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MANNITOL INFUSION BP 10% AS POLYFUSOR K AND FREEFLEX

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mannitol Infusion BP 10% as Polyfusor K and freeex Mannitol Infusion BP 20% as Polyfusor M and freeex
Read all of this leaet carefully before you start taking this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you suffer any serious side effects, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Mannitol Infusion is and what it is used for 2. Before you receive Mannitol Infusion 3. How you are administered Mannitol Infusion 4. Possible side effects 5. How to store Mannitol Infusion 6. Further information

2. BEFORE YOU RECEIVE MANNITOL INFUSION
You should not receive Mannitol Infusion if you are allergic (hypersensitive) to mannitol or any of the ingredients of Mannitol Infusion mentioned in Section 6. You have abnormally fragile blood vessels (capillary fragility) You have uid on the lungs (pulmonary congestion or pulmonary oedema) You have bleeding inside your head (intracranial bleeding) You have heart failure You have kidney failure (unless a test dose has produced a diuretic response) Care should be taken when being administered with Mannitol Infusion Tell your doctor if you suffer from abnormal uid retention in your body cells (called oedematous conditions) associated with reduced heart function. Mannitol Infusion should be administered to you slowly and should not be mixed with blood. Your doctor or nurse will make sure the infusion is given to you correctly. Kidney cells may be damaged if mannitol is administered simultaneously. Your doctor or nurse will ensure the solution is clear and free from any particles before use. Your doctor may monitor your salt and uid levels during treatment. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor if you take or have recently taken any of the below medicines: Tubocurarine (a medicine used during anesthesia) Cyclosporin (used in organ transplantation) Electrolyte solutions (salts) Corticotrophin (a hormone) Barbiturates (sleeping medicines or anaesthetics) Noradrennaline (a hormone) Metaraminol (a medicine used if you have very low blood pressure) Suxamethonium (a muscle relaxant) Tetracyclines (antibiotics ) Pregnancy and breast-feeding You should tell your doctor if you are pregnant, if you think you are pregnant or you are planning to be pregnant or if you are breastfeeding. He/she will decide whether you should receive Mannitol Infusion. Driving and using machines Mannitol Infusion has no effect on driving or using machines.

1. WHAT MANNITOL INFUSION IS AND WHAT IT IS USED FOR
The name of this medicine is: Mannitol Infusion BP 10% as Polyfusor K and freeex Mannitol Infusion BP 20% as Polyfusor M and freeex. In this leaet it is jointly referred to as Mannitol Infusion. Mannitol Infusion is used as an osmotic diuretic. Diuretics increase the amount of urine passed, which causes the body to lose water and salt. Your doctor will be able to explain this to you. Mannitol Infusion is used on its own or to supplement the action of other diuretics in order to treat or prevent kidney failure and help get rid of toxic substances from the body by increasing urine ow. Mannitol also promotes the excretion of substances such as aspirin and barbiturates (drugs used in treatment of sleeping problems). Mannitol Infusion is given by intravenous (into a vein) infusion.

3. HOW YOU ARE GIVEN MANNITOL INFUSION
Mannitol Infusion must only be given to you in a hospital by healthcare professionals You will receive your medicine by infusion (IV drip). Dosage Your doctor will decide on the correct dose for you to receive. The amount and rate at which the infusion is given depends on your requirements. Adults and Children A dosage of 200g daily by intravenous infusion should not be exceeded. Elderly Elderly patients are more likely to be affected by the side effects associated with mannitol. This is due to diminished kidney function and heart capacity. You should therefore be given a test dose as described below for patients with any kidney impairment. Kidney Impairment If you have reduced kidney function you should be given a test dose of 200 mg per kilogram body weight administered to you over ve minutes. If your body produces 40 ml or more of urine within an hour, mannitol may then be given to you in smaller doses. If you receive more Mannitol Infusion than you should It is very unlikely that you will receive more infusion than you should. If you suspect an overdosage with mannitol you should look for the symptoms/side effects described below in this leaet. You should immediately inform your doctor describing the symptoms. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Rapid intravenous infusion of mannitol may produce: Headache Chills Chest pain Breathing difculties Convulsions (ts) If any of the side effects gets serious or if you notice any side effects not listed in this leaet, please tell you doctor or pharmacist.

5.

HOW TO STORE MANNITOL INFUSION

Keep out of the reach and sight of children. Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Mannitol Infusion solution. Mannitol Infusion solution should be stored between 20C and 30C. The solution must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month. Any solution remaining after treatment should be disposed of using the approved hospital procedures. The solution should not be diluted before use.

6. FURTHER INFORMATION
What Mannitol Infusion contains Mannitol Infusion BP 10% as Polyfusor K and freeex contains mannitol 10% w/v Mannitol Infusion BP 20% as Polyfusor M and freeex contains mannitol 20% w/v The infusions also contain: water for injections, hydrochloric acid, and sodium hydroxide. What Mannitol Infusion looks like and contents of the pack Mannitol Infusion is a clear solution contained in a sealed semi-rigid, cylindrical neutral polythene container with a Twist off seal at one end and a ring tab at the opposite end. The solution is available in 500 ml containers. Not all pack sizes may be marketed. Marketing Authorisation Holder Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT. UK. Manufacturer: Ivex Pharmaceuticals Limited, Old Belfast Road, Millbrook, Larne, Co. Antrim, BT40 2SH. UK. Last updated August 2009

4. POSSIBLE SIDE EFFECTS
Like all medicines Mannitol Infusion can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after receiving this medicine, you should contact your doctor immediately: Nausea Vomiting Upper abdomen discomfort Headache Confusion Cramps Tachycardia (an increase in heart rate) Skin Rash Swelling

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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