FENTORA 100 MCG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

FENTANYL AS CITRATE

Dostupné z:

ABIC MARKETING LTD, ISRAEL

ATC kód:

N01AH01

Forma lieku:

TABLETS

Zloženie:

FENTANYL AS CITRATE 100 MCG

Spôsob podávania:

BUCCAL

Typ predpisu:

Required

Výrobca:

CEPHALON LLC, USA

Terapeutické oblasti:

FENTANYL

Terapeutické indikácie:

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

Dátum Autorizácia:

2019-10-31

Príbalový leták

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: [phone]
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

Súhrn charakteristických

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