Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
cefaclor monohydrate, Quantity: 393.4 mg (Equivalent: cefaclor, Qty 375 mg)
Viatris Pty Ltd
Tablet, modified release
Excipient Ingredients: mannitol; hypromellose; hyprolose; methacrylic acid copolymer; stearic acid; magnesium stearate; propylene glycol; purified talc; Colour
Oral
2 - physician sample, 10
(S4) Prescription Only Medicine
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.
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
Licence status A
1997-03-14
CECLOR ® CD C E 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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