ZINNAT Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Zinnat 125 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 125 mg cefuroxime (as cefuroxime axetil). Excipient(s) with known effect: Each tablet contains 0.00152 mg sodium benzoate (E211) Each tablet contains Methyl parahydroxybenzoate (E218) ...
Pharmaceutical form
Film-coated tablet (tablet).
Therapeutic indications
Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). Acute streptococcal tonsillitis and pharyngitis. Acute bacterial ...
Posology and method of administration
Posology The usual course of therapy is seven days (may range from five to ten days). Table 1. Adults and children (≥40 kg): Indication Dosage Acute tonsillitis and pharyngitis, acute bacterial sinusitis ...
Contraindications
Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic ...
Special warnings and precautions for use
Hypersensitivity reactions Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. ...
Interaction with other medicinal products and other forms of interaction
Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food. Cefuroxime ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of cefuroxime in pregnant women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, as this medicine may cause dizziness, patients should be warned to be cautious when driving or operating ...
Undesirable effects
The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes. The frequency categories assigned to the ...
Overdose
Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see ...
Pharmacodynamic properties
Pharmacotherapeutic group: antibacterials for systemic use, second-generation cephalosporins ATC code: J01DC02 Mechanism of action Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active ...
Pharmacokinetic properties
Absorption After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation. ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies ...
List of excipients
Microcrystalline cellulose Sodium Laurilsulfate Croscarmellose Sodium Hydrogenated vegetable oil Silica Colloidal Anhydrous Hypromellose Propylene glycol Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate ...
Incompatibilities
A positive Coombs' test has been reported during treatment with cephalosporins this phenomenon can interfere with cross-matching of blood.
Shelf life
36 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Aluminium foil blister pack with an aluminium lid. Pack size: 6, 10, 12, 14, 16, 20, 24 and 50 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
Glaxo Wellcome UK Limited trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Marketing authorization number(s)
PL 10949/0095
Date of first authorization / renewal of the authorization
15 October 1998
Date of revision of the text
20 January 2019
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