Voleze 13.3mg/24hours transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine

Available from:

Advanz Pharma

ATC code:

N06DA03

INN (International Name):

Rivastigmine

Dosage:

13.3mg/24hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04110000; GTIN: 5060064792605

Summary of Product characteristics

OBJECT 1
VOLEZE 13.3MG/24H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 16-Jan-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Voleze 13.3 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch releases 13.3 mg rivastigmine per 24 hours.
Each transdermal patch of 15 cm2 contains 27 mg rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch.
Round-shaped three-layer matrix transdermal patches.
The outside of the backing layer is translucent, white and imprinted
with black printing ink as follows:
“Rivastigmine, 13.3 mg/24 h”
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
Voleze 4.6 mg/24 h
4.6 mg*
Voleze 9.5 mg/24 h
9.5 mg*
Voleze 13.3 mg/24 h
13.3 mg*
* For doses not realisable with this medicinal product other strengths
of the medicinal product 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 long as the patient
continues to demonstrate therapeutic benefit. If w