Transiderm-Nitro

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
15-05-2024
Tabia za bidhaa Tabia za bidhaa (SPC)
15-05-2024

Viambatanisho vya kazi:

Glyceryl trinitrate

Inapatikana kutoka:

Novartis Pharmaceuticals Australia Pty Ltd

Darasa:

Medicine Registered

Taarifa za kipeperushi

                                TRANSIDERM-NITRO
®
 
_glyceryl trinitrate_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Transiderm-Nitro.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Transiderm-
Nitro against the benefits they expect
it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRANSIDERM-
NITRO IS USED FOR
Transiderm-Nitro is used to prevent
angina. It is an adhesive patch that
delivers a medicine called glyceryl
trinitrate through the skin and into
the bloodstream.
Transiderm-Nitro belongs to a group
of medicines called nitrates. Nitrates
work by widening blood vessels,
letting more blood and oxygen reach
the heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
There is not enough information to
recommend this medicine for
children.
BEFORE YOU USE
TRANSIDERM-NITRO
_WHEN YOU MUST NOT USE IT_
DO NOT USE TRANSIDERM-NITRO IF
YOU ARE ALLERGIC TO:
•
glyceryl trinitrate (the active
ingredient) or any of the other
ingredients of Transiderm-Nitro
listed at the end of this leaflet
•
any other medicine or food
containing nitrates or nitrites
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swel
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                 
 
1 
NAME OF DRUG 
 
TRANSIDERM-NITRO
®
 
 
 
 
(GLYCERYL TRINITRATE) 
 
DESCRIPTION 
 
Glyceryl
Trinitrate is an organic nitrate derivative with the chemical
name 1,2,3-propanetriol 
trinitrate with the following molecular structure: 
 
CH2  - ONO2 
 
 
| 
CH  - ONO2 
 
 
| 
CH2  - ONO2 
 
 
Transiderm-Nitro is a transdermal therapeutic system
for application to intact skin.  
 
Transiderm-Nitro is a flat self-contained
multilayer unit designed to provide continuous, 
controlled release of glyceryl trinitrate through a semipermeable
membrane for the 
recommended application period.  In
cases where the permeability of the skin is excessive, 
drug release is limited by the release membrane. 
 
Transiderm-Nitro is composed of four layers.
 Proceeding from the visible outer surface 
towards the inner surface which adheres to the skin, these
layers are: 
1) 
an impermeable tan-coloured backing film; 
2) 
a drug reservoir containing glyceryl trinitrate; 
3) 
a semi-permeable release membrane that
controls the release of glyceryl trinitrate to the 
 
skin; 
4) 
a layer of silicone adhesive; 
5) 
a white to off-white coloured protective liner which is removed
prior to use. 
 
 
 
2
 
 
The following two systems are available: 
 
 
Transiderm 
-Nitro 25 
Transiderm 
-Nitro 50 
Glyceryl Trinitrate 
 
Nominal amount of glyceryl trinitrate  
released over 24 hours. 
 
Nominal amount of glyceryl trinitrate  
released per hour 
 
Drug-releasing area 
 
25 mg 
 
5mg 
 
 
≈ 0.2mg 
 
 
10cm² 
 
50mg 
 
10mg 
 
 
≈  0.4mg 
 
 
20cm² 
 
 
The remainder of the glyceryl trinitrate
in each system serves as a reserve and is not 
delivered in normal use. 
Since glyceryl trinitrate
is released from Transiderm-Nitro at a constant rate  
per cm², the dose administered is related to
the size o
                                
                                Soma hati kamili
                                
                            

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