Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Heparin sodium
Wockhardt UK Limited
B01AB; B01AB01
Heparin sodium
10 international unit(s)/millilitre
Flushing solution maintenance patency intravenous devices
Product subject to prescription which may not be renewed (A)
Heparin group; heparin
Marketed
1985-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION FOR MAINTENANCE OF PATENCY OF INTRAVENOUS DEVICES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, please ask your doctor 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Heparin Sodium 10 I.U./ml Flushing Solution for maintenance of patency of intravenous devices. In the rest of this leaflet, it is called Heparin Sodium 10 I.U./ml Flushing Solution. WHAT IS IN THIS LEAFLET 1. What Heparin Sodium 10 I.U./ml Flushing Solution is and what it is used for 2. What you need to know before you use Heparin Sodium 10 I.U./ml Flushing Solution 3. How to use Heparin Sodium 10 I.U./ml Flushing Solution 4. Possible side effects 5. How to store Heparin Sodium 10 I.U./ml Flushing Solution 6. Contents of the pack and other information 1. WHAT HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION IS AND WHAT IT IS USED FOR Heparin Sodium 10 I.U./ml Flushing Solution is heparinised saline which is heparin dissolved in a salt water solution. Heparin is an anti-clotting agent and is produced naturally in the body. Heparin Sodium 10 I.U./ml Flushing Solution is used to wash and rinse the inside of catheters, cannulas and other surgical forms of tubing to ensure they do not become blocked while they are in use. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION DO NOT USE HEPARIN SODIUM 10 I.U./ML FLUSHING SOLUTION IF: • you have been told you are allergic to heparin. • you are about to be treated for pain and inflammation with intravenous diclofenac Take special care with Heparin Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Heparin Sodium 10 I.U./ml Flushing Solution 10 I.U./ml Flushing solution for maintenance of patency of intravenous devices. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Heparin sodium 10 I.U./ml (50 I.U. in 5 ml) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Flushing solution for the maintenance of patency of intravenous devices. A colourless or straw coloured liquid, free from turbidity and from matter that deposits on standing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Heparin is an anticoagulant and acts by potentiating the naturally occurring inhibitors of thrombin and factor X (Xa). Heparin Sodium 10 I.U./ml Flushing Solution is indicated in any clinical circumstances in which it is desired to maintain the patency of indwelling catheters/cannulae, attendant lines or heparin locks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Heparin Sodium 10 I.U./ml Flushing Solution is not recommended for systemic use. For cleaning indwelling cannulae. Material to be used as a cannula flush (5ml; 50 units) every four hours or as required. 4.3 CONTRAINDICATIONS The very rare occurrence of established hypersensitivity to heparin is the only contraindication to Heparin Sodium 10 I.U./ml Flushing Solution. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins._ Rigorous aseptic technique should be observed at all times in its use. Platelet counts should be measured in patients receiving heparin flushes for longer than five days (or earlier in patients with previous esposure to heparin). In those who develop thrombocytopenia or paradoxical thrombosis, heparin should immediately be eliminated from all flushes and ports. Repeated flushing of a catheter device with heparin may result in a systemic anticoagulant effect. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитать полный документ