Relistor 12mg0.6ml solution for injection vials

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Methylnaltrexone bromide

Предлага се от:

Swedish Orphan Biovitrum Ltd

АТС код:

A06AH01

INN (Международно Name):

Methylnaltrexone bromide

дозиране:

20mg/1ml

Лекарствена форма:

Solution for injection

Начин на приложение:

Subcutaneous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01060600; GTIN: 5010981002974 5010981002981

Листовка

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 using Relistor
•
If you

Данни за продукта

OBJECT 1
RELISTOR 12 MG/0.6 ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 08-Feb-2017 | Swedish
Orphan Biovitrum Ltd
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