Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
PIRFENIDONE
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AX05
HARD CAPSULE
PIRFENIDONE 267 MG
PER OS
Required
F. HOFFMANN-LA ROCHE LTD.
PIRFENIDONE
Esbriet is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF).27/01/2019 בקשה לתוספת התויה Renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment. Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment.
2015-07-29
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ESBRIET ® 267 MG HARD CAPSULES Composition: EACH CAPSULE CONTAINS: Pirfenidone 267 mg INACTIVE INGREDIENTS SEE IN SECTION 6 ”FURTHER INFORMATION”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet; you may need to read it again. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. This medicine is not intended for children and adolescents under 18 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? ESBRIET contains the active ingredient PIRFENIDONE and is used for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adults. THERAPEUTIC GROUP: ESBRIET is an immunosuppressant. Idiopathic pulmonary fibrosis is a condition in which the lung tissues become swollen and scarred over time and as a result, it is difficult to breathe deeply. This makes it hard for the lungs to function properly. ESBRIET helps to reduce scarring and swelling in the lungs, and helps you breathe better. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: ∙ you are allergic to the active ingredient pirfenidone, or to any of the additional ingredients of the medicine mentioned in section 6 ”Further Information” ∙ you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with breathing difficulties and wheezing ∙ you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder) ∙ you have a severe or end-stage liver disease ∙ you have a severe or end-stage kidney disease requiring dialysis If any of the aforementioned conditions apply to Διαβάστε το πλήρες έγγραφο
1 Ref: EU SPC and PIL EMEA/H/C/002154/X/0035/G Esbriet PI Ver 3 ע עבקנ הז ןולע טמרופ " תואירבה דרשמ י , ודי לע רשואו קדבנ ונכות ב יאמ 2017 ESBRIET ® r pirfenidone HARD CAPSULES 267 MG 1. NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 267 mg pirfenidone._ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. Posology _Adults_ Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine capsules per day over a 14-day period as follows: Days 1 to 7: one capsule, three times a day (801 mg/day) Days 8 to 14: two capsules, three times a day (1602 mg/day) Day 15 onward: three capsules, three times a day (2403 mg/day) The recommended maintenance daily dose of Esbriet is three 267 mg capsules three times a day with food for a total of 2403 mg/day. Doses above 2403 mg/day are not recommended for any patient (see section 4.9). 2 Ref: EU SPC and PIL EMEA/H/C/002154/X/0035/G Esbriet PI Ver 3 Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose. _ _ For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration. _Dose adjustments and other considerations for safe use _ _Gastrointestinal events:_ In patients who experien Διαβάστε το πλήρες έγγραφο