Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
GLUCOSE AS MONOHYDRATE
BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL
B05CX01
SOLUTION FOR INFUSION
GLUCOSE AS MONOHYDRATE 500 G / 1 L
I.V
Required
BAXTER HEALTHCARE LTD. U.K.
GLUCOSE
High caloric carbohydrate infusion, hypoglycaemia
2023-01-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Glucose 50% Baxter 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 mL concentrate for solution for infusion Contain Glucose monohydrate 55.0 g (Equivalent to 50.0 g anhydrous glucose) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless or not more than faintly yellow solution. Energy: 835 kJ/100 mL ≙ 200 kcal/100 mL Theoretical osmolarity: 2,770 mOsm/L Titratable acidity (pH 7.4): < 1.5 mmol/L pH: 3.2-5.5 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. Up to 14 ml/kg body weight/day. Flow rate: 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 ac cordingly. 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 cen- tral 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 ● Hypokalaemia ● Acidosis 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Glucose 50% Baxter is a hypertonic solution. In the body, however, glucose-containing fluids can become extremely hypotonic due to rapid glucose metabolisation. Depending on the tonicity of the solution, the volume and the rate of infusion and dependin Διαβάστε το πλήρες έγγραφο