Zavicefta
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-02-2024
Valmisteyhteenveto
(SPC)
20-02-2024
Julkisesta arviointikertomuksesta
(PAR)
20-11-2020
Aktiivinen ainesosa:
avibactam sodium, ceftazidime pentahydrate
Saatavilla:
Pfizer Ireland Pharmaceuticals
ATC-koodi:
J01
INN (Kansainvälinen yleisnimi):
ceftazidime, avibactam
Terapeuttinen ryhmä:
Antibacterials for systemic use,
Terapeuttinen alue:
Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Käyttöaiheet:
Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:Complicated intra-abdominal infection (cIAI)Complicated urinary tract infection (cUTI), including pyelonephritisHospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)Treatment of 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.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-06-23
Pakkausseloste
29
B. PACKAGE LEAFLET
30
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 antibiotics
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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).
3
Posology
_Dosage in adults with creatinine clearance (CrCL) > 50 mL/min_
Table 1 shows the reco
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