ESBRIET Hard capsule (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Esbriet 267 mg hard capsules.
Qualitative and quantitative composition
Each capsule contains 267 mg pirfenidone. For the full list of excipients, see section 6.1.
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. ...
Therapeutic indications
Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of angioedema with pirfenidone (see section 4.4). Concomitant use of fluvoxamine (see section 4.5). ...
Special warnings and precautions for use
Hepatic function Elevations in ALT and AST >3 × upper limit of normal (ULN) have been reported in patients receiving therapy with Esbriet. Rarely these have been associated with concomitant elevations ...
Interaction with other medicinal products and other forms of interaction
Approximately 70–80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1. Consumption of grapefruit juice is associated with ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Esbriet in pregnant women. In animals placental transfer of pirfenidone and/or its metabolites occurs with the potential for accumulation of pirfenidone and/or ...
Effects on ability to drive and use machines
Esbriet may cause dizziness and fatigue, which could have a moderate influence on the ability to drive or use machines, therefore patients should exercise caution when driving or operating machinery if ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions during clinical study experience with Esbriet at a dose of 2,403 mg/day compared to placebo, respectively, were nausea (32.4% ...
Overdose
There is limited clinical experience with overdose. Multiple doses of pirfenidone up to a total dose of 4,806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, other immunosuppressants ATC code: L04AX05 The mechanism of action of pirfenidone has not been fully established. However, existing data suggest that pirfenidone ...
Pharmacokinetic properties
Absorption Administration of Esbriet capsules with food results in a large reduction in C<sub>max</sub> (by 50%) and a smaller effect on AUC, compared to the fasted state. Following oral administration ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In repeated dose toxicity studies ...
List of excipients
Capsule content: Microcrystalline cellulose Croscarmellose sodium Povidone Magnesium stearate Capsule shell: Titanium dioxide (E171) Gelatin Printing Inks: Brown S-1-16530 or 03A2 inks containing: Shellac ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years for blisters. 3 years for bottles.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Pack sizes 2-week treatment initiation pack: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Marketing authorization number(s)
EU/1/11/667/001 EU/1/11/667/002 EU/1/11/667/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 February 2011 Date of latest renewal: 08 September 2015
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