TRANSIDERM-NITRO 50 glyceryl trinitrate 50 mg transdermal drug delivery system sachet

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

glyceryl trinitrate, Quantity: 50 mg

זמין מ:

Sandoz Pty Ltd

טופס פרצבטיות:

Drug delivery system, transdermal

הרכב:

Excipient Ingredients: lactose monohydrate; dimeticone; colloidal anhydrous silica; polyethylene terephthalate; aluminium; ethylene/vinyl acetate copolymer; polyvinyl chloride; trichlorotrifluoroethane; simethicone

מסלול נתינה (של תרופות):

Transdermal

יחידות באריזה:

2 patches, 10, 30

סוג מרשם:

(S2) Pharmacy Medicine

סממני תרפויטית:

Indicated for the prevention of chronic stable angina pectoris due to coronary artery disease.

leaflet_short:

Visual Identification: oval shaped patch with tab on one edge. White protective liner on one side, tan on the top printed with "CG DPD"; Container Type: Sachet; Container Material: PE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

מצב אישור:

Registered

תאריך אישור:

1991-10-03

עלון מידע

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; swelling of the face

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION – TRANSIDERM-NITRO
®
(GLYCERYL TRINITRATE) TRANSDERMAL DRUG DELIVERY SYSTEM
SACHET
1
NAME OF THE MEDICINE
Glyceryl trinitrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
2

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 of the drug-releasing area.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Transdermal drug delivery system (patch).
Transiderm-Nitro 25 contains glyceryl trinitrate 25mg and has a
release rate of 0.2mg/hour. The tan
coloured backing film is marked with the letters "CG DOD".
Transiderm-Nitro 50 contains glyceryl trinitrate 50mg and has a
release rate of 0.4mg/hour. The tan