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Groprinosin-Richter 250 mg/5 ml 150 ml syrup

INSTRUCTIONS for the medical use of the drug GROPRINOSIN - Richter Trade name Groprinosin-Richter International nonproprietary name No Dosage form Syrup, 250 mg/5 ml, 150 ml Composition 1 ml of syrup contains the active substance - inosine pranobex 50.00 mg excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate , sucrose, sodium hydroxide, citric acid monohydrate, purified water. Description Transparent liquid with a sweet taste Pharmacotherapeutic group Direct-acting antiviral drugs. Other antiviral drugs. Inosine pranobex Code ATX J05AX05 PHARMACOLOGICAL PROPERTIES Pharmacokinetics Absorption: after oral administration, the drug is quickly and almost completely (≥ 90%) absorbed from the gastrointestinal tract and determined in the blood. Distribution: the drug is determined in the following organs, in descending order of its amount: kidneys, lungs, heart, spleen, pancreas, brain and skeletal muscles. Metabolism: after oral administration at a dose of 1 g, the concentration of DIP (dimethylaminopropanol) in the blood plasma is 3.7 μg/ml (after 2 hours), and PAsBA (para-aminobenzoic acid) is 9.4 μg/ml (after 1 hour). In human tolerability studies, the maximum increase in uric acid concentration after oral administration was non-linear and could fluctuate within ±10% over 1-3 hours. The main metabolites are o-acyl glucuronide for PACBA, and N,N - dimethylamino-2-propanol is metabolized to N-oxide. Excretion: Inosine and its metabolites are excreted by the kidneys. The daily excretion of PAsBA and its main metabolite is approximately 85% under steady-state kinetic conditions when taking inosine pranobex at a dose of 4 g/day. 95% of radiolabeled DIP and its N-oxide are detected unchanged in urine. The half-life is 3.5 hours for DIP and 50 minutes for PAsBA. After administering the tablet orally to animals, up to 70% is metabolized to uric acid, and 30% is determined in the form of xanthine and hypoxanthine. Pharmacodynamics The active substance of the drug Groprinosin®-Richter, inosine pranobex, is a synthetic purine derivative that has immunomodulatory and direct antiviral properties, which in vivo is manifested by an increase in the immune response. Each component of the drug has its own pharmacological properties. The pharmacologically active substance of this complex is inosine, and the second component of the complex, pranobex, increases its bioavailability for lymphocytes and other cells. Inosine pranobex is a complex containing inosine and a salt of 4-acetamidobenzoic acid with N,N – dimethylamino-2-propanol in a molar ratio of 1:3. In clinical studies, inosine pranobex has been shown to normalize deficient or impaired cell-mediated immune responses by activating a Th1 response that triggers T cell maturation as well as differentiation and potentiation of the induced lymphoproliferative response in mitogen- or antigen-activated cells. Similarly, the drug has been shown to have a stimulating effect on the activity of cytotoxic T lymphocytes and NK cells, the