The instruction for medical use
of Groprinosin Torgovoye medicine a name
Groprinosin
Mezhdunarodnoye the unlicensed
name Inosine Dosage Form
of the Tablet of 500 mg
Structure
One tablet contains
active agent - inosine pranobex 500 mg,
excipients: potato starch, K-25 povidone, magnesium stearate.
The description
of the Tablet from white till cream color, an oval form with a biconvex surface, with risky for division on one party, 17 mm long and 7 mm wide.
Pharmacotherapeutic group
Antiviral drugs of direct action. Antiviral drugs other.
ATC J05AX05 code
Pharmacological
Pharmacokinetics Absorption properties: inosine pranobex has high bioavailability, is quickly soaked up.
Distribution: the maximum concentration of inosine in plasma after intake, is reached in 1 hour, pharmacological action is shown approximately in 30 min. and keeps till 6 o'clock.
Biotransformation and elimination: Inosine is metabolized on the cycle typical for purine nucleosides with formation of uric acid, other components are removed by kidneys in the form of the glucuronic and oxidized derivatives and also in not changed look. Cumulation in an organism is not revealed. Full removal of drug and its metabolites comes in 48 hours.
Groprinosin's pharmacodynamics has active agent - inosine pranobex, shows direct antiviral and immunomodulatory action. Direct antiviral action is caused by linking with ribosomes of the cells affected with a virus that slows down synthesis virus i-RNK (disturbance of a transcription and broadcasting) and leads to oppression of RNA replication and DNA-genomic viruses, the mediated action is explained by powerful induction of an interferonoobrazovaniye.
The immunomodulatory effect is caused by influence on T lymphocytes (activation of synthesis of cytokines) and increase in phagocytal activity of macrophages. Under the influence of drug the differentiation pre-T-limfotsitov amplifies, the proliferation of T induced by mitogens is stimulated - and V-lymphocytes, their ability to synthesis of lymphokines increases functional aktivnostt-lymphocytes, including, the ratio between subpopulations T-helperov and T-suppressors is normalized. Groprinosin considerably strengthens products of interleukin-2 lymphocytes and promotes an expression of receptors for this interleukin on lymphoid cells. Stimulates activity of natural killers (NK cells) at healthy people, stimulates activity of macrophages to phagocytosis, processing and the presentation of antigen that promotes increase in antibody producers in an organism from the first days of treatment. Stimulates also interleukin-1 synthesis, a mikrobitsidnost, an expression of membrane receptors and ability to react to lymphokines and chemotactic factors. In a herpes infection the development of specific antiherpetic antibodies accelerates, clinical manifestations and frequency of a recurrence decrease. Drug also prevents post-virus weakening of cellular synthesis of RNA and protein in the infected cells that is especially important for the cells occupied in processes of host defense of an organism. As a result of such complex action viral load decreases by an organism, activity of the immune system is normalized, synthesis of own interferon is considerably activated that promotes resistance to infectious diseases and fast localization of the center of an infection in case of its emergence.
Indications
- infectious diseases of a virus etiology at patients with the reduced immune status: flu, a parainfluenza, acute respiratory viral infections, including rinovirusny and adenoviral infections, bronchitis of a virus etiology, epidemic parotitis, measles
- the herpes infection caused by Herpes simplex I and the II type (herpes of lips, face skin, mucous membrane of an oral cavity, skin of hands, oftalmogerpes, genital herpes), Herpes (Varicella) zoster (chicken pox, the shingles including recuring at patients with an immunodeficiency)
- the infection caused by the human papillomavirus (HP) of 16 and 18 types
- a subacute sclerosing panencephalitis of a virus etiology
- chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (clamidiosis)
Groprinosin accept the Route of administration and doses inside, after a meal and at regular intervals, if necessary the tablet can be chewed, crushed and/or dissolved in a small amount of water just before use. Duration of treatment weights of process and frequency of a recurrence, on average determine individually, depending on a nosology, treatment duration - 5 - 14 days, if necessary after 7 - a 10-day break repeat a course of treatment, treatment with breaks and maintenance doses can last from 1 to 6 months.
The recommended doses and schemes of use
of the drug Flu, a parainfluenza, acute respiratory viral infections
to Children from 6 to 12 years a-day dose at the rate of 50 mg/kg of body weight in 3-4 receptions within 5-7 days. The drug is taken 1 - 2 more day after disappearance of symptoms, if necessary treatment can be continued or repeated in 7-8 days.
From 12 years - on 2 tablets, for achievement of the greatest efficiency, treatment it is better for adults and children to begin 3-4 times a day at the first symptoms of a disease or from first day of a disease.
