País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
cefaclor monohydrate
Sun Pharma ANZ Pty Ltd
cefaclor monohydrate
Registered
APO-CEFACLOR ORAL SUSPENSION _Cefaclor monohydrate)_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about cefaclor. 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 using this medicine 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 THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Cefaclor is used to treat infections caused by bacteria in different parts of the body, including: • chest and lungs (lower respiratory tract) • ears, nose, throat and tonsils (upper respiratory tract) • bladder and kidneys (urinary tract) • skin Cefaclor belongs to a group of medicines called cephalosporin antibiotics. These are closely related to penicillin antibiotics. It works by killing the bacteria causing your infection or by stopping its growth. It will not work against infections caused by viruses such as colds or the flu. 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. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in premature infants or infants under 1 month of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • cefaclor • other cephalosporins • any of the ingredients listed at the end of this leaflet. DO NOT TAKE CEFACLOR IF YOU HAVE HAD A SERIOUS ALLERGIC REACTION TO PENICILLIN. Some of the symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue, thro Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION APO-CEFACLOR (CEFACLOR MONOHYDRATE) SUSPENSION 1 NAME OF THE MEDICINE Cefaclor monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains either 125 mg or 250 mg cefaclor per 5mL when reconstituted. EXCIPIENTS WITH KNOWN EFFECT Sodium benzoate, sucrose. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 125 MG/5 ML White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 70 mL water. 250 MG/5 ML White to off-white granular powder which forms a red strawberry flavoured suspension upon reconstitution with 53 mL water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefaclor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms: • LOWER RESPIRATORY INFECTIONS, including pneumonia, bronchitis and exacerbations of chronic bronchitis. • UPPER RESPIRATORY TRACT INFECTIONS, including pharyngitis, tonsillitis and otitis media. • SKIN AND SKIN STRUCTURE INFECTIONS. • URINARY TRACT INFECTIONS, including pyelonephritis and cystitis. NOTE:_ _ 1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Cefaclor Oral Suspension is intended for oral administration. RECONSTITUTION OF ORAL SUSPENSION For 125 mg/5 mL bottles add 70 mL water, in two portions, to the granular powder. Shake well after each addition. For 250 mg/5 mL bottles add 53 mL water, in two portions, to the granular po Leia o documento completo