cellular functions of T8 suppressor and T4 helper cells, and also increases the number of surface receptors for IgG and complement. Inosine pranobex increases the production of the cytokine IL-1, IL-2 and the expression of IL-4 receptors in vitro. The drug significantly increases the secretion of endogenous IFN-γ and reduces the production of proinflammatory cytokines IL-4 in vivo. It has also been shown to potentiate neutrophil, monocyte and macrophage chemotaxis as well as phagocytosis. Under natural conditions (in vivo), inosine pranobex promotes the potentiation of reduced RNA synthesis and transcription rates in lymphocytes, while preventing the synthesis of viral RNA to a degree still to be clarified, by: incorporating inosine-mediated orotic acid into polyribosomes, inhibiting the attachment of polyadenylic acid to viral messenger RNA, molecular rearrangement of intramembrane particles (IMP) of lymphocytes, which leads to an almost threefold increase in density. Inosine pranobex in vitro inhibits cGMP phosphodiesterase only at high concentrations, and in vivo - at levels that do not cause immunopharmacological effects. INDICATIONS FOR USE GROPRINOSIN®-RICHTER SYRUP, 250 MG/5 ML, INDICATED FOR USE IN PATIENTS OVER 1 YEAR OF AGE FOR THE FOLLOWING INDICATIONS: AS ADDITIONAL THERAPY IN PATIENTS WITH IMPAIRED IMMUNITY WITH RECURRENT UPPER RESPIRATORY TRACT INFECTIONS, INFECTIONS OF THE SKIN AND MUCOUS MEMBRANES CAUSED BY HERPES SIMPLEX I OR II VIRUS TYPE, AND ALSO VARICELLA ZOSTER VIRUS (CHICKEN ZOX VIRUS) OTHER INFECTIONS VIRAL ETIOLOGY (SUBACUTE SCLEROSING PANENCEPHALITIS) DOSAGE AND ADMINISTRATION FOR ORAL USE ONLY. THE DOSE OF THE DRUG DEPENDS ON THE PATIENT'S BODY WEIGHT AND THE SEVERITY OF THE DISEASE. THE DAILY DOSE IS DIVIDED INTO SEVERAL PARTS, WHICH SHOULD BE TAKEN AT EQUAL INTERVALS DURING THE DAY. THE DURATION OF TREATMENT IS USUALLY 5-14 DAYS. TAKEN THE DRUG SHOULD BE CONTINUED FOR 1-2 DAYS AFTER THE SYMPTOMS OF THE DISEASE HAVE DISAPPEARED. IF THERE IS NO EFFECT WITHIN 5-14 DAYS, YOU SHOULD CONSULT A DOCTOR ABOUT REPLACING THE DRUG FOR CORRECT DOSING, YOU SHOULD USE THE ATTACHED SYRINGE WITH A MEASURING SCALE. ADULTS AND ELDERLY PEOPLE 1 ML OF GROPRINOSIN®-RICHTER SYRUP CONTAINS 50 MG INOSINE PRANOBEX. THE RECOMMENDED DAILY DOSE IS 50 MG/KG BODY WEIGHT (1 ML/KG BODY WEIGHT), USUALLY 3 G/DAY (I.E., 60 ML SYRUP PER DAY); THE MAXIMUM DAILY DOSE OF THE DRUG IS 4 G IN 3-4 ADMINISTRATIONS (80 ML PER DAY). CHILDREN OVER 1 YEAR OF AGE THE RECOMMENDED DAILY DOSE IS 50 MG/KG BODY WEIGHT, USUALLY 1 ML/KG BODY WEIGHT DIVIDED INTO 3-4 EQUAL PORTIONS TO BE TAKEN DURING THE DAY ACCORDING TO THE FOLLOWING TABLE: BODY WEIGHT DOSE 10 – 14 KG 3 X 5 ML 15 – 20 KG 3 X 5-7.5 ML 21 – 30 KG 3 X 7.5-10 ML 31 – 40 KG 3 X 10-15 ML 41 – 50 KG 3 X 15-17.5 ML FOR CORRECT DOSING, YOU SHOULD USE THE ATTACHED SYRINGE WITH A MEASURING SCALE. IN CHILDREN AND ADOLESCENTS WITH REDUCED IMMUNITY, THE DRUG SHOULD BE TAKEN FOR 10 DAYS FOR 3 MONTHS IN A CONSECUTIVE. SUBACUTE SCLEROSING PANENCEPHALITIS: IN THE ACUTE PHASE OF THE DISEASE, THE DOSE OF THE DRUG CAN BE INCREASED TO 2 MG/KG