ZINNAT cefuroxime (as axetil) 125 mg granules for oral suspension sachet

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

cefuroxime axetil

Предлага се от:

Aspen Pharmacare Australia Pty Ltd

Статус Оторизация:

Registered

Данни за продукта

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