Страна: Мальта
Язык: английский
Источник: Medicines Authority
ALBUMIN, HUMAN
Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom
B05AA01
ALBUMIN, HUMAN
SOLUTION FOR INFUSION
ALBUMIN, HUMAN 4.5 percent weight/volume
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2006-03-24
PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB ® 4.5 4.5% W/V SOLUTION FOR INFUSION HUMAN ALBUMIN SOLUTION ADL 18 REDE DESIGN LTD. Tel: 020 8863 7676 JOB NO. CLIENT: CONTACT: PROJECT NAME: CLIENT ORDER NO. DATE: PROOF NO. OPERATOR: DOC. SIZE: 7754 BPL Chidi Wek Zenalb 4.5 PIL UK Leaflet UK BPL233413 8/1/2008 7 Hema Joshi 150 x 220mm PROOF APPROVED PROOF UNAPPROVED SIGNED PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - 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 any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. WHAT ZENALB ® 4.5 IS AND WHAT IT IS USED FOR 2. BEFORE YOU ARE GIVEN ZENALB ® 4.5 3. HOW YOU WILL BE GIVEN ZENALB ® 4.5 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ZENALB ® 4.5 6. FURTHER INFORMATION 1. WHAT ZENALB ® 4.5 IS AND WHAT IT IS USED FOR Zenalb 4.5 ® is a solution containing the active substance called human albumin (a protein found naturally in your blood which is needed for many different functions). Human albumin is obtained from blood plasma from screened donors selected from the USA. Zenalb 4.5 ® is used to replace the blood or body fluids that you have lost because of bleeding, surgery, or kidney dialysis (blood “cleaning” by a machine). It contains a similar amount of albumin as normal blood. The product is given by injection into a vein (intravenous infusion). It is only available on a doctor’s prescription. This medicine is also suitable for premature babies and patients on kidney dialysis as it contains only very small quantities of aluminium. 2. BEFORE YOU ARE GIVEN ZENALB ® 4.5 DO NOT ALLOW ZENALB ® 4.5 TO BE GIVEN TO YOU IF YOU: • are allergic to albumin or any of the other ingredients of Zenalb ® 4.5 Прочитать полный документ
Page 1 of 5 S S U U M M M M A A R R Y Y O O F F P P R R O O D D U U C C T T C C H H A A R R A A C C T T E E R R I I S S T T I I C C S S 1. NAME OF MEDICINAL PRODUCT Zenalb 4.5, a Human Albumin 4.5% Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENTS Human albumin is prepared from plasma from screened donors. Donors are selected from the USA. 2.2 QUANTITATIVE COMPOSITION Zenalb 4.5 is a clear, yellow to green, sterilised solution. It is a solution containing 40 - 50 g/L of plasma protein of which not less than 95% is albumin. Zenalb 4.5 is free from the plasma proteins associated with the blood clotting mechanism and blood group antibodies. Zenalb 4.5 contains 100 - 160 mmol/L sodium. The assayed sodium content is stated on the label of the bottle. For excipients see section 6.1. 3. PHARMACEUTICAL FORM Zenalb 4.5 is an isotonic (and isooncotic) solution ready to be administered as an intravenous infusion only. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zenalb 4.5 is used for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid, such as albumin, is appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zenalb 4.5 is given by intravenous infusion. In general the dosage and the infusion-rate should be adjusted to the patient’s individual requirements. In anaphylactic reactions, treatment should follow the current recommendations for shock therapy. 4.2.1 POSOLOGY The dose required depends on Прочитать полный документ