Bronchitis of a virus etiology
to Adults and children since 12 years - on 2 tablets 3 times a day.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3 - 4 receptions within 2 - 4 weeks.
Epidemic parotitis: a daily dose at the rate of 70 mg/kg in 3 - 4 receptions during 7-10dny.
Measles: a daily dose at the rate of 100 mg/kg in 3 - 4 receptions during
- 7-14 days.
Herpes of a mucous membrane of an oral cavity
to Adults and children since 12 years - in a sharp phase on 2 tablets 4 times a day, a subacute phase - on 2 tablets 3 times a day.
To children from 6 to 12 years in a sharp phase - a daily dose at the rate of 70 mg/kg in 3 - 4 receptions within 6 - 8 days, in a subacute phase - 50 mg/kg/days in 3 - 4 receptions 2 times a week within 6 weeks.
Shingles and labial herpes
to Adults and children since 12 years - on 2 tablets 3-4 times a day.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3 - 4 receptions within 10-14 days (before disappearance of symptoms).
Genital herpes
to Adults and children since 12 years during an acute period - on 2 tablets 3 times a day within 5 - 6 days, during remission a maintenance dose - on 2 tablets (1000 mg) of 1 times a day - up to 6 months.
A subacute sclerosing panencephalitis
a daily dose at the rate of 50 - 100 mg/kg in 6 receptions in 4 hours a course of 8-10 days, after a 8-day break at moderate severity in addition 1 - 3 more course, at heavy severity - up to 9 courses.
The peaked condylomas caused by HPV
on 2 tablets 3 times a day, a course of treatment - 14-28 days, at a combination with cryotherapy or CO2-lazernoy therapy - on 2 tablets 3 times a day for 5 days, 3 courses at an interval of 1 month.
Chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (as a part of complex therapy)
to Adults and children since 12 years - on 2 tablets 3 – 4 times a day, a course of treatment from 2 weeks to 3 months.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3-4 receptions within 21 days (or 3 courses for 7 - 10 days).
For restoration of function of the immune system and achievement of steady immunomodulatory effect at patients with the weakened immunity the course of treatment has to proceed from 3 to 9 weeks.
Use for elderly patients
Dose adjustment depending on age is not required.
Side effects
Very often (≥1/10)
- the passing increase in concentration of uric acid in blood serum and urine caused by inosine metabolism
Often (≥1/100 to & lt, 1/10)
- headaches, dizziness
- nausea, pain vomiting in epigastriums
- allergic reactions: the itching, skin rash
- exhaustion, weakness
- articulate pains
- increase in activity of aminotransferases, alkaline phosphatase or nitrogen in blood
- a hyperuricemia
not often (≥1/1,000 to & lt, 1/100)
- nervousness, drowsiness or insomnia
- diarrhea, constipations
-
the Contraindication polyuria
- hypersensitivity to any component of drug
- gout and also patients from the uric acid increased by concentration in blood and in urine
- an urolithiasis
- a heavy renal failure of the III degree
- pregnancy and the period of a lactation (due to the lack of experience of use)
- children's age up to 6 years
Medicinal interactions
Immunosuppressive means can weaken immunopromoting effect of Groprinosin. Drug should be used carefully at the patients accepting at the same time the inhibitors of a xanthineoxidase, means increasing removal of uric acid with urine or diuretics.
Special instructions
Groprinosin is metabolized to uric acid. At continuous treatment over 14 days it is necessary to carry out control of level of uric acid in blood serum and urine, at treatment over 21 day it is reasonable to control monthly function of a liver and kidneys (activity of transaminases, creatinine level), composition of peripheral blood. If during treatment the level of uric acid increases, patients can appoint the drugs lowering its level.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
did not study Influence of drug on speed of response at control of vehicles or other mechanisms.
Overdose
any case of overdose of Groprinosin is not registered. Symptoms: in case of overdose the increase in concentration of uric acid in blood serum and in urine is observed.
Treatment: gastric lavage, symptomatic.
A form of release and packing
On 10 tablets in blister strip packaging from aluminum foil and a film polyvinylchloride.
On 2 or 5 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard pack.
To Store storage conditions in original packing, at a temperature from +15 °C to +25 °C, in the dry, protected from light place.
To store out of children's reach!
3 years
not to use a period of storage after the expiry date specified on packing.
Prescription status
Without prescription
Producer LLC Gideon Richter Polsha, Grodzisk Mazowiecki, Poland
the Owner of the registration certificate
of JSC Gideon Richter, Budapest, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
E-mail: info@ richter.kz
Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23
To develop
of Groprinosin Torgovoye medicine a name
Groprinosin
Mezhdunarodnoye the unlicensed
name Inosine Dosage Form
of the Tablet of 500 mg
Structure
One tablet contains
active agent - inosine pranobex 500 mg,
excipients: potato starch, K-25 povidone, magnesium stearate.
