Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
cefalexin, Quantity: 25 mg/mL
Aspen Pharmacare Australia Pty Ltd
Oral Liquid, powder for
Excipient Ingredients: sodium lauryl sulfate; allura red AC; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; Flavour
Oral
100mL
(S4) Prescription Only Medicine
INDICATIONS AS AT 24 FEBRUARY 2004: KEFLEX is indicated in the 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. KEFLEX is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of KEFLEX 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 soft tissue infections caused by staphlococci anr/or streptococci; Genitourinary tract infections, including acute prostatic caused by E. coli, P. mirabilis, and Klebsiella sp. The effectiveness of KEFLEX in the treatment of bacterial infections of the brain and spinal column has not been established and KEFLEX is not indicated in these conditions. NOTE: Appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to KEFLEX. Renal function studies should be performed when indicated.
Visual Identification: A white free-flowing powder before reconstitution and a red suspension after reconstitution.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2003-03-26
KEFLEX-CMI– oct19 Page 1 of 4 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Keflex. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Keflex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KEFLEX IS USED FOR Keflex contains cefalexin monohydrate as the active ingredient. It is used to treat infections caused by bacteria in different parts of the body, including infections of the: • respiratory tract (throat, tonsils, chest and lungs) • nose (sinusitis) • ears (otitis media) • skin and soft tissue • kidneys and bladder (genitourinary tract). This medicine belongs to a group of medicines called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE KEFLEX IF YOU HAVE AN ALLERGIC REACTION TO: • any medicine containing cefalexin monohydrate • other cephalosporins • any of the ingredients listed at the end of this leaflet. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SERIOUS ALLERGIC REACTION TO PENICILLIN. 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; rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your Read the complete document
Keflex-pi-24oct19 AUSTRALIAN PRODUCT INFORMATION - KEFLEX (CEFALEXIN MONOHYDRATE) CAPSULES AND POWDER FOR ORAL LIQUID 1 NAME OF THE MEDICINE Cefalexin monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KEFLEX capsules contain the active cefalexin monohydrate equivalent to 250 mg or 500 mg of cefalexin . KEFLEX powder for oral liquid in bottles contains the active cefalexin monohydrate equivalent to 125 mg or 250 mg of cefalexin per 5 mL upon reconstitution. Excipient with known effect: sucrose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM KEFLEX is available in hard gelatin capsules and powder for oral liquid in bottles. _ _ KEFLEX CAPSULES 250 mg: An opaque dark green and white size 1 capsule marked with “GP1” on the cap and body containing 250 mg cefalexin. 500 mg: An opaque dark green and light green size 0 capsule marked with “GP2” on the cap and body containing 500 mg cefalexin. KEFLEX POWDER FOR ORAL LIQUID 125 mg/5 mL: A white free flowing powder before reconstitution and a red suspension after reconstitution containing 125 mg cefalexin per 5 mL. 250 mg/5 mL: A white free flowing powder before reconstitution and a red suspension after reconstitution containing 250 mg cefalexin per 5 mL. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS KEFLEX is indicated in the 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, Keflex-pi-24oct19 including the prophylaxis of rheumatic fever. KEFLEX is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of KEFLEX 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) Read the complete document