ACTIQ 600 MCG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FENTANYL AS CITRATE

متاح من:

ABIC MARKETING LTD, ISRAEL

ATC رمز:

N02AB03

الشكل الصيدلاني:

COMPRESSED TABLET ON A HANDLE

تركيب:

FENTANYL AS CITRATE 600 MCG/DOSE

طريقة التعاطي:

ORAL TRANSMUCOSAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CEPHALON LLC, USA

المجموعة العلاجية:

FENTANYL

المجال العلاجي:

FENTANYL

الخصائص العلاجية:

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.

تاريخ الترخيص:

2023-09-30

نشرة المعلومات

ACTIQ® LOZENGES
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 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

خصائص المنتج

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