国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Enoxaparin sodium
PCO Manufacturing Ltd.
B01AB05
Enoxaparin sodium
10000 international unit(s)
Solution for injection in pre-filled syringe
enoxaparin
2021-08-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CLEXANE ® 2,000 IU (20MG)/0.2ML SOLUTION FOR INJECTION IN PRE ‐ FILLED SYRINGES CLEXANE ® 4,000 IU (40 MG)/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES CLEXANE ® 6,000 IU (60 MG)/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES CLEXANE ® 8,000 IU (80 MG)/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES CLEXANE ® 10,000 IU (100 MG)/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES CLEXANE ® FORTE 12,000 IU (120 MG)/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES ENOXAPARIN 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 or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CLEXANE is and what it is used for 2. What you need to know before you use CLEXANE 3. How to use CLEXANE 4. Possible side effects 5. How to store CLEXANE 6. Contents of the pack and other information 1. WHAT CLEXANE IS AND WHAT IT IS USED FOR CLEXANE contains the active substance called enoxaparin sodium. This belongs to a group of medicines called ‘low molecular weight heparin’ or LMWH. HOW CLEXANE WORKS CLEXANE works in two ways: 1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm. 2) Stopping new blood clots from forming in your blood. WHAT CLEXANE IS USED FOR CLEXANE can be used to: • Treat blood clots that are in your blood • Stop blood clots from forming in your blood in the following situations: o before and after an operation o when you have a short-term illness and will not be able to move 阅读完整的文件
Health Products Regulatory Authority 01 July 2022 CRN00CYS8 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clexane 10,000 IU (100 mg)/1 ml Solution for Injection in pre-filled syringes 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections. For the full list of excipients, see section 6.1. Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringes. _Product imported from Belgium_ Clear, colourless to yellowish solution, pH value 5.5-7.5. 4 CLINICAL PARTICULARS As per PA0540/097/001 5 PHARMACOLOGICAL PROPERTIES As per PA0540/097/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Water for injections 6.2 INCOMPATIBILITIES SC injection Do not mix with other products. IV (Bolus) Injection (for acute STEMI indication only): This medicinal product must not be mixed with other medicinal products except those mentioned in SmPC section 4.2 of PA0540/097/001. 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. Diluted solution Diluted solution should be used immediately. Health Products Regulatory Authority 01 July 2022 CRN00CYS8 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Do not freeze. 6.5 NATURE AND CONTENTS OF CONTAINER Solution for injection in glass pre-filled syringes fitted with an injection needle (without an automatic safety system). Supplied in packs of 10 pre-filled syringes. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Pre-filled syringes are ready for immediate use. For method of administration see SmPC section 4.2 of PA0540/097/001. Use only clear, 阅读完整的文件