Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
Nadroparin calcium, Quantity: 5700 anti-Xa IU
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: calcium hydroxide; water for injections
Subcutaneous
2 x 0.6mL, 10 x 0.6mL
(S4) Prescription Only Medicine
Prophylaxis against deep vein thrombosis (DVT) associated with general or orthopaedic surgery. Treatment of DVT. Prevention of clotting during haemodialysis. Prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.
Visual Identification: Syringe containing a clear to slightly opalescent, colourless or slightly yellow 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
1995-09-11
Fraxiparine ® Injection FRAXIPARINE ® INJECTION _nadroparin calcium_ _9,500 IU anti-Xa / mL solution for injection_ _ _ AUSTRALIAN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fraxiparine 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 against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE INJECTION. You may need to read it again. WHAT FRAXIPARINE IS USED FOR Fraxiparine belongs to a group of medicines called Low Molecular Weight Heparins. Fraxiparine is used to prevent the blood from clotting after having surgery, during haemodialysis, during hospitalisation for acute illness or in intensive care unit with extended bed rest and is also 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. 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 is not recommended for use in children or adolescents. BEFORE YOU USE FRAXIPARINE _WHEN YOU MUST NOT USE IT_ DO NOT USE FRAXIPARINE IF YOU HAVE AN ALLERGY TO: • any medicine containing nadroparin calcium • heparin or low-molecular weight heparins • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • whee Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION - FRAXIPARINE ® (NADROPARIN CALCIUM) 1 . NAME OF THE MEDICINE Nadroparin calcium 2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Sterile, clear preservative-free solution containing nadroparin calcium 9,500 IU anti-Xa/mL per 1.0mL dissolved in water for injections with sufficient calcium hydroxide or dilute hydrochloric acid to adjust the pH to between 5 and 7.5. The excipients contained in the Fraxiparine 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 usually for subcutaneous injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis against deep vein thrombosis (DVT) associated with general or orthopaedic surgery. Treatment of DVT. Prevention of clotting during haemodialysis. Prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit. 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 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 (see See Section 4.4 Special warnings and precautions for use). Specific recommendations regarding the timing of Fraxiparine dosing surrounding spinal/epidural anaesthesia or spinal lumbar puncture should be followed (see See Section 4.4 Special warnings and precautions for use). ADMINISTRATION Usually by subcutaneous injection into the lateral abdom Прочитать полный документ