TARGINACT - TARGINACT - CT 10861 - English version

Has

Description

Introduction TARGINACT 5 mg/2.5 mg, prolonged-release tablet B/14 (CIP code: 395 163-5) B/28 (CIP code: 395 165-8) TARGINACT 10 mg/5 mg, prolonged-release tablet B/14 (CIP code: 395 179-9) B/28 (CIP code: 395 181-3) TARGINACT 20 mg/10 mg, prolonged-release tablet B/14 (CIP code: 395 190-2) B/28 (CIP code: 395 192-5) TARGINACT 40 mg/20 mg, prolonged-release tablet B/14 (CIP code: 395 200-8) B/28 (CIP code: 395 202-0) Posted on Dec 07 2011 Active substance (DCI) oxycodone hydrochloride, naloxone hydrochloride Pas d’avantage clinique démontré dans la prise en charge de la douleur sévère d’origine cancéreuseAvis défavorable au remboursement dans les autres types de douleur sévère TARGINACT a l’AMM dans la douleur sévère qui ne peut être correctement traitée que par des analgésiques opioïdes. La naloxone, antagoniste opioïde, est ajoutée afin de neutraliser la constipation induite par l’opioïde en bloquant localement l’action de l’oxycodone au niveau des récepteurs intestinaux.Dans la douleur cancéreuse, son efficacité analgésique est non-inférieure à celle de l’oxycodone seule ; elle ne réduit pas la consommation de laxatifs ni celle d’antalgiques de secours.Dans la lombalgie chronique, qui n'est pas un modèle pertinent d’étude des opiacés, la quantité d’effet est minime et difficile à interpréter.On ne dispose pas de comparaison entre TARGINACT et la prise séparée d’oxycodone et d’un laxatif.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code N02AA55 Laboratory / Manufacturer MUNDIPHARMA TARGINACT 5 mg/2.5 mg, prolonged-release tablet B/14 (CIP code: 395 163-5) B/28 (CIP code: 395 165-8) TARGINACT 10 mg/5 mg, prolonged-release tablet B/14 (CIP code: 395 179-9) B/28 (CIP code: 395 181-3) TARGINACT 20 mg/10 mg, prolonged-release tablet B/14 (CIP code: 395 190-2) B/28 (CIP code: 395 192-5) TARGINACT 40 mg/20 mg, prolonged-release tablet B/14 (CIP code: 395 200-8) B/28 (CIP code: 395 202-0) Posted on Dec 07 2011

Sujets

• Douleur
• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 07 décembre 2011
• Nombre de lectures: 69
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

    The legally binding text is the original French version   TRANSPARENCY COMMITTEE

  OPINION   7 December 2011     TARGINACT 5 mg/2.5 mg, prolonged-release tablet B/14 (CIP code: 395 163-5) B/28 (CIP code: 395 165-8)   TARGINACT 10 mg/5 mg, prolonged-release tablet B/14 (CIP code: 395 179-9) B/28 (CIP code: 395 181-3)   TARGINACT 20 mg/10 mg, prolonged-release tablet B/14 (CIP code: 395 190-2) B/28 (CIP code: 395 192-5)   TARGINACT 40 mg/20 mg, prolonged-release tablet B/14 (CIP code: 395 200-8) B/28 (CIP code: 395 202-0)     Applicant: MUNDIPHARMA   oxycodone hydrochloride, naloxone hydrochloride ATC Code (2011): N02AA55 (oxycodone combinations)     List I   Narcotic – Prescription limited to 28 days.     Date of Marketing Authorisation: 1 July 2009 (decentralised procedure, reporting country: Germany).   Reason for request: Inclusion on the list of medicines refundable by National Health Insurance and approved for hospital use.   "MUNDIPHARMA laboratories have requested the inclusion of TARGINACT in the sub-section of the indication for severe pain due to cancer."           Medical, Economic and Public Health Assessment Division

 

1/23

 

1

CHARACTERISTICS OF THE MEDICINAL PRODUCT

1.1. Active ingredients Oxycodone hydrochloride, naloxone hydrochloride.

1.2. Background This medicinal product is a fixed combination of oxycodone and its antagonist, naloxone, in the form of a prolonged-release tablet, indicated for the management of severe pain in adults. Naloxone is metabolised to 98% by the liver following oral administration; competition with oxycodone thus takes place locally in the gut, which potentially results in a reduction in opioid-induced constipation without causing a change in the analgesic efficacy of oxycodone. This combination could possibly limit the switch to an addictive use of this medicinal product.

1.3. Indication "Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.”

1.4. Dosage "TARGINACT is for oral use. The analgesic efficacy of TARGINACT is equivalent to oxycodone hydrochloride prolonged-release formulations. The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient. Unless otherwise prescribed, TARGINACT should be administered as follows:   Adults The usual starting dose for an opioid naive patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals. Patients already receiving opioids may be started on higher doses of TARGINACT,  depending on their previous opioid experience. TARGINACT 5 mg/2.5 mg, prolonged-release tablet is intended for dose titration when initiating opioid therapy and individual dose adjustment. The maximum daily dose of TARGINACT   is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. For patients requiring higher doses of TARGINACT, administration of supplemental oxycodone hydrochloride prolonged-release at the same time intervals should be considered, taking into account the maximum daily dose of 400 mg prolonged-release oxycodone hydrochloride. In the case of supplemental oxycodone hydrochloride dosing, the beneficial effect of naloxone hydrochloride on bowel function may be impaired. After complete discontinuation of therapy with TARGINACT and with a subsequent switch to another opioid, a worsening of the bowel function can be expected. Some patients taking TARGINACT according to a regular time schedule require immediate-release analgesics as "rescue" medication for breakthrough pain. TARGINACT is a prolonged-release formulation and therefore not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should approximate one sixth of the equivalent daily dose of oxycodone hydrochloride. The need for more than two “rescues” per day is usually an indication that the dose of TARGINACT requires upward adjustment. This adjustment should be made every 1-2 days in steps of twice daily 5 mg/2.5 mg, or where demanded 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride, until a stable dose is reached. The aim is to establish a patient-specific twice daily dose that will maintain adequate analgesia and make use of as little rescue medication as possible for as long as pain therapy is necessary.   TARGINACT is taken at the determined dosage twice daily according to a fixed time schedule. While symmetric administration (the same dose mornings and evenings) subject to a fixed time schedule (every 12 hours) is appropriate for the majority of patients, some   2/23