País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Glucose
B. Braun Melsungen AG
B05BA; B05BA03
Glucose
5 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions for parenteral nutrition; carbohydrates
Marketed
1998-02-06
PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCOSE INTRAVENOUS INFUSION BP 5% W/V SOLUTION FOR INFUSION GLUCOSE 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. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Glucose Intravenous Infusion BP 5% w/v is and what it is used for 2. What you need to know before you use Glucose Intravenous Infusion BP 5% w/v 3. How to use Glucose Intravenous Infusion BP 5% w/v 4. Possible side effects 5. How to store Glucose Intravenous Infusion BP 5% w/v 6. Contents of the pack and other information 1. WHAT GLUCOSE INTRAVENOUS INFUSION BP 5% W/V IS AND WHAT IT IS USED FOR Glucose Intravenous Infusion BP 5% w/v is a sterile solution of glucose in water which can be used to give you fluids and glucose, or can be used as a solution to dissolve other medicines in. Glucose Intravenous Infusion BP 5% w/v will be given to you in the form of a vein drip (that is, by intravenous infusion). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCOSE INTRAVENOUS INFUSION BP 5% W/V YOU WILL NOT RECEIVE GLUCOSE INTRAVENOUS INFUSION BP 5% W/V If you have: too high blood sugar level (hyperglycaemia) that needs more than 6 units of insulin per hour to be controlledhigh levels of lactic acid in your blood (lactic acidosis). You should not receive large amounts of this solution if you have – too much water in your body (hypotonic hyperhydration or isotonic hyperhydration) – acute heart failure (acute congestive heart failure) – water in your lungs (pulmonary oedema) Glucose Intravenous Infusion BP 5% w/v must not be use Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucose Intravenous Infusion BP 5% w/v, Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 50 mg glucose as glucose monohydrate 1000 ml contain 50.0 g glucose (as glucose monohydrate, 55.0 g) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Infusion. Clear, colourless or almost colourless, aqueous solution. Energy: 837kJ/l 200kcal/l Theoretical osmolarity: 278 mOsm/l Acidity titre (titration to pH 7.4): < 0.5 mmol/l pH: 3.5 – 5.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vehicle solution for compatible electrolyte concentrates and medicinal products. For use in prophylactic and replacement therapy requiring the use of glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fluid balance, serum glucose, 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 physiologically hypotonic fluids. Glucose Intravenous Infusion BP 5% w/v may become extremely hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8). PROPHYLACTIC AND REPLACEMENT THERAPY REQUIRING THE USE OF GLUCOSE The quantity and rate of administration is dependent on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician. VEHICLE SOLUTION FOR COMPATIBLE MEDICINAL PRODUCTS The volume to be chosen depends on the desired concentration of the medicinal product for which the solution is to be used as vehicle, having regard to the maximum dose stated below. Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. See sections 4.3 and 4.4. H E Leer el documento completo