Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
Nadroparin calcium, Quantity: 19000 anti-Xa IU
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: calcium hydroxide; water for injections
Subcutaneous
6 Syringes, 10 Syringes, 2 Syringes
(S4) Prescription Only Medicine
Treatment of deep vein thrombosis.
Visual Identification: Syringe containing a clear to slightly opalescent, colourless or slightly coloured solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1998-12-14
Fraxiparine ® Forte Injection FRAXIPARINE ® FORTE INJECTION _nadroparin calcium_ _19,000 IU anti-Xa / mL solution for injection_ _ _ AUSTRALIAN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fraxiparine Forte injections. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or nurse. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Fraxiparine Forte against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT This medicine is available only with a doctor's prescription. There is not enough information to recommend how the use of this medicine can affect your ability to drive a car or operate machinery. There is not enough information to recommend the use of this medicine for patients aged less than 18 years. Therefore, Fraxiparine Forte is not recommended for use in children or adolescents. BEFORE YOU USE FRAXIPARINE FORTE • have an increased risk of bleeding or a bleeding disorder • have a history of ulcers in the stomach or intestine • have had a burst blood vessel in your brain • have infective endocarditis (an infection of the lining of the heart) • have severe kidney failure and are being treated for a blood clot DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE CARTON OR IF THE PACKAGING IS TORN OR SHOWS TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. SIGNS OF TAMPERING. KEEP THIS LEAFLET WITH THE INJECTION. You may need to read it again. WHAT FRAXIPARINE FORTE IS USED FOR Fraxiparine Forte belongs to a group of medicines called Low Molecular Weight Heparins. Fraxiparine Forte is used to treat existing blood clots that are blocking blood vessels. It is a medicine that works by delaying the action by which blood clots form. This results in the blood remaining thin and prevents formation of clots which may become lodged in blood vessels and treats blood clots if they have already formed. _WHEN YOU MUST Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION - FRAXIPARINE ® FORTE (NADROPARIN CALCIUM) 1. NAME OF THE MEDICINE Nadroparin calcium 2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Sterile, clear preservative-free solution for subcutaneous injection containing nadroparin calcium 19,000 IU anti-Xa per 1.0 mL dissolved in water for injections. Nadroparin is a low molecular weight heparin made by depolymerisation of standard heparin. It is a glycosaminoglycan with a mean molecular weight around 4,500 daltons. It possesses a high ratio of anti-Xa activity to anti-IIa activity, between 2.5 to 4.0 compared to unfractionated heparin for which this ratio is one. Anti-Xa denotes anti factor Xa activity. The ratio of anti-Xa to anti-IIa activity is 2.5 to 4.0. One ICU is equivalent to 0.38 IU anti-Xa. The excipients contained in the Fraxiparine Forte solution are: Calcium hydroxide solution or dilute hydrochloric acid (to adjust pH) and water for injections. For the full list of excipients, see Section 6.1 List of excipients. Disposable glass pre-filled single use syringes containing a clear solution for subcutaneous injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of deep vein thrombosis (DVT). 4.2 DOSE AND METHOD OF ADMINISTRATION Particular attention should be paid to the specific dosing instructions for each proprietary LMWH as different units of measurement (units or mg) are used to express doses. Fraxiparine Forte should therefore not be used interchangeably with other low weight molecular weight heparins during ongoing treatment. In addition, care should be taken to use the correct formulation of nadroparin, either Fraxiparine or Fraxiparine Forte, as this will affect the dosing regimen. Platelet count must be monitored throughout treatment with Fraxiparine Forte (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Specific recommendations regarding the timing of Fraxiparine Forte dosing surrounding spinal/epidural anaesthesia or spinal lumbar puncture should be followed (see 4.4 S Perskaitykite visą dokumentą