ZINNAT cefuroxime (as axetil) 125 mg/5mL granules for oral suspension bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

cefuroxime axetil, Quantity: 150 mg (Equivalent: cefuroxime, Qty 125 mg)

Tilgængelig fra:

Aspen Pharmacare Australia Pty Ltd

Lægemiddelform:

Suspension, powder for

Sammensætning:

Excipient Ingredients: stearic acid; sucrose; povidone; Flavour

Indgivelsesvej:

Oral

Enheder i pakken:

100 mL, 140 mL, 200 mL, 50 mL, 70 mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

2002-02-25

Indlægsseddel

ZINNAT suspension
1
ZINNAT SUSPENSION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY MY CHILD IS USING ZINNAT SUSPENSION?
ZINNAT suspension contains the active ingredient cefuroxime axetil.
ZINNAT suspension is used to treat mild to moderately
severe infections caused by sensitive bacteria in paediatric patients
3 months to 12 years; tonsillitis and pharyngitis, acute
bacterial otitis media.
For more information, see Section 1. Why my child is using ZINNAT
suspension?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE GIVING MY CHILD ZINNAT SUSPENSION?
Do not use if your child has ever had an allergic reaction to ZINNAT
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before giving
my child ZINNAT suspension?
in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with ZINNAT suspension and affect how it
works.
A list of these medicines is in Section 3. What if my child is taking
other medicines?
in the full CMI.
4.
HOW TO GIVE ZINNAT SUSPENSION?
•
Give the complete course of ZINNAT suspension as directed by the
doctor or pharmacist.
•
In infants and children (3 months to 2 years), it may be preferable to
adjust dosage according to weight and age.
•
The dose of ZINNAT oral suspension recommended for children with
tonsillitis and/or pharyngitis is 10 mg/kg twice daily
to a maximum of 250 mg daily.
•
The dose of ZINNAT oral suspension recommended for children with an
ear infection (otitis media) is 15 mg/kg twice daily.
More instructions can be found in Section 4. How to give ZINNAT
suspension? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE GIVING ZINNAT SUSPENSION?
THINGS YOU
SHOULD DO
•
Tell your doctor if, for any reason, your child has not been given the
medicine exactly as directed.
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Produktets egenskaber

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