SUPRAX Film-coated tablet (2019)
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
Suprax Tablets 200mg.
Qualitative and quantitative composition
Each tablet contains 200mg cefixime (anhydrous). For the full list of excipients, see section 6.1.
Pharmaceutical form
Convex, off-white, film-coated tablets engraved with ORO on one side. For oral administration.
Therapeutic indications
Suprax is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms. It is indicated for the treatment ...
Posology and method of administration
The usual course of treatment is 7 days. This may be continued for up to 14 days if required. Posology Adults and Children over 10 Years or weighing more than 50 kg The recommended adult dosage is 200-400 ...
Contraindications
Hypersensitivity to cephalosporin antibiotics or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Encephalopathy Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly ...
Interaction with other medicinal products and other forms of interaction
Anticoagulants In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy. Cefixime ...
Pregnancy and lactation
Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, ...
Effects on ability to drive and use machines
In the case of side effects such as encephalopathy (which may include convulsion, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle. ...
Undesirable effects
Suprax is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. The following adverse reaction (Preferred term# or equivalent) will ...
Overdose
There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including cefixime, particularly in case of overdose or renal impairment. Adverse reactions seen at dose levels ...
Pharmacodynamic properties
Pharmacotherapeutic group: third generation cephalosporin ATC code: J01DD08 Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of ...
Pharmacokinetic properties
The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals. From ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
List of excipients
Tablet cores: microcrystalline cellulose, pregelatinised starch, calcium hydrogen phosphate dihydrate and magnesium stearate. Tablet coating: hypromellose, Macrogol 6000 and titanium dioxide.
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC/aluminium foil blister packs pack sizes of 1, 2, 7 and 14. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0623
Date of first authorization / renewal of the authorization
26 November 2009
Date of revision of the text
15 August 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
