מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Ceftazidime pentahydrate 2.329 g equivalent to ceftazidime 2.0 g
Pfizer New Zealand Limited
Ceftazidime pentahydrate 2.329 g (equivalent to ceftazidime 2.0 g)
2 g
Powder for injection
Active: Ceftazidime pentahydrate 2.329 g equivalent to ceftazidime 2.0 g Excipient: Sodium carbonate
Vial, glass, Type 1, clear 100 mL with bromobutyl rubber stopper, 2 g
Prescription
Prescription
Hospira Healthcare India Pvt. Ltd
Indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycoside in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: - Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, for example infected burns. - Respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. - Severe ear, nose and throat infections: for example, otitis media, mastoiditis. - Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. - Skin and soft tissue infections: for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. - Gastrointestinal and abdominal infections: for example, intra-abdominal abscesses, enterocolitis. - Bone and joint infections: for example, osteitis, osteomyelitis, septic arthritis, infected bursitis. - Infections associted with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)
Package - Contents - Shelf Life: Vial, glass, Type 1, clear 100 mL with bromobutyl rubber stopper - 2 g - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2012-05-08
Data Sheet – New Zealand Version 3.0 Page 1 HOSPIRA™ CEFTAZIDIME, POWDER FOR INJECTION NAME OF THE MEDICINE Ceftazidime (as ceftazidime pentahydrate) CAS No. 78439-06-2 Molecular Weight: 636.6 Molecular formula: C 22 H 22 N 6 O 7 S 2 , 5H 2 O Chemical name: (6_R_,7_R_)-7-[[(2_Z_)-2-(2-Aminothiazol-4-yl)-2-[(1-carboxy-1 methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate pentahydrate. DESCRIPTION Hospira™ Ceftazidime Powder for Injection is a cephalosporin antibiotic for use by injection only. It is supplied as a white to cream coloured crystalline powder in vials containing 1 g and 2 g ceftazidime (as pentahydrate) with sodium carbonate anhydrous (117 mg per gram of ceftazidime). On the addition of Water for Injections, Hospira™ Ceftazidime Powder for Injection dissolves with effervescence to produce a light yellow to amber coloured solution for injection. Ceftazidime pentahydrate is slightly soluble in water and in methanol, practically insoluble in acetone and in ethanol (96 per cent). It dissolves in acid and alkali solutions. Ceftazidime pentahydrate decomposes at about 150 °C . Ceftazidime penthahydrate is hygroscopic and crystalline in nature . No potential polymorphism is reported. Hospira™ Ceftazidime Powder for Injection contains approximately 51 mg (2.17 mEq) of sodium per gram of ceftazidime. 116 mg ceftazidime pentahydrate is equivalent to 100 mg ceftazidime anhydrous. For laboratory tests associated with ceftazidime administration, ceftazidime pentahydrate should be used. PHARMACOLOGY PHARMACOKINETICS Absorption of ceftazidime after oral administration is negligible, therefore Hospira™ Ceftazidime Powder for Injection is intended for parenteral use only. Data Sheet – New Zealand Version 3.0 Page 2 In humans, after a single intramuscular administration of 500 mg and 1 g, mean peak serum levels of 18 and 37 mg/L respectively are achieved at 1 hour, falling to 8 and 2 mg/L and 20 and 5 mg/L at four and eight hours respectively קרא את המסמך השלם