ENTYVIO S.C

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

VEDOLIZUMAB

Disponibil de la:

TAKEDA ISRAEL LTD

Codul ATC:

A04AA33

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

VEDOLIZUMAB 158.8 MG / 1 ML

Calea de administrare:

S.C

Tip de prescriptie medicala:

Required

Produs de:

TAKEDA PHARMA A/S, DENMARK

Zonă Terapeutică:

VEDOLIZUMAB

Indicații terapeutice:

Ulcerative colitisEntyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.Crohn’s diseaseEntyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Data de autorizare:

2022-07-26

Prospect

1
File Name
Entyvio SC-Pen-PIL-ENG-D24
Product
Entyvio
Job No.
23000806
Language
English
Artwork
Patient Leaflet
Document History
Ver.
Date
Change description
By
29-Aug-23 12:22
Last save
_Our Expertise. Your Success._
2
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Entyvio
®
S.C.
Solution for subcutaneous injection in a pre-filled pen
Active ingredient and its quantity:
Each pre-filled pen contains 108 mg of vedolizumab in 0.68 ml
solution.
Inactive ingredients and allergens: See section 6 'Additional
information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. What is this medicine intended for?
Entyvio S.C. is used to treat the signs and symptoms in adults of
:

moderately to severely active ulcerative colitis
.

moderately to severely active Crohn’s disease .
Ulcerative colitis
Entyvio S.C. is indicated for treatment of adults with moderately to
severely active ulcerative
colitis who demonstrated inadequate response, stopped responding or
exhibited intolerance to the
standard of care or to tumor necrosis factor-alpha (TNFα) antagonist.
Crohn’s disease
Entyvio S.C. is indicated for treatment of adults with moderately to
severely active Crohn’s
disease who demonstrated inadequate response, stopped responding or
exhibited intolerance to
the standard of care or to tumor necrosis factor-alpha (TNFα)
antagonist.
Therapeutic group: Selective immunosuppressants (monoclonal antibodies
- MAbs).
Entyvio contains the active substance vedolizumab. Vedolizumab belongs
to a group of biological
medicines called monoclonal antibodies (MAbs). Entyvio works by
blocking a protein located on the

Caracteristicilor produsului

1
1.
NAME OF THE MEDICINAL PRODUCT
Entyvio SC
Solution for injection in pre-filled syringe
Solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entyvio 108 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 108 mg of vedolizumab in 0.68 mL.
Entyvio 108 mg solution for injection in pre-filled pen
Each pre-filled pen contains 108 mg of vedolizumab in 0.68 mL.
Vedolizumab is a humanised IgG
1
monoclonal antibody produced in Chinese hamster ovary (CHO)
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ulcerative colitis
Entyvio is indicated for the treatment of adult patients with
moderately to severely active ulcerative
colitis who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist.
Crohn’s disease
Entyvio is indicated for the treatment of adult patients with
moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist.
4.2
Posology and method of administration
Treatment should be initiated and supervised by specialist healthcare
professionals experienced in the
diagnosis and treatment of ulcerative colitis or Crohn’s disease
(see section 4.4). Patients should be
given the package leaflet.
2
Posology
_Ulcerative colitis and Crohn’s disease _
The recommended dose regimen of subcutaneous vedolizumab as a
maintenance treatment, following
at least 2 intravenous infusions, is 108 mg administered by
subcutaneous injection once every
2 weeks. The first subcutaneous dose should be administered in place
of the next scheduled
intravenous dose and every 2 weeks thereafter.
For the intravenous dose regimen, see section 4.2 of the En