MINITRAN 15 glyceryl trinitrate 15mg/24 hour transdermal drug delivery system, sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glyceryl trinitrate, Quantity: 54 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: ethyl oleate; glyceryl laurate; acrylates/acrylamide copolymer

Administration route:

Transdermal

Units in package:

1 patch, 3 sachets, 30 sachets per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention of chronic stable angina pectoris due to coronary artery disease.

Product summary:

Visual Identification: thin, transparent, oval patch 20.0 cm squared with "Minitran 15" printed on the patch in grey.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-08-08

Patient Information leaflet

MINITRAN™
(mini-tran)
TRANSDERMAL DELIVERY SYSTEM
_Glyceryl trinitrate (gliss-er-ill tri-nite-rate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minitran.
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 risk of you using Minitran against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING MINITRAN PLEASE ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT MINITRAN IS USED
FOR
Minitran is used to help prevent
angina attacks (chest pain). It is an
adhesive patch that delivers a
medicine called glyceryl trinitrate
through the skin and into the
bloodstream.
Glyceryl trinitrate belongs to a group
of medicines called nitrates. When a
Minitran patch is placed on the skin,
glyceryl trinitrate passes slowly
through the skin and into the blood
stream. Glyceryl trinitrate works 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 reason.
There is not enough information to
recommend this medicine for
children.
Minitran is available only with a
doctor's prescription.
BEFORE USING MINITRAN
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINITRAN IF YOU ARE
ALLERGIC TO:
•
glyceryl trinitrate (the active
ingredient) or any other
ingredients of Minitran 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, lips, tongue
or other parts of the body
•
rash, itching or hives of the skin.
DO NOT USE MINITRAN IF YOU HAVE
ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
severe anaemia
•
raised pressure in the eye from
any

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – MINITRAN (GLYCERYL
TRINITRATE INGREDIENT) TRANSDERMAL DELIVERY SYSTEM
1
NAME OF THE MEDICINE
Glyceryl trinitrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minitran 5 has a surface area of 6.7 cm
2
and contains 18 mg of glyceryl trinitrate (GTN). The amount
of GTN released over 24 hours is 5 mg.
Minitran 10 has a surface area of 13.3 cm
2
and contains 36 mg of glyceryl trinitrate. The amount of
GTN released over 24 hours is 10 mg.
Minitran 15 has a surface area of 20.0 cm
2
and contains 54 mg of glyceryl trinitrate. The amount of
GTN released over 24 hours is 15 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Drug delivery system, transdermal
Minitran 5: Thin, transparent oval patch 6.7 cm squared with
“Minitran 5” printed on the patch in
grey.
Minitran 10: Thin, transparent oval patch 13.3 cm squared with
“Minitran 10” printed on the patch
in grey.
Minitran 15: Thin, transparent oval patch 20.0 cm squared with
“Minitran 15” printed on the patch
in grey.
The Minitran Transdermal Delivery System is a unit designed to provide
continuous controlled release
of glyceryl trinitrate through intact skin to overcome the problems of
the short half-life and extensive
first-pass metabolism of glyceryl trinitrate.
The rate of release of glyceryl trinitrate from Minitran is linearly
dependent upon the area of the
applied system; each cm
2
of applied system delivers approximately 0.75mg of glyceryl trinitrate
over
24 hours which is equivalent to 0.03 mg/h.
2
Amount
Total
Rate of
of GTN
GTN
System
Release
Released
in System
Size
_in-vivo_
over 24 h
MINITRAN 5
18 mg
6.7 cm
2
0.2 mg/h
5 mg
MINITRAN 10
36 mg
13.3 cm
2
0.4 mg/h
10 mg
MINITRAN 15
54 mg
20 cm
2
0.6 mg/h
15 mg
The remainder of the glyceryl trinitrate in the system serves as a
reservoir and is not delivered in
normal use.
The Minitran Transdermal Delivery System consists of a thin,
transparent, low-density, polyethylene
film covered by a hypoallergenic, medical grade, acrylat