Almuriva 9.5mg/24hours transdermal patches

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Rivastigmine

Доступна з:

Sandoz Ltd

Код атс:

N06DA03

ІПН (Міжнародна Ім'я):

Rivastigmine

Дозування:

9.5mg/24hour

Фармацевтична форма:

Transdermal patch

Адміністрація маршрут:

Transdermal

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04110000; GTIN: 5055382301431

Характеристики продукта

OBJECT 1
ALMURIVA 9.5 MG/24H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 04-Oct-2017 | Sandoz
Limited
1. Name of the medicinal product
Almuriva 9.5 mg/24h transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of 10 cm
2
contains 18 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers. The outside of
the backing layer is beige and labelled with “RIV”, 9.5mg/24h.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderately severe Alzheimer's
dementia.
4.2 Posology and method of administration
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of
Alzheimer's dementia. Diagnosis should be made according to current
guidelines. Similar to any
treatment initiated in patients with dementia, therapy with
rivastigmine should only be started if a
caregiver is available to regularly administer and monitor the
treatment.
Posology
TRANSDERMAL PATCHES
RIVASTIGMINE _IN VIVO_ RELEASE RATES PER 24 H
Almuriva 4.6 mg/24 h
4.6 mg
Almuriva 9.5 mg/24 h
9.5 mg
Almuriva 13.3 mg/24 h*
13.3 mg
*The 13.3 mg/24 h dose strength cannot be achieved with this product.
For conditions where this strength
should be used, please refer to other rivastigmine products for which
transdermal patches of the 13.3
mg/24 h strength are available.
Initial dose
Treatment is started with 4.6 mg/24 h.
Maintenance dose
After a minimum of four weeks of treatment and if well tolerated
according to the treating physician, the
dose of 4.6 mg/ 24 h should be increased to 9.5 mg/24 h, the daily
recommended effective dose, which
should be continued for as long as the patient continues to
demonstrate therapeutic benefit.
Dose escalation
9.5 mg/24 h is the recommended daily effective dose which should be
continued for as