PECFENT 100

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FENTANYL AS CITRATE

متاح من:

MEDISON PHARMA LTD

ATC رمز:

N01AH01

الشكل الصيدلاني:

NASAL SPRAY, SOLUTION

تركيب:

FENTANYL AS CITRATE 1 MG / 1 ML

طريقة التعاطي:

NASAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

KYOWA KIRIN HOLDINGS B.V., THE NETHERLANDS

المجال العلاجي:

FENTANYL

الخصائص العلاجية:

PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain 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.

تاريخ الترخيص:

2019-07-31

نشرة المعلومات

This is an information document that should be referred to in
conjunction
with important information contained within the PecFent Physician's
Prescribing Information (PPI).
This educational material is essential to ensure the safe and
effective
use of the product and appropriate management of the important risks
and it is advised therefore that it be read carefully before
prescribing/
dispensing/administering the product.
Please consult the PPI for full prescribing information.
PRESCRIBER GUIDE
CONTENTS
This guide contains specific information on the safe prescribing
and use of PecFent (fentanyl citrate). This guide contains the
following information:
1
THERAPEUTIC INDICATIONS
2
IMPORTANT INFORMATION
3
DOSING
4
OVERDOSE
5
OPIOID USE DISORDER (ABUSE AND DEPENDENCE)
6
DISCUSS
7
PRESCRIBER'S CHECKLIST
THERAPEUTIC INDICATIONS
IMPORTANT INFORMATION
•
PecFent is indicated for the management of breakthrough pain (BTP) in
adults who are already receiving maintenance opioid therapy for
chronic
cancer pain.
•
Breakthrough pain 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.
1.
Treatment with PecFent should be initiated by and remain under the
supervision of a physician experienced in the management of opioid
therapy in cancer patients, in particularly regarding transition from
hospital to home.
2.
Physicians should keep in mind the potential for abuse of fentanyl.
3.
PecFent should not be prescribed to or used by children and
adolescents aged below 18 years as the safety and efficacy of such use
have not yet been established. The indication stated in the PPI must
be
adhered to.
4.
Abuse or intentional misuse of PecFent may result in overdose and/or
death.

خصائص المنتج

1
_ _
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
PECFENT 100
PECFENT 400
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PecFent 100
Each ml of solution contains 1,000 micrograms fentanyl (as citrate)
1 spray (100 microlitres) contains 100 micrograms fentanyl (as
citrate)
Each
Bottle contains:
1.55 ml (1,550 micrograms fentanyl
PecFent 400E
ach ml of solution contains 4,000 micrograms fentanyl (as citrate)
1 spray (100 microlitres) contains 400 micrograms fentanyl (as
citrate)
Each bottle contains 1.55 ml (6,200 micrograms fentanyl)
Excipients with known effect:
_ _
Each spray contains 0.02 mg propylparahydroxybenzoate (E216).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray).
A clear to practically clear colourless aqueous solution.
4.
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression, coma, and
death [see Special warnings and precautions for use (4.4)]
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment
options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation
4.1
THERAPEUTIC INDICATIONS
2
PecFent is indicated for the management of breakthrough pain (BTP) in
adults who are already
receiving maintenance opioid therapy for chronic cancer pain.
Breakthrough pain 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.
4.