Neupro

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Rotigotine 9mg; Rotigotine 9mg

Доступна з:

Seqirus (NZ) Ltd

ІПН (Міжнародна Ім'я):

Rotigotine 9 mg

Дозування:

4 mg/24h

Фармацевтична форма:

Transdermal patch

Склад:

Active: Rotigotine 9mg Excipient: Ascorbyl palmitate dl-Alpha tocopherol Silicone Adhesive BIO-PSA Q7-4301 Silicone Adhesive BIO-PSA Q7-4201 Povidone Sodium metabisulfite Active: Rotigotine 9mg Excipient: Ascorbyl palmitate dl-Alpha tocopherol Silicone adhesive BIO-PSA Q7-4301 Silicone adhesive BIO-PSA Q7-4201 Povidone Sodium metabisulfite

Одиниць в упаковці:

Sachet, laminate, EMAA/Al/PE/paper & PE/Al/PE/paper, 7 patches

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Cambrex Karlskoga AB

Терапевтичні свідчення:

Neupro is indicated as monotherapy, or in combination with levodopa, for the treatment of idiopathic Parkinson's disease from early stage to advanced disease.

Огляд продуктів:

Package - Contents - Shelf Life: Sachet, laminate, EMAA/Al/PE/paper & PE/Al/PE/paper - 7 patches - 24 months from date of manufacture stored at or below 25°C - Sachet, laminate, EMAA/Al/PE/paper & PE/Al/PE/paper - 28 patches - 24 months from date of manufacture stored at or below 25°C - Sachet, laminate, EMAA/Al/PE/paper & PE/Al/PE/paper - 100 patches - 24 months from date of manufacture stored at or below 25°C

Дата Авторизація:

2010-01-14

Характеристики продукта

Neupro PI 151201 Neu PI g2015-464 CCDS c2014-023
Page 1
NEW ZEALAND DATASHEET
NEUPRO
® (ROTIGOTINE) TRANSDERMAL PATCHES
1
NAME OF THE MEDICINE
Rotigotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neupro 1 mg: 5 cm
2
patch containing 2.25 mg rotigotine with a nominal release rate of 1
mg
rotigotine per 24 hours.
Neupro 2 mg: 10 cm
2
patch containing 4.5 mg rotigotine with a nominal release rate of 2 mg
rotigotine per 24 hours.
Neupro 3 mg: 15 cm
2
patch containing 6.75 mg rotigotine with a nominal release rate of 3
mg
rotigotine per 24 hours.
Neupro 4 mg: 20 cm
2
patch containing 9.0 mg rotigotine with a nominal release rate of 4 mg
rotigotine per 24 hours.
Neupro 6 mg: 30 cm
2
patch containing 13.5 mg rotigotine with a nominal release rate of 6
mg
rotigotine per 24 hours.
Neupro 8 mg: 40 cm
2
patch containing 18.0 mg rotigotine with a nominal release rate of 8
mg
rotigotine per 24 hours.
The active ingredient rotigotine is a white to light brownish powder.
It is very slightly soluble to
freely soluble in organic solvents, sparingly soluble in acidic
aqueous solutions and practically
insoluble in alkaline aqueous solutions.
The formulation contains sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Neupro is a thin, matrix-type transdermal patch composed of 3 layers:
1.
A flexible, tan-colored backfilm that provides structural support and
protection of the drug
loaded adhesive layer.
2.
A self-adhesive drug matrix layer.
3.
A clear protective liner which is removed prior to use.
Thin, matrix type transdermal patch that is square shaped with rounded
edges. The backing layer
comprises a polyester film, siliconized, aluminized, colour coated
with a tan coloured pigment
(titanium dioxide (E171), pigment yellow 95, pigment red 166) layer
and imprinted (pigment red 144,
pigment yellow 95, pigment black 7). The protective liner comprises a
transparent fluoropolymer
coated polyester film. The outside of the tan coloured backing layer
is imprinted with Neupro