The description
of the Tablet from white till cream color, an oval form with a biconvex surface, with risky for division on one party, 17 mm long and 7 mm wide.
Pharmacotherapeutic group
Antiviral drugs of direct action. Antiviral drugs other.
ATC J05AX05 code
Pharmacological
Pharmacokinetics Absorption properties: inosine pranobex has high bioavailability, is quickly soaked up.
Distribution: the maximum concentration of inosine in plasma after intake, is reached in 1 hour, pharmacological action is shown approximately in 30 min. and keeps till 6 o'clock.
Biotransformation and elimination: Inosine is metabolized on the cycle typical for purine nucleosides with formation of uric acid, other components are removed by kidneys in the form of the glucuronic and oxidized derivatives and also in not changed look. Cumulation in an organism is not revealed. Full removal of drug and its metabolites comes in 48 hours.
Groprinosin's pharmacodynamics has active agent - inosine pranobex, shows direct antiviral and immunomodulatory action. Direct antiviral action is caused by linking with ribosomes of the cells affected with a virus that slows down synthesis virus i-RNK (disturbance of a transcription and broadcasting) and leads to oppression of RNA replication and DNA-genomic viruses, the mediated action is explained by powerful induction of an interferonoobrazovaniye.
The immunomodulatory effect is caused by influence on T lymphocytes (activation of synthesis of cytokines) and increase in phagocytal activity of macrophages. Under the influence of drug the differentiation pre-T-limfotsitov amplifies, the proliferation of T induced by mitogens is stimulated - and V-lymphocytes, their ability to synthesis of lymphokines increases functional aktivnostt-lymphocytes, including, the ratio between subpopulations T-helperov and T-suppressors is normalized. Groprinosin considerably strengthens products of interleukin-2 lymphocytes and promotes an expression of receptors for this interleukin on lymphoid cells. Stimulates activity of natural killers (NK cells) at healthy people, stimulates activity of macrophages to phagocytosis, processing and the presentation of antigen that promotes increase in antibody producers in an organism from the first days of treatment. Stimulates also interleukin-1 synthesis, a mikrobitsidnost, an expression of membrane receptors and ability to react to lymphokines and chemotactic factors. In a herpes infection the development of specific antiherpetic antibodies accelerates, clinical manifestations and frequency of a recurrence decrease. Drug also prevents post-virus weakening of cellular synthesis of RNA and protein in the infected cells that is especially important for the cells occupied in processes of host defense of an organism. As a result of such complex action viral load decreases by an organism, activity of the immune system is normalized, synthesis of own interferon is considerably activated that promotes resistance to infectious diseases and fast localization of the center of an infection in case of its emergence.
Indications
- infectious diseases of a virus etiology at patients with the reduced immune status: flu, a parainfluenza, acute respiratory viral infections, including rinovirusny and adenoviral infections, bronchitis of a virus etiology, epidemic parotitis, measles
- the herpes infection caused by Herpes simplex I and the II type (herpes of lips, face skin, mucous membrane of an oral cavity, skin of hands, oftalmogerpes, genital herpes), Herpes (Varicella) zoster (chicken pox, the shingles including recuring at patients with an immunodeficiency)
- the infection caused by the human papillomavirus (HP) of 16 and 18 types
- a subacute sclerosing panencephalitis of a virus etiology
- chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (clamidiosis)
Groprinosin accept the Route of administration and doses inside, after a meal and at regular intervals, if necessary the tablet can be chewed, crushed and/or dissolved in a small amount of water just before use. Duration of treatment weights of process and frequency of a recurrence, on average determine individually, depending on a nosology, treatment duration - 5 - 14 days, if necessary after 7 - a 10-day break repeat a course of treatment, treatment with breaks and maintenance doses can last from 1 to 6 months.
The recommended doses and schemes of use
of the drug Flu, a parainfluenza, acute respiratory viral infections
to Children from 6 to 12 years a-day dose at the rate of 50 mg/kg of body weight in 3-4 receptions within 5-7 days. The drug is taken 1 - 2 more day after disappearance of symptoms, if necessary treatment can be continued or repeated in 7-8 days.
From 12 years - on 2 tablets, for achievement of the greatest efficiency, treatment it is better for adults and children to begin 3-4 times a day at the first symptoms of a disease or from first day of a disease.
Bronchitis of a virus etiology
to Adults and children since 12 years - on 2 tablets 3 times a day.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3 - 4 receptions within 2 - 4 weeks.
