Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftazidime (ceftazidime pentahydrate)
ACS Dobfar S.p.A.
J01DD02
ceftazidime (ceftazidime pentahydrate)
1000mg
powder for solution for injection/infusion
(1) glass vial
Prescription
Registered
2021-10-08
Reason for update: Project Cleo – MAH Change – Stockley Park to Brentford Market: UK Agency Approval Date: N/A as Type 1AIN so implemented before agency approval_ _ Text Date: 23-Mar-2020 Text Issue and Draft No.: Issue 7 Draft 2 [GSK Logo] PACKAGE LEAFLET: INFORMATION FOR THE USER FORTUM® 500 MG POWDER FOR SOLUTION FOR INJECTION FORTUM® 1 G, 2 G, 3 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFTAZIDIME READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 What Fortum is and what it is used for 2 What you need to know before you are given Fortum 3 How Fortum is given 4 Possible side effects 5 How to store Fortum 6 Contents of the pack and other information 1. WHAT FORTUM IS AND WHAT IT IS USED FOR Fortum is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called _cephalosporins_. FORTUM IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF: the lungs or chest the lungs and bronchi in patients suffering from cystic fibrosis the brain (_meningitis_) the ear the urinary tract the skin and soft tissues the abdomen and abdominal wall (_peritonitis_) the bones and joints. Fortum can also be used: to prevent infections during prostate surgery in men to treat patients with low white blood cell counts (_neutropenia_) who have a fever due to a bacterial infection. Reason for update: Project Cleo – MAH Change – Stockley Park to Brentford Market: UK Agency Approval Date: N/A as Type 1AIN so implemented before agency approval_ _ Text Date: 23-Mar-2020 Text Issue and Draft No.: Issue 7 Draft 2 2. WHAT YOU NEED TO KNOW B Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fortum 1 g powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 g ceftazidime (as pentahydrate) with sodium carbonate (118 mg per gram of ceftazidime). Excipient with known effect Each vial contains 52 mg (2.3 mmol) of sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion Vials containing white to cream sterile powder. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fortum is indicated for the treatment of the infections listed below in adults and children including neonates (from birth). Nosocomial pneumonia Broncho-pulmonary infections in cystic fibrosis Bacterial meningitis Chronic suppurative otitis media Malignant otitis externa Complicated urinary tract infections Complicated skin and soft tissue infections Complicated intra-abdominal infections Bone and joint infections Peritonitis associated with dialysis in patient on CAPD. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing transurethral resection of the prostate (TURP). The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1). Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Table 1: Adults and children Preberite celoten dokument