Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Interferon gamma-1b, Quantity: 4 million IU/mL
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Injection, solution
Excipient Ingredients: succinic acid; sodium succinate hexahydrate; mannitol; water for injections; polysorbate 20
Subcutaneous
6 x 0.5mL vial, 1 x 0.5mL vial
(S4) Prescription Only Medicine
As an adjunct for reduction of the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD). The benefits of Imukin have been most marked in children with CGD although Imukin may be used in adult patients.
Visual Identification: Colourless to pale yellow, clear to slightly opalescent solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1994-04-08
Imukin CMI 1 IMUKIN® _Interferon gamma-1b _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Imukin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Imukin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IMUKIN IS USED FOR Interferons are substances which are normally produced by the body and which play a role in the body's response to infection. Interferon gamma-1b is just one of several types of interferon. Imukin contains interferon gamma-1b which is produced in the laboratory by recombinant technology. It modifies the body's response to infection in the same way as naturally-occurring interferon gamma. Chronic Granulomatous Disease (CGD) is a rare disorder in which the body's own natural defence against infection is not working properly. Imukin is used with other treatments to reduce the frequency of serious infections in people with CGD. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU USE IMUKIN _WHEN YOU MUST NOT USE IT _ DO NOT USE IMUKIN IF YOU HAVE AN ALLERGY TO: • any medicine containing interferons • any of the ingredients listed at the end of this leaflet • any other similar medicines. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breat Preberite celoten dokument
Imukin Product Information v4.0 1 1 NAME OF THE MEDICINE Interferon Gamma-1b recombinant human. 2 QUALITATIVE AND QUANTITATIVE INFORMATION Vials containing 2 x 10 6 IU (100 g) interferon gamma-1b (rbe) per 0.5mL. Imukin (interferon gamma - 1b [rbe]), a biologic response modifier, is a single-chain polypeptide containing 140 amino acids. Production of Imukin is achieved by fermentation of a genetically engineered _Escherichia coli _bacterium containing the DNA which encodes the human protein. Purification of the product is achieved by conventional column chromatography. Imukin is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 Dalton monomers, with a specific activity of 20 million IU/mg. List of excipients: For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imukin is indicated as an adjunct for reduction of the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD). The benefits of Imukin have been most marked in children with CGD although Imukin may be used in adult patients. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dosage of Imukin for injection for the treatment of patients with CGD is 1 x 10 6 IU (50 g)/m 2 for patients whose body surface area is greater than 0.5m 2 , and 3 x 10 4 IU (1.5 g)/kg/dose for patients whose body surface area is equal to or less than 0.5m 2 . Care should be taken to ensure accurate adjustment of the volume of solution drawn into the syringe prior to injection. Injections should be administered subcutaneously three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and the left deltoid region and anterior thigh. Imukin can be administered by a physician, nurse, family member or patient once they are trained in the administration of subcutaneous injections. Treatment with Imukin should continue in the event of infectious compl Preberite celoten dokument