ZINPLAVA bezlotoxumab (rch) 1000 mg/40 mL concentrated injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

bezlotoxumab

제공처:

Merck Sharp & Dohme (Australia) Pty Ltd

승인 상태:

Registered

환자 정보 전단

ZINPLAVA
®
_CONCENTRATED INJECTION_
_Bezlotoxumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZINPLAVA. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having ZINPLAVA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZINPLAVA IS
USED FOR
ZINPLAVA contains the active
ingredient bezlotoxumab.
ZINPLAVA is a medicine to prevent
Clostridium difficile infection (CDI)
from coming back in adults who are
taking an antibiotic for CDI and have
a high risk of CDI coming back.
CDI is a bacterial infection that can
damage your colon and cause
stomach pain and severe diarrhoea.
When people get CDI, they often
take an antibiotic to get rid of the
infection. Even when treated with
antibiotics, CDI can come back
within weeks to months.
ZINPLAVA prevents the infection
coming back. It works when given
along with your antibiotic that you
are taking for CDI.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZINPLAVA
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ZINPLAVA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN ZINPLAVA
IF YOU HAVE AN ALLERGY TO:
•
BEZLOTOXUMAB
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
ZINPLAVA SHOULD NOT BE USED IN
CHILDREN BELOW 18 YEARS OF AGE UNTIL
MORE INFORMATION BECOMES
AVAILABLE.
_BEFORE YOU ARE GIVEN IT_
•
TELL YOUR DOCTOR IF YOU HAVE ANY
ALLERGIES TO ANY OTHER MEDICINES,
OR ANY OTHER SUBSTANCES SUCH AS
FOODS, PRESERVATIVES OR DYES.
•
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD CONGESTIVE HEART
FAILURE (CHF)
•
TELL YOUR DOCTOR IF YOU ARE
PREGNANT, THINK YOU MAY BE
PREGNANT OR TRYING TO BECOME
PREGNANT.
It is unknown if ZINPLAVA will
harm your baby while you are
pr

제품 특성 요약

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION - ZINPLAVA
®
(BEZLOTOXUMAB)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Bezlotoxumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains bezlotoxumab 1,000 mg/40 mL.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ZINPLAVA
concentrated
injection
is
a
sterile,
preservative-free,
clear
to
moderately
opalescent, colourless to pale yellow liquid that requires dilution
for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZINPLAVA (bezlotoxumab) is indicated for the prevention of recurrence
of _Clostridium difficile_
infection (CDI) in adult patients 18 years or older at high risk for
recurrence of CDI who are
receiving antibacterial therapy for CDI (see Section 5.1
Pharmacodynamic Properties, Clinical
trials).
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an
antibacterial drug.
ZINPLAVA should only be used in conjunction with antibacterial drug
treatment of CDI.
The safety and efficacy of repeat administration of ZINPLAVA in
patients with CDI have not
been studied.
4.2
DOSE AND METHOD OF ADMINISTRATION
ZINPLAVA (bezlotoxumab) should be administered during a course of
antibacterial therapy
for CDI (see Section 4.4 Special Warnings and Precautions for Use).
DOSE RECOMMENDATIONS IN ADULTS
The recommended dose of ZINPLAVA is 10 mg/kg based on patient body
weight administered
as an intravenous (IV) infusion over 60 minutes as a single dose.
PREPARATION AND ADMINISTRATION
Preparation of Diluted Solution
•
Prepare the diluted solution immediately after removal of the vial(s)
from refrigerated
storage, or the vial(s) may be stored at room temperature protected
from light for up to
24 hours prior to preparation of the diluted solution.
•
Inspect
vial
contents
for
discoloration
and
particulate
matter
prior
to
dilution.
ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow
liquid. Do not
use the vial if the solution is discolored or contains visible
particles.
•
D