SOVENOR 5 micrograms/h Transdermal Patch

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

Buprenorphine

Dostupné s:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Mezinárodní Name):

Buprenorphine

Jednotky v balení:

2Pieces Pieces

Výrobce:

LTS LOHMANN THERAPIE-SYSTEM AG

Informace pro uživatele

_CONSUMER_
_ _
_MEDICATION_
_ _
_INFORMATION_
_ _
_LEAFLET_
_ _
_(RIMUP)_
_ _
1
SOVENOR
®
TRANSDERMAL
PATCH
Buprenorphine
(5mcg/hr,
10mcg/hr,
20mcg/hr)
WHAT IS IN THIS LEAFLET
1.
What Sovenor
®
is used for
2.
How Sovenor
®
works
3.
Before you use Sovenor®
4.
How to use Sovenor
®
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of Sovenor
®
8.
Product
Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SOVENOR
® IS USED FOR
These patches contain the active
ingredient
buprenorphine
which
belongs to a group of medicines called
strong analgesics or ‘painkillers’. They
have been prescribed for you by your
doctor to relieve moderate, long-lasting
pain that requires the use of a strong
painkiller.
HOW SOVENOR
® WORKS
Sovenor® patches act through the skin.
After application, buprenorphine passes
through the skin into the blood. Each
patch can be worn up to seven days.
They should not be used to relieve
acute pain.
BEFORE YOU TAKE SOVENOR
®
_-When you must not use it _
Do not use Sovenor
®
if you:
-
are allergic (hypersensitive) to
buprenorphine or any of the other
ingredients of Sovenor
®
(see
section ‘Product Description’);
-
have breathing problems such as
acute asthma, impaired lung
function or chronic bronchitis;
-
are addicted to drugs;
-
are taking a type of medicine known
as a monoamine oxidase inhibitor or
you have taken this type of medicine
in the last two weeks;
-
suffer from myasthenia gravis, a
condition in which the muscles
become weak and tire easily;
-
have previously suffered from
withdrawal symptoms such as
agitation, anxiety, shaking or
sweating upon stopping taking
alcohol;
-
are pregnant
.
Sovenor®
must
not
be
used
to
treat
symptoms
associated
with
drug
withdrawal.
_-Before you start take it _
-
Before treatment with these patches
tell your doctor or pharmacist if
you:are treated with antidepressants.
The use of these medicines together
with Sovenor
®
patches can lead to
serotonin syndrome, a potentially
life-threatening condit

Charakteristika produktu

PACKAGE INSERT
_SOVENOR_® 5 MICROGRAMS/H TRANSDERMAL PATCH
_SOVENOR_® 10 MICROGRAMS/H TRANSDERMAL PATCH
_SOVENOR_® 20 MICROGRAMS/H TRANSDERMAL PATCH
COMPOSITION
_Buprenorphine _
Buprenorphine is a white or almost white crystalline powder very
slightly soluble in water, freely soluble in acetone,
soluble in methanol, ethanol and diethyl ether, and slightly soluble
in cyclohexane. The chemical name is (2S)-2-[(-)-
(5R,6R,7R,14S)-9α-cyclopropylmethyl-
4,5-epoxy-6,14-ethanomorphinan-7-yl]
-3-hydroxy-6-methoxy-3,3-
dimethylbutan-2-ol (CAS No:52485-79-7). The molecular formula is
C29H41NO4 and molecular weight is 467.6.
The inactive ingredients in
_SOVENOR_®
transdermal patches are: Adhesive matrix (containing buprenorphine):
[(Z)-
octadec-9-en-1-yl]
oleate,
povidone
K90,
4oxopentanic
acid,
poly[acrylic
acid-cobutylacrylate-co-(2-
ethylhexyl)acrylate-covinylacetate] (5:15:75:5), crosslinked.
Adhesive
matrix
(without
buprenorphine):
poly[acrylic
acid-co-butylacrylate-co-(2-ethylhexyl)
acrylate-co-
vinylacetate]
(5:15:75:5).
Separating
foil
between
the
adhesive
matrices
with
and
without
buprenorphine:
poly(ethyleneterephthalate) – foil.
Backing layer: poly(ethyleneterephthalate) – tissue.
Release liner (on the front covering the adhesive matrix containing
buprenorphine) (to be removed before applying
the patch): poly(ethyleneterephthalate) – foil, siliconised, coated
on one side with aluminium.
DESCRIPTION
_SOVENOR_® 5 MICROGRAMS/H TRANSDERMAL PATCH:
contains 5 mg buprenorphine, with a release rate of 5 micrograms
per hour, to be administered every 7
th
day.
Square, beige coloured patch with rounded corners marked
_SOVENOR_®
5 mg 5 μg/h
Area containing active substance: 6.25 cm
2
_SOVENOR_® 10 MICROGRAMS/H TRANSDERMAL PATCH:
contains 10 mg buprenorphine, with a release rate of 10 micrograms
per hour, to be administered every 7
th
day.
Square, beige coloured patch with rounded corners marked
_SOVENOR_®
10 mg 10 μg/h
Area containing active substance: 12.5 cm
2
_SOVENOR_® 20 MICROGRAMS/H TRANSDERMAL PATCH: