SOVENOR 20 micrograms/h Transdermal Patch

国家: 马来西亚

语言: 英文

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

有效成分:

Buprenorphine

可用日期:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN（国际名称）:

Buprenorphine

每包单位数:

2Pieces Pieces

厂商:

LTS LOHMANN THERAPIE-SYSTEM AG

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SOVENOR
® TRANSDERMAL PATCH
Buprenorphine (5mcg/hr, 10mcg/hr, 20mcg/hr)
1
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 severe, pain that
requires the use of a strong painkiller.
_ _
HOW SOVENOR
® WORKS
Sovenor®es 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:
-
suffer from seizures, fits or
convulsions;
-
have a severe headache or feel sick
due to a head injury as this may
indicate that the pressure in your
skull is increased;
-
are feeling severely dr

产品特点

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-metho xy-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, pov idone K90, 4 oxopentanic 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 bupre norphine) (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 microgr ams
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 tra