RELISTOR Solution for injection Ref.[9197] Active ingredients: Methylnaltrexone

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00, Praha 7, Czech republic

Product name and form

Relistor 12 mg/0.6 mL solution for injection.

Pharmaceutical Form

Solution for injection.

Clear solution, colourless to pale-yellow, essentially free from visible particulates.

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.

Active Ingredient Description
Methylnaltrexone

Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor. As a quaternary amine, the ability of methylnaltrexone bromide to cross the blood-brain barrier is restricted. This allows methylnaltrexone bromide to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
List of Excipients

Sodium chloride
Sodium calcium edetate
Glycine hydrochloride
Water for injections
Hydrochloric acid (to adjust pH)
Sodium hydroxide (to adjust pH)

Pack sizes and marketing

Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flip-off-cap.

Each vial contains 0.6 mL of solution for injection.

Pack sizes of:

  • 1 vial,
  • 2 vials with 2 sterile 1 mL injection syringes with retractable injection needle and 4 alcohol swabs; or
  • 7 vials with 7 sterile 1 mL injection syringes with retractable injection needle and 14 alcohol swabs.

Not all pack sizes may be marketed.

Marketing authorization holder

PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00, Praha 7, Czech republic

Marketing authorization dates and numbers

EU/1/08/463/001
EU/1/08/463/002
EU/1/08/463/003

Date of first authorisation: 02 July 2008
Date of latest renewal: 27 May 2013

Drugs

Drug Countries
RELISTOR Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States
 
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