Country: Malta
Language: English
Source: Medicines Authority
CEFTAZIDIME PENTAHYDRATE
DALI Pharma GmbH Brehmstrasse 56, 40239, Dusseldorf,, Germany
J01DD02
CEFTAZIDIME PENTAHYDRATE 2 g
POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFTAZIDIME PENTAHYDRATE 2 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-01-05
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTAZIDIME DALI PHARMA 2 G POWDER FOR SOLUTION FOR INJECTION/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, pharmacist or nurse. ▪ If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ceftazidime DALI Pharma is and what it is used for 2. What you need to know before you are given Ceftazidime DALI Pharma 3. How Ceftazidime DALI Pharma is given 4. Possible side effects 5. How to store Ceftazidime DALI Pharma 6. Contents of the pack and other information 1. WHAT CEFTAZIDIME DALI PHARMA IS AND WHAT IT IS USED FOR Ceftazidime DALI Pharma contains the active substance ceftazidime and is an antibiotic given to adults, adolescents and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called Cephalosporins _. _ _ _ Ceftazidime DALI Pharma is 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 Ceftazidime DALI Pharma 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. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Page 2 of 9 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME DALI PHARMA YOU MUST NOT BE GIVEN CEFTAZIDIME DALI PHARMA: If you are allergic to ceftazidime, to any other cephalosporins or any of the other Read the complete document
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ceftazidime DALI Pharma 2 g Powder for Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2 g of ceftazidime (as pentahydrate). Excipients with known effects: Each vial contains 102.4 mg (4.45 mmol) of sodium. This medicinal product contains maximum 1.16 mg sodium metabisulfite per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White or pale yellow powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftazidime DALI Pharma is indicated for the treatment of the infections listed below in adults, adolescents and children including neonates (from birth): ▪ Nosocomial pneumonia ▪ Broncho-pulmonary infections in cystic fibrosis ▪ Bacterial meningitis ▪ Chronic suppurative otitis media(otitis media suppurativa chronica) ▪ Malignant inflammation of the external auditory canal (otitis externa maligna) ▪ Complicated urinary tract infections ▪ Complicated skin and soft tissue infections ▪ Complicated intra-abdominal infections ▪ Bone and joint infections ▪ Peritonitis associated with dialysis in patients 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 DALI Pharma may be used: ▪ in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection; ▪ in the peri-operative prophylaxis of urinary tract infections for patients undergoing trans- urethral resection of the prostate (TURP).; The selection of Ceftazidime DALI Pharma should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1). Page 2 of 17 Ceftazidime DALI Pharma should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum of Read the complete document