GATTEX

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

TEDUGLUTIDE

Disponible desde:

NEOPHARM LTD, ISRAEL

Código ATC:

A16AX08

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION

Composición:

TEDUGLUTIDE 5 MG/VIAL

Vía de administración:

S.C

tipo de receta:

Required

Fabricado por:

SHIRE NPS PHARMACEUTICALS INC., USA

Área terapéutica:

TEDUGLUTIDE

indicaciones terapéuticas:

Gattex is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.

Fecha de autorización:

2023-02-08

Información para el usuario

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(MEDICINAL PRODUCTS) 1986
This medicine can be sold with a physician's prescription only
GATTEX 5MG
POWDER FOR SOLUTION FOR SUBCUTANEOUS INJECTION
ACTIVE INGREDIENT:
Each vial contains 5 mg Teduglutide.
For the list of excipients in the medicinal product, please see
section 6: “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, contact the physician
or the pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar.
In addition to the leaflet, a Patient Safety Information Card is
available for Gattex. This card
contains important safety information which you must know prior to
starting treatment and during
the treatment with Gattex and follow it. Read the Patient Safety
Information Card and the Patient
Leaflet prior to starting treatment with the medicinal product. Keep
the card for further reading if
required.
1. WHAT IS THE MEDICINE INTENDED FOR
?
Gattex contains the active substance teduglutide. It improves the
absorption of nutrients
and fluid from your remaining gastrointestinal tract (gut).
Gattex is used to treat adults, children and adolescents (aged 1 year
and above) with
Short Bowel Syndrome. Short Bowel Syndrome is a
disorder arising from an inability to
absorb food nutrients and fluid across the gut. It is often caused by
surgical removal of all
or part of the small intestine.
No safety and efficacy data is available for children below the age of
1 year.
THERAPEUTIC GROUP:
alimentary tract and metabolism products.
2. BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are hypersensitive (allergic) to the active ingredient or any of
the other ingredients
that this medicine contains or to tetracyclines.
•
If you have or are suspected to have cancer
.
•
If you have had can

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
GATTEX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 5 mg of teduglutide*.
*A glucagon-like peptide-2 (GLP-2) analogue produced in
_Escherichia coli_
cells by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
The powder is white.
PATIENT SAFETY INFORMATION CARD
The marketing of Gattex is subject to a risk management plan (RMP)
including a ‘Patient safety
information card’. The ‘Patient safety information card’,
emphasizes important safety information that
the patient should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gattex is indicated for the treatment of patients aged 1 year and
above with Short Bowel Syndrome
(SBS). Patients should be stable following a period of intestinal
adaptation after surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a medical
professional with experience in the
treatment of Short Bowel Syndrome (SBS).
Treatment should not be initiated until it is reasonable to assume
that a patient is stable following a
period of intestinal adaptation. Optimisation and stabilisation of
intravenous fluid and nutrition
support should be performed before initiation of treatment.
Clinical assessment by the physician should consider individual
treatment objectives and patient
preferences. Treatment should be stopped if no overall improvement of
the patient condition is
achieved. Efficacy and safety in all patients should be closely
monitored on an ongoing basis
according to clinical treatment guidelines.
Posology
_Adults_
The recommended dose of Gattex is 0.05 mg/kg body weight once daily.
The injection volume per
body weight is provided below in Table 1. Due to the heterogeneity of
the SBS population, a carefully
monitored down-titr