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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

RELISTOR Solution for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Relistor 12 mg/0.6 mL solution for injection.

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.

Pharmaceutical form

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

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.

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) ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction, ...

Special warnings and precautions for use

Severity and worsening symptoms Patients should be advised to promptly report severe, persistent, and/or worsening symptoms. If severe or persistent diarrhoea occurs during treatment, patients should be ...

Interaction with other medicinal products and other forms of interaction

Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes. Methylnaltrexone bromide is minimally metabolised by CYP isozymes. In ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data with the use of methylnaltrexone bromide in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk ...

Effects on ability to drive and use machines

Methylnaltrexone bromide has minor influence on the ability to drive and use machines. Dizziness may occur and this may have an effect on the ability to drive and use machines (see section 4.8).

Undesirable effects

Summary of the safety profile The most common adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea ...

Overdose

A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus. In the event of an overdose, signs and symptoms of orthostatic hypotension ...

Pharmacodynamic properties

Pharmacotherapeutic group: Laxatives, Peripheral opioid receptor antagonists ATC code: A06AH01 Mechanism of action Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor. ...

Pharmacokinetic properties

Absorption Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (C<sub>max</sub>) achieved at approximately 0.5 hours following subcutaneous administration. The C<sub>max</sub> and area ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Cardiac effects were observed ...

List of excipients

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

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 4 years. After withdrawal in the injection syringe: Due to light sensitivity, the solution for injection should be used within 24 hours.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light. For storage conditions of the medicinal product in ...

Nature and contents of container

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 ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

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

Marketing authorization number(s)

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

Date of first authorization / renewal of the authorization

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

Date of revision of the text

09/01/2017

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