DUROGESIC 12 ug/h TRANSDERMAL PATCH

Země: Jihoafrická republika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné s:

Janssen Pharmaceutica (Pty) Ltd

Dávkování:

See ingredients

Léková forma:

TRANSDERMAL PATCH

Složení:

EACH PATCH CONTAINS FENTANYL 2,1 mg

Stav Autorizace:

Registered

Datum autorizace:

2009-03-08

Informace pro uživatele

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
DUROGESIC® RANGE (Transdermal patch)
_ _
_PAGE 1 OF 11 _ PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 6
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
DUROGESIC
®
(fentanyl) 12 µg/h transdermal patch
DUROGESIC
®
(fentanyl) 25 µg/h transdermal patch
DUROGESIC
®
(fentanyl) 50 µg/h transdermal patch
DUROGESIC
®
(fentanyl) 75 µg/h transdermal patch
DUROGESIC
®
(fentanyl) 100 µg/h transdermal patch
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DUROGESIC

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
1.
WHAT DUROGESIC CONTAINS_ _

The active substance in DUROGESIC is fentanyl. There are 5 different
strengths of
DUROGESIC: 12 µg/h; 25 µg/h; 50 µg/h; 75 µg/h; 100 µg/h,
respectively._ _

The adhesive patches also contain other ingredients: _ _
Backing layer: Polyester
*
/EVA
**
;
Medicine layer: Polyacrylate adhesive;
Inks (on backing): Orange / Red / Green / Blue / Grey printing ink;
Protective liner: Siliconised polyester
*Polyester = Polyethylene terephthalate
**EVA = Ethinyl vinyl acetate
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
DUROGESIC® RANGE (Transdermal patch)
_ _
_PAGE 2 OF 11 _
2.
WHAT DUROGESIC IS USED FOR
It is used to relieve severe long-lasting pain, which requires
morphine-like painkillers.
3.
BEFORE YOU USE DUROGESIC
DO NOT USE DUROGESIC:

if you are hypersensitive (allergic) to fentanyl or any of the other
ingredients of
DUROGESIC (Refer to WHAT DUROGESIC CONTAINS, above.)

unless your doctor has prescribed it for pain.

if you are pregnant or breastfeeding.

in children less than 2 years of age. DUROGESIC should only be used in
children
ages 2 – 16 years who are already using narcotic pa

Charakteristika produktu

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
DUROGESIC® RANGE (Transdermal patch)
Page 1 of 21
PACKAGE INSERT
_ _
SCHEDULING STATUS
Schedule 6
PROPRIETARY NAME AND DOSAGE FORM
DUROGESIC
®
12 µg/h transdermal patch
DUROGESIC
®
25 µg/h transdermal patch
DUROGESIC
®
50 µg/h transdermal patch
DUROGESIC
®
75 µg/h transdermal patch
DUROGESIC
®
100 µg/h transdermal patch
COMPOSITION
DUROGESIC Dose
µg/h)
Active Surface Area
(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 µg/h (however, the
actual dose is 12,5 µg/h) to distinguish it
from 125 µg/h dose that could be prescribed by using multiple
patches.
Excipients:
Backing layer: Polyester*/EVA**
Medicine layer: Polyacrylate adhesive
Inks (on backing): Orange/red/green/blue/grey printing ink
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
DUROGESIC® RANGE (Transdermal patch)
Page 2 of 21
Protective liner: Siliconised polyester
* Polyester = Polyethylene terephthalate
**EVA = Ethyl vinyl acetate
PHARMACOLOGICAL CLASSIFICATION
A.2.9 Central nervous system depressants. Other.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Fentanyl is an opioid analgesic, interacting predominantly with the
µ-opioid receptor. Its primary actions
of therapeutic value are analgesia and sedation. Minimum effective
analgesic serum concentrations of
fentanyl in opioid-naive patients range from 0,3 - 1,2 ng/mℓ; side
effects increase in frequency at serum
levels above 2 ng/mℓ. Both the minimum concentration and the
concentration at which opioid-related
toxicity occurs, rise with increasing patient exposure to the
medicine. The rate of development of
tolerance varies widely among individuals.
PHARMACOKINETIC PROPERTIES
While there is variation in the dose delivered among patients, the
normal flux of the individual patch
is sufficiently accurate to allow individual titration of dosage for a
gi