Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
GLUCOSE MONOHYDRATE
Maco Pharma (UK) Ltd
B05BB02
GLUCOSE MONOHYDRATE
5 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes with carbohydrates
Marketed
1999-05-31
WHAT IS IN THIS LEAFLET 1. What 5% Glucose Intravenous Infusion Solution is and what it is used for 2. What you need to know before you are given 5% Glucose Intravenous Infusion Solution 3. How 5% Glucose Intravenous Infusion Solution is given 4. Possible side effects 5. How to store 5% Glucose Intravenous Infusion Solution 6. Contents of the pack and other information 1. WHAT 5% GLUCOSE INTRAVENOUS INFUSION SOLUTION IS AND WHAT IT IS USED FOR 5% Glucose Intravenous Infusion Solution is a clear colourless to faintly straw-coloured solution of glucose in water. The solution is stored in a sealed flexible plastic bag. Glucose is a simple sugar, which provides a source of energy. Glucose infusions are used to replace fluid loss from the body, to restore the body’s water balance. Glucose infusions can be given alone but may be given with added salts such as sodium or potassium. You may be given glucose solution with other medicines added, depending on your condition. Glucose infusions will be given to you in hospital by a doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN 5% GLUCOSE INTRAVENOUS INFUSION SOLUTION YOU MUST NOT BE GIVEN this solution if you have: • an ALLERGY to glucose or any of the other ingredients • HYPERGLYCAEMIA (high levels of glucose in the blood) • a condition of WATER EXCESS, such as liver disease or heart failure. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse if you: • have DIABETES MELLITUS • have KIDNEY FAILURE • have suffered a STROKE • are PREGNANT or are BREAST-FEEDING OTHER MEDICINES AND 5% GLUCOSE INTRAVENOUS INFUSION SOLUTION Tell your doctor if you are taking or have recently taken any other medicines. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor for advice before being given this medicine. The solution should be used with care during pregnancy and breast-feeding to avoid extreme levels of glucose in the mother and the fœtus or baby. DRIVING AND USING MACHINES Glucose Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 5% Glucose Intravenous Infusion Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dextrose (glucose) monohydrate equivalent to 50.00g anhydrous dextrose per litre. 278mmol/l. Approximately 836 kJ/litre (200 kcal/litre) _For a full list of excipients, see Section 6.1_ 3 PHARMACEUTICAL FORM Solution for infusion. Colourless to faintly straw-coloured solution without visible particles in bags, individually overwrapped. pH 4.15.- Osmolality approx 300mOsm/kgH 2 O. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 5% Glucose Intravenous Infusion Solution is indicated for: o fluid replacement, administered alone or in regimens with electrolytes or additives known to be compatible with 5% glucose o medium for intravenous administration of medicinal products known to be compatible with 5% glucose 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 physiologically hypotonic fluids. 5% Glucose Intravenous Infusion Solution may become extremely hypotonic after administration due to glucose metabolization in the body (see sections 4.4, 4.5 and 4.8). To avoid dehydration in a healthy adult or in patients with no complicating factors such as fever or excessive fluid losse daily fluid requirements are 1.5 to 2.5 litres. The volume of glucose solution needed to replenish deficits will vary with body weight, complementary treatment, severity of the clinical condition and hydration status of the patient, but in adult will usually lie between 2 and 10 litres. The pathophysiological response to dehydration, to electrolyte loss and to gluco infusion will vary with the ag Прочитайте повний документ