CECLOR 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: 393.4 mg (Equivalent: cefaclor, Qty 375 mg)

Dostupno od:

Viatris Pty Ltd

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 - physician sample, 10

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

INDICATIONS AS 7 AUGUST 1996: Ceclor CD is indicated for the treatment of the following types of infections caused by susceptible organisms, in adults and children aged 12years 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. Ceclor CD is generally effective in the eradication of streptococci from the oropharynx; however, substantial data establishing the efficacy of Ceclor 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.

Proizvod sažetak:

Visual Identification: Blue capsule shaped tablets with no engraving; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

1997-03-14

Uputa o lijeku

CECLOR
® CD
C
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C
L
O
R
C
D
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 AM I USING CECLOR CD?
CECLOR CD contains the active ingredient cefaclor. CECLOR CD is used
to treat infections caused by bacteria in different parts of
the body.
For more information, see Section 1. Why am I using CECLOR CD? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CECLOR CD?
Do not use if you have ever had an allergic reaction to CECLOR CD or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CECLOR CD? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CECLOR CD and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CECLOR CD?
•
Your doctor will tell you how much CECLOR CD you need to take.
•
Take CECLOR CD at about the same time each day with food.
More instructions can be found in Section 4. How do I use CECLOR CD?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CECLOR CD?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CECLOR CD.
•
Tell your doctor if the symptoms of your infection do not improve
within a few days, or if they become
worse.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take CECLOR CD to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you k

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION
CECLOR
® CD
_cefaclor (as monohydrate) modified release tablets _
1
NAME OF THE MEDICINE
Cefaclor (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CECLOR 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
CECLOR CD modified release tablets are blue capsule-shaped tablets
with no engraving.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CECLOR 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. CECLOR CD is generally effective
in the eradication of streptococci from
the oropharynx; however, substantial data establishing the efficacy of
CECLOR 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
CECLOR CD can be taken with or without food. However, absorption is
enhanced when CECLOR 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