DUROGESIC 25 mcg/h

Kraj: Indonezja

Język: indonezyjski

Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Składnik aktywny:

FENTANYL

Dostępny od:

KIMIA FARMA, Jakarta - Indonesia

INN (International Nazwa):

FENTANYL

Dawkowanie:

4,2 MG/PATCH (MATRIX)

Forma farmaceutyczna:

TRANSDERMAL

Sztuk w opakowaniu:

DUS, 5 PATCH

Wyprodukowano przez:

JANSSEN - Belgia

Data autoryzacji:

2016-07-11

Charakterystyka produktu

Page 1
DUROGESIC
®
NAME OF THE MEDICINAL PRODUCT
Trade Name
DUROGESIC
Fentanyl Transdermal System
INTERNATIONAL NON-PROPRIETARY NAME
Fentanyl
(Chemical Name)
(N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide)
DOSAGE FORMS AND STRENGTHS
DUROGESIC
®
patches are for transdermal use only.
Transdermal patch providing continuous systemic delivery of fentanyl,
a potent opioid analgesic, for 72
hours.
DUROGESIC
®
Dose
(mcg/h)
Active
Surface Area
(cm
2
)
Fentanyl Content
in Patch (mg)
DUROGESIC
®
12*
5.25
2.1
DUROGESIC
®
25
10.5
4.2
DUROGESIC
®
50
21.0
8.4
* The lowest dose is designed as 12 mcg/h (however, the actual dose is
12.5 mcg/h) to distinguish it from
a 125 mcg/h dose that could be prescribed by using multiple patches.
For excipients, see list of Excipients
CLINICAL INFORMATION
INDICATIONS
DUROGESIC
®
is indicated in the management of chronic pain and intractable pain
that requires continuous
opioid administration for an extended period of time.
DOSAGE AND ADMINISTRATION
DUROGESIC
®
doses should be individualized based upon the status of the patient
and should be assessed
at regular intervals after application. The patches are designed to
deliver approximately 12, 25, 50, 75, and
100 mcg/hour fentanyl to the systemic circulation, which represent
about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per
day (see _Dosage Forms and Strengths_), respectively.
ID : EREG10030312100092; EREG10030312100093; EREG10030312100094
DISETUJUI BPOM : 6/1/2022
Page 2
INITIAL DOSE SELECTION
The appropriate initiating dose of DUROGESIC
®
should be based on the patient’s current opioid use. It is
recommended that DUROGESIC
®
be used in patients who have demonstrated opiod tolerance. Other
factors
to be considered are the current general condition and medical status
of the patient, including body size,
age, and extent of debilitation as well as degree of opioid tolerance.
DOSAGE - ADULTS
OPIOID-TOLERANT PATIENTS
To convert opioid-tolerant patients from oral or parenteral opioids to
DUROGESIC
®
refer to _Equianalgesic _
_potency c