KARLOR CD cefaclor 375 mg (as monohydrate) modified release tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

cefaclor monohydrate, Quantity: 392.3 mg (Equivalent: cefaclor, Qty 375 mg)

Dostupno od:

Viatris Pty Ltd

INN (International ime):

cefaclor monohydrate

Farmaceutski oblik:

Tablet, modified release

Sastav:

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

Administracija rute:

Oral

Jedinice u paketu:

2 tablets - physician's sample, 10 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Karlor 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 phryngitis, tonsillitis and acute bacterial sinusitis; Community-acquired pneumonia of mild to moderate severity (excluding atypical pneumonia); Symptomatic lower urinary tact 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. Karlor CD is generally effective in the eradication of streptococci from the oropharynx; however, substantial data establishing the efficacy of Karlor 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

Proizvod sažetak:

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

Status autorizacije:

Registered

Datum autorizacije:

2004-05-20

Uputa o lijeku

KARLOR CD
_cefaclor (as monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KARLOR CD. 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 taking KARLOR CD
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KARLOR CD IS
USED FOR
This medicine is used to treat
infections caused by bacteria in
different parts of the body. This
includes infections of the:
•
ears, nose, throat and tonsils
(upper respiratory tract)
•
chest and lungs (lower respiratory
tract)
•
bladder and kidneys (lower
urinary tract)
•
skin
This medicine belongs to a group of
medicines called cephalosporins.
This medicine works by killing the
bacteria that are causing your
infection.
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.
BEFORE YOU TAKE
KARLOR CD
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE KARLOR CD IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing cefaclor
monohydrate
•
any other similar medicines such
as cephalosporins
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT GIVE THIS MEDICINE TO A CHILD
UNDER THE AGE OF 12 YEARS.
Safety and effectiveness in children
younger than 12 years have not been
established.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION
KARLOR CD
_cefaclor (as monohydrate) modified release tablets _
1
NAME OF THE MEDICINE
Cefaclor (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each KARLOR CD modified release tablet contains 375 mg of cefaclor (as
monohydrate) as the active
ingredient.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
KARLOR CD modified release tablets are film-coated compressed tablets.
They are blue, paracapsule shaped,
dual radii, 7.62 mm, approx. length 16 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KARLOR 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. KARLOR CD is generally effective
in the eradication of streptococci from
the oropharynx; however, substantial data establishing the efficacy of
KARLOR 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
KARLOR CD can be taken with or without food. However, absorption is
enhanced when KARLOR CD is
administered with food (see section 5.2 Pharmacokinetic Properties -
Absorption). The tablets should not be
cut, crushed or chewed.
The usual adult dosage is 375 mg tw