Glucose Intravenous Infusion BP 200g/litre Glucose BP Read all of this leaflet carefully before you start using this medicine. It contains important information. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or nurse. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. Glucose Intravenous Infusion BP will reverse the effects of insulin, a medicine used to treat diabetes. 5. How to store Glucose Intravenous Infusion BP If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse. Store below 25°C. Pregnancy and breast-feeding This medicine should be used with extreme caution during labour. Ask your doctor for advice if you are pregnant, trying to become pregnant or are breast-feeding before you are given this medicine. Driving and using machinery Glucose has no known effect on your ability to drive or use machines. 3. How Glucose Intravenous Infusion BP is given In this leaflet: 1. What Glucose Intravenous Infusion BP is and what it is used for 2. Before Glucose Intravenous Infusion BP is given 3. How Glucose Intravenous Infusion BP will be given 4. Possible side effects 5. How to store Glucose Intravenous Infusion BP 6. Further information Glucose Intravenous Infusion will be given to you by a doctor or nurse. Your doctor will decide your dose, how often you should be given it and how long you will receive it for. 1. What Glucose Intravenous Infusion BP is and what it is used As an energy source or in carbohydrate depletion: Up to 3 litres per day may be injected as an infusion slowly into a central vein or, after dilution to less than 50g/litre (5%), into any suitable vein. Glucose is a type of sugar that is essential for normal body function as it is an important source of energy. Glucose Intravenous Infusion BP is used to reverse a coma caused by low levels of glucose in the blood. It is also used as a source of energy or when carbohydrates levels are low. 2. Before Glucose Intravenous Infusion BP is given You should not be given Glucose Intravenous Infusion BP if: • you are allergic (hypersensitive) to Glucose (Dextrose) or any of the other ingredients of this medicine, listed in section 6 of this leaflet • you are unable to or have difficulty in passing urine • you suffer from alcoholism • you have suffered a recent head or spinal injury. Take special care with Glucose Intravenous Infusion BP, tell your doctor if: • you are pregnant, trying to become pregnant or breast feeding If any of the above apply to you or your child please tell your doctor before you are given Glucose Intravenous Infusion BP. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. TECHNICAL PRESCRIBING INFORMATION Adults and the elderly To reverse a coma caused by a low blood sugar level: Your doctor will slowly inject up to 125ml of the 200g/litre infusion into a central vein. Children The precise dose and route of administration must be decided by a doctor qualified in the treatment of children. If you are given too much of Glucose Intravenous Infusion BP As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. In the event that an overdose does occur, your doctor will know what to do. The symptoms of overdose include thirst, water retention and an imbalance in the electrolytes in your body. Glucose Intravenous Infusion BP 200g/litre Indications: For the reversal of hypoglycaemic coma, as an energy source and in carbohydrate depletion. Composition/ excipients: Glucose Intravenous Infusion BP is a sterile solution of Glucose (Dextrose) containing 20% w/v (200g/L). It also contains Water for Injections. Dose: • • • • Children Only to be used under the supervision of a paediatrician. Contra-indications: Anuria, intracranial or intraspinal haemorrhage or delirium tremens where there is dehydration. Warnings: To be used with extreme caution during labour. Special care should be taken to avoid leakage into surrounding tissue. Interactions: The effects of insulin are reversed by glucose. Pregnancy: There is no, or inadequate, evidence of safety of the drug in human pregnancy or breast feeding, but it has been in wide use for many years without apparent ill consequence. Side effects: Children Up to 3 litres per day of either product depending on the needs of the patient. What Glucose Intravenous Infusion BP looks like and contents of the pack Glucose Intravenous Infusion BP is available in clear colourless neutral glass ampoules containing 10 or 20ml of Glucose Intravenous Infusion BP. The medicine is supplied to your pharmacist or doctor in packs of 10 clear glass ampoules. Marketing Authorisation Holder and Manufacturer Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford Essex RM3 8UG, United Kingdom. Product Licence Number (s): PL 1883/6129R If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address This leaflet was last approved in: MM/YYYY Date of revision: September 2011 Continued overleaf Up to 125ml of 200g/litre Glucose Intravenous Infusion. As an energy source and in carbohydrate depletion. What Glucose Intravenous Infusion BP contains The active ingredient is Glucose (Dextrose) 200g/Litre. The other ingredient is water for injections. If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor or nurse. For the reversal of hypoglycaemic coma. Only to be used under the supervision of a paediatrician. 6. Further Information pain at the site of injection vein irritation and /or inflammation water retention an imbalance of the electrolytes in your body (your doctor may need to do a test to check this). For slow intravenous infusion into a central vein. Adults and the elderly This medicine will be used in the hospital environment and will be disposed of safely by your doctor or nurse. Like all medicines Glucose Intravenous Infusion BP can cause side effects, although not everybody gets them. Possible side effects include: Glucose Intravenous Infusion BP 200g/litre Product: Glucose Intravenous Infusion BP should not be used after the expiry date which is stated on the ampoule label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date. 4. Possible side effects D01921 Glucose BP Keep out of the reach and sight of children. D01921 D01921 Overdose: Intravenous administration of hypertonic ( > 5%) glucose can cause local pain, vein irritation and thrombophlebitis. Infusion of glucose can cause fluid and electrolyte imbalances including oedema, hypokalaemia, hypomagnesaemia and hypophosphataemia. See also “Overdose”. Pharmacodynamics:The metabolism of Glucose is an energy source for the body. Pharmacokinetics: Glucose is rapidly metabolised into carbon dioxide and water. Incompatibilities: Do not mix with whole blood as haemolysis and clumping can occur. Shelf life: 24 months unopened. Storage: Store below 25°C. Nature and content of containers: Colourless ampoules of type I neutral glass. Packed into cartons containing 10 ampoules. The infusion is available in 10 and 20ml ampoules. Authorisation holder: Martindale Pharmaceuticals Bampton Road, Harold Hill, Romford, RM3 8UG Product Licence number: PL1883/6129R 200g/litre Last revised: September 2011 © Martindale Pharmaceuticals Symptoms would include thirst, oedema and electrochemical disturbances. The blood levels of glucose can be adjusted by slow infusion of insulin. Careful blood monitoring would be necessary. Continued overleaf D01921 PACKAGE LEAFLET: INFORMATION FOR THE USER
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