Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Enoxaparin sodium 150 mg/mL;
AFT Pharmaceuticals Ltd
150 mg/mL
Solution for injection
Active: Enoxaparin sodium 150 mg/mL Excipient: Water for injection
Prescription
Treatment of venous thromboembolic disease.
Package - Contents - Shelf Life: Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, with automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 1 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze - Syringe, 0.8 mL Type 1 glass with chlorobutyl rubber stopper, without automatic safety - 30 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze
2016-02-29
Page 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION CRUSIA-AFT ® AND CRUSIA-AFT ® FORTE* _ENOXAPARIN SODIUM 100 MG/ML AND 150 MG/ML SOLUTION FOR INJECTION _ _* Subsequent references to "Crusia-AFT" refer to both Crusia-AFT and Crusia-AFT Forte. _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Crusia-AFT. 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 Crusia- AFT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT CRUSIA-AFT IS USED FOR Crusia-AFT is used in a number of medical conditions. It is used to: treat blood clots treat certain types of heart disease (e.g. angina and heart attacks), when used with aspirin prevent blood clots forming after an operation, during hospitalisation or extended bed rest or during purification of the blood by an artificial kidney (haemodialysis). Crusia-AFT is one of a group of medicines called low molecular weight heparins (LMWHs). These medicines work by reducing blood clotting activity. Your doctor may have prescribed Crusia-AFT for another reason. Ask your doctor if you have any questions about why Crusia-AFT has been prescribed for you. There is no evidence that Crusia-AFT is addictive. This medicine is only available with a doctor's prescription. Page 2 BEFORE YOU ARE GIVEN CRUSIA-AFT _ _ _WHEN YOU MUST NOT USE IT _ _ _ DO NOT USE CRUSIA-AFT IF YOU HAVE AN ALLERGY TO CRUSIA-AFT, HEPARIN OR ITS DERIVATIVES INCLUDING OTHER LMWHS. SOME SIGNS AND SYMPTOMS OF AN ALLERGIC REACTION CAN INCLUDE SWELLING OF THE FACE, LIPS OR TONGUE, WHEEZING OR TROUBLED BREATHING, SKIN RASH, ITCHING HIVES, BLISTERS OR PEELING SKIN. DO NOT USE CRUSIA-AFT IF YOU HAVE, OR HAVE EVER HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: major blood disorders c Preberite celoten dokument
Page 1 of 24 NEW ZEALAND DATA SHEET 1. CRUSIA-AFT AND CRUSIA-AFT FORTE Crusia-AFT 100 mg/mL solution for injection Crusia-AFT Forte 150 mg/mL solution for injection. Crusia-AFT and Crusia-AFT Forte are biosimilar medicines. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Crusia-AFT 100 mg/mL solution for injection: Each 0.2 mL prefilled syringe contains 20 mg (anti-Xa: 2,000 IU) enoxaparin sodium. Each 0.4 mL prefilled syringe contains 40 mg (anti-Xa: 4,000 IU) enoxaparin sodium. Each 0.6 mL prefilled syringe contains 60 mg (anti-Xa: 6,000 IU) enoxaparin sodium. Each 0.8 mL prefilled syringe contains 80 mg (anti-Xa: 8,000 IU) enoxaparin sodium. Each 1 mL prefilled syringe contains 100 mg (anti-Xa: 10,000 IU) enoxaparin sodium. Crusia-AFT Forte 150 mg/mL solution for injection: Each 0.8 mL prefilled syringe contains 120 mg (anti-Xa: 12,000 IU) enoxaparin sodium. Each 1 mL prefilled syringe contains 150 mg (anti-Xa: 15,000 IU) enoxaparin sodium. Enoxaparin sodium is a biological substance obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. For the full list of excipients, see section 6.1. Crusia-AFT* is a biosimilar medicine. The prescribing physician should be involved in any decision regarding interchangeability with other products. Additional information is available on the following website (http://www.medsafe.govt.nz/profs/RIss/Biosimilars.asp). Data comparing Crusia-AFT to Clexane can be found in section 5.1 of this datasheet. *Any subsequent reference to Crusia-AFT refers to both Crusia-AFT and Crusia-AFT Forte. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS Page 2 of 24 4.1 THERAPEUTIC INDICATIONS Crusia-AFT is indicated in adults for: Prophylaxis of venous thromboembolic disease, in particular those which may be associated with orthopaedic, general, major colorectal or cancer surgery. Prophylaxis of venous thromboembolism in general medical patients bedridden due to acute illnesses inclu Preberite celoten dokument