País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Cefuroxime axetil
GlaxoSmithKline (Ireland) Limited
J01DC; J01DC02
Cefuroxime axetil
125 mg/5ml
Granules for oral suspension
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefuroxime
Marketed
1991-01-16
62000000047864 cefuroxime ZINNAT 125 MG/5 ML GRANULES FOR ORAL SUSPENSION ZINNAT 250 MG/5 ML GRANULES FOR ORAL SUSPENSION cefuroxime READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zinnat is and what it is used for 2. What you need to know before you take Zinnat 3. How to take Zinnat 4. Possible side effects 5. How to store Zinnat 6. Contents of the pack and other information 1. WHAT ZINNAT IS AND WHAT IT IS USED FOR Zinnat is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called _cephalosporins_. Zinnat is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. Zinnat can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). Your doctor may test the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Zinnat during your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZINNAT DO NOT TAKE ZINNAT: • IF YOU ARE ALLERGIC to cefuroxime or ANY CEPHALOSPORIN ANTIBIOTICS, or any of the other ingredients of Zinnat (listed in section 6). • if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). If you think this applies to you, DON’T TAKE ZINNAT until you have checked with your doctor. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmac Leer el documento completo
Health Products Regulatory Authority 29 October 2019 CRN009F9L Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zinnat 125 mg/5 ml granules for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 125 mg cefuroxime per 5 ml (as 150 mg cefuroxime axetil) Excipient(s) with known effect: Contains 0.021 g aspartame (E951) per 5 ml dose Contains 3.1 g of sucrose per 5 ml dose Contains 6 mg of propylene glycol (E1520) per 5 ml dose Contains 4.5 mg benzyl alcohol (E1519) per 5 ml dose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. 4 CLINICAL PARTICULARS 4.1 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 sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 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 250 mg twice daily Acute otitis media 500 mg twice daily Acute exacerbations of chronic bronchitis 500 mg twice daily Cystitis 250 mg twice daily Pyelonephritis 250 mg twice daily Uncomplicated skin and soft tissue infections 250 mg twice daily Health Products Regulatory Authority 29 October 2019 CRN009F9L Page 2 of 11 Lyme disease 500 mg twice daily for 14 days (range of 10 to 21 days) _Table 2. Children (<40 kg)_ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial sinusitis 10 mg/kg twice daily to a maximum of 125 mg twice daily Children aged two years or older with otitis media Leer el documento completo