Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
methylnaltrexone bromide
Bausch Health Ireland Limited
A06AH01
methylnaltrexone bromide
Peripheral opioid receptor antagonists
Opioid-Related Disorders; Constipation
Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Revision: 18
Authorised
2008-07-01
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 Izlasiet visu dokumentu
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 Izlasiet visu dokumentu