국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
cefalexin monohydrate, Quantity: 525.76 mg (Equivalent: cefalexin, Qty 500 mg)
Sandoz Pty Ltd
Capsule, hard
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; Gelatin; purified water; titanium dioxide
Oral
20 capsules
(S4) Prescription Only Medicine
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 skin structure 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: White opaque hard gelatine capsule, size 0 (500 mg); Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2002-03-05
CEFALEXIN SANDOZ ® 1 CEFALEXIN SANDOZ ® _Cefalexin Monohydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cefalexin Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cefalexin Sandoz 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 CEFALEXIN SANDOZ IS USED FOR The name of your medicine is Cefalexin Sandoz. It contains the active ingredient cefalexin monohydrate. Cefalexin Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria. Cefalexin Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. Cefalexin Sandoz can be used to treat infections of the: • respiratory tract (throat, tonsils, chest and lungs) • nose (sinusitis) • ears (otitis media) • skin and soft tissue • kidneys and bladder (genitourinary tract). Your doctor may have prescribed Cefalexin Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CEFALEXIN SANDOZ HAS BEEN PRESCRIBED FOR YOU. Cefalexin Sandoz is available only with a doctor's prescription. It is not addictive. BEFORE YOU TAKE CEFALEXIN SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CEFALEXIN SANDOZ IF: 1. YOU HAVE AN ALLERGY TO CEFALEXIN MONOHYDRATE, OTHER CEPHALOSPORINS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; skin rash, itching or hives. 2. YOU HAVE HAD A SERIOUS ALLERGIC REACTION TO ANY PENICILLINS. You may be more likely to have an al 전체 문서 읽기
210517-Cefalexin Sandoz-pi Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION CEFALEXIN SANDOZ (CEFALEXIN MONOHYDRATE) CAPSULES AND POWDER FOR SUSPENSION 1. NAME OF THE MEDICINE Cefalexin monohydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefalexin Sandoz capsules contains cefalexin (as monohydrate) equivalent to 500 mg of cefalexin anhydrous. Cefalexin Sandoz Powder for Oral Suspension contains cefalexin (as monohydrate) equivalent to 125 mg/5 mL or 250 mg/5 mL of cefalexin anhydrous. _Excipients with known effect:_ Sucrose (Cefalexin Sandoz Powder for Oral Suspension) For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM _Capsules _ 500 mg -The capsules are white opaque in colour, containing a white to yellowish powder. _Powder for Oral Suspension _ The suspension is orange-yellow in colour with a fruity flavour. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS 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 _ _ ß-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 _. _ 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 cond 전체 문서 읽기