País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENOXAPARIN SODIUM
UNIMED SDN BHD
ENOXAPARIN SODIUM
10 Pre-Filled Syringes; 2 Pre-Filled Syringes
Rovi Pharmaceutical Industrial Service
CRUSIA ® Enoxaparin Sodium Solution for Injection in Pre-filled Syringe (20mg/0.2ml, 40mg/0.4ml, 60mg/0.6ml, 80mg/0.8ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What CRUSIA is used for. 2. How CRUSIA works. 3. Before you use CRUSIA. 4. How to use CRUSIA. 5. While you are using it. 6. Side effects. 7. Storage and Disposal of CRUSIA. 8. Product Description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. 11. Serial Number. WHAT _CRUSIA_ IS USED FOR. CRUSIA contains enoxaparin sodium as the active ingredient which belongs to a group of a medicine called Low Molecular Weight Heparins (LMWH). Your doctor may have prescribed CRUSIA to PREVENT the following conditions of: • Formation of blood clots in the veins (thromboembolic disorders), including in orthopedic and general surgery. • Formation of blood clots in the veins of bedridden patients admitted because of a sudden illness, including heart failure, acute respiratory failure, severe infections or rheumatic diseases. • Blood clotting (coagulation) in the extracorporeal circulation by hemodialysis (kidney replacement therapy). Your doctor may have prescribed CRUSIA to TREAT the following conditions of: • Blood clots in the veins (deep vein thrombosis) with or without pulmonary embolism (a blockage of an artery by a blood clot). • A sudden painful feeling tightness in the chest (unstable angina) and some form of a heart attack (myocardial infarction without Q-wave), in combination with acetylsalicylic acid (aspirin). • An acute heart attack (STEMI: ST- segment Elevation Myocardial Infarction) in patient not for subsequent coronary angioplasty- Percutaneous Coronary Intervention (PCI). HOW _CRUSIA_ WORKS? CRUSIA WORKS IN TWO WAYS; i. Stopping existing blood clots from getting any bigger. This helps your body to break them down and stop them causing you harm. ii. Stopping blood clots forming in your blood. BEFORE YOU USE _CRUSIA_ • _When you must not use it? _ Do not use CRUSIA if: - If you ar Leia o documento completo
AIP002146A AIP002146A _ELDERLY_ For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired (see below “renal impairment” and section Special warnings and special precautions for use). )RUWUHDWPHQWRIDFXWH67(0,LQHOGHUO\SDWLHQWV¶\HDUVRIDJHDQLQLWLDO,9EROXVPXVWQRWEHXVHG,QLWLDWH GRVLQJZLWK,8NJPJNJ6&HYHU\KRXUVPD[LPXP,8PJIRUHDFKRIWKHILUVWWZR6& GRVHVRQO\IROORZHGE\,8NJPJNJ6&GRVLQJIRUWKHUHPDLQLQJGRVHV)RUGRVDJHLQHOGHUO\SDWLHQWV with impaired kidney function, see below “renal impairment” and section Special warnings and special precautions for use. _HEPATIC IMPAIRMENT _ /LPLWHG GDWD DUH DYDLODEOH LQ SDWLHQWV ZLWK KHSDWLF LPSDLUPHQWVHH VHFWLRQV 3KDUPDFRG\QDPLF SURSHUWLHV DQG 3KDUPDFRNLQHWLF SURSHUWLHV DQG FDXWLRQ VKRXOG EH XVHG LQ WKHVH SDWLHQWVVHH VHFWLRQ 6SHFLDO ZDUQLQJV DQG special precautions for use). _RENAL IMPAIRMENT (SEE SECTIONS SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND PHARMACOKINETIC PROPERTIES)_ 6HYHUHUHQDOLPSDLUPHQW (QR[DSDULQVRGLXPLVQRWUHFRPPHQGHGIRUSDWLHQWVZLWKHQGVWDJHUHQDOGLVHDVHFUHDWLQLQHFOHDUDQFHPOPLQ GXHWRODFNRIGDWDLQWKLVSRSXODWLRQRXWVLGHWKHSUHYHQWLRQRIWKURPEXVIRUPDWLRQLQH[WUDFRUSRUHDOFLUFXODWLRQ during haemodialysis. 'RVDJHWDEOHIRUSDWLHQWVZLWKVHYHUHUHQDOLPSDLUPHQWFUHDWLQLQHFOHDUDQFH>@POPLQ The recommended dosage adjustments do not apply to the haemodialysis indication. • Moderate and mild renal impairment $OWKRXJKQRGRVHDGMXVWPHQWLVUHFRPPHQGHGLQSDWLHQWVZLWKPRGHUDWHFUHDWLQLQHFOHDUDQFHPOPLQDQG PLOGFUHDWLQLQHFOHDUDQFHPOPLQUHQDOLPSDLUPHQWFDUHIXOFOLQLFDOPRQLWRULQJLVDGYLVHG METHOD OF ADMINISTRATION &586,$V\ULQJHVVKRXOGNOT be administered by the intramuscular route. )RUWKHSURSK\OD[LVRIYHQRXVWKURPERHPEROLFGLVHDVHIROORZLQJVXUJHU\WUHDWPHQWRI'97DQG3(WUHDWPHQWRI XQVWDEOHDQJLQDDQ Leia o documento completo