Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Cefixime
NECLIFE PT UNIPESSOAL LDA
J01DA08
Cefixime
100/5 milligram(s)/millilitre
Powder for oral suspension
CEFACLOR
Not marketed
2018-11-16
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFIXIME NECTAR LIFESCIENCES 100MG/5ML POWDER FOR ORAL SUSPENSION CEFIXIME READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. 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 symptoms 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 leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Cefixime Nectar Lifesciences Lifesciences is and what it is used for 2. What you need to know before you take Cefixime Nectar Lifesciences Lifesciences 3. How to take Cefixime Nectar Lifesciences Lifesciences 4. Possible side effects 5. How to store Cefixime Nectar Lifesciences Lifesciences 6. Contents of the pack and other information 1. WHAT CEFIXIME NECTAR LIFESCIENCES LIFESCIENCES IS AND WHAT IT IS USED FOR Cefixime Nectar Lifesciences Lifesciences Powder for Oral Suspension (called “Cefixime Nectar Lifesciences Lifesciences” in this leaflet) belongs to a group of medicines called Cephalosporins, which are used for treating mild to moderate infection caused by susceptible organisms. Cefixime Nectar Lifesciences Lifesciences can be used to treat: • Acute infection of the middle ear • Infection causing sudden worsening of long-standing bronchitis • Uncomplicated acute infection of the bladder • Acute throat infection caused by bacteria • Uncomplicated acute infections in the urinary tract (Uncomplicated acute cystitis) • Uncomplicated acute gonorrhoea 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFIXIME NECTAR LIFESCIENCES LIFESCIENCES DO NOT TAKE CEFIXIME NECTAR LIFESCIENCES LIFESCIENCES IF YOU • Are allergic to cefixime or any of the other ingredients of this medicine (listed in section 6). An allergic reaction m Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 07 July 2023 CRN00DCRC Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefixime Nectar Lifesciences 100 mg/5 ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of reconstituted suspension contains cefixime trihydrate equivalent to 100 mg of cefixime. Excipient(s): This medicine contains approximately 2.33g of sucrose in each 5 ml after reconstitution. This medicine contains 10.0 mg of sodium benzoate in each 5 ml after reconstitution. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral suspension. Off-white to pale yellow coloured granular powder with strawberry guarana flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefixime is indicated for the treatment of the following infections when caused by susceptible organisms (see sections 4.4 and 5.1): Acute exacerbations of chronic bronchitis (AECB) Acute otitis media (AOM) Uncomplicated acute cystitis Uncomplicated pyelonephritis. Acute bacterial pharyngitis Uncomplicated acute gonorrhoea The use of cefixime should be reserved for infections in which the causative organism is known or suspected to be resistant to other commonly used antibacterial agents. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral ADULTS AND ADOLESCENTS OLDER THAN 12 YEARS (OR MORE THAN 50 KG BODY WEIGHT): The recommended dose is 400 mg daily, given either as a single dose or in two divided doses of 200 mg every 12 hours. (see section 4.4 and 5.1). The usual course of treatment is 7 days. This may be continued for up to 14 days if required. 400 mg (in 1-2 doses) 7 up to 10 days for Acute otitis media (AOM) and Acute bacterial pharyngitis 400 mg (in 1-2 doses) 1 to 3 days for uncomplicated acute cystitis in female patients 400 mg (in 1 dose), 1 day for uncomplicated gonorrhoea ELDERLY PATIENTS Elde Lesen Sie das vollständige Dokument