Страна: Израиль
Язык: английский
Источник: Ministry of Health
GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE
TEVA ISRAEL LTD
B05BB02
SOLUTION FOR INFUSION
GLUCOSE AS MONOHYDRATE 5 %W/V; SODIUM CHLORIDE 0.9 %W/V
I.V
Required
BIEFFE MEDITAL S.A., SPAIN
ELECTROLYTES WITH CARBOHYDRATES
Sodium Chloride 0.9 % And Glucose 5 % Solution For Infusion Baxter is indicated as a source of water, electrolytes and/or calories.
2020-03-24
1. NAME OF THE MEDICINAL PRODUCT Sodium chloride 0.9% and Glucose 5% Solution for infusion Baxter 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride: 9.0 g/l (0.9% w/v) Glucose (as monohydrate): 50.0 g/l (5.0% w/v) Each ml contains 50 mg glucose (as monohydrate) and 9.0 mg sodium chloride. Mmol/l: Na + : 154 Cl - :154 Meq/l: Na + : 154 Cl - :154 Nutritional value: approximately 840 kJ/l (or 200 kcal/l) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. Osmolarity: 585 mosm/l (approx) pH: 3.5 to 6.5 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Sodium Chloride 0.9 % And Glucose 5 % Solution For Infusion Baxter is indicated as a source of water, electrolytes and/or calories. 4.2. Posology and method of administration _Adults_ The dose is adjusted according to individual requirements of fluid, electrolyte and energy. Thus the patient`s age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account. Maximum daily dose 40 ml/kg body weight (BW) per day, corresponding to 2 g glucose/kg BW per day and 6 mmol of sodium /kg BW per day. Maximum Infusion rate: 5 ml/kg BW per hour, corresponding to 0.25 g glucose/kg BW per hour. Partial coverage of energy requirements, i. e. substitution of the obligatory daily glucose requirements, is only possible with the maximum dose stated above. _Pediatric patients_ The dose is adjusted according to the individual requirements of fluid, electrolytes and energy. Thus the patients age, weight, clinical and biological (acid-base balance) conditions and concomitant therapy should be taken into account. When administering this solution the total daily fluid and glucose requirements should be taken into account. _Elderly patients_ Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be assoc Прочитать полный документ