ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G0.5G

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Avibactam sodium 543.5 mg eqv. to Avibactam; Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime

から入手可能:

PFIZER PRIVATE LIMITED

ATCコード:

J01DD52

医薬品形態:

INJECTION, POWDER, FOR SOLUTION

構図:

Avibactam sodium 543.5 mg eqv. to Avibactam 500mg; Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime 2g

投与経路:

INTRAVENOUS

処方タイプ:

Prescription Only

製:

ACS Dobfar S.p.A.

認証ステータス:

ACTIVE

承認日:

2019-12-12

製品の特徴

Page 1 of 26
ZAVICEFTA 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftazidime pentahydrate equivalent to 2 g
ceftazidime and avibactam
sodium equivalent to 0.5 g avibactam.
After reconstitution, 1 mL of solution contains 167.3 mg of
ceftazidime and 41.8 mg of
avibactam (see section 6.6).
Excipient with known effect: each vial contains 6.37 mmol of sodium
(approximately
146 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
A white to yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zavicefta is indicated in adults, infants (aged 3 months and older),
children, and adolescents
for the treatment of the following infections (see sections 4.4 and
5.1):

Complicated Intra-Abdominal Infection (cIAI)

Complicated Urinary Tract Infection (cUTI), including pyelonephritis

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 cIAI, cUTI, or HAP/VAP.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents. For treatment of cIAI use in combination with metronidazole.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage in Adults with Creatinine Clearance (CrCl >50 mL/min)
The recommended dosage of Zavicefta in adults is 1 vial where each
vial contains 2 g
ceftazidime and 0.5 g avibactam administered by intravenous (IV)
infusion over 2 hours.
Treatment is repeated every 8 hours. The duration of treatment is
provided in Table 1.
Page 2 of 26
Treatment Duration for Adult Patients
TABLE 1
SUMMARY OF THE TREATMENT DURATION BY INDICATION OR CONDITION
INDICATION
TREATMENT DURATION
Complicated Intra-Abdominal Infection (cIAI)
a,b
5-14 days
Complicated