CELEBREX Capsule, hard (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Celebrex 100 mg capsules, hard.
Qualitative and quantitative composition
Each capsule contains 100 mg celecoxib. Excipient with known effect: Lactose (each capsule contains 149.7 mg lactose monohydrate; see section 4.4). For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. Opaque, white with two blue bands marked 7767 and 100.
Therapeutic indications
Celebrex is indicated in adults for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective cyclooxygenase-2 (COX-2) ...
Posology and method of administration
Posology As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patients need ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known hypersensitivity to sulfonamides. Active peptic ulceration or gastrointestinal (GI) bleeding. Patients ...
Special warnings and precautions for use
Gastrointestinal (GI) effects Upper and lower gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Anticoagulants Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin ...
Fertility, pregnancy and lactation
Pregnancy Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see sections 4.3 and 5.3). Inhibition of prostaglandin synthesis might adversely affect pregnancy. ...
Effects on ability to drive and use machines
Patients who experience dizziness, vertigo or somnolence while taking Celebrex should refrain from driving or operating machinery.
Undesirable effects
Adverse reactions are listed by system organ class and ranked by frequency in Table 1, reflecting data from the following sources: Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis ...
Overdose
There is no clinical experience of overdose. Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant ...
Pharmacodynamic properties
Pharmacotherapeutic group: Non-steroidal anti-inflammatory and antirheumatic drugs, NSAIDs, Coxibs ATC code: M01AH01 Mechanism of action Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor ...
Pharmacokinetic properties
Absorption Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours. Dosing with food (high fat meal) delays absorption of celecoxib by about 1 hour resulting in a T ...
Preclinical safety data
Non-clinical safety data revealed no special hazard for humans based on conventional studies of repeated dose toxicity, mutagenicity or carcinogenicity beyond those addressed in section 4.4, 4.6, and 5.1 ...
List of excipients
Capsules content: Lactose monohydrate Sodium laurilsulfate Povidone Croscarmellose sodium Magnesium stearate Capsule shells: Gelatin Titanium dioxide E171 Sodium laurilsulfate Sorbitan monolaurate Printing ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Clear or opaque PVC/aluminium blisters. Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, 5x(10x10). Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1275
Date of first authorization / renewal of the authorization
03/05/2011
Date of revision of the text
10 October 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
