Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Moroctocog alfa, Quantity: 500 IU
Pfizer Australia Pty Ltd
Moroctocog alfa
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intravenous
1's
Not scheduled. Not considered by committee
The control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings. XYNTHA does not contain von Willebrand factor and should not be used by patients with von Willebrand's disease.
Visual Identification: Clear, colourless solution; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2011-10-04
XYNTHA ® X Y N T H A ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING XYNTHA? XYNTHA contains the active ingredient moroctocog alfa, a coagulation factor VIII product. XYNTHA is used to control and treat bleeding and prevent bleeding in people with haemophilia A. People with haemophilia A are deficient in coagulation factor VIII. For more information, see Section 1. Why am I using XYNTHA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE XYNTHA? Do not use XYNTHA if you have had an allergic reaction to moroctocog alfa, hamster proteins or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, are on a low salt diet, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use XYNTHA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with XYNTHA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE XYNTHA? • XYNTHA comes in five dosage strengths. Your doctor will decide the dosage strength and dose that you will receive. • XYNTHA is given by injection directly into your veins. It should be injected using the infusion set provided in the pack. • XYNTHA is supplied as a freeze-dried powder. Before it can be injected into your vein it must be mixed with 0.9% sodium chloride solution. • Your doctor, nurse or pharmacist will show you how to prepare and give an injection of XYNTHA. More instructions can be found in Section 4. How do I use XYNTHA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING XYNTHA? THINGS YOU SHOULD DO • Remind any doctor, dentist and pharmacist you visit that you are using XYNTHA. • Contact your doctor immediately if your bleeding does not stop as expected. • Sto Read the complete document
Version: pfpxyntv10719 Supersedes: pfpxyntv10117 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION – XYNTHA ® (MOROCTOCOG ALFA) POWDER FOR INJECTION 1. NAME OF THE MEDICINE moroctocog alfa 2. QUALITATIVE AND QUANTITATIVE COMPOSITION XYNTHA is formulated as a sterile, non-pyrogenic, lyophilised powder for intravenous (IV) injection. It is available in single use vials and in single use prefilled dual chamber syringes containing the labelled amount of factor VIII activity, expressed in IUs. Each vial contains nominally 250, 500, 1000 or 2000 IU of XYNTHA per vial. Each prefilled dual chamber syringe contains nominally 250, 500, 1000, 2000 or 3000 IU of XYNTHA per syringe. Each vial/prefilled dual chamber syringe of XYNTHA contains 1.23 mmol (or 29 mg) sodium, to be taken into consideration by patients on a controlled sodium diet. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM Powder for injection. The product reconstituted with 4 mL Sodium Chloride Diluent [(9 mg/mL (0.9%)] is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XYNTHA is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings. XYNTHA does not contain von Willebrand factor and should not be used by patients with von Willebrand’s disease. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with XYNTHA should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. Individual patients may Version: pfpxyntv10719 Supersedes: pfpxyntv10117 Page 2 of 15 vary in their response to factor VIII, achieving different levels of recovery and demonstrating different half-lives. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher d Read the complete document