Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Tinzaparin sodium
Leo Laboratories Limited
B01AB; B01AB10
Tinzaparin sodium
2,500 IU/ 0.25 ml international unit(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Heparin group; tinzaparin
Marketed
1997-12-11
PACKAGE LEAFLET: INFORMATION FOR THE USER INNOHEP ® 2,500 IU INNOHEP ® 3,500 IU INNOHEP ® 4,500 IU SOLUTION FOR INJECTION (10,000 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 10,000 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 to: • Prevent blood clots in adults before and after an operation. • Prevent blood clots in adults who have an increased risk of blood clots e.g. due to an acute illness with limited mobility. • Prevent blood clots being formed in haemodialysis equipment in patients undergoing haemodialysis or haemofiltration. In haemodialysis, wastes and fluids from the blood are removed by a dialysis machine and a dialysis filter, which acts as a kind of artificial kidney. 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 of this medicine (listed in sec Baca dokumen lengkapnya
Health Products Regulatory Authority 15 March 2023 CRN00CZX0 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT innohep 2,500 IU, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tinzaparin sodium 10,000 anti-Factor Xa IU/ml Excipients with known effect: Sodium (in total < 23 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 Prophylaxis of venous thromboembolism in adult patients undergoing surgery, particularly orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in non-surgical adult patients immobilised due to acute medical illness including: acute heart failure, acute respiratory failure, severe infections, active cancer, as well as exacerbation of rheumatic diseases. Prevention of clotting in extracorporeal circuits during haemodialysis and haemofiltration in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prophylaxisof thromboembolic events in adults: Administration is by subcutaneous injection. _Surgical patients at moderate risk of thromboembolic events:_ 3,500 anti-Xa IU given SC 2 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE. _Surgical patients at high risk of thromboembolic events e.g. undergoing orthopaedic or cancer surgery:_ 4,500 anti-Xa IU given SC 12 hours before surgery and then once daily for as long as the patient is considered to be at risk of VTE. _Non-surgical patients immobilised due to acute medical illness:_ 3,500 anti-Xa IU given SC once daily in patients at moderate risk of VTE, or 4,500 anti-Xa IU given SC once daily in patients at high risk of VTE. Administration should continue for as long as the patient is considered to be at risk of VTE. Neuraxial anaesthesia Caution is advised when performing neuraxial anaesthesia or lumbar puncture in patients receiving prophylactic doses of innohep, see Baca dokumen lengkapnya