Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
nintedanib esilate, Quantity: 120.4 mg (Equivalent: nintedanib, Qty 100 mg)
Boehringer Ingelheim Pty Ltd
nintedanib esilate
Capsule, soft
Excipient Ingredients: Hard fat; lecithin; glycerol; iron oxide red; Gelatin; medium chain triglycerides; titanium dioxide; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
60 soft capsules
(S4) Prescription Only Medicine
OFEV is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy.,OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).,OFEV is also indicated for the treatment of other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype.,OFEV is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Visual Identification: Peach-coloured, opaque, oblong, soft gelatin capsules imprinted in black on one side with the Boehringer Ingelheim company logo and 100; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-09-01
OFEV ® _SOFT CAPSULES_ _nintedanib (as esilate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ofev. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ofev against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING 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 (Australia) and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OFEV IS USED FOR Ofev contains the active ingredient nintedanib (as esilate). Nintedanib is a tyrosine kinase inhibitor that works by blocking the activity of a group of proteins which are involved in the building and the growth of blood vessels. These blood vessels are necessary to provide growing cancer cells with nutrients and oxygen. By blocking the activity of these proteins, nintedanib can inhibit the growth and the spread of cancer cells. Ofev is used in combination with the chemotherapy docetaxel to treat a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC). It is used in adult patients with a certain type of lung cancer called adenocarcinoma who have already received one treatment with another medicine to treat this cancer but whose tumour started to grow again. Ofev is also used for the treatment of 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. Ofev helps to reduc Aqra d-dokument sħiħ
OFEV PI0153-14 1 AUSTRALIAN PRODUCT INFORMATION – OFEV ® NINTEDANIB (AS ESILATE) CAPSULES 1 NAME OF THE MEDICINE nintedanib esilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OFEV are soft gelatin capsules for oral administration containing 100 mg or 150 mg nintedanib (as nintedanib esilate). Excipients with known effect: Each OFEV 100 mg capsule contains 1.2 mg of soya lecithin. Each OFEV 150 mg capsule contains 1.8 mg of soya lecithin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM OFEV 100 mg capsules are peach-coloured, opaque, oblong, soft gelatin capsules imprinted in black on one side with the Boehringer Ingelheim company logo and “100”. The capsules contain a bright yellow viscous suspension. OFEV 150 mg capsules are brown-coloured, opaque, oblong, soft gelatin capsules imprinted in black on one side with the Boehringer Ingelheim company logo and “150”. The capsules contain a bright yellow viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OFEV is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy. OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). OFEV is also indicated for the treatment of other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype. OFEV is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION OFEV capsules should be taken orally, preferably with food, swallowed whole with water, and should not be chewed. If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed, the patient should not be given an additional dose. The capsule should not be opened or crushed. If contact wi Aqra d-dokument sħiħ