Relistor
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
05-12-2023
Fachinformation
(SPC)
05-12-2023
Öffentlichen Beurteilungsberichts
(PAR)
06-02-2017
Wirkstoff:
methylnaltrexone bromide
Verfügbar ab:
Bausch Health Ireland Limited
ATC-Code:
A06AH01
INN (Internationale Bezeichnung):
methylnaltrexone bromide
Therapiegruppe:
Peripheral opioid receptor antagonists
Therapiebereich:
Opioid-Related Disorders; Constipation
Anwendungsgebiete:
Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2008-07-01
Gebrauchsinformation
67
B. PACKAGE LEAFLET
68
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
RELISTOR 12 MG/0.6 ML SOLUTION FOR INJECTION
Methylnaltrexone bromide
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 doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Relistor is and what it is used for
2.
What you need to know before you use Relistor
3.
How to use Relistor
4.
Possible side effects
5.
How to store Relistor
6.
Contents of the pack and other information
1.
WHAT RELISTOR IS AND WHAT IT IS USED FOR
Relistor contains an active substance called methylnaltrexone bromide
which acts by blocking the side
effects of opioid pain medicines that affect the bowel.
It treats constipation that is caused by medicines for moderate to
severe pain called opioids (for
example morphine or codeine). It is used for patients when other
medicines for constipation, called
laxatives, have not worked well enough. Opioids are prescribed by your
doctor. Your doctor will tell
you whether you should stop or continue taking your usual laxatives
when you start using this
medicine.
This medicine is for use in adults (aged 18 and over).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RELISTOR
_ _
DO NOT USE RELISTOR
•
If you are allergic to methylnaltrexone bromide or any of the other
ingredients of this medicine
(listed in section 6).
•
If you or your doctor know that your bowels were or are obstructed or
your bowels are in a state
where there is an immediate need for surgical intervention (which has
to be diagnosed by your
doctor).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Relistor 12 mg/0.6 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 0.6 mL contains 12 mg of methylnaltrexone bromide.
One mL of solution contains 20 mg of methylnaltrexone bromide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear solution, colourless to pale-yellow, essentially free from
visible particulates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relistor is indicated for the treatment of opioid-induced constipation
when response to laxative
therapy has not been sufficient in adult patients, aged 18 years and
older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Opioid-induced constipation in adult patients with chronic pain
(except palliative care patients with _
_advanced illness) _
The recommended dose of methylnaltrexone bromide is 12 mg (0.6 mL of
solution) subcutaneously,
as needed, given as at least 4 doses weekly, up to once daily (7 doses
weekly).
In these patients, the treatment with usual laxatives should be
stopped when commencing treatment
with Relistor (see section 5.1).
_Opioid-induced constipation in adult patients with advanced illness
(palliative care patients) _
The recommended dose of methylnaltrexone bromide is 8 mg (0.4 mL of
solution) (for patients
weighing 38-61 kg) or 12 mg (0.6 mL of solution) (for patients
weighing 62-114 kg).
The usual administration schedule is one single dose every other day.
Doses may also be given with
longer intervals, as per clinical need.
Patients may receive two consecutive doses 24 hours apart, only when
there has been no response
(bowel movement) to the dose on the preceding day.
Patients whose weight falls outside of the ranges should be dosed at
0.15 mg/kg. The injection volume
for these patients should be calculated as follows:
Dose (mL) = patient weight (kg) x 0.0075
In palliative care patients, Relistor is added to usual laxative
treatment (see section 5.1).
_ _
Special
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