Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
GLUCOSE MONOHYDRATE
Baxter Healthcare Limited
GLUCOSE MONOHYDRATE
5 %w/v
Solution for Infusion
Withdrawn
2008-03-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucose Intravenous Infusion BP 5% w/v (Viaflex container). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each litre contains: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Infusion. Clear, colourless solution, free from visible particles. pH: 3.5-6.5 and Osmolarity (approx): 278 mOsm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in prophylactic and replacement therapy requiring the use of Glucose. Glucose Intravenous Infusion BP 5.0% w/v can be used to increase the volume of circulating blood in shock and haemorrhage and counteracts dehydration. It may also be used as a vehicle for the reconstitution and administration of intravenous medications known to be compatible with 5% glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE The dosage is dependant upon the age, weight and clinical condition of the patient. ADMINISTRATION The solution is for administration by intravenous infusion. 4.3 CONTRAINDICATIONS Administration in congestive heart failure or in conditions of severe impairment of renal function. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE i. Glucose tolerance may be impaired in patients with renal failure or diabetes mellitus. If administered to diabetics or patients with renal insufficiency for appropriate clinical reasons, they should be monitored very closely. The need for electrolyte control should be kept in mind. Glusose monohydrate 55 g/l equivalent to Anhydrous Glucose 50 g/1 (5% w/v) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/11/2007_ _CRN 2043998_ _page number: 1_ ii. The solution should not be administered simultaneously with, before or after an Lestu allt skjalið