ZINPLAVA 25 MGML

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

BEZLOTOXUMAB

Mevcut itibaren:

MERCK SHARP & DOHME ISRAEL LTD

ATC kodu:

J06BB21

Farmasötik formu:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompozisyon:

BEZLOTOXUMAB 25 MG / 1 ML

Uygulama yolu:

I.V

Reçete türü:

Required

Tarafından üretildi:

MERCK SHARP & DOHME CORP., USA

Terapötik alanı:

BEZLOTOXUMAB

Terapötik endikasyonlar:

ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment of CDI and are at high risk for recurrence of CDI

Yetkilendirme tarihi:

2018-12-10

Bilgilendirme broşürü

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is to be supplied upon physician’s prescription only
ZINPLAVA
® 25 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
Each mL of concentrate contains:
25 mg of bezlotoxumab
For a list of inactive ingredients see section 6. “FURTHER
INFORMATION”. See also section
2.7 “Important information about some of the ingredients of the
medicine”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.

This leaflet contains concise information about the medicine. If you
have any further
questions, refer to the doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their medical condition seems similar to yours.
1.
WHAT ZINPLAVA IS INTENDED FOR?
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.
THERAPEUTIC GROUP: Antiinfectives for systemic use, specific
immunoglobulins.
HOW ZINPLAVA WORKS

When people get CDI, they are usually given an antibiotic to get rid
of the infection, but
CDI can 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.
BEFORE USING ZINPLAVA
Talk to your doctor before you are given ZINPLAVA.
2.1
DO NOT USE ZINPLAVA IF:
you are hypersensitive (allergic) to bezlotoxumab or any of the other
ingredients of this
medicine (For a list of inactive ingredients, see section 6).
2.2 SPECIAL WARNINGS REGARDING USE OF ZINPLAVA
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.
2.3 CHILDREN AND ADOLESCENTS
ZINPLAVA should not be used in c

Ürün özellikleri

1
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 who are receiving antibacterial drug treatment of CDI and are
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).
2
_Hepatic impairment_
No dose adjustment is necessary for patients with hepatic impairment
(see section 5.2).
_ _
_Paediatric population _
The safety and efficacy of ZINPLAVA in patients below 18 years of age
have not been established.
No data are available.
Method of administration

Administer the diluted solution for infusion intravenously over 60
minutes using a sterile,
non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or
add-on filter. ZINPLAVA
sh