البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Tenecteplase 40mg (recombinant)
Boehringer Ingelheim (NZ) Limited
Tenecteplase 40 mg (recombinant)
40 mg
Powder for injection
Active: Tenecteplase 40mg (recombinant) Excipient: Arginine Phosphoric acid Polysorbate 20 Water for injection
Combination pack, vial and diluent syringe, 1 dose unit
Prescription
Prescription
Boehringer Ingelheim Pharma GmbH & Co KG
METALYSE is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (AMI). Treatment should be initiated as soon as possible after symptom onset. Treatment can be initiated within 12 hours of symptom onset.
Package - Contents - Shelf Life: Combination pack, vial and diluent syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, TopPac, Diluent, ex-BI - 10 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, type 1 - 20 mL - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
1999-09-29
NEW ZEALAND CONSUMER MEDICINE INFORMATION METALYSE ® _TENECTEPLASE_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about METALYSE. 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 METALYSE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. 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 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 information with the medicine. You may need to read it again. WHAT METALYSE IS USED FOR METALYSE is used during the early stages of a heart attack. METALYSE 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 METALYSE has been prescribed for you. Your doctor may have prescribed METALYSE for another reason. BEFORE BEING GIVEN METALYSE _WHEN YOU MUST NOT BE GIVEN IT_ _ _ You must not be given METALYSE if you have or have had: • an allergy to any medicine containing tenecteplase; gentamicin (a trace residue from the manufacturing process) or to any of the ingredients listed at the end of this leaflet • current bleeding or severe bleeding in the past 6 months • current treatment with an anticlotting agent (anticoagulant), such as warfarin, unless its effect has had time to wear off • major surgery, biopsy or significant trauma in the past 2 months • a stroke due to bleeding in the brain or a stroke of unknown origin at any time • a stroke caused by a blood clot or a transient ischaemic attack (TIA) in the past 6 months • severe and uncontrolled high blood pressure (hypertension) • tum اقرأ الوثيقة كاملة
METALYSE NZ DS v02 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME METALYSE 40 mg powder and solvent for solution for injection METALYSE 50 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION METALYSE 40 mg: 1 vial containing 8,000 units (40 mg) tenecteplase.1 prefilled syringe containing 8 mL water for injection. (Not marketed) METALYSE 50 mg: 1 vial contains 10,000 units (50 mg) tenecteplase. 1 prefilled syringe containing 10 mL water for injection. The reconstituted solution contains 1,000 units (5 mg) tenecteplase per mL. Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents. Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white powder and solvent for solution for injection. Reconstitution results in a colourless to pale yellow, transparent, clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS METALYSE is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (AMI). Treatment should be initiated as soon as possible after symptom onset. Treatment can be initiated within 12 hours of symptom onset. 4.2 DOSE AND METHOD OF ADMINISTRATION METALYSE should be administered as early as possible after symptom onset on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase). The volume required to administer the correct dose can be calculated from the following scheme: Patients' body weight category (kg) Tenecteplase (U) Tenecteplase (mg) Volume of reconstituted solution (mL) < 60 6,000 30 6 ≥ 60 to < 70 7,000 35 7 ≥ 70 to < 80 8,000 40 8 ≥ 80 to < 90 9,000 45 9 ≥ 90 10,000 50 10 METALYSE NZ DS v02 2 Adjunctive Therapy Antithrombotic adjunctive therapy is recommended according to the current international guidelines اقرأ الوثيقة كاملة