البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
FENTANYL AS CITRATE
ABIC MARKETING LTD, ISRAEL
N01AH01
TABLETS
FENTANYL AS CITRATE 100 MCG
BUCCAL
Required
CEPHALON LLC, USA
FENTANYL
Fentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer
2019-10-31
FENTORA® BUCCAL TABLETS 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 FENTORA®? ........................................................................................... 4 How Is FENTORA® Used? .................................................................................. 4 Overdose and Unintentional Exposure ........................................................... 8 Safety, Storage And Disposal ........................................................................... 9 What Are The Risks Associated With Off-Label Use Of FENTORA®? .............. 10 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 FENTORA® ...................................................... 13 Checklist For Dispensing FENTORA® ................................................................ 15 3 INTRODUCTION This guide is designed to help you understand the proper prescribing of FENTORA® (fentanyl) Buccal tablets for patients with breakthrough cancer pain (BTcP). Please read this guide carefully before prescribing FENTORA® 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. FENTORA® buccal tablets 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-ba اقرأ الوثيقة كاملة
Fentora Buccal Tablets, M.W 07-2023 SUMMARY OF PRODUCT CHARACTERISTICS Fentora ® 100 mcg Fentora ® 200 mcg Fentora ® 400 mcg Fentora ® 600 mcg Fentora ® 800 mcg 1. NAME OF THE MEDICINAL PRODUCT Fentora ® 100 micrograms buccal tablets Fentora ® 200 micrograms buccal tablets Fentora ® 400 micrograms buccal tablets Fentora ® 600 micrograms buccal tablets Fentora ® 800 micrograms buccal tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Fentora 100 micrograms buccal tablets _ Each buccal tablet contains 100 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 10 mg of sodium. _Fentora 200 micrograms buccal tablets _ Each buccal tablet contains 200 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. _Fentora 400 micrograms buccal tablets _ Each buccal tablet contains 400 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. _Fentora 600 micrograms buccal tablets _ Each buccal tablet contains 600 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of sodium. _Fentora 800 micrograms buccal tablets _ Each buccal tablet contains 800 micrograms fentanyl (as citrate). Excipient with known effect: Each tablet contains 20 mg of 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 Buccal tablet. _Fentora 100 micrograms buccal tablets _ Fentora Buccal Tablets, M.W 07-2023 Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”. _Fentora 200 micrograms buccal tablets _ Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”. _Fentora 400 micrograms buccal tablets _ Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”. _Fentora 600 اقرأ الوثيقة كاملة