APO-CEFACLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

cefaclor monohydrate

Tillgänglig från:

Sun Pharma ANZ Pty Ltd

INN (International namn):

cefaclor monohydrate

Bemyndigande status:

Registered

Bipacksedel

APO-CEFACLOR ORAL
SUSPENSION
_Cefaclor monohydrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about cefaclor. It does not
contain all 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 risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Cefaclor is used to treat infections
caused by bacteria in different parts
of the body, including:
•
chest and lungs (lower respiratory
tract)
•
ears, nose, throat and tonsils
(upper respiratory tract)
•
bladder and kidneys (urinary
tract)
•
skin
Cefaclor belongs to a group of
medicines called cephalosporin
antibiotics. These are closely related
to penicillin antibiotics.
It works by killing the bacteria
causing your infection or by stopping
its growth.
It will not work against infections
caused by viruses such as colds or
the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in premature infants or infants under
1 month of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
cefaclor
•
other cephalosporins
•
any of the ingredients listed at the
end of this leaflet.
DO NOT TAKE CEFACLOR IF YOU HAVE
HAD A SERIOUS ALLERGIC REACTION TO
PENICILLIN.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue,
thro

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION
APO-CEFACLOR (CEFACLOR MONOHYDRATE)
SUSPENSION
1
NAME OF THE MEDICINE
Cefaclor monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains either 125 mg or 250 mg cefaclor per 5mL when
reconstituted.
EXCIPIENTS WITH KNOWN EFFECT
Sodium benzoate, sucrose.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
125 MG/5 ML
White to off-white granular powder which forms a red strawberry
flavoured suspension upon
reconstitution with 70 mL water.
250 MG/5 ML
White to off-white granular powder which forms a red strawberry
flavoured suspension upon
reconstitution with 53 mL water.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefaclor is indicated for the treatment of the following types of
infections caused by or likely to
be caused by susceptible organisms:
•
LOWER RESPIRATORY INFECTIONS, including pneumonia, bronchitis and
exacerbations of
chronic bronchitis.
•
UPPER RESPIRATORY TRACT INFECTIONS, including pharyngitis, tonsillitis
and otitis media.
•
SKIN AND SKIN STRUCTURE INFECTIONS.
•
URINARY TRACT INFECTIONS, including pyelonephritis and cystitis.
NOTE:_ _
1.
Penicillin is the usual drug of choice in the treatment and prevention
of streptococcal
infections, including the prophylaxis of rheumatic fever. Cefaclor
appears to be as effective
as phenoxymethylpenicillin in the eradication of streptococci from the
nasopharynx;
however, substantial data establishing the efficacy of cefaclor in the
subsequent prevention
of rheumatic fever are not available at present.
2.
Appropriate
culture
and
susceptibility
studies
should
be
performed
to
determine
susceptibility of the causative organism to cefaclor.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Cefaclor Oral Suspension is intended for oral administration.
RECONSTITUTION OF ORAL SUSPENSION
For 125 mg/5 mL bottles add 70 mL water, in two portions, to the
granular powder. Shake well
after each addition.
For 250 mg/5 mL bottles add 53 mL water, in two portions, to the
granular po