Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
GLUCOSE AS MONOHYDRATE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
B05CX01
CONCENTRATE FOR SOLUTION FOR INFUSION
GLUCOSE AS MONOHYDRATE 50 %
I.V
Required
B.BRAUN MELSUNGEN AG., GERMANY
GLUCOSE
GLUCOSE
High caloric carbohydrate infusion hypoglycaemia.
2020-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucose 20% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml of solution for infusion contains: Glucose monohydrate 220.0g (equivalent to anhydrous glucose) (200.0g) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless or slightly yellowish aqueous solution. Caloric value 3350 kJ/l 800 kcal/l Theoretical osmolarity 1110 mOsm/l Titration acidity (to pH 7.4) < 1 mmol/l pH 3.5 - 5.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • High caloric carbohydrate infusion • Hypoglycemia 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE _Adults: _ The dosage depends on age, weight and clinical condition of the patient. Glucose 20 %: Up to 35 ml/kg body weight/day Glucose 50 %: Up to 14 ml/kg body weight/day _Flow rate: _ Glucose 20 %: Up to 2.5 ml/kg bw/h or (for 70 kg patient) up to 58 drops/min = 175 ml/h Glucose 50 %: Up to 1.0 ml/kg bw/h or (for 70 kg patient) up to 23 drops/min = 70 ml/h. For patients in a markedly depleted nutritional state, the above drop/flow rates have to be reduced accordingly. _Insulin induced hypoglycemia:_ Determine blood glucose before injecting dextrose. _Children: _ According to individual requirements. ROUTE OF ADMINISTRATION I.V. via a central venous catheter. For total parenteral nutrition Glucose Injection is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements. 4.3 CONTRAINDICATIONS – Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. – Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour – Delirium tremens if such patients are already dehydrated – Acute states of shock or collapse – Metabolic acidosis – Since Baca dokumen lengkapnya