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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Cefuroxime axetil

Pharmaceutical form:

Suspension, powder for

Composition:

Excipient Ingredients: aspartame; stearic acid; sucrose; povidone; xanthan gum; acesulfame potassium; Flavour

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2011-05-10

Patient Information leaflet

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

Summary of Product characteristics

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