País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL (AMORPHOUS)
Milpharm Limited
J01DA
CEFUROXIME AXETIL (AMORPHOUS)
250 Milligram
Film Coated Tablet
oral use
6, 8, 10, 12, 14, 15, 16, 20, 24, 30, 50, 100 & 500 film-coated tablets
Product subject to prescription which may not be renewed (A)
APL Swift Services (Malta) Limited
antibacterials for systemic use, second-generation cephalosporins
CEPHALOSPORINS AND RELATED SUBSTANCES
Cefuroxime Milpharm is indicated for the treatment of the infections listed below in adults and children from the age of 3 months • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease.
Transfer Pending
2015-10-23
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFUROXIME MILPHARM 250 MG FILM-COATED TABLETS CEFUROXIME MILPHARM 500 MG FILM-COATED TABLETS Cefuroxime CEFUROXIME MILPHARM P150 CEFUROXIME MILPHARM P150 Medicines used to REDUCE THE AMOUNT OF ACID IN YOUR STOMACH (e.g. antacids used to treat heartburn) can affect how Cefuroxime Milpharm works. Probenecid Oral anticoagulants " TELL YOUR DOCTOR OR PHARMACIST if you are taking any medicine like this. PREGNANCY AND BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Tell your doctor before you take Cefuroxime Milpharm: • if you are pregnant, think you might be pregnant or are planning to become pregnant • if you are breastfeeding. Your doctor will consider the benefit of treating you with Cefuroxime Milpharm against the risk to your baby. DRIVING AND USING MACHINES Cefuroxime Milpharm CAN MAKE YOU DIZZY and have other side effects that make you less alert. " DON'T DRIVE OR USE MACHINES if you do not feel well. Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. TAKE CEFUROXIME MILPHARM AFTER FOOD. This will help to make the treatment more effective. Swallow Cefuroxime Milpharm tablets whole with some water. DON'T CHEW, CRUSH OR SPLIT THE TABLETS — this may make the treatment less effective. THE RECOMMENDED DOSE ADULTS The recommended dose of Cefuroxime Milpharm is 250 mg to 500 mg twice daily depending on the severity and type of infection. CHILDREN The recommended dose of Cefuroxime is 10 mg/kg (to a maximum of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily depending on: • the severity and type of infection CEFUROXIME MILPHARM IS NOT RECOMMENDED FOR CHILDREN AGED UNDER 3 MONTHS, as the safety and effectiveness are not known in this age group. Depending on the illness or how you or your child responds to treatment, the initial dose Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Milpharm 250mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300.72 mg cefuroxime axetil equivalent to 250 mg cefuroxime. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film-coated capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. The size is 16.1 mm X 6.6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Milpharm is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual course of therapy is seven days (may range from five to ten days). _Table 1. Adults and children (_ _40 kg)_ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acute bacterial sinusitis 250 mg twice daily Acute otitis media 500 mg twice daily Acute exacerbations of chronic bronchitis 500 mg twice daily Cystitis 250 mg twice daily Pyelonephritis 250 mg twice daily Uncomplicated skin and soft tissue infections 250 mg twice daily Lyme disease 500 mg twice daily for 14 days (range of 10 to 21 days) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Leia o documento completo