BODY WEIGHT (100 MG/KG/Day, MAXIMUM 4 G PER DAY), WITH CONTINUOUS TREATMENT IT IS NECESSARY TO CONDUCT REGULAR PATIENT ASSESSMENTS. CHILDREN DO NOT USE IN CHILDREN UNDER 1 YEAR OF AGE. ADVERSE EFFECTS TO CLASSIFY THE FREQUENCY OF ADVERSE EFFECTS, THE FOLLOWING TERMINOLOGY IS USED (IN ACCORDANCE WITH MEDDRA): VERY COMMON (≥1/10), COMMON (≥1/100 TO <1/10), INCREASED (≥1/10) 00 TO <1 / 100), RARE (≥1 / 10,000 TO <1 / 1000), VERY RARE (<1 / 10,000), FREQUENCY UNKNOWN (FREQUENCY CANNOT BE ESTIMATED BASED ON AVAILABLE DATA). THE ONLY CONSTANTLY OBSERVED SIDE EFFECT ASSOCIATED WITH THE DRUG IS A TRANSIENT INCREASE IN THE CONCENTRATION OF URIC ACID IN THE BLOOD SERUM AND IN THE URINE. URIC ACID CONCENTRATIONS RETURN TO ORIGINAL VALUES WITHIN A SEVERAL DAYS AFTER CANCELLATION OF THE DRUG. COMMON (FROM ≥1/100 TO <1/10) NERVOUS SYSTEM DISORDERS: HEADACHE, Dizziness, FATIGUE, MALAIN DISORDERS OF THE DIGESTIVE SYSTEM: REDUCED APPETITE, NAUSEA, VOMITING, EPIGASTRAL PAIN AREAS OF DISORDERS IN THE SKIN AND SUBCUTANEOUS FIBER: ITCHING, RASH DISORDERS OF THE MUSCULOCAL SYSTEM AND CONNECTIVE TISSUE: ARTHALGIA, EXacERBATION OF GOUT DISORDERS OF THE HEPATOBILIARY SYSTEM: INCREASED ACTIVITY OF TRANSAMINASES AND SERUM ALKALINE PHOSPHATASE BLOOD, INCREASED UREA CONCENTRATION IN BLOOD PLASMA INCREASED (FROM ≥1/1000 TO < 1 / 100) - NERVOUS SYSTEM DISORDERS: NERVOUSNESS, Drowsiness OR INSOMNIA, VERTIGO - DIGESTIVE SYSTEM DISORDERS: DIARRHEA, CONSTIPATION - URINARY SYSTEM AND KIDNEY DISORDERS: POLYURIA (INCREASED) REDUCTION IN URINE VOLUME), INCREASED URIC ACID LEVEL IN URINE — ALLERGIC REACTIONS: PAPULOUS RASH, HURTICS, ANGIONEUROTIC EDEMA, HYPERSENSITIVITY REACTIONS, ANAPHYLACTIC REACTIONS CONTRAINDICATIONS HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR ANY OF THE EXCIENTENTS SUBSTANCES GOUT, AS WELL AS PATIENTS WITH INCREASED CONCENTRATION OF URIC ACID IN THE BLOOD AND URINE URINARY DISEASE PREGNANCY AND LACTATION (DUE TO LACK OF EXPERIENCE IN USE) CHILDREN UNDER 1 YEAR OF AGE AND WEIGHING ≤ 10 KG DRUG INTERACTIONS GROPRINOSIN®-RICHTER SHOULD BE USED WITH CAUTION IN PATIENTS CONCURRENTLY RECEIVING CS INHIBITORS ANTIOXIDASES (E.G. ALLOPURINOL), DRUGS THAT INCREASE THE EXCRETION OF URIC ACID URINE, INCLUDING THIAZIDE DIURETICS (E.G. HYDROCHLOROTHIAZIDE, CHLORTHALIDONE, INDAPAMIDE) AND LOOP DIURETICS (FUROSEMIDE, TORESEMIDE, ETHACRYNOIC ACID). GROPRINOSIN®-RICHTER SHOULD NOT BE PRESCRIBED IN COMBINATION WITH IMMUNOSUPPRESSANTS DUE TO THE POSSIBILITY OF PHARMACOKINETIC INTERACTIONS WHICH MAY AFFECT THE EXPECTED TREATMENT EFFECT. SIMULTANEOUS APPLICATION WITH ZIDOVUDINE (AZIDOTYMIDINE, AZT) INCREASES THE FORMATION OF NUCLEOTIDES BY ZIDOVUDINE THROUGH VARIOUS MECHANISMS, WHICH RESULTS IN INCREASED SERUM BIOAVAILABILITY OF FPN AND INCREASED INTRACELLULAR PHOSPHORYLATION IN MONO QUOTES. THIS RESULTS IN AN INCREASED EFFECT OF AZT UNDER THE INFLUENCE OF THE DRUG GROPRINOSIN®-RICHTER SPECIAL INSTRUCTIONS THE DRUG GROPRINOSIN®-RICHTER SYRUP MAY CAUSE A TRANSITORY INCREASE IN THE CONCENTRATION OF URIC ACID IN THE BLOOD SERUM AND URINE, USUALLY, IN WITHIN NORMAL VALUES (UP TO 8 MG/DL, WHICH