País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
cefaclor monohydrate, Quantity: 392.3 mg (Equivalent: cefaclor, Qty 375 mg)
Viatris Pty Ltd
cefaclor monohydrate
Tablet, modified release
Excipient Ingredients: mannitol; hypromellose; hyprolose; methacrylic acid copolymer; stearic acid; magnesium stearate; propylene glycol; purified talc; Colour
Oral
2 tablets - physician's sample, 10 tablets
(S4) Prescription Only Medicine
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
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
Registered
2004-05-20
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 Leia o documento completo
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 Leia o documento completo