Revestive
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-07-2023
Produktets egenskaber
(SPC)
11-07-2023
Offentlige vurderingsrapport
(PAR)
11-07-2023
Aktiv bestanddel:
teduglutide
Tilgængelig fra:
Takeda Pharmaceuticals International AG Ireland Branch
ATC-kode:
A16AX08
INN (International Name):
teduglutide
Terapeutisk gruppe:
Other alimentary tract and metabolism products,
Terapeutisk område:
Malabsorption Syndromes
Terapeutiske indikationer:
Revestive 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.Revestive 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.
Produkt oversigt:
Revision: 22
Autorisation status:
Authorised
Autorisation dato:
2012-08-30
Indlægsseddel
47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REVESTIVE 1.25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
teduglutide
For children and adolescents
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 START USING 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 child’s doctor,
pharmacist or nurse.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same.
-
If the child gets any side effects, talk to your child’s doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Revestive is and what it is used for
2.
What you need to know before you use Revestive
3.
How to use Revestive
4.
Possible side effects
5
How to store Revestive
6.
Contents of the pack and other information
1.
WHAT REVESTIVE IS AND WHAT IT IS USED FOR
Revestive contains the active substance teduglutide. It improves the
absorption of nutrients and fluid
from your child’s remaining gastrointestinal tract (gut).
Revestive is used to treat children and adolescents (aged 4 months 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REVESTIVE
DO NOT USE REVESTIVE
-
if your child is allergic to teduglutide or any of the other
ingredients of this medicine (listed in
section 6) or trace residues of tetracycline.
-
if your child has or is suspected to have cancer.
-
if your child has had cancer in the gastrointes
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Revestive 1.25 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 1.25 mg of teduglutide*.
After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml
of solution, corresponding to a
concentration of 2.5 mg/ml.
*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 and solvent for solution for injection.
The powder is white and the solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Revestive is indicated for the treatment of patients 4 months
corrected gestational age 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 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
_Paediatric population (≥4 months) _
Treatment should be initiated under the supervision of a m
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