Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
cefalexin monohydrate, Quantity: 262.94 mg (Equivalent: cefalexin, Qty 250 mg)
Pharmacor Pty Ltd
cefalexin monohydrate
Capsule
Excipient Ingredients: lactose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; brilliant blue FCF; purified water; quinoline yellow; allura red AC; Gelatin; sodium lauryl sulfate
Oral
20 capsules)
(S4) Prescription Only Medicine
Cephalexin is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:,- Respiratory tract infections caused by S. pneumoniae and group A beta-haemolytic streptococci (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.),- Bacterial sinusitis caused by streptococci, S. pneumoniae and S. aureus (methicillin-sensitive only),- Otitis media due to S. pneumoniae, staphylococci,- Skin and soft-tissue infections caused by staphylococci and/or streptococci,- Genitourinary tract infections, including acute prostatitis caused by E. coli, P. mirabilis, and Klebsiella sp.,The effectiveness of cephalexin in the treatment of bacterial infections of the brain and spinal column has not been established and cephalexin is not indicated in these conditions.,NOTE: Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to cephalexin. Renal function studies should be performed when indicated.
Visual Identification: Dark green size 2 hard gelatin capsules printed "250" on body and " CEP" on cap in black ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-10-02
CEPHALEX 250 MG AND 500 MG (Cephalexin BP 250 mg and 500 mg Capsules) CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cephalex 250 mg and 500 mg. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cephalex 250 mg and 500 mg 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 need to read it again. WHAT CEPHALEX 250 MG AND 500 MG IS USED FOR Cephalex 250 mg and 500 mg contains cephalexin monohydrate as the active ingredient. It is used to treat infections caused by bacteria in different parts of the body, including infections of the: • respiratory tract (throat, tonsils, chest and lungs) • nose (sinusitis) • ears (otitis media) • skin and soft tissue • kidneys and bladder (genitourinary tract). This medicine belongs to a group of medicines called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. ASK YOUR DOCTOR OR PHARMACIST 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. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CEPHALEX 250 MG AND 500 MG IF YOU HAVE AN ALLERGIC REACTION TO: • any medicine containing cephalexin monohydrate • other cephalosporins • any of the ingredients listed at the end of this leaflet. DO NOT TAKE THIS MEDICINE 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 or other parts of the body; rash, itching or hives on the skin. DO Baca dokumen lengkapnya
CEPHALEX PI Ver: 02 1 AUSTRALIAN PRODUCT INFORMATION - CEPHALEX (CEPHALEXIN) 1. NAME OF THE MEDICINE Cephalexin monohydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CEPHALEX 250 MG CAPSULES Each capsule contains cephalexin (as monohydrate) equivalent to 250 mg cephalexin anhydrous CEPHALEX 500 MG CAPSULES Each capsule contains cephalexin (as monohydrate) equivalent to 500 mg cephalexin anhydrous EXCIPIENTS WITH KNOWN EFFECT: Lactose For the full list of excipients, see SECTION 6.1 - LIST OF EXCIPIENTS 3. PHARMACEUTICAL FORM CEPHALEX 250 MG CAPSULES: Hard Gelatin Capsules Size “2”, body dark green and cap dark green with printing “220” on both body and cap in black ink containing 250 mg cephalexin. CEPHALEX 500 MG CAPSULES: Hard Gelatin Capsules Size “0”, body light green and cap light green with printing “219” on both body and cap in black ink containing 500 mg cephalexin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cephalexin is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by _S. _ _pneumoniae _ and group A beta-haemolytic streptococci (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Bacterial sinusitis caused by streptococci, _S. pneumoniae _ and _S. aureus _ (methicillin-sensitive only) Otitis media due to _S. pneumoniae, _ staphylococci CEPHALEX PI Ver: 02 2 Skin and soft-tissue infections caused by staphylococci and/or streptococci Genitourinary tract infections, including acute prostatitis caused by _E. coli, P. mirabilis, _ and _Klebsiella _ sp. The effectiveness of cephalexin in the treatment of bacterial infections of the brain and spina Baca dokumen lengkapnya