Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Alteplase 10mg
Boehringer Ingelheim (NZ) Ltd
Alteplase 10 mg
10 mg
Injection with diluent
Active: Alteplase 10mg Excipient: Arginine Nitrogen Phosphoric acid Polysorbate 80 Water for injection
Ampoule, 10 mL
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
ACTILYSE is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.
Package - Contents - Shelf Life: Ampoule, - 10 mL - - Combination pack, 1 x ( powder + diluent ) - 10 mg - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at or below 25°C protect from light - Vial, glass, - 10 mg - 24 months from date of manufacture stored at or below 25°C protect from light
1987-03-19
ACTILYSE NZ CMI v03 1 ACTILYSE ® _INJECTION WITH DILUENT _ _alteplase, rch _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Actilyse. 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 being treated with Actilyse against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medsafe.govt.nz/ Consumers/cmi/CMIForm.asp and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET. You may need to read it again. WHAT ACTILYSE IS USED FOR Actilyse is used to treat a number of conditions caused by blood clots forming within blood vessels, including: • heart attacks caused by blood clots in the arteries of the heart (myocardial infarction) • blood clots in the arteries of the lung (pulmonary embolism) • stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke). Actilyse contains the active ingredient alteplase. It belongs to a group of medicines called thrombolytic agents. Actilyse works by dissolving clots in the blood vessels. These clots cause disease by interfering with normal blood flow. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN ACTILYSE _WHEN YOU MUST NOT BE GIVEN _ _IT _ YOU SHOULD NOT BE GIVEN ACTILYSE IF YOU HAVE AN ALLERGY TO: • any medicine containing alteplase (the active ingredient in Actilyse) • gentamycin (an antibiotic) • any of the ingredients listed at the end of this leaflet. Some of the sympto Olvassa el a teljes dokumentumot
Actilyse NZ DS v06 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ACTILYSE 10 mg powder and solvent for solution for injection and infusion ACTILYSE 20 mg powder and solvent for solution for injection and infusion ACTILYSE 50 mg powder and solvent for solution for injection and infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTILYSE 10 mg 1 vial contains: 10 mg alteplase in 466.6 mg dry substance 1 vial of solvent contains: 10 mL sterilised water for injection. ACTILYSE 20 mg 1 vial contains: 20 mg alteplase in 933.2 mg dry substance 1 vial of solvent contains: 20 mL sterilised water for injection. (Not marketed) ACTILYSE 50 mg 1 vial contains: 50 mg alteplase in 2333 mg dry substance 1 vial of solvent contains: 50 mL sterilised water for injection. Alteplase is produced by recombinant DNA technique using a Chinese hamster ovary cell-line. The specific activity of alteplase in-house reference material is 580,000 IU/mg. This has been confirmed by comparison with the second international WHO standard for t-PA. The specification for the specific activity of alteplase is 522,000 to 696,000 IU/mg. For the full list of excipients, see section 6.1. The reconstituted solution contains 1 mg alteplase per mL. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection and infusion. The powder is presented as a colourless to pale yellow lyophilisate cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute Myocardial Infarction ACTILYSE is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality. • 90 minutes (accelerated) dose regimen (see section 4.2): for patients in whom treatment can be started within 6 h of symptom onset; • 3 hour dose regimen (see section 4.2): for patients in whom treatment can be started between 6 - 12 hrs after symptom onset. Acute Massive Pulmonary Embolism ACTILYSE is also indicated in patients with acute massive pulmonary em Olvassa el a teljes dokumentumot