Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Tinzaparin sodium
Leo Laboratories Limited
B01AB; B01AB10
Tinzaparin sodium
14,000 IU/ 0.7 ml international unit(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Heparin group; tinzaparin
Marketed
1997-01-24
PACKAGE LEAFLET: INFORMATION FOR THE USER INNOHEP ® 8,000 IU IN 0.4 ML INNOHEP ® 10,000 IU IN 0.5 ML INNOHEP ® 12,000 IU IN 0.6 ML INNOHEP ® 14,000 IU IN 0.7 ML INNOHEP ® 16,000 IU IN 0.8 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 is a type of heparin – a low molecular weight heparin – and belongs to a group of medicines called anticoagulants; these medicines affect how your blood clots. innohep prevents clotting, allowing normal blood flow through the arteries and veins. innohep is used in adults to treat: Harmful blood clots that have formed in a deep vein (deep vein thrombosis, DVT). This usually occurs in a leg. Clots that may travel in your bloodstream and cause a blockage (a thromboembolism). A clot that has travelled to your lung and caused a blockage (pulmonary embolism, PE). This can cause breathing difficulties and chest pain. 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 INNOH Lire le document complet
Health Products Regulatory Authority 15 March 2023 CRN00CZX0 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT innohep 14,000 IU in 0.7 ml, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tinzaparin sodium 20,000 anti-Factor Xa IU/ml Excipients with known effect: Sodium metabisulfite (1.83 mg/mL) and sodium (up to 40 mg/mL). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Colourless or slightly yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis and pulmonary embolus in adults. Extended treatment of venous thromboembolism and prevention of recurrences in adult patients with active cancer. For some patients with pulmonary embolism (e.g. those with severe haemodynamic instability) alternative treatment, such as surgery or thrombolysis, may be indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Treatment in adults_ 175 anti-Xa IU/kg body weight given subcutaneously once daily for at least 6 days and until adequate oral anticoagulation is established. _Extended treatment in adult patients with active cancer_ 175 anti-Xa IU/kg body weight given subcutaneously once daily for a recommended treatment period of 6 months. The benefit of continued anticoagulation treatment beyond 6 months should be evaluated. _Neuraxial anaesthesia_ Treatment doses of innohep (175 IU/kg) are contraindicated in patients who receive neuraxial anaesthesia, see section 4.3. If neuraxial anaesthesia is planned, innohep should be discontinued at least 24 hours before the procedure is performed. innohep should not be resumed until at least 4-6 hours after the use of spinal anaesthesia or after the catheter has been removed. _Interchangeability_ For interchangeability with other LMWHs, see section 4.4. _Paediatric population_ The safety and efficacy of innohep in children below 18 years have not yet been established. Currently availa Lire le document complet