Zavicefta (Ceftazidime 2gAvibactam 0.5g) Powder for Concentrate for Solution for Infusion

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

Avibactam Sodium; Ceftazidime Pentahydrate

Beschikbaar vanaf:

PFIZER (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

Avibactam Sodium; Ceftazidime Pentahydrate

Eenheden in pakket:

10 Vials

Geproduceerd door:

ACS Dobfar S.p.A.

Bijsluiter

NOT APPLICABLE

Productkenmerken

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