Kraj: Malta
Język: angielski
Źródło: Medicines Authority
CEFAZOLIN SODIUM
PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta
J01DB04
CEFAZOLIN SODIUM 1 g
POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFAZOLIN SODIUM 1 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-07-30
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER CEFAZOLIN PHARMSOL 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFAZOLIN 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 notice 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 Cefazolin PharmSol is and what it is used for 2. What you need to know before you take Cefazolin PharmSol 3. How to take Cefazolin PharmSol 4. Possible side effects 5. How to store Cefazolin PharmSol 6. Contents of the pack and other information 1. WHAT CEFAZOLIN PHARMSOL IS AND WHAT IT IS USED FOR CEFAZOLIN PHARMSOL contains the active substance cefazolin which belongs to a group of medicines called cephalosporins which are antibiotics. These medicines work by killing bacteria that cause infections. Cefazolin is used to treat bacterial infections caused by cefazolin-susceptible bacteria in adults and children over the age of 1 month, e.g.: • Infections of the skin and soft tissue • Infections of the bones and joints Due to or as a precaution against the occurrence of infection before, during or after an operation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFAZOLIN PHARMSOL DO NOT USE CEFAZOLIN PHARMSOL: • If you are allergic to cefazolin, any other cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6). • If you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking CEFAZOLIN PHARMSOL if you: • are prone to allergic reactions (e.g. hay fever or bronchial asthma), or if you had other than serious allergic reactions to penic Przeczytaj cały dokument
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefazolin PharmSol 1000 mg powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1g cefazolin (as 1.048 g cefazolin sodium). The sodium content of each vial is 2.2 mmol (50.6 mg per 1 g cefazolin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion А white or almost white powder, very hydroscopic. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefazolin is indicated for the treatment of the following infections caused by cefazolin-susceptible micro- organisms in adults and children over the age of 1 month (see section 5.1): • infections of the skin and soft tissue • infections of the bones and joints • perioperative prophylaxis: the prophylactic preoperatively, intraoperatively and postoperatively to reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated. The use of cefazolin should be limited to cases where parenteral treatment is necessary. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage depends on the sensitivity of the pathogen (see section 5.1) and the severity of the disease. Posology _Adults and adolescents > 12 years with normal kidney function _ _Infections caused by highly sensitive pathogens: _ The usual dosage in adults is 1 g to 2 g per day, administered in two or three equal doses (one dose every 8 or 12 hours). _Infections caused by less sensitive pathogens: _ The usual dose is 3 g to 4 g per day, administered in three or four equal doses (one dose every 6 or 8 hours). In severe infections, doses of up to 6 g per day can be administered in three or four equal doses (one dose every 6 or 8 hours). Page 2 of 13 _Prophylaxis of perioperative infections _ To prevent postoperative infecti Przeczytaj cały dokument