Rivastigmine Patch 10

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Rivastigmine 18mg;  

Disponibil de la:

Arrotex Pharmaceuticals (NZ) Limited

Dozare:

9.5 mg/24h

Forma farmaceutică:

Transdermal patch

Compoziție:

Active: Rivastigmine 18mg   Excipient: Acrylates copolymer Acrylic adhesive Fluoro-coated polyester release liner (22.5 cm2/patch) Silicone adhesive

Tip de prescriptie medicala:

Prescription

Indicații terapeutice:

Treatment of patients with: · Mild to moderately severe dementia of the Alzheimer's type (also termed probable Alzheimer's Disease or Alzheimer's Disease) · Severe dementia of the Alzheimer's type.

Rezumat produs:

Package - Contents - Shelf Life: Sachet, Paper/PET/Al/polyacrylonitrile - 7 patches - 2 years from date of manufacture stored at or below 25°C - Sachet, Paper/PET/Al/polyacrylonitrile - 30 patches - 2 years from date of manufacture stored at or below 25°C

Data de autorizare:

2018-01-26

Prospect

Rivastigmine Patch (Generic Partners) CMI v0.1
RIVASTIMINE PATCH
GENERIC PARTNERS
_Rivastigmine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rivastigmine Patch.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. The information in this leaflet was
last updated on the date listed on the
final page. More
recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain important
information about the medicine and
its use of which you should
be aware. All medicines have risks and benefits.
Your doctor has weighed the risks of
you using it
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RIVASTIGMINE PATCH IS USED FOR
Rivastigmine Patch contains rivastigmine as
the active substance. Rivastigmine
belongs to a class of
substances called cholinesterase inhibitors and is
used to treat a condition called
Alzheimer’s disease.
Alzheimer’s disease is a condition in
which changes in the brain cause
problems with memory,
thinking and
behaviour. These problems gradually
become worse with time. In patients with
Alzheimer’s
dementia, certain nerve cells die in
the brain, resulting in low levels of
the
neurotransmitter: acetylcholine (a
substance that allows nerve cells to
communicate with each other).
Rivastigmine Patch works by preventing
the breakdown of acetylcholine. This
chemical is needed to
help keep the
brain working properly.
Rivastigmine Patch helps to reduce the
symptoms of Alzheimer’s disease and
to slow down the mental
decline that
happens in people with this condition. It helps to improve the
patient’s ability to cop

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Rivastigmine Patch 5 (Arrotex Pharmaceuticals) 4.6mg/24 hours
transdermal patch
Rivastigmine Patch 10 (Arrotex Pharmaceuticals) 9.5mg/ 24 hours
transdermal patch
Rivastigmine Patch 15 (Arrotex Pharmaceuticals) 13.3mg/ 24 hours
transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIVASTIGMINE PATCH
AREA (CM
2
)
RIVASTIGMINE
BASE DOSE LOAD
RIVASTIGMINE BASE _IN VIVO _
RELEASE RATES
5
9 mg
4.6 mg/24 hr
10
18 mg
9.5 mg/24 hr
15*
27 mg
13.3 mg/24 hr
For full list of excipients, see
SECTION 6.1
3.
PHARMACEUTICAL FORM
Transdermal patch. Each patch is a thin, matrix-type transdermal patch
consisting of three layers.
The outside of the backing layer is beige and labelled with text for
each patch dose as follows:
•
RIVASTIGMINE PATCH 5 with “Rivastigmine” and “4.6mg/24 h”
•
RIVASTIGMINE PATCH 10 with “Rivastigmine” and “9.5mg/24 h”
•
RIVASTIGMINE PATCH 15 with “Rivastigmine” and “13.3mg/24 h”
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with:
•
Mild to moderately severe dementia of the Alzheimer’s type (also
termed probable Alzheimer’s
Disease or Alzheimer’s Disease)
•
Severe dementia of the Alzheimer’s type.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
MILD TO MODERATELY SEVERE DEMENTIA OF THE ALZHEIMER’S TYPE
Initial dose and dose titration to the effective dose:
Treatment is started with Rivastigmine Patch 5 once a day.
After a minimum of four weeks of treatment and if well tolerated, this
dose should be increased to
Rivastigmine Patch 10, which is the recommended effective dose to be
continued for as long as a
therapeutic benefit for the patient exists.
Individual responses to rivastigmine may vary and some patients may
derive additional benefit from
higher doses. Subsequent increases to Rivastigmine Patch 15 should
always be based on good
tolerability of the current dose and may be considered only after a
minimum of four weeks of
treatment at each dose level.
SEVERE DEMENTIA OF THE ALZHEIMER’S TYPE