DUROGESIC 12 MCGHR TRANSDERMAL PATCH

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FENTANYL BASE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

FENTANYL BASE

Unit dalam pakej:

5Pieces Pieces

Dikeluarkan oleh:

JANSSEN PHARMACEUTICA N.V.

Risalah maklumat

DUROGESIC
® TRANSDERMAL PATCH
Fentanyl (12mcg/hr, 25mcg/hr, 50mcg/hr)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DUROGESIC
®
_ _
is used for
2.
How DUROGESIC
®
works
3.
Before you use DUROGESIC
®
4.
How to use DUROGESIC
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
DUROGESIC
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT DUROGESIC
®
_ _IS USED FOR
DUROGESIC
®
is a strong painkiller. It
is used to relieve severe long-lasting
pain, which requires strong painkillers.
HOW DUROGESIC
®
_ _WORKS
DUROGESIC
®
patches contain a
medicine called fentanyl. This strong
pain reliever belongs to a group of
medicines known as opioid analgesics.
Its primary therapeutic actions are
analgesia and sedation.
BEFORE YOU USE DUROGESIC
®
-
_When you must not use it _
•
If you know you are oversensitive to it
_ _
•
Unless your doctor has prescribed it
for your pain
_ _
•
For the relief of pain following
surgery or short-term pain
_ _
•
if you have breathing difficulties, with
slow or shallow breathing.
_ _
_Pregnancy and lactation _
_Pregnancy _
•
If you are pregnant or plan to become
pregnant, you should inform your
doctor, who will decide whether you
may use DUROGESIC
®
.
DUROGESIC
®
should not be used
during childbirth as the medicine can
slow the breathing of the newborn
child. Prolonged use of
DUROGESIC
®
during pregnancy can
cause withdrawal symptoms in your
newborn baby that could be life-
threatening if not recognized and
treated.
_Breastfeeding _
•
If you are breast-feeding, you should
not use DUROGESIC
®
since it may
be present in your milk. See your
doctor.
_Children _
DUROGESIC
®
is not for children, unless
your doctor has decided otherwise
_ _
_ _
-
_Before you start use it _
Opioids can be abused and misused,
and you are at risk for opioid
addiction, even if you take your dose
as prescribed. Opioid addiction, abuse
and misuse can lead to death.
Keep unused and used DUROGESIC
®
pat

Ciri produk

1
PRODUCT NAME
DUROGESIC
®
TRANSDERMAL PATCH
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
DUROGESIC
DOSE (MCG/H)
PATCH SIZE (CM
2
)
FENTANYL CONTENT
IN PATCH (MG)
DUROGESIC
12
1
5.25
2.1
DUROGESIC
25
10.5
4.2
DUROGESIC
50
21.0
8.4
DUROGESIC
75
31.5
12.6
DUROGESIC
100
42.0
16.8
1
The lowest dose is designated 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 lowest
effective dose should
be used. 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.
_Initial Dosage 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 opioid tolerance. Other factors to be considered are the
current general
2
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 Conversion_
below. The dosage may subsequently be titrated
upwards or downwards, if required, in increments of 12 mcg/hour to
achieve the lowest
appropriate dosage of DUROGESIC depending on respo