Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
INTERFERON GAMMA
Boehringer Ingelheim Limited
L03AB03
INTERFERON GAMMA
International Unit
Solution for Injection
Product subject to prescription which may not be renewed (A)
Interferons
Transfer Pending
1993-01-14
PACKAGE LEAFLET: INFORMATION FOR THE USER IMMUKIN® 2 X 10 6 IU (0.1 MG) SOLUTION FOR INJECTION Active substance: recombinant human interferon gamma-1b READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if the symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What IMMUKIN is and what it is used for 2. Before you use IMMUKIN 3. How to use IMMUKIN 4. Possible side effects 5. How to store IMMUKIN 6. Further information 1. WHAT IMMUKIN IS AND WHAT IT IS USED FOR IMMUKIN contains a substance called recombinant human interferon gamma-1b. Interferons are so-called immunomodulators. These are small proteins that can stimulate the body’s immune system defences. They protect against micro-organisms (e.g. bacteria, viruses and fungi) that can cause disease. IMMUKIN is for use by patients with chronic granulomatous disease (CGD). CGD is a defect in the metabolism of neutrophils, a type of white blood cell. These normally kill invading bacteria or fungi. The defect with CGD makes neutrophils less able to prevent infections. IMMUKIN is used to reduce the number of serious infections that may occur with this disease. IMMUKIN is also used in patients with severe, progressive marble bone disease (osteopetrosis). This is an inherited defect in bone cells, which leads to excessive, abnormal bone growth. It also affects the bone marrow and the blood cells that are usually formed in it. As a result, patients with osteopetrosis are also at risk of serious infections. 2. BEFORE YOU USE IMMUKIN DO NOT USE IMMUKIN • if you are allergic (hypersensitive) to interferon gamma or to other related Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Immukin 2 x 10 6 IU (0.1 mg) solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial (0.5 ml) contains 2 x 10 6 IU (0.1 mg) recombinant human interferon gamma-1b. Interferon gamma-1b is produced in an _E. coli _expression system. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Immukin is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) (see also section 4.4). Immukin is indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis (see also section 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Immukin is for subcutaneous use. The recommended dosage of Immukin for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg / m 2 for patients whose body surface area is greater than 0.5 m 2 and 1.5 mcg / kg / dose for patients whose body surface area is equal to or less than 0.5 m 2 . The actually drawn volume has to be controlled before injection. Injections should be administered subcutaneously preferably in the evening three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and the left deltoid and anterior thigh. Immukine can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections. Although the most beneficial dose of Immukin is not known yet higher doses are not recommended. Safety and efficacy has not been established for Immukine given in doses greater or less than the recommended dose o Read the complete document