Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Nintedanib esilate
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
Nintedanib esilate
60capsule Capsules; 120capsule Capsules
Catalent Germany Eberbach GmbH
OFEV ® SOFT CAPSULES Nintedanib (100 mg, 150 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What OFEV is used for 2. How OFEV works 3. Before you use OFEV 4. How to use OFEV 5. While you are using it 6. Side effects 7. Storage and Disposal of OFEV 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number 1. WHAT OFEV IS USED FOR OFEV is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF). OFEV is used to treat people with other chronic (long lasting) fibrosing interstitial lung diseases (ILDs) in which lung fibrosis continues to worsen (progressive phenotype). OFEV is used to slow the rate of decline in lung function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 2. HOW OFEV WORKS OFEV capsules contain the active substance nintedanib, a medicine belonging to the class of tyrosine kinase inhibitors. _Idiopathic pulmonary fibrosis (IPF) _ IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply. _Other chronic fibrosing interstitial lung _ _diseases (ILDs) with a progressive _ _phenotype _ Besides IPF, there are other conditions in which the tissue in your lungs becomes thickened, stiff, and scarred over time (lung fibrosis) and keeps worsening (progressive phenotype). Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. rheumatoid arthritis associated ILD), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. _Systemic sclerosis associated interstitial _ _lung disease (SSc-ILD) _ Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic autoimmune disease that affects connective tissue in many parts of the body. SSc causes fibrosis of the skin and other internal organs such as the lungs. When the Přečtěte si celý dokument
1 | P a g e Ofev ® Abcd 1. NAME OF THE MEDICINAL PRODUCT OFEV Soft Capsules 100 mg OFEV Soft Capsules 150 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 100 mg nintedanib (as esilate) One capsule contains 150 mg nintedanib (as esilate) Excipient of animal origin: Gelatin (porcine) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. 100 mg capsules: Peach-colored, opaque, oblong, soft gelatin capsules, imprinted in black on one side with Boehringer Ingelheim company symbol and with“100”, and containing a bright yellow viscous suspension. 150 mg capsules: Brown-colored, opaque, oblong, soft gelatin capsules, imprinted in black on one side with Boehringer Ingelheim company symbol and with“150”, and containing a bright yellow viscous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OFEV is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF). OFEV is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1 “Clinical Trials”). OFEV is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis- associated interstitial lung disease (SSc-ILD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Treatment should be initiated by physicians experienced in the diagnosis and treatment of conditions for which OFEV is indicated. Posology The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart. The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. 2 | P a g e If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded. _Dose adjustments _ In addition to symptomatic treatment if applicable, the management of adverse effe Přečtěte si celý dokument