORM: lyophilisate for solution preparation for intake
THE COMPOSITION FOR ONE DOSE:
ACTIVE SUBSTANCE: Immunoglobulin complex preparation - 300 mg (according to the content of human plasma proteins)
Auxiliary substance: Glycine-100 mg
DESCRIPTION: Amorphous mass of white or bluish color.
PHARMACOTHERAPEUTIC GROUP: MIBP-globulin
ATX CODE: [J06BA]
PHARMACOLOGICAL EFFECT
Immunoglobulin complex drug is a lyophilized protein solution containing IgG, IgA, and IgM immunoglobulins isolated from human blood plasma tested for the absence of antibodies to human immunodeficiency virus HIV-1 and HIV-2, antibodies to hepatitis C virus (HCV) and hepatitis b virus surface antigen (HBsAg). The technology for obtaining the drug provides two special stages of inactivation of possibly present viruses.
The active principle of the drug is an immunologically active fraction of human serum proteins containing immunoglobulins of classes G, A, and M. Immunoglobulins have a high titer of antibodies against a wide range of viruses and bacteria of various classes, which provides an effective therapeutic effect of the drug.
After oral administration, it has a local effect in the lumen of the small and large intestine, blocking the receptors of microbial cells, thereby reducing the adsorption of microbes on the epithelial cells of the intestinal mucosa and inhibiting the reproduction of adsorbed microbial cells, weakening or preventing the development of the infectious process.
PHARMACOKINETICS
Immunoglobulins and their fragments that have retained serological activity are detected both in the contents of the colon and in coprophiltrates within a few days after taking the drug.
INDICATIONS FOR USE
The drug is used as part of complex therapy in the treatment of viral and bacterial intestinal infections in children from 1 month and adults.
CONTRAINDICATIONS FOR USE
Allergic reactions to human immunoglobulins in the anamnesis.
DOSAGE REGIMEN AND METHOD OF ADMINISTRATION
After opening, add 5 ml (1/2 tablespoon) of boiled water at room temperature to the bottle. The drug is dissolved with a light shake.
Apply inside 1-2 doses (bottle) 2-3 times a day, depending on the age of the patient and the severity of the disease for 30 minutes before meals for 5 days. If necessary, repeat the course of treatment.
The drug should not be used if there is no label on the bottle or if there is incomplete information on it, as well as if there are cracks on the bottles.
The SYMPTOMS of OVERDOSE are not described.
POSSIBLE SIDE EFFECTS
Local allergic reactions in the form of rashes are possible. In this case, the drug is continued on the background of Hi-histamine receptor blockers.
INTERACTION WITH OTHER MEDICATIONS
The use of Immunoglobulin complex drug is possible in combination with antibiotics, chemotherapeutic agents and bacteriophages.
USE DURING PREGNANCY AND LACTATION
Studies on the use of the drug in women during pregnancy and breast-feeding have not been conducted, so the drug is prescribed to pregnant and nursing women with caution when the potential benefit to the mother exceeds the potential risk to the child.
INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS:
it has no effect.
FORM RELEASE
Lyophilizate for the preparation of a solution for oral administration is produced in vials containing 300 mg of protein (one dose). Five vials in a pack with instructions for use.
STORAGE CONDITIONS: Store at a temperature of 2 to 8 °C out of the reach of children.
SHELF LIFE: 3 years. Do not use after the expiration date!
RELEASE from PHARMACIES: prescription.
MANUFACTURER
LLC Immuno-Hem, 125212, Moscow, Golovinskoe shosse, 8, building 2A. Tel: (495) 232-61-74, (495) 232-48-95, tel / Fax: (495) 232-61-75 production Address: 610027, Kirov, Krasnoarmeyskaya str., 70, 72
It is recommended to send information about all cases of undesirable effects to the Ministry of health and social development of the Russian Federation and to the manufacturer.
General Director of JSC "Immuno-Hem" A.V. Kharchenko
