Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
cefalexin
Sandoz Pty Ltd
cefalexin
Registered
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 Olvassa el a teljes dokumentumot
200326-cefalexin sandoz-pi Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION CEFALEXIN SANDOZ ® (CEFALEXIN) CAPSULES 1. NAME OF THE MEDICINE Cefalexin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cefalexin Sandoz ® capsule contains 250 mg of cefalexin. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Cefalexin Sandoz 250 mg capsules are size ‘2’ capsules with dark green cap imprinted with “250” in black ink and white body. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Treatment of the following bacterial infections when caused by susceptible strains of the designated micro-organisms. _RESPIRATORY TRACT INFECTIONS _ _Strep. pneumoniae_ and group A β -haemolytic streptococci. Although 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. Substantial data establishing the efficacy of cefalexin 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 cefalexin in the treatment of bacterial infections of the brain and spinal column has not been established and Cefalexin Sandoz is not indicated in these conditions (see Section 4.3 Contraindications). _Note:_ Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to Cefalexin Sandoz. Renal function studies should be performed when indicated. 200326-cefalexin sandoz-pi Page 2 of 10 4.2. D OSE AND METHOD OF AD Olvassa el a teljes dokumentumot