Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Glucose anhydrous
Fresenius Kabi Deutschland GmbH
B05BA; B05BA03
Glucose anhydrous
10 percent weight/volume
Solution for infusion
Solutions for parenteral nutrition; carbohydrates
Not marketed
2004-01-09
B204752-03 - V003-IE/LV (FFX) WHAT IS IN THIS LEAFLET: 1. What GLUCOSE 10 % is and what it is used for 2. What you need to know before you use GLUCOSE 10% 3. How to use GLUCOSE 10% 4. Possible side effects 5. How to store GLUCOSE 10 % 6. Contents of the pack and other information 1. WHAT GLUCOSE 10% IS AND WHAT IT IS USED FOR GLUCOSE 10 % is a sterile, colourless solution for infusion. It is used where there has been excessive water loss from the body (dehydration) and to prevent it. It is used as a solvent and carrier for other compatible drugs for parenteral administration of medicines. This infusion may also be for the prevention and treatment of ketosis (acetone in the blood) during malnutrition. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCOSE 10% DO NOT USE GLUCOSE 10% IN CASE OF: - water retention - glucose intolerance. Your doctor will check these. WARNINGS AND PRECAUTIONS: Tell your doctor if you: • suffer from diabetes • suffer from acute illness, pain, post-operative stress, infections, burns, diseases PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCOSE 10% W/V, SOLUTION FOR INFUSION Anhydrous glucose (as glucose monohydrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. _- Keep this leaflet. You may need to read it again. _ _- If you have any further questions, ask your doctor, pharmacist or nurse. _ _- If you get any side effects, talk to your doctor, pharmacist or nurse. This _ _includes any possible side effects not listed in this leaflet. _ Do not throw away any medicines via wastewater or household waste. Ask our pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. FURTHER INFORMATION WHAT GLUCOSE 10% CONTAINS The active substance is : Glucose anhydrous . . . . . . . . . . . . . . . . . . . . . . . 100 g/l As glucose monohydrate . . . . . . . . . . . . . . . . 110 g/l Osmolality: . . . . . . . . . . . . . . . . . . . . . . 580 mosmol/kg Osmolarity: . . . . . . . Read the complete document
Health Products Regulatory Authority 06 November 2019 CRN008J2N Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucose 10 % w/v Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glucose anhydrous........................................................................... 100 g/l As glucose monohydrate................................................................... 110 g/l Each ml contains 100 mg anhydrous glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear solution, non coloured to slightly yellow. Osmolality:......................................................................... 580 mosmol/kg Osmolarity:............................................................................ 555 mosmol/l Carbohydrate caloric content: 400 kcal/l pH = 3.5 - 6.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated in the following situations: - Rehydration when there is loss of water greater than loss of sodium chloride and other osmoles. - Prevention of dehydration. - Vehicle for other medicines during the preoperative, peroperative and immediate postoperative periods. - Prevention and treatment of ketosis during malnutrition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous infusion by peripheral or central vein. Posology is to be adapted according to patient's clinical status, body weight, diet and any possible other treatments. Infusion rate must not exceed a volume corresponding to 0.5 g of glucose per minute. Fluid balance, serum glucose, serum sodium and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs due to the risk of hyponatraemia. Monitoring of serum sodium is particularly important for products with lower sodium concentration compared to serum sodium concent Read the complete document