Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
TINZAPARIN SODIUM
PCO Manufacturing
B01AB10
TINZAPARIN SODIUM
20000 IU/ML
Solution for Injection
Product subject to prescription which may not be renewed (A)
tinzaparin
Authorised
2014-04-04
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER INNOHEP ® 10,000 IU IN 0.5 ML INNOHEP ® 14,000 IU IN 0.7 ML INNOHEP ® 18,000 IU IN 0.9 ML SOLUTION FOR INJECTION (20,000 IU/ML) tinzaparin sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, ask your doctor, pharmacist 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. – In this leaflet the innohep ® syringe 20,000 IU/ml presentations listed above will be called innohep ® . WHAT IS IN THIS LEAFLET: 1. What innohep ® is and what it is used for. 2. What you need to know before you use innohep ® . 3. How to use innohep ® . 4. Possible side effects. 5. How to store innohep ® . 6. Contents of the pack and other information. 1. WHAT INNOHEP ® IS AND WHAT IT IS USED FOR innohep ® belongs to a group of medicines called low molecular weight heparins which help to stop the blood from clotting. innohep ® is used in adults to treat: Harmful blood clots that have formed in a vein deep inside your body. This is usually in your leg (deep vein thrombosis or DVT for short). Harmful blood clots that have formed may travel in your bloodstream and then get stuck in another blood vessel (thromboembolism). A clot may block the blood supply to your lungs (pulmonary embolism or PE for short). It can cause breathing difficulties. Blood clots that have developed because of cancer and to prevent further clots from forming. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INNOHEP ® ✖ DO NOT USE INNOHEP ® If you are allergic (hypersensitive) to tinzaparin or any of the other ingredients in your medicine. You can find a list of these in Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT innohep 10,000 IU in 0.5 ml, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tinzaparin sodium 20,000 anti-Factor Xa IU/mL. Excipients with known effect: Sodium metabisulphite. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection _Product imported from Greece_ Colourless or slightly yellow aqueous solution. 4 CLINICAL PARTICULARS PA0046/060/010 5 PHARMACOLOGICAL PROPERTIES PA0046/060/010 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium metabisulfite Sodium hydroxide (for pH-adjustment) Water for injections 6.2 INCOMPATIBILITIES In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Any portion of the contents not used at once should be discarded. The liquid may turn yellow in storage but this does not affect product quality. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. For storage conditions after first opening of the medicinal product, see section 6.3. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _8_ _3_ _4_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Glass syringe contains 0.5ml so Lestu allt skjalið