KEFLOR CD cefaclor 375mg (as monohydrate) sustained release tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

cefaclor monohydrate, Quantity: 393.4 mg (Equivalent: cefaclor, Qty 375 mg)

Tilgængelig fra:

Alphapharm Pty Ltd

Lægemiddelform:

Tablet, modified release

Sammensætning:

Excipient Ingredients: mannitol; hypromellose; hyprolose; methacrylic acid copolymer; stearic acid; magnesium stearate; propylene glycol; purified talc; Colour

Indgivelsesvej:

Oral

Enheder i pakken:

10, 2 - Physician sample

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

INDICATIONS AS 16 DECEMBER 1997: Keflor CD is indicated for the treatment of the following types of infections caused by susceptible organisms, in adults and children aged 12 years or older: Acute bronchitis and acute exacerbations of chronic bronchitis; Upper respiratory infections, including pharyngitis, tonsillitis and acute bacterial sinusitis: Community-acquired pneumonia of mild to moderate severity (excluding atypical pneumonia); Symptomatic lower urinary tract infections, including cystisis; Skin and skin structure infections. NOTE 1. Penicillin in the usual drug of choice in the treatment and prevention of streptoccocal infections, including the prophylaxis of rheumatic fever. Keflor CD is generally effective in the eradication of streptococci from the oropharynx; however, substantial data establishing the efficacy of Keflor CD in the subsequent prevention of rheumatic fever are not available. 2. Bacteriological studies to determine the causative organism and its susceptibility to cefaclor should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

Produkt oversigt:

Visual Identification: film-coated compressed tablet. Blue paracapsule shaped, dual radii, 7.62mm, approx length 16mm.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1997-02-19

Indlægsseddel

KEFLOR CD
_cefaclor monohydrate modified release tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Keflor CD.
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 benefits and
risks. Your doctor has weighed the
risks of you taking Keflor CD 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 your medicine.
You may need to read it again.
WHAT KEFLOR CD IS
USED FOR
Keflor CD is used to treat infections
in different parts of the body caused
by bacteria. Keflor CD can be used to
treat infections of the:
•
Ears, nose, throat and tonsils
(upper respiratory tract)
•
chest and lungs (lower respiratory
tract)
•
bladder and kidneys (lower
urinary tract)
•
skin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KEFLOR CD
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Keflor CD for another reason.
Keflor CD is an antibiotic that
belongs to a group of medicines
called cephalosporins. These
medicines work by killing the
bacteria that are causing your
infection.
Keflor CD will not work against
infections caused by viruses, such as
colds or flu.
Keflor CD is not recommended for
use in children under 12 years of age,
as there is not enough information
available on its safety and
effectiveness in this age group.
Keflor CD is available only with a
doctor's prescription.
There is no evidence that Keflor CD
is addictive.
BEFORE YOU TAKE KEFLOR
CD
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE KEFLOR CD IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING:
•
CEFACLOR MONOHYDRATE
•
ANY OTHER CEPHALOSPORIN
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
DO NOT TAKE KEFLOR CD IF YOU HAVE
HAD A SEVERE ALLERGIC REACTION TO
PENICILLIN.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, tongue o

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
KEFLOR CD
_Cefaclor monohydrate modified release tablets _
1
NAME OF THE MEDICINE
Cefaclor monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains cefaclor monohydrate equivalent
to 375 mg (1.02 mmol) anhydrous
cefaclor.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
KEFLOR CD 375 mg is a blue modified release tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Keflor CD is indicated for the treatment of the following types of
infections caused by susceptible organisms,
in adults and children aged 12 years or older:
•
Acute bronchitis and acute exacerbations of chronic bronchitis.
•
Upper respiratory infections, including pharyngitis, tonsillitis and
acute bacterial sinusitis.
•
Community-acquired pneumonia of mild to moderate severity (excluding
atypical pneumonia).
•
Symptomatic lower urinary tract infections, including cystitis.
•
Skin and skin structure infections.
NOTE:
1.
Penicillin is the usual drug of choice in the treatment and prevention
of streptococcal infections,
including the prophylaxis of rheumatic fever. Keflor CD is generally
effective in the eradication of
streptococci from the oropharynx; however, substantial data
establishing the efficacy of Keflor CD
in the subsequent prevention of rheumatic fever are not available.
2.
Bacteriologic studies to determine the causative organism and its
susceptibility to cefaclor should be
performed. Therapy may be started while awaiting the results of these
studies. Once these results
become available, antimicrobial therapy should be adjusted
accordingly.
4.2
DOSE AND METHOD OF ADMINISTRATION
Keflor CD can be taken with or without food. However, absorption is
enhanced when Keflor CD is
administered with food (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
). The tablets should not
be cut, crushed or chewed.
The usual adult dosage is 375 mg twice daily.
For lower urinary tract infections, 500 mg once daily may be given.
For pneumonia and