Zinplava
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
01-03-2024
Produktets egenskaber
(SPC)
01-03-2024
Offentlige vurderingsrapport
(PAR)
23-03-2017
Aktiv bestanddel:
Bezlotoxumab
Tilgængelig fra:
Merck Sharp & Dohme B.V.
ATC-kode:
J06BB21
INN (International Name):
bezlotoxumab
Terapeutisk gruppe:
Immune sera and immunoglobulins,
Terapeutisk område:
Enterocolitis, Pseudomembranous
Terapeutiske indikationer:
Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.
Produkt oversigt:
Revision: 10
Autorisation status:
Authorised
Autorisation dato:
2017-01-18
Indlægsseddel
26
B.
PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZINPLAVA 25 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
bezlotoxumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN
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.
-
If you get any sid
e effects, talk to your docto
r.
This includes any possible side effects not listed
in this leaflet
. See section
4.
WHAT IS IN THIS LEAFLET
1.
What
ZINPLAVA
is and what it is used for
2.
What you need to know before you
are given
ZINPLAVA
3.
How you are given
ZINPLAVA
4.
Possible side effects
5.
How to store
ZINPLAVA
6.
Contents of the pack and other information
1.
WHAT
ZINPLAVA IS
AND WHAT IT IS USED FOR
ZINPLAVA
contains the active substance bezlotoxumab.
ZINPLAVA
is a medicine that is given together with an antibiotic
to prevent Clostridioides difficile
infection (CDI)
from coming back
in
adults and children 1
year of age or older who have a high risk of
CDI coming back.
HOW
ZINPLAVA WORKS
•
When people get CDI, they
are usually given
an antibiotic to get rid of the infection
, but CDI
can often
come back within weeks or months
.
•
The bacteria responsible for CDI produce a toxin that can inflame and
damage your colo
n,
causing stomach pain and
severe diarrhoea.
ZINPLAVA
acts by attaching to the toxin and
blocking it, thereby preventing the symptoms of CDI
from coming back
.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU
ARE GIVEN
ZINPLAVA
Talk to your doctor before you are given
ZINPLAVA
.
YOU SHOULD NOT BE GIVEN
ZINPLAVA IF:
•
you are allergic to
bezlotoxumab
or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
ZINPLAVA is not a treatment for CDI. ZINPLAVA has no effect on the CDI
you have now.
ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
CHILDREN
ZINPLAVA should not be used in children below 1
year of age.
O
THER MEDICINES AND
ZINPLAVA
T
ell your doctor if you are
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZINPLAVA
25 mg/mL
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 25
mg bezlotoxumab.
One 40 mL
vial contains
1 000
mg of bezl
otoxumab.
One 25
mL vial contains 625
mg of bezlotoxumab.
Bezlotoxumab
is a human monoclonal antibody
produced in Chinese hamster ovary cells by
recombinant DNA technology.
It binds to C. difficile toxin B.
Excipient
with known effect
Each mL
of concentrate contains
0.2 mmol
sodium, which is
4.57 mg sodium.
This corresponds to
182.8 mg of sodium per vial (for the 40
mL vial presentation
) or 114.3 mg of
sodium per vial (for the 25
mL vial presentation)
.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Concentrate for solution for infusion.
Clear to moderately opalescent, colourless to pale yellow liquid
.
4.
C
LINICAL PARTICUL
ARS
4.1
THERAPEUTIC INDICATIONS
ZINPLAVA
is indicated for the prevention of recurrence
of Clostridioides difficile
infection (CDI) in
adult
and paediatric patients 1
year of age and older
at high risk for recurrence of CDI (see sections
4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ZINPLAVA should be administered during the course of antibacterial
therapy for CDI (see sections
4.4 and 5.1).
Adult and paediatric patients 1
year of age and older
ZINPLAVA
should be administered as a single intravenous infusion of 10
mg/kg (see below and
section 6.6).
The experience with
ZINPLAVA in patients is limited to a single CDI episode and single
administration
(see section 4.4).
Special populations
Elderly
No dose adjustment is necessary in patients
≥
65
years of age
(see section 5.2).
3
Renal impairment
No dose
adjustment is necessary for patients with renal impairment
(see section 5.2).
Hepatic impairment
No dose adjustment is necessary for patients with hepatic impairment
(see section
5.2).
Pa
ediatric population
There is no relevant use of
bezlotoxumab in children under 1
year of a
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