国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
cefuroxime axetil, Quantity: 150 mg (Equivalent: cefuroxime, Qty 125 mg)
Aspen Pharmacare Australia Pty Ltd
Cefuroxime axetil
Suspension, powder for
Excipient Ingredients: aspartame; stearic acid; sucrose; povidone; xanthan gum; acesulfame potassium; Flavour
Oral
100 mL, 140 mL, 200 mL, 50 mL, 70 mL
(S4) Prescription Only Medicine
ZINNAT suspension is indicated for the treatment of the following mild to moderately severe infections caused by sensitive bacteria in paediatric patients aged 3 months to 12 years: tonsillitis and pharyngitis, acute bacterial otitis media. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefuroxime axetil appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime axetil in the subsequent prevention of rheumatic fever are not available at present.
Visual Identification: White to off-white free-flowing granules forming a white to pale yellow suspension upon reconstitution with water; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2011-05-10
ZINNAT SUSPENSION-ANN-11NOV19 1 ZINNAT SUSPENSION _cefuroxime axetil _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you give ZINNAT suspension to your child. This leaflet answers some common questions about ZINNAT suspension. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of your child taking ZINNAT suspension against the risks this medicine could have for him/her. IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE UNTIL YOUR CHILD HAS FINISHED THE COURSE OF ZINNAT SUSPENSION. You may need to read it again. WHAT IS ZINNAT SUSPENSION USED FOR? ZINNAT suspension belongs to a group of medicines called cephalosporin antibiotics. The active ingredient in ZINNAT suspension (cefuroxime axetil) works by killing bacteria (germs) that cause infections such as infections of the ear, throat and tonsils. Your doctor may have prescribed ZINNAT suspension for another reason. ZINNAT SUSPENSION IS NOT ADDICTIVE.BEFORE YOUR CHILD TAKES ZINNAT SUSPENSION. _ZINNAT SUSPENSION MUST _ _NOT BE GIVEN IF: _ • YOUR CHILD HAS EVER HAD AN ALLERGIC REACTION TO CEFUROXIME AXETIL OR ANY OF THE INGREDIENTS LISTED TOWARD THE END OF THIS LEAFLET. SOME OF THE SYMPTOMS OF ALLERGIC REACTION MAY INCLUDE SKIN RASH, ITCHINESS, SHORTNESS OF BREATH, SWELLING OF THE FACE, LIPS OR TONGUE. • YOUR CHILD HAS HAD A SERIOUS ALLERGIC REACTION TO PENICILLINS. • THERE MAY BE AN INCREASED RISK OF YOUR CHILD BEING ALLERGIC TO ZINNAT SUSPENSION IF HE/SHE IS ALLERGIC TO PENICILLINS. • IF YOU ARE NOT SURE WHETHER TO GIVE ZINNAT SUSPENSION TO YOUR CHILD, CONTACT YOUR DOCTOR. • THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING _TELL YOUR DOCTOR IF: _ You must tell your doctor if: • YOUR CHILD HAS HAD AN ALLERGIC REAC 完全なドキュメントを読む
Zinnat-susp-pi-11nov19 AUSTRALIAN PRODUCT INFORMATION ZINNAT (CEFUROXIME AXETIL) GRANULES FOR ORAL SUSPENSION 1 NAME OF THE MEDICINE Cefuroxime axetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinnat granules for oral suspension contains either 125 mg or 250 mg cefuroxime (as cefuroxime axetil) per 5 mL. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Zinnat granules for oral suspension are presented in bottles and sachets. Multidose bottles: ZINNAT suspension is provided as white to off-white free-flowing granules forming a white to pale yellow suspension upon reconstitution in water. When reconstituted as directed, it provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. Sachets: ZINNAT suspension is provided as dry, white to off-white, tutti-frutti flavoured granule in laminated sachets. When reconstituted as directed, it provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per dose. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ZINNAT suspension is indicated for the treatment of the following mild to moderately severe infections caused by sensitive bacteria in paediatric patients 3 months to 12 years; tonsillitis and pharyngitis, acute bacterial otitis media. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefuroxime axetil appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx. However, substantial data establishing the efficacy of cefuroxime axetil in the subsequent prevention of rheumatic fever is not available at present. 4.2 D OSE AND METHOD OF ADMINISTRATION Zinnat tablets and Zinnat oral suspension are not bioequivalent and are therefore not substitutable on a mg per mg basis (see Pharmacokinetics). The usual course of therapy with Zinnat suspension is 7 days (with a range of 5 to 10 days). Cefuroxime axetil should be taken w 完全なドキュメントを読む