Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefalexin
Milpharm Ltd
J01DB01
Cefalexin
25mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5060035110759
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFALEXIN 125MG/5ML POWDER FOR ORAL SUSPENSION CEFALEXIN 250MG/5ML POWDER FOR ORAL SUSPENSION (cefalexin) READ ALL OF THIS LEAET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaet. See section 4. WHAT IS IN THIS LEAET: 1. What Cefalexin Oral Suspension is and what it is used for 2. What you need to know before you take Cefalexin Oral Suspension 3. How to take Cefalexin Oral Suspension 4. Possible side effects 5. How to store Cefalexin Oral Suspension 6. Contents of the pack and other information 1. WAT CEFALEXIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR Cefalexin Oral Suspension contain cefalexin as the active ingredient, which belongs to a class of antibiotics called 'cephalosporins'. Cefalexin Oral Suspension is used to treat following infections caused by bacteria that can be killed by cefalexin: • Respiratory tract (lung and airways) e.g. tonsillitis, pharyngitis and bronchitis • Middle ear infections (otitis media) • Skin and soft tissue (e.g. muscle) infections • Bone and joint infections • Infections of the reproductive organs and urinary tract (e.g. cystitis), including acute inammation of the prostate gland (prostatitis) • Dental infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFALEXIN ORAL SUSPENSION DO NOT TAKE CEFALEXIN ORAL SUSPENSION IF YOU: • Are allergic (hypersensitive) to cefalexin, other cephalosporins (similar antibiotics) or penicillin group of antibiotics, or to any of the ingredients in the product (see Section 6 and end of Section 2). An allergic reaction may include rash, i Baca dokumen lengkap
OBJECT 1 CEFALEXIN 125MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 13-Jun-2018 | Aurobindo Pharma - Milpharm Ltd. 1. Name of the medicinal product Cefalexin 125mg/5ml Powder for Oral Suspension 2. Qualitative and quantitative composition Each 5ml contains Cefalexin 125mg (as Monohydrate), after reconstitution. Each 5ml contains 4.82mg sodium benzoate, after reconstitution. Each 5ml contains 847.24mg sorbitol, after reconstitution. For full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for Oral Suspension. A pale pink, free flowing granular powder, which readily disperses in water to give a pink suspension with an odour of strawberry. 4. Clinical particulars 4.1 Therapeutic indications Cefalexin is a semi synthetic cephalosporin antibiotic for oral administration. Cefalexin is indicated in the treatment of the following infections: Respiratory tract infections; otitis media; skin and soft tissue infections; bone and joint infections; genito-urinary infections, including acute prostatitis and dental infections. Cefalexin is active against the following organisms in vitro: β-haemolytic streptococci; staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains; Streptococcus pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella species, Haemophilus influenza; Branhamella catarrhalis. Most strains of enterococci (Streptococcus faecalis) and a few strains of staphylococci are resistant to cefalexin. Cefalexin is inactive against most strains of enterobacter, morganella morganii, pr. Vulgaris, colstridium difficule, and the following species: legionella, campylobacter, pseudomonas or herellea species. When tested by in vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics. 4.2 Posology and method of administration Adults 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mi Baca dokumen lengkap