Rivastigmine CF 9,5 mg/24 u, pleister voor transdermaal gebruik

Valsts: Nīderlande

Valoda: holandiešu

Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktīvā sastāvdaļa:

RIVASTIGMINE

Pieejams no:

Centrafarm B.V.

ATĶ kods:

N06DA03

SNN (starptautisko nepatentēto nosaukumu):

RIVASTIGMINE

Zāļu forma:

Pleister voor transdermaal gebruik

Kompozīcija:

COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, METHYLACRYLAAT, ACRYLZUUR, TETRAMETHYLSUCCINODINITRIL ; COPOLYMEER VAN BUTYLMETHACRYLAAT-METHYLMETHACRYLAAT ; POLYESTERFILM, GEFLUORIDEERD ; POLYETHYLEENTEREPHTHALAAT ; SILICONEN KLEEFSTOF BIO-PSA Q7-4302,

Ievadīšanas:

Cutaan gebruik

Ārstniecības joma:

Rivastigmine

Produktu pārskats:

Hulpstoffen: COPOLYMEER VAN BUTYLMETHACRYLAAT-METHYLMETHACRYLAAT; COPOLYMEER VAN 2-ETHYLHEXYLACRYLAAT, METHYLACRYLAAT, ACRYLZUUR, TETRAMETHYLSUCCINODINITRIL; POLYESTERFILM, GEFLUORIDEERD; POLYETHYLEENTEREPHTHALAAT; SILICONEN KLEEFSTOF BIO-PSA Q7-4302;

Autorizācija datums:

2013-06-03

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
RIVASTIGMINE CF 4,6 MG/24 U, PLEISTER VOOR TRANSDERMAAL GEBRUIK
RIVASTIGMINE CF 9,5 MG/24 U, PLEISTER VOOR TRANSDERMAAL GEBRUIK
Rivastigmine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
The active substance of is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase
inhibitors. 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 works by blocking the enzymes that break
down acetylcholine:
acetylcholinesterase
and
butyrylcholinesterase.
By
blocking
these
enzymes,
allows levels of acetylcholine to be increased in the brain,
helping to reduce the
symptoms of Alzheimer’s disease.
is used for the treatment of adult patients with mild
to moderately severe
Alzheimer’s dementia, a progressive brain disorder that gradually
affects memory, intellectual
ability and behaviour.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
_ _
DO NOT USE

if you are allergic to rivastigmine or any of the other ingredient

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rivastigmine CF 4,6 mg/24 u, pleister voor transdermaal gebruik
Rivastigmine CF 9,5 mg/24 u, pleister voor transdermaal gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_[ 4.6 mg/24 h transdermal patch:] _
Each transdermal patch releases 4.6 mg rivastigmine per 24 hours.
Each transdermal patch of 5 cm
2
contains 9 mg of rivastigmine.
_[ 9.5 mg/24 h transdermal patch:] _
Each transdermal patch releases 9.5 mg 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
Round-shaped three-layer matrix transdermal patches
The outside of the backing layer is translucent, white and imprinted
with black printing ink as
follows:
_- [ 4.6 mg/24 h transdermal patch:] _
“Rivastigmine, 4.6 mg/24 h”
_- [ 9.5 mg/24 h transdermal patch:] _
“Rivastigmine, 9.5 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_ _
4.6 mg/24 h
4.6 mg
9.5 mg/24 h
9.5 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,
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 cont