Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Avibactam Sodium; Ceftazidime Pentahydrate
PFIZER (MALAYSIA) SDN. BHD.
Avibactam Sodium; Ceftazidime Pentahydrate
10 Vials
ACS Dobfar S.p.A.
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1 1. NAME OF THE MEDICINAL PRODUCT Zavicefta (Ceftazidime 2 g/Avibactam 0.5 g) powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftazidime (as pentahydrate) equivalent to 2000 mg ceftazidime and avibactam (as sodium salt) equivalent to 500 mg avibactam. After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime (CAZ) and 41.8 mg of avibactam (AVI). Ceftazidime (as pentahydrate) is a white to almost white crystalline powder. It is soluble in acid, alkali and dimethyl sulphoxide and slightly soluble in water, methanol and dimethylformamide. Avibactam (as sodium) is a crystalline powder. It is freely soluble in water, relatively soluble in methanol and insoluble in ethanol. EXCIPIENTS WITH KNOWN EFFECT Each vial contains approximately 6.44 mmol of sodium (approximately 148 mg). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for solution for infusion. Zavicefta is a white to yellow sterile powder. The reconstituted solution is a clear and colourless to yellow solution free from visible particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections (see sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties): • Complicated intra-abdominal infection (cIAI), in combination with metronidazole. • Complicated urinary tract infection (cUTI), including pyelonephritis. Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties): 2 • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidanc Izlasiet visu dokumentu