ENTYVIO I.V.

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

VEDOLIZUMAB

Verfügbar ab:

TAKEDA ISRAEL LTD

ATC-Code:

L04AA33

Darreichungsform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Zusammensetzung:

VEDOLIZUMAB 300 MG/VIAL

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

TAKEDA PHARMA A/S, DENMARK

Therapiebereich:

VEDOLIZUMAB

Anwendungsgebiete:

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.

Berechtigungsdatum:

2020-02-29

Gebrauchsinformation

1
File Name
Entyvio300mg-solution for injection-PIL-ENG-D25
Product
Entyvio IV
Job No.
230000806
Language
English
Artwork
Patient Leaflet
Document History
Ver.
Date
Change description
By
18-Dec-23 13:47
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

I.V
.
Powder for concentrate for solution for infusion
Active ingredient
Each vial contains 300 mg of vedolizumab.
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 with 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?
Ulcerative colitis
Entyvio I.V. is indicated for the treatment of adult patients with
moderately to
severely active ulcerative colitis who have shown an inadequate
response with or lost
response to, or were intolerant to either conventional therapy or to a
tumor necrosis
factor-alpha (TNFα) antagonist.
Crohn’s disease
Entyvio I.V. is indicated for the treatment of adult patients with
moderately to
severely active Crohn’s disease who have shown an inadequate
response with or
lost response to or were intolerant to either conventional therapy or
to a tumor
necrosis factor-alpha (TNFα) antagonist.
Therapeutic group: Selective immunosuppressants.
Entyvio contains the active ingredient vedolizumab. Vedolizumab
belongs to a group
of biological medicines called monoclonal antibodies (MAbs). Entyvio
works by
blocking a protein on the surface of white blood cells that cause the
inflammation in
ulcerative colitis and in Crohn’s disease. This reduces the severity
of the
inflammation.
2. Before using this medicine
Do no

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entyvio
®
I.V.
Powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of vedolizumab.
After reconstitution, each mL contains 60 mg of vedolizumab.
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
Powder for concentrate for solution for infusion.
White to off-white lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ulcerative colitis
Entyvio I.V. 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 I.V. 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 _
The recommended dose regimen of intravenous vedolizumab is 300 mg
administered by intravenous
infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
Therapy for patients with ulcerative colitis should be discontinued if
no evidence of therapeutic benefit
is observed by week 10 (see section 5.1).
Some patients who have experienced a decrease in their response may
benefit from an increase in
dosing frequency to intravenous vedolizumab 300 mg every 4 weeks.
In patients who have responded to treatmen