Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
dalteparin sodium, Quantity: 18000 anti-Xa IU
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections
Subcutaneous, Intravenous
10 x 0.72mL, 2 x 0.72mL, 5 x 0.72mL
(S4) Prescription Only Medicine
Prophylaxis against thrombotic complications during haemodialysis and treatment of acute deep vein thrombosis (DVT). Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or pulmonary embolism) to reduce the recurrence of VTE in patients with solid tumour cancers. Treatment of unstable coronary artery disease, i.e. unstable angina and non-ST-elevation myocardial infarction (also known as non-Q-wave myocardial infarction). Prophylaxis against thrombo-embolic complications in the peri- or postoperative period of surgery.
Visual Identification: A clear, colourless or straw-coloured solution for injection; Container Type: Syringe; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1997-11-11
FRAGMIN ® _Dalteparin sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FRAGMIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using FRAGMIN against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again later. WHAT FRAGMIN IS USED FOR FRAGMIN is used to prevent blood clots forming in blood vessels. It is used in the following conditions: • treatment of deep vein thrombosis (also known as DVT, a blood clot in the veins of the leg) • treatment of DVT and pulmonary embolism (blood clot in the veins of the lungs) for up to 6 months in patients with certain types of cancers • prevention of DVT before and after an operation • treatment of unstable heart disease (e.g. angina and heart attack), which is caused by poor blood flow in the blood vessels of the heart. • FRAGMIN is also used to prevent blood clotting during haemodialysis, a procedure that uses a machine to remove waste products from the blood in people with kidney failure. • FRAGMIN belongs to a group of medicines called low molecular weight heparins (LMWHs). These medicines work by reducing blood clotting activity. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FRAGMIN HAS BEEN PRESCRIBED FOR YOU. • Your doctor may have prescribed FRAGMIN for another reason. • This medicine is available only with a doctor's prescription. BEFORE YOU USE FRAGMIN _WHEN YOU MUST NOT USE IT_ • DO NOT USE FRAGMIN IF YOU HAVE AN ALLERGY TO: • any medicine containing dalteparin sodium • any other low molecular weight heparin or similar medicines such as heparin • pork products • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of b Đọc toàn bộ tài liệu
Version: pfpfragi10420 Supersedes: pfpfragi11219 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION - FRAGMIN ® INJECTION (DALTEPARIN SODIUM) 1. NAME OF THE MEDICINE Dalteparin sodium. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2,500 IU (anti-Xa) dalteparin sodium/0.2 mL injection syringe 5,000 IU (anti Xa) dalteparin sodium/0.2 mL injection syringe 7,500 IU (anti-Xa) dalteparin sodium/0.75 mL injection syringe 10,000 IU (anti-Xa) dalteparin sodium/1 mL injection syringe 12,500 IU (anti-Xa) dalteparin sodium/0.5mL injection syringe 15,000 IU (anti-Xa) dalteparin sodium/0.6mL injection syringe 18,000 IU (anti-Xa) dalteparin sodium/0.72mL injection syringe The 10000 IU (anti-Xa)/1 mL syringe, 7500 IU (anti-Xa)/0.75 mL syringe, 5000 IU (anti Xa)/0.2 mL syringe and 2500 IU (anti-Xa)/0.2 mL syringe have the following anti-IIa factor potencies 3900, 2940, 1960 and 980 respectively. The 0.5, 0.6 and 0.72 mL single dose syringe presentations have the same anti-IIa factor potency per mL as the 5000 IU (anti-Xa)/0.2 mL single dose syringe, corresponding to 4900, 5880 and 7060 IU anti-IIa respectively per syringe. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Solution for injection A clear colourless or straw-coloured solution. Version: pfpfragi10420 Supersedes: pfpfragi11219 Page 2 of 21 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis against thrombotic complications during haemodialysis and treatment of acute deep vein thrombosis (DVT). Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or pulmonary embolism) to reduce the recurrence of VTE in patients with solid tumour cancers. Treatment of unstable coronary artery disease, i.e. unstable angina and non-ST-elevation myocardial infarction (also known as non-Q wave myocardial infarction). Prophylaxis against thromboembolic complications in the peri- or postoperative period of surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION THROMBOPROPHYLAXIS IN CONJUNCTION WITH SURGERY 2 5 Đọc toàn bộ tài liệu