Voleze 9.5mg/24hours transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Rivastigmine

Available from:

Focus Pharmaceuticals Ltd

ATC code:

N06DA03

INN (International Name):

Rivastigmine

Dosage:

9.5mg/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: 5060064792469

Summary of Product characteristics

OBJECT 1
VOLEZE 9.5 MG/24 H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 19-Jan-2017 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Voleze 9.5 mg/24 h transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch releases 9.5 mg rivastigmine per 24 hours.
Each transdermal patch of 10 cm2 contains 18 mg rivastigmine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch.
The drug product is a three-layer matrix transdermal round shaped
patch consisting of backing film, drug
(acrylic) matrix containing drug substance, adhesive (silicone) matrix
and furthermore a rectangular
release liner.
The outside of the backing layer is translucent, white and
black-printed as follows;
“Rivastigmine, 9.5 mg/24 h”
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderately severe Alzheimer's
dementia.
Voleze 9.5 mg/24 h transdermal patch is indicated in adults.
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
_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, this
dose 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 maintenance
dose which should be continu