Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Cefalexin monohydrate 525.8mg equivalent to Cephalexin 500 mg;
Sandoz New Zealand Limited
Cefalexin monohydrate 525.8 mg (=Cephalexin 500 mg)
500 mg
Capsule
Active: Cefalexin monohydrate 525.8mg equivalent to Cephalexin 500 mg Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Titanium dioxide Water
Blister pack, PVC/PVDC/Al foil strip, 20 capsules
Prescription
Prescription
DSM Sinochem Pharmaceuticals Spain, S.A.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil strip - 20 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al foil strip - 100 capsules - 48 months from date of manufacture stored at or below 30°C
2000-10-12
_ _ _Version 05 _ _ _ _ _ 1 _ _ CEFALEXIN SANDOZ ® _Cephalexin 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 cephalexin 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 CEPHALEXIN 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 likel Læs hele dokumentet
NEW ZEALAND DATA SHEET Page 1 of 10 1 PRODUCT NAME Cefalexin Sandoz _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefalexin Sandoz capsules contain 250 mg or 500 mg cefalexin Cefalexin Sandoz granules for oral suspension contain 125 mg or 250 mg cefalexin per 5mL when reconstituted Excipient(s) with known effect: n/a For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cefalexin Sandoz capsules, hard 250 mg: Capsule, powder filled, Size 2, orange opaque cap and grey opaque body, approximately 17.5 mm length and 6.3 mm diameter. 500 mg: Capsule, powder filled, Size 0, orange opaque cap and grey opaque body, approximately 21.2 mm length and 7.6 mm diameter. Cefalexin Sandoz granules for oral suspension 125 mg/5 mL: Orange to yellow granules 250 mg/5 mL: Orange to yellow granules 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 microorganisms: _ _ bacterial sinusitis caused by streptococci, S. pneumoniae, and Staphylococcus aureus (methicillin-sensitive only); _ _ respiratory tract infections caused by S. pneumoniae and S. pyogenes (penicillin is the usual medicine 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 either rheumatic fever or bacterial endocarditis are not available at present); _ _ otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis; _ _ skin and skin-structure infections caused by staphylococci and/or streptococci; _ _ bone infections caused by staphylococci and/or P. mirabilis; _ _ genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and Klebsiella pneumoniae; _ _ dental infections caused by sta Læs hele dokumentet