NITRODERM TTS 5

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

GLYCERYL TRINITRATE

제공처:

NOVARTIS ISRAEL LTD

ATC 코드:

C01DA02

약제 형태:

PATCHES

구성:

GLYCERYL TRINITRATE 25 MG/PATCH

관리 경로:

TRANSDERMAL

처방전 유형:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

치료 그룹:

GLYCERYL TRINITRATE

치료 영역:

GLYCERYL TRINITRATE

치료 징후:

Prophylaxis of angina pectoris.

승인 날짜:

2015-04-30

환자 정보 전단

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
NITRODERM TTS 5
Transdermal Patch
ACTIVE INGREDIENT:
Each patch contains 25 mg nitroglycerin.
NITRODERM TTS 10
Transdermal Patch
ACTIVE INGREDIENT:
Each patch contains 50 mg nitroglycerin.
INACTIVE INGREDIENTS: See section 6 “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information about
the medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for the treatment of your
ailment.
Do not pass it on to others. It may harm them, even if it seems
to you that their ailment is similar.
This medicine is not intended for children.
If an angina attack has already started, you should use
fast-acting nitrate preparations (sublingual tablets or spray)
instead of Nitroderm TTS patches.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is used to prevent or reduce the frequency of
angina pectoris attacks.
THERAPEUTIC GROUP: A vasodilator belonging to a group of
medicines called nitrates.
Nitroderm TTS is an adhesive patch containing the active
substance nitroglycerin, which is delivered through the skin
into the bloodstream. Nitroglycerin widens the blood vessels,
which makes it easier for the heart to do its work.
2. BEFORE USING THE MEDICINE
X DO NOT USE THIS PREPARATION IF:
you are sensitive (allergic) to the active ingredient or any of
the additional ingredients contained in the medicine, listed in
section 6 “Further information” or to nitrates or nitrites.
you suffer from a breakdown of the blood circulation, with
very low blood pressure, such as in a state of shock.
you suffer from increased intracranial pressure (a condition
that your doctor will recognize and inform you about).
you suffer from a disease of the valves of the heart or an
inflammatory disease of the heart.
you are currently taking a medicine to treat erectile

제품 특성 요약

NIT API JUN21 V4.1
Page 1 of 11
NITRODERM
® TTS
(nitroglycerin)
25 mg or 50 mg transdermal patch
PRESCRIBING INFORMATION
1
TRADE NAME
NITRODERM
®
TTS 5
NITRODERM
®
TTS 10
2
DESCRIPTION AND COMPOSITION
ACTIVE SUBSTANCE
Nitroderm TTS contains Nitroglycerin (25mg or 50mg) in a transdermal
therapeutic system
(TTS).
LIST OF EXCIPIENTS
Lactose monohydrate, Dimeticone / Dimethicone, Silica, colloidal
anhydrous / Colloidal
silicon dioxide / Light Anhydrous Silicic Acid.
PHARMACEUTICAL FORM
Transdermal Patch
Flat multilayer system designed to deliver nitroglycerin continuously
through a release
membrane following application to the skin. The release membrane
limits delivery through
hyperpermeable skin. The active substance penetrates the skin and thus
becomes directly
bioavailable to the systemic circulation at relatively constant
concentrations during the
recommended application period. The following two systems are
available:
TABLE 2-1
NITRODERM TTS PHARMACEUTICAL FORMS
Nitroderm TTS 5
Nitroderm TTS 10
Nitroglycerin content
25 mg
50 mg
Drug-releasing area
10 cm
2
20 cm
2
Imprint (backing side)
CG
CG
DOD
DPD
Colour
of
the
release
liner
off-white to yellowish
The numeric components of the product designations TTS 5 and TTS 10
denote the nominal
amount of nitroglycerin in mg delivered by the system per 24 hours.
The remainder of the nitroglycerin in each system serves as a reserve
and is not delivered
during normal use. After 12 hours, for example, each system has
delivered 10% of its original
nitroglycerin content. Since nitroglycerin is released from Nitroderm
TTS at a constant rate
per cm

, the dose administered is related to the size of the drug-releasing
area. The nominal
rate of nitroglycerin release in vivo is approximately 20-25
microgram/cm

.h.
The following cross-sectional diagram shows the composition of
Nitroderm TTS.
NIT API JUN21 V4.1
Page 2 of 11
3
INDICATIONS
Prophylaxis of angina pectoris
4
DOSAGE AND ADMINISTRATION
GENERAL RULES
Nitroderm TTS is not intended for the immediate relief of acute
at