Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
Nonacog alfa, Quantity: 250 IU
Pfizer Australia Pty Ltd
factor IX (Recombinant)
Injection, powder for
Excipient Ingredients: polysorbate 80; histidine; glycine; sucrose
Intravenous
1 x powder for injection vial + 1 x diluent syringe
(S4) Prescription Only Medicine
BeneFIX is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (e.g. factors II, VII and X), nor for the treatment of haemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.
Visual Identification: Lyophilised white powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2007-09-27
BENEFIX ® B e n e F I X ® 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 BENEFIX? BeneFIX contains the active ingredient nonacog alfa, a coagulation factor IX product. BeneFIX is used to control and treat bleeding and prevent bleeding in people with haemophilia B. People with haemophilia B are deficient in coagulation factor IX. For more information, see Section 1. Why am I using BeneFIX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BENEFIX? Do not use BeneFIX if you have had an allergic reaction to nonacog 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, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use BeneFIX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BeneFIX and affect how it works. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BENEFIX? • BeneFIX comes in five dosage strengths. Your doctor will prescribe the dosage strength and dose that is right for you. • BeneFIX is given by injection directly into your veins. • The BeneFIX powder needs to be reconstituted (made-up) before use. Use only the materials provided in the pack for dissolving the BeneFIX powder with the sodium chloride solution and injecting the made-up BeneFIX solution. • Your doctor, nurse or pharmacist will show you how to use BeneFIX before you use it for the first time. More instructions can be found in Section 4. How do I use BeneFIX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BENEFIX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using BeneFIX. • See your doctor immediately if your bleeding does not stop as expected. • St Lue koko asiakirja
Version: pfpbenev10719 Supersedes: pfpbenev10217 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – BENEFIX ® (NONACOG ALFA) 1. NAME OF THE MEDICINE Nonacog alfa 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The potency (in international units, IU) is determined using an _in vitro_ one-stage clotting assay against the World Health Organisation (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX is not derived from human blood and contains no preservatives or added animal or human components. BeneFIX is inherently free from the risk of transmission of human blood-borne pathogens such as HIV, hepatitis viruses and parvovirus. BeneFIX is formulated as a sterile, non-pyrogenic, lyophilised powder preparation. BeneFIX is intended for intravenous (IV) injection. It is available in single use vials containing the labelled amount of factor IX activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 2000 or 3000 IU of nonacog alfa. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM Sterile, lyophilised white powder for injection. All dosage strengths yield a clear, colourless solution upon reconstitution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BeneFIX is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (e.g. factors II, VII and X), nor for the treatment of haemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors. Version: pfpbenev10719 Supersedes: pfpbenev10217 Page 2 of 14 4.2 DO Lue koko asiakirja