Zinplava 1g40ml concentrate for solution for infusion vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Bezlotoxumab

থেকে পাওয়া:

Merck Sharp & Dohme Ltd

INN (আন্তর্জাতিক নাম):

Bezlotoxumab

ডোজ:

25mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 14040000; GTIN: 5013945301908

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZINPLAVA® 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
bezlotoxumab
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 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 side effects, talk to your doctor. 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
_Clostridium difficile _
infection (CDI) from coming back in patients 18 years 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 colon,
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.
ZINPLA

পণ্য বৈশিষ্ট্য

OBJECT 1
ZINPLAVA 25 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 04-Apr-2018 | Merck Sharp &
Dohme 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
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 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.
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. Clinical particulars
4.1 Therapeutic indications
ZINPLAVA is indicated for the prevention of recurrence of _Clostridium
difficile _infection (CDI) in adults
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).
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).
_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).
_Paediatric population_
The sa