Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
cefalexin monohydrate, Quantity: 550 mg (Equivalent: cefalexin, Qty 500 mg)
Arrotex Pharmaceuticals Pty Ltd
cefalexin monohydrate
Capsule, hard
Excipient Ingredients: iron oxide yellow; Gelatin; sunset yellow FCF; titanium dioxide; magnesium stearate; lactose monohydrate; brilliant blue FCF; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
20 capsules
(S4) Prescription Only Medicine
Treatment of the following bacterial infections when caused by susceptible strains of the designated micro-organisms. Respiratory tract infections; Strep. pneumoniae and group A B-haemolytic streptococci. Although 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. Substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present. Bacterial sinusitis: Streptococci, Strep. pneumoniae and Staph. Aureus (methicillin sensitive only). Otitis media: Strep. pneumoniae, staphylococci (methicillin sensitive only). Skin and skin structure infections: Staphylococci (methicillin sensitive only) and/or streptococci. Genitourinary tract infections, including acute prostatitis: 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 GENRX 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 GENRX CEPHALEXIN. Renal function studies should be perfomed when indicated.
Visual Identification: Dark green/light green, hard gelatin, self locked Size 0 capsule, imprinted with 'RX657' in edible black ink, containing white to off-white granular powder/pellet.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-02-20
APO- CEPHALEXIN CAPSULES 1 APO-CEPHALEXIN CAPSULES _Contains the active ingredient cefalexin 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 this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Cephalexin. It contains the active ingredient cefalexin monohydrate. It is used to treat infections in different parts of the body caused by bacteria, such as: • respiratory tract (chest, lungs, tonsils or throat) • sinuses • ears (middle ear infection) • skin • genitourinary tract (kidney, bladder or prostate). Cefalexin belongs to a group of antibiotics called cephalosporins that are closely related to penicillins. It works by killing the bacteria causing your infection or by stopping its growth. Cefalexin 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 cefalexin for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • cefalexin • other 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 Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION APO- CEPHALEXIN (CEFALEXIN MONOHYDRATE) CAPSULES 1 NAME OF THE MEDICINE Cefalexin monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains cefalexin monohydrate equivalent to 250 mg or 500 mg cefalexin anhydrous as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Contains sugars as lactose. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 250 MG CAPSULES: Dark green and white, self-locked hard gelatin capsules of size 2, imprinted with RX656 in black ink, containing white to off-white granular powder/pellets. 500 MG CAPSULES: Dark green and light green, self-locked hard gelatin capsules of size 0, imprinted with RX657 in black ink, containing white to off-white granular powder/pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated micro-organisms. RESPIRATORY TRACT INFECTIONS Caused by _S. pneumoniae_ and group A -haemolytic Streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefalexin is generally effective in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin 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 SKIN STRUCTURE INFECTIONS Caused by Staphylococci and/or Streptococci. 2 GENITOURINARY TRACT INFECTIONS, INCLUDING ACUTE PROSTATITIS Caused by _E. coli, P. mirabilis_ and Klebsiella sp. The effectiveness of cefalexin in the treatment of bacterial infections of the brain and spinal column has not been established and cefalexin is not indicated in these conditions. Note:_ _Appropriate culture and susceptibility tests Прочитајте комплетан документ