국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TINZAPARIN SODIUM
DKSH MALAYSIA SDN BHD
TINZAPARIN SODIUM
mcg/mL; 0.7 ml mL
LEO Pharma A/S
INNOHEP ® Tinzaparin Sodium (10,000 anti-Xa IU/ml, 20,000 anti-Xa IU/ml) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What _innohep_ _® _ is used for 2. How _innohep_ _® _ works _3._ _ _ Before you use _innohep_ _®_ _ _ _4._ _ _ How to use _innohep_ _®_ _ _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _innohep_ _®_ _ _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Reference Number WHAT _INNOHEP_ _® _ IS USED FOR _innohep_ _® _ is a blood thinning medication that inhibit the natural ability of the blood to clot (coagulate). _innohep_ _® _ is used to treat blood clots and prevent blood clots. You must talk to a doctor if you do not feel better or if you feel worse. HOW _INNOHEP_ _® _ WORKS _innohep® _ is a type of heparin – a low molecular weight heparin – and belongs to a group of medicines called anticoagulants; these medicines prevents clotting, allowing normal blood flow through the arteries and veins. BEFORE YOU USE _INNOHEP_ _®_ _ _ _When you must not use it _ If you are allergic to Tinzaparin sodium or any other ingredients of this medicine If you have ever had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) - this reaction is called heparin- induced thrombocytopenia (HIT). If you have a major bleeding (e.g. in the brain, spine, eye or stomach). If you have an infection in the heart membranes (septic endocarditis) (For treatment indication) If you are planned to undergo spinal or epidural anaesthesia or lumbar puncture. _Pregnancy and lactation _ _ _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If epidural anaesthesia is needed you must tell your doctor that you are using _innohep_ ®. Talk to your doctor of nurse if you have an artificial heart valve. _Before you start use it _ _ _ 전체 문서 읽기
028625-00 INNOHEP® ANTICOAGULANT _Tinzaparin _ _sodium_ VIALS OF 2 ML _Tinzaparin sodium _ _10,000 _ _anti-Xa IU/ml, preserved _ _with _ _benzyl _ _alcohol. _ _Tinzaparin sodium _ _20,000 _ _anti-Xa IU/ml, preserved _ _with _ _benzyl _ _alcohol, _ _stabilized with sodium _ _bisulphite._ SYRINGE OF 0.35 ML OR 0.45 ML FOR INJECTION _Tinzaparin sodium _ _10,000 _ _anti-Xa _ _IU/ml._ SYRINGE OF 0.5 ML, 0.7 ML FOR INJECTION _Tinzaparin sodium _ _20,000 _ _anti-Xa IU/ml, stabilized with sodium _ _bisulphite._ PRODUCT DESCRIPTION innohep® injection 14,000 anti-Xa IU/0.7 ml (pre-filled syringes) innohep® injection 3,500 anti-Xa IU/0.35 ml (pre-filled syringes) innohep® injection 4,500 anti-Xa IU/0.45 ml (pre-filled syringes) innohep® injection 10,000 anti-Xa IU/0,5 ml (pre-filled syringes) Clear solution, colorless to straw colored, free of particles. innohep® injection 10,000 anti-Xa IU/ml (vials) innohep® injection 20,000 anti-Xa IU/ml (vials) Colorless to slightly yellow solution. PROPERTIES _Tinzaparin sodium is a low molecular weight heparin produced _ _by _ _enzymatic _ _depolymerization of conventional heparin of porcine origin. _ _The molecular _ _mass is between _ _1,000 and 14,000 dalton, with a peak _ _maximum molecular _ _mass of approx. _ _4,500 _ _dalton. Tinzaparin sodium is an _ _anti- _ _thrombotic _ _agent._ INNOHEP _®_ _ _ _has a bioavailability of about _ _90% _ _following _ _subcutaneous _ _injection. _ _The absorption half-life is _ _200 _ _minutes, peak plasma activity _ _being _ _observed _ _after 4–6 _ _hours._ _The elimination half-life is about _ _80 _ _minutes. Tinzaparin sodium is _ _eliminated, _ _primarily with the urine, as unchanged _ _drug._ _The _ _pharmacokinetics/pharmacodynamics of _ INNOHEP _®_ _ _ _are monitored _ _by _ _anti-Xa activity. There is a linear dose-response relationship _ _between _ _plasma activity and the dose _ _administered._ _The biological activity of _ INNOHEP _®_ _ _ _is expressed in anti-Xa international _ _units._ PHARMACODYNAMICS INNOHEP _®_ _ _ 전체 문서 읽기