Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Cefalexin monohydrate 26.295 mg/mL equivalent to cefalexin 25mg/mL;
Max Health Limited
125 mg/5mL
Granules for oral suspension
Active: Cefalexin monohydrate 26.295 mg/mL equivalent to cefalexin 25mg/mL Excipient: Allura red AC Dimeticone Imitation guarana flavour 051880 TP0551 Methylcellulose Pregelatinised maize starch Sodium laurilsulfate Sucrose Xanthan gum
Prescription
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 staphylococci and/or streptococci. Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with child safety cap in outer carton - 100 mL - 24 months from date of manufacture stored at or below 25°C 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2020-06-26
New Zealand Consumer Medicine Information CEFALEXIN _Cephalexin Monohydrate _ _ _ _Oral suspension_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cefalexin. 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 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 IS USED FOR The name of your medicine is Cefalexin. It contains the active ingredient cefalexin monohydrate. Cefalexin is an antibiotic used to treat infections in different parts of the body caused by bacteria. Cefalexin belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. Cefalexin 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 for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CEFALEXIN HAS BEEN PRESCRIBED FOR YOU. Cefalexin is available only with a doctor’s prescription. It is not addictive. BEFORE YOU TAKE CEFALEXIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CEFALEXIN 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 allergic reaction to Cefalexin if you are aller Прочетете целия документ
NEW ZEALAND DATA SHEET 1 PRODUCT NAME Cefalexin 125 mg/5 mL Granules for oral suspension Cefalexin 250 mg/5 mL Granules for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefalexin 125 mg/5 mL Granules for oral suspension: When prepared as directed, each 5 mL of reconstituted suspension contains (as the active ingredient) cefalexin monohydrate equivalent to 125 mg of cefalexin base. Excipients with known effect: contains 3.119 g of sucrose per 5 mL after reconstitution. Cefalexin 250 mg/5 mL Granules for oral suspension: When prepared as directed, each 5 mL of reconstituted suspension contains as the active ingredient, cefalexin monohydrate equivalent to 250 mg of cefalexin base. Excipients with known effect: contains 2.972 g of sucrose per 5 mL after reconstitution. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White 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. m Прочетете целия документ