PROTELOS - PROTELOS - CT 8814 - English version

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Description

Introduction PROTELOS 2 g, granules for oral suspension B/28 (CIP code: 365 170.3) Posted on Sep 21 2011 Active substance (DCI) strontium ranelate Rhumatologie - Mise au point Intérêt clinique modéré dans une population restreintePas d’avantage clinique démontré dans la prise en charge de l’ostéoporose post-ménopausique PROTELOS est indiqué dans le traitement de l’ostéoporose chez la femme ménopausée.Son efficacité est démontrée pour réduire le risque de fractures vertébrales et périphériques incluant la hanche.Les données de tolérance ont confirmé l’existence d’un risque d’événement thromboembolique veineux et ont montré un risque de syndrome d’hypersensibilité grave (Drug Rash with Eosinophilia and Systemic Symptoms ou DRESS).C’est un traitement de deuxième intention chez les patientes :ayant une contre-indication ou une intolérance aux bisphosphonates ;n’ayant pas de facteurs de risque thrombo-embolique veineux (antécédent d’événement thromboembolique veineux, âge supérieur à 80 ans, immobilisation...). Son intérêt clinique est modéré. Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code M05BX03 Laboratory / Manufacturer LES LABORATOIRES SERVIER PROTELOS 2 g, granules for oral suspension B/28 (CIP code: 365 170.3) Posted on Sep 21 2011

Sujets

• Ménopause
• Andropause
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-appareil-locomoteur
• Publié le: 21 septembre 2011
• Nombre de lectures: 27
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

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The legally binding text is the original French version

TRANSPARENCY COMMITTEE  

OPINION

  21 September 2011       Review of the dossier for the proprietary medicinal product listed for a period of 5 years by the order of 16 December 2005 (Journal Officielof 29 December 2005)   PROTELOS 2 g, granules for oral suspension B/28 (CIP code: 365 170.3)     Applicant: LES LABORATOIRES SERVIER   strontium ranelate ATC code (2011): M05BX03   List I     Date of Marketing Authorisation: 21 September 2004 (centralised procedure, rapporteur: Sweden)       Reason for request: Renewal of inclusion on the list of medicines refundable by National Health Insurance.                                Medical, Economic and Public Health Assessment Division

 

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CHARACTERISTICS OF THE MEDICINAL PRODUCT

1.1. Active ingredient strontium ranelate  

1.2. Indications "Treatment of osteoporosis in postmenopausal women. PROTELOS reduces the risk of vertebral and hip fractures.”  

1.3. Dosage "The recommended dose is one 2 g sachet once daily by oral administration. Due to the nature of the treated disease, strontium ranelate is intended for long-term use.   The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals. Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating.   Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate. Elderly patients The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis. No dose adjustment is required in relation to age.   Renal impairment Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 mL/min). No dose adjustment is required in patients with mild-to- moderate renal impairment (30-70 mL/min creatinine clearance).   Hepatic impairment As strontium ranelate is not metabolised, no dose adjustment is required in patients with hepatic impairment.   Paediatric population The safety and efficacy of PROTELOS in children aged below 18 years have not been established. No data are available.            

 

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