EMERPAND

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

RIVASTIGMINE

Доступно од:

Accord Healthcare Limited

АТЦ код:

N06DA03

INN (Међународно име):

RIVASTIGMINE

Дозирање:

9.5 mg/24 hours

Фармацеутски облик:

Transdermal Patch

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

rivastigmine

Статус ауторизације:

Not Marketed

Датум одобрења:

2015-01-09

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emerpand 9.5mg/24h Transdermal Patches
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 18.0
mg of rivastigmine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Circular matrix transdermal patches of active surface area 10cm
2
. The patch is comprised of three layers: a backing
film, an adhesive layer, and a square protective release liner.
The backing layer is a translucent low-density
polyethylene (LDPE) material printed with the text "RIV9.5” in a
repeating pattern. The polyester (PET) release liner,
which is removed prior to patch application, is translucent and coated
with silicone.
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
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 long as the patient continues to
demonstrate therapeutic benefit. If well tolerated and only after a
minimum of six months of treatment at 9.5 mg/ 24 h, the
TRANSDERMAL PATCHES
RIVASTIGMINE
DOSE LOAD
RIVASTIGMINE