Zavicefta 2g0.5g powder for concentrate for solution for infusion vials

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Ceftazidime pentahydrate; Avibactam sodium

Հասանելի է:

Pfizer Ltd

INN (Միջազգային անվանումը):

Ceftazidime pentahydrate; Avibactam sodium

Դոզան:

2gram ; 500mg

Դեղագործական ձեւ:

Powder for solution for infusion

Կառավարման երթուղին:

Intravenous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 05010201; GTIN: 5000456013680

Տեղեկատվական թերթիկ

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZAVICEFTA ® 2 G/0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
ceftazidime/avibactam
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 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
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 a

Ապրանքի հատկությունները

OBJECT 1
ZAVICEFTA 2G/0.5G POWDER FOR CONCENTRATION FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 06-Feb-2018 | Pfizer
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 6.44 mmol of sodium
(approximately 148 mg).
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 for the treatment of the following infections
in adults (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)
Zavicefta is also indicated for the treatment of infections due to
aerobic Gram-negative organisms in adult
patients 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 adult patients with limited treatment options only after
consultation with a physician with
appropriate experience in the management of infectious diseases (see
section 4.4).
Posology
Table