CORRESPONDS 420 µmol/L), ESPECIALLY IN MEN AND ELDERLY PEOPLE OF BOTH SEXES. INCREASED URIC ACID CONCENTRATION IS DUE TO THE PARTICIPATION OF INOSINE IN ITS FORMATION, BUT IS NOT ASSOCIATED WITH CHANGES IN THE BASIC FUNCTIONS OF THE ENZYME OR RENAL CLEARANCE. THEREFORE, THE DRUG GROPRINOSIN®-RICHTER SHOULD BE APPLIED WITH CAUTION IN PATIENTS WITH URINARIC DISEASE AND WITH IMPAIRED RENAL FUNCTION. URIC ACID LEVELS SHOULD BE CAREFULLY MONITORED DURING TREATMENT IN THESE PATIENTS. DURING LONG-TERM TREATMENT WITH GROPRINOSIN®-RICHTER (3 MONTHS OR LONGER), EACH PATIENT SHOULD REGULARLY MONITOR THE CONCENTRATION OF URIC ACID IN THE BLOOD SERUM AND URINE, COMPLETE BLOOD TEST VALUES, AND LIVER FUNCTION AND KIDNEY (TRANSAMINASE ACTIVITY, CREATININE LEVEL). IF URIC ACID LEVELS INCREASE DURING TREATMENT, PATIENTS CAN BE PRESCRIBED WITH DRUGS THAT LOWER ITS LEVELS. THE DRUG GROPRINOSIN®-RICHTER CONTAINS METHYL PARAHYDROXYBENZOATE AND PROPYL PARAHYDROXYBENZOATE, WHICH CAN CAUSE ALLERGIC REACTIONS (INCLUDING A DELAYED TYPE). THE PREPARATION GROPRINOSIN®-RICHTER CONTAINS SUCHAROSE. PATIENTS WITH RARE HEREDITARY DISEASES IN THE FORM OF FRUCTOSE INTOLERANCE, GLUCOSE-GALACTOSE MALABSORPTION OR SUCCARASE-ISOMALTASE DEFICIENCY SHOULD NOT TAKE GROPRINOSIN®-RICHTER. 1 ML OF GROPRINOSIN®-RICHTER CONTAINS 650 MG OF SUGAROSE. THIS SHOULD BE CONSIDERED WHEN PRESCRIBING TO PATIENTS WITH DIABETES. PREGNANCY AND LACTATION THERE ARE NO CONTROLLED CLINICAL STUDIES RELATED TO THE INFLUENCE ON FETAL DEVELOPMENT AND FERTILITY. IT IS NOT RECOMMENDED TO USE GROPRINOSIN®-RICHTER DURING PREGNANCY AND BREAST-FEEDING, SINCE THE SAFETY OF USE HAS NOT BEEN STUDYED. FEATURES OF THE INFLUENCE OF THE DRUG ON THE ABILITY TO DRIVE VEHICLES AND POTENTIALLY DANGEROUS MECHANISMS THE DRUG GROPRINOSIN®-RICHTER HAS NO OR ALMOST NO INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE AND MECHANISMS MAMI. OVERDOSE NO CASES OF OVERDOSE WITH INOSINE PRANOBEX HAVE BEEN RECORDED. IN THE EVENT OF OVERDOSE, SYMPTOMATIC AND SUPPORTANT THERAPY SHOULD BE PROVIDED. RELEASE FORM AND PACKAGING OF 150 ML OF THE DRUG IN DARK GLASS BOTTLES, SEALED WITH A SCREW CAP. 1 BOTTLE TOGETHER WITH A DISPENSER SYRINGE WITH GRADUATION FROM 0.5 ML TO 5 ML AND WITH INSTRUCTIONS FOR MEDICAL USE IN THE STATE AND RUSSIAN LANGUAGES IS PLACED IN A CARDBOARD BOX. STORAGE CONDITIONS STORE AT A TEMPERATURE NOT ABOVE 30°C. DO NOT REFRIGERATE OR FREEZE. KEEP OUT OF THE REACH OF CHILDREN! SHELF LIFE 2 YEARS PERIOD OF APPLICATION AFTER THE FIRST OPENING OF THE BOTTLE – 6 MONTHS. DO NOT USE AFTER THE EXPIRATION DATE STATED ON THE LABEL. CONDITIONS OF RELEASE FROM PHARMACIES ACCORDING TO A PRESCRIPTION MANUFACTURER GEDEON RICHTER ROMANIA A.O., TIRGU-MURES, ROMANIA REGISTRATION CERTIFICATES HOLDER JSC "GEDEON RICHTER", BUDAPEST, HUNGARY COMPANY REPRESENTING THE INTERESTS OF THE MANUFACTURER APPLICANT AND APPLICANT: JSC "GEDEON RICHTER" 1103 BUDAPEST, ST. DÖMROYI, 19-21, HUNGARY ADDRESS OF THE ORGANIZATION THAT ACCEPTS CLAIMS FROM CONSUMERS FOR PRODUCT QUALITY IN THE TERRITORY OF THE REPUBLIC OF KAZAKHSTAN: REPRESENTATIVE OFFICE OF JSC "GEDEON RICHTER" IN RK