Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
CEFTAZIDIME AS PENTAHYDRATE
NOVARTIS ISRAEL LTD., ISRAEL
J01DD02
POWDER FOR SOLUTION FOR INJ/INF
CEFTAZIDIME AS PENTAHYDRATE 1 G/VIAL
I.M, I.V
Required
SANDOZ AG, SWITZERLAND
CEFTAZIDIME
CEFTAZIDIME
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 trans-urethral 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.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.
2023-02-28
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפור אפור אפור ןכדועמ( ןכדועמ( ןכדועמ( .102.50 .102.50 .102.50 ) ) ) ךיראת : 71.5.71 תילגנאב רישכת םש םושירה רפסמו : 23499) - 40 - 23497); FORTUM 2 GRAM (046 - 44 - FORTUM 1 GRAM (046 םושירה לעב םש : GLAXOSMITHKLINE (ISRAEL) LTD ! דבלב תורמחהה טורפל דעוימ הז ספוט ןולעב ןולעב ןולעב אפורל אפורל אפורל תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט UNDESIRABLE EFFECTS … SKIN AND SUBCUTANEOUS TISSUE DISORDERS Common - Maculopapular or urticarial rash Uncommon - Pruritus Very rare Unknown - Toxic epidermal necrolysis Stevens-Johnson syndrome Erythema multiforme Angioedema … … SKIN AND SUBCUTANEOUS TISSUE DISORDERS Common - Maculopapular or urticarial rash Uncommon - Pruritus Very rare Unknown - Toxic epidermal necrolysis Stevens-Johnson syndrome Erythema multiforme Angioedema Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) 4 … 4 There have been rare reports where DRESS has been associated with ceftazidime. ... תושקובמה תורמחהה תונמוסמ ובש ,ןולעה ב"צמ .בוהצ עקר לע עבצב )ןולעב( ונמוס תורמחה רדגב םניאש םייוניש קורי 0 Aqra d-dokument sħiħ
_Page 1 of 16 _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS FORTUM 1 GRAM FORTUM 2 GRAM 1. NAME OF THE MEDICINAL PRODUCT Fortum 1 gram Fortum 2 gram 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fortum 1 gram: Vials contain 1g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime). Fortum 2 gram: Vials contain 2g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime). Excipient known effect Fortum 1 gram: Each vial contains 52 mg (2.26 mmol) of sodium per vial. Fortum 2 gram: Each vial contains 104 mg (4.52 mmol) of sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Fortum 1 gram - Powder for solution for injection or infusion Fortum 2 gram - 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. _Page 2 of 16 _ 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- Aqra d-dokument sħiħ