Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Streptokinase
Beacon Pharmaceuticals Ltd
B01AD01
Streptokinase
750000unit
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02100200; GTIN: 0793573976048
Biofactor GmbH Streptokinase 250 000 & 750 000 – V3 Page 1 PATIENT INFORMATION LEAFLET BIOFACTOR STREPTOKINASE 250 000 AND 750 000 Powder for solution for infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET? 1. What Biofactor Streptokinase is and what it is used for. 2. What you need to know before you are given Biofactor Streptokinase. 3. How Biofactor Streptokinase is given to you. 4. Possible side effects. 5. How Biofactor Streptokinase is stored. 6. Contents of the pack and further information. 1. WHAT BIOFACTOR STREPTOKINASE IS AND WHAT IT IS USED FOR. Biofactor Streptokinase contains a number of ingredients. The active substance is a protein called streptokinase, an antithrombotic agent which dissolves blood clots. You are being treated with Biofactor Streptokinase to break down blood clots in blood vessels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BIOFACTOR STREPTOKINASE. You should not be treated with Biofactor Streptokinase if you: - are allergic to streptokinase or any of the other ingredients in this medicine (listed in section 6) - are pregnant - are suffering from or have recently had internal bleeding - have recently suffered a stroke or a serious head injury - have recently had surgery, especially on your head (intracranial) or spine (intraspinal) - have a brain tumour or a tumour with a risk of bleeding - have uncontrollable high blood pressure - have problems with your blood vessels (e.g. weakness in an artery) - have a clotting disorder or are taking drugs to prevent blood clotting (anticoagulants) - have an unusual susceptibility to bleeding - have inflammation of the pancreas (acute pancreatitis) or inflammation in or around your he Đọc toàn bộ tài liệu
OBJECT 1 STREPTOKINASE 750,000 IU Summary of Product Characteristics Updated 11-Aug-2015 | Beacon Pharmaceuticals 1. Name of the medicinal product Biofactor Streptokinase 250 000 and 750 000 2. Qualitative and quantitative composition Biofactor Streptokinase 250 000 and 750 000 are presented as a powder for solution in vials containing 250 000 and 750 000 International Units (IU) of purified streptokinase as the active ingredient. For a full list of excipients, see section 6.1. Highly purified streptokinase is extracted from the culture filtrate of certain strains of the streptococcus group C. It is presented as a white to slightly yellow powder and contains stabilisers. 3. Pharmaceutical form Powder for solution for infusion. White to slightly yellow powder. 4. Clinical particulars 4.1 Therapeutic indications Biofactor Streptokinase is indicated in adults. Biofactor Streptokinase is a fibrinolytic agent which may be used for the intravascular dissolution of thrombi and emboli in: - acute massive pulmonary embolism - acute, sub-acute or chronic (not older than 6 weeks) occlusion of peripheral arteries - extensive deep vein thrombosis - central retinal venous or arterial thrombosis (arterial occlusions not older than 8 hours, venous occlusions not older than 10 days). Note: No statement on therapy outcome can be made for administration beyond the time windows indicated above. 4.2 Posology and method of administration Posology _Adults_ Deep vein thrombosis An initial dose of 250 000 IU streptokinase should be infused into a peripheral vein over 30 minutes. A maintenance infusion of 100 000 IU/hour for 72 hours should follow. Pulmonary embolism Infuse 1 500 000 IU streptokinase into a peripheral vein preferably over a short time of 1-2 hours. As an alternative, an initial dose of 250 000 IU streptokinase should be infused into a peripheral vein over 30 minutes. A maintenance infusion of 100 000 IU/hour for 24 hours should follow. Occlusive peripheral arterial diseases Administer streptokinase with a local intra-arte Đọc toàn bộ tài liệu