Zavicefta powder for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftazidime (ceftazidime pentahydrate), avibactam (avibactam sodium)

Available from:

ACS DOBFAR SpA

ATC code:

J01DD52

INN (International Name):

ceftazidime (ceftazidime pentahydrate), avibactam (avibactam sodium)

Dosage:

2g+ 0,5g

Pharmaceutical form:

powder for solution for infusion

Units in package:

(10) glass vials 20ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-05-21

Patient Information leaflet

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2020-0063629
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZAVICEFTA ® 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
ceftazidime/avibactam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zavicefta is and what it is used for
2.
What you need to know before you use Zavicefta
3.
How to use Zavicefta
4.
Possible side effects
5.
How to store Zavicefta
6.
Contents of the pack and other information
1.
WHAT ZAVICEFTA IS AND WHAT IT IS USED FOR
WHAT ZAVICEFTA IS
Zavicefta is an antibiotic medicine that contains two active
substances ceftazidime and avibactam.

Ceftazidime belongs to the group of antibiotics called
“cephalosporins”. It can kill many types of
bacteria.

Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime
kill some bacteria that it cannot
kill on its own.
WHAT ZAVICEFTA IS USED FOR
Zavicefta is used in adults and paediatric patients aged 3 months and
over to treat:

infections of the stomach and gut (abdomen)

infections of the bladder or kidneys called “urinary tract
infections”

an infection of the lungs called “pneumonia”

infections caused by bacteria that other antibiotics may not be able
to kill
Zavicefta is used in adults to treat infection of the blood associated
with infections of the abdomen,
urinary tract, or pneumonia.
HOW ZAVICEFTA WORKS
Zavicefta works by killing certain types of bacteria, which can cause
serious infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZAVICEFTA
_ _
DO NOT USE ZAVICEFTA IF:

you are allergic to ceftazidime, avibactam or any of the other
ingredients of this medicine (listed in
section 6)

you are allergic to other cephalosporin antib

Summary of Product characteristics

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2020-0063857
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:
Zavicefta contains approximately 146 mg sodium per vial.
For the 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 and paediatric patients aged 3 months
and older 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, any of the infections listed above.
_ _
Zavicefta is also indicated for the treatment of infections due to
aerobic Gram-negative organisms in
adults and paediatric patients aged 3 months and older with limited
treatment options (see sections 4.2,
4.4 and 5.1)._ _
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Zavicefta should be used to treat infections
due to aerobic Gram-negative
organisms in adults and paediatric patients aged 3 months and older
with limited treatment options only
after consultation with a physician with appropriate experience in the
management of infectious diseases
(see section 4.4).
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2020-0063857
Posology
_Dosage in adults with creatinine clearance (CrCL) > 50 mL/min _
Table 1