Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
GLUCOSE MONOHYDRATE
TEVA MEDICAL MARKETING LTD.
B05CX01
SOLUTION FOR INFUSION
GLUCOSE MONOHYDRATE 5.5 %W/V
I.V
Required
BAXTER HEALTHCARE LTD.UK
GLUCOSE
GLUCOSE
Glucose 5 % intravenous infusion is indicated for the treatment of carbohydrate and fluid depletion. Glucose 5 % is also used as a vehicle and diluent for compatible medicinal products for parenteral administration.
2014-03-31
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) ךיראת .102.30 תילגנאב רישכת םש םושירה רפסמו GLUCOSE 5% INTRAVENOUS INFUSION BP (VIAFLO®) 140 24 30797 00 ; 140 24 30797 01; 134 06 31397 00 םושירה לעב םש TEVA MEDICAL (MARKETING) LTD., HAORGIM ST 8, ASHDOD 77100 ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles Solution for infusion. Clear solution, free from visible particles. Osmolarity : 278 mOsm/l (approx.) pH : 3.5 – 6.5 I NDICATION POSOLOGY, DOSAGE & ADMINISTRATION When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored. Glucose 5% intravenous infusion is an isosmotic solution. Please see section 3 for the information about the osmolarity of the solution. _Precautions to be taken before handling or administering the _ _medicinal product _ Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Electrolyte supplementation may be indicated according to the clinical needs of the patient. When introducing additives, the final osmolarity of solutions need to be checked. Administration of hyperosmolar solutions may cause venous irritation and phlebitis. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored. Please see section 4.4 for the risk of air embolism . CONTRA- INDICATIONS Hypersensitivity to the Przeczytaj cały dokument
GLUCOSE 5% IV Infusion BP Notification 06.2022 N.A 1 GLUCOSE 5% INTRAVENOUS INFUSION BP SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glucose 5% Intravenous Infusion BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glucose (as monohydrate): 50.0 g/l Each ml contains 50 mg glucose (as monohydrate) Approximately 840 kJ/l (or 200 kcal/l) For the full list of excipients: see 6.1 3. PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. Osmolarity : 278 mOsm/l (approx.) pH : 3.5 – 6.5 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Glucose 5% is indicated for the treatment of carbohydrate and fluid depletion. Glucose 5% is also used as a vehicle and diluent for compatible medicinal products for parenteral administration. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the Elderly and Children : _ The concentration and dosage of Glucose 5% Intravenous Infusion is determined by several factors including the age, weight, and clinical condition of the patient. Serum-glucose concentrations may need to be carefully monitored. The recommended dosage for treatment of carbohydrate and fluid depletion is: - for adults : 500 ml to 3 litres/24h - for babies and children : - 0-10 kg body weight: 100 ml/kg/24 h. - 10-20 kg body weight: 1000 ml + 50 ml/kg over 10 kg/24 h. - > 20 kg body weight : 1500 ml + 20 ml/kg over 20 kg/24 h. _ _ The infusion rate depends on the patient's clinical condition. Infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore, the maximum dose ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for babies and children depending on the age and the total body mass. GLUCOSE 5% IV Infusion BP Notification 06.2022 N.A 2 The recommended dosage when used as a vehicle or diluent ranges from 50 to 250 ml per dose of medicinal product to be administered. When Glucose 5% is used as a diluent for injectable preparations of other drugs, the dosage and the infusion rate will be princi Przeczytaj cały dokument