Epidemic parotitis: a daily dose at the rate of 70 mg/kg in 3 - 4 receptions during 7-10dny.
Measles: a daily dose at the rate of 100 mg/kg in 3 - 4 receptions during
- 7-14 days.
Herpes of a mucous membrane of an oral cavity
to Adults and children since 12 years - in a sharp phase on 2 tablets 4 times a day, a subacute phase - on 2 tablets 3 times a day.
To children from 6 to 12 years in a sharp phase - a daily dose at the rate of 70 mg/kg in 3 - 4 receptions within 6 - 8 days, in a subacute phase - 50 mg/kg/days in 3 - 4 receptions 2 times a week within 6 weeks.
Shingles and labial herpes
to Adults and children since 12 years - on 2 tablets 3-4 times a day.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3 - 4 receptions within 10-14 days (before disappearance of symptoms).
Genital herpes
to Adults and children since 12 years during an acute period - on 2 tablets 3 times a day within 5 - 6 days, during remission a maintenance dose - on 2 tablets (1000 mg) of 1 times a day - up to 6 months.
A subacute sclerosing panencephalitis
a daily dose at the rate of 50 - 100 mg/kg in 6 receptions in 4 hours a course of 8-10 days, after a 8-day break at moderate severity in addition 1 - 3 more course, at heavy severity - up to 9 courses.
The peaked condylomas caused by HPV
on 2 tablets 3 times a day, a course of treatment - 14-28 days, at a combination with cryotherapy or CO2-lazernoy therapy - on 2 tablets 3 times a day for 5 days, 3 courses at an interval of 1 month.
Chronic recurrent respiratory infections and an urinogenital system at patients with the weakened immunity (as a part of complex therapy)
to Adults and children since 12 years - on 2 tablets 3 – 4 times a day, a course of treatment from 2 weeks to 3 months.
To children from 6 to 12 years - a daily dose at the rate of 50 mg/kg in 3-4 receptions within 21 days (or 3 courses for 7 - 10 days).
For restoration of function of the immune system and achievement of steady immunomodulatory effect at patients with the weakened immunity the course of treatment has to proceed from 3 to 9 weeks.
Use for elderly patients
Dose adjustment depending on age is not required.
Side effects
Very often (≥1/10)
- the passing increase in concentration of uric acid in blood serum and urine caused by inosine metabolism
Often (≥1/100 to & lt, 1/10)
- headaches, dizziness
- nausea, pain vomiting in epigastriums
- allergic reactions: the itching, skin rash
- exhaustion, weakness
- articulate pains
- increase in activity of aminotransferases, alkaline phosphatase or nitrogen in blood
- a hyperuricemia
not often (≥1/1,000 to & lt, 1/100)
- nervousness, drowsiness or insomnia
- diarrhea, constipations
-
the Contraindication polyuria
- hypersensitivity to any component of drug
- gout and also patients from the uric acid increased by concentration in blood and in urine
- an urolithiasis
- a heavy renal failure of the III degree
- pregnancy and the period of a lactation (due to the lack of experience of use)
- children's age up to 6 years
Medicinal interactions
Immunosuppressive means can weaken immunopromoting effect of Groprinosin. Drug should be used carefully at the patients accepting at the same time the inhibitors of a xanthineoxidase, means increasing removal of uric acid with urine or diuretics.
Special instructions
Groprinosin is metabolized to uric acid. At continuous treatment over 14 days it is necessary to carry out control of level of uric acid in blood serum and urine, at treatment over 21 day it is reasonable to control monthly function of a liver and kidneys (activity of transaminases, creatinine level), composition of peripheral blood. If during treatment the level of uric acid increases, patients can appoint the drugs lowering its level.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
did not study Influence of drug on speed of response at control of vehicles or other mechanisms.
Overdose
any case of overdose of Groprinosin is not registered. Symptoms: in case of overdose the increase in concentration of uric acid in blood serum and in urine is observed.
Treatment: gastric lavage, symptomatic.
A form of release and packing
On 10 tablets in blister strip packaging from aluminum foil and a film polyvinylchloride.
On 2 or 5 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard pack.
To Store storage conditions in original packing, at a temperature from +15 °C to +25 °C, in the dry, protected from light place.
To store out of children's reach!
3 years
not to use a period of storage after the expiry date specified on packing.
Prescription status
Without prescription
Producer LLC Gideon Richter Polsha, Grodzisk Mazowiecki, Poland
the Owner of the registration certificate
of JSC Gideon Richter, Budapest, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
E-mail: info@ richter.kz
Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23
To develop
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