Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
FENTANYL AS CITRATE
ABIC MARKETING LTD, ISRAEL
N02AB03
COMPRESSED TABLET ON A HANDLE
FENTANYL AS CITRATE 400 MCG/DOSE
ORAL TRANSMUCOSAL
Required
CEPHALON LLC, USA
FENTANYL
FENTANYL
Actiq is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
2023-09-30
ACTIQ® LOZENGES PHYSICIAN’S GUIDE FOR PRESCRIBING Teva Israel LTD, P.O. Box 3190, 124 Dvora Hanevi'a St., Tel Aviv 6944020, Israel, Tel: 1-800-805-005 This document has been reviewed and approved by the Ministry of Health on February 2023 CONTENTS Introduction ...................................................................................................... 3 Reporting Side Effects ...................................................................................... 3 What Is ACTIQ®? ................................................................................................ 4 How Is ACTIQ® Used? ........................................................................................ 4 What are the risks associated with off-label use of ACTIQ®? ......................... 9 Risks Associated With "Opioid Use Disorder" (OUD) ..................................... 11 What to do if you suspect that your patient is suffering from oud? ............. 12 Other important points about ACTIQ® ........................................................... 13 Checklist for prescribing ACTIQ® LOZENGES .................................................. 14 For full information about the drug please refer to Prescribing Information of ACTIQ® LOZENGES. 3 INTRODUCTION This guide is designed to help you understand the proper prescribing of ACTIQ® (fentanyl) lozenges for patients with breakthrough cancer pain (BTcP). Please read this guide carefully before prescribing ACTIQ® and keep it for future reference. Critically, select patients based upon labelled information and use the Prescriber’s Checklist provided. Encourage patients to talk about all medication-related issues. ACTIQ® lozenges may only be prescribed by physicians who are experienced, knowledgeable, and qualified in the use of opioid therapy in cancer patients. Special care should be taken when patients transition from hospital to home-based care. THE FOLLOWING MATERIALS ARE ALSO AVAILABLE: » A Patient/Carer Guide to the safe use of ACTIQ® Lozenges » A Baca dokumen lengkapnya
Actiq Tabs SPC Minor Changes (RMP) 07/2023 OKD SUMMARY OF PRODUCT CHARACTERISTICS ACTIQ COMPRESSED TABLETS ON A HANDLE. 1. NAME OF THE MEDICINAL PRODUCT ACTIQ 200 MCG ACTIQ 400 MCG ACTIQ 600 MCG ACTIQ 800 MCG ACTIQ 1200 MCG ACTIQ 1600 MCG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIQ 200 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 200 micrograms fentanyl (as citrate). ACTIQ 400 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 400 micrograms fentanyl (as citrate). ACTIQ 600 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 600 micrograms fentanyl (as citrate). ACTIQ 800 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 800 micrograms fentanyl (as citrate). ACTIQ 1,200 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 1,200 micrograms fentanyl (as citrate). ACTIQ 1,600 MCG, compressed tablets on a handle, oral transmucosal. One tablet contains 1,600 micrograms fentanyl (as citrate). Excipient(s) with known effect: Each tablet contains: - Dextrates (equivalent to approximately 1.89 grams of glucose), - Sucrose (approximately 30 milligrams confectioner’s sugar), - 9 mg Sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Compressed tablet on a handle. ACTIQ is formulated as a white to off-white, cylindrical tablets with rounded end, with ACTIQ and the dosage strength printed on it. Each Actiq unit fixed to a holder printing: ACTIQ and the dosage strength. Actiq Tabs SPC Minor Changes (RMP) 07/2023 OKD PRESCRIBER GUIDE This product is marketed with prescriber guide providing recommendations for the risk minimization in the use of Actiq. Please ensure you are familiar with this material as it contains important safety information . PATIENT SAFETY INFORMATION CARD The marketing of Actiq is subject to a risk management plan (RMP) including a Baca dokumen lengkapnya