Rivacure Patch 5

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

RIVASTIGMINE

Διαθέσιμο από:

SUN PHARMACEUTICAL SDN BHD

INN (Διεθνής Όνομα):

RIVASTIGMINE

Μονάδες σε πακέτο:

30 Pieces

Κατασκευάζεται από:

ICURE Pharmaceutical Inc.

Φύλλο οδηγιών χρήσης

RIVACURE PATCH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
RIVASTIGMINE
4.6 MG/24 H TRANSDERMAL PATCH (RIVACURE PATCH 5)
9.5 MG/24 H TRANSDERMAL PATCH (RIVACURE PATCH 10)
1
WHAT IN THIS LEAFLET
1.
WHAT RIVACURE PATCH IS USED
FOR
2.
HOW RIVACURE PATCH WORKS
3.
BEFORE YOU USE RIVACURE
PATCH
4.
HOW TO USE RIVACURE PATCH
5.
WHILE YOU ARE USING RIVACURE
PATCH
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF RIVACURE
PATCH
8. PRODUCT DESCRIPTION
9. MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10. DATE OF REVISION
11.
SERIAL NUMBER
WHAT RIVACURE PATCH IS USE FOR
Rivacure is used for:
1)Mild to moderately severe
dementia of the Alzeimer’s type
2)Severe dementia of Alzeimer’s
type
3)Mild to moderate severe dementia
associated with Parkinson’s disease.
HOW RIVACURE PATCH WORKS
Rivacure belongs to a class of
substances called cholinesterase
inhibitors.The active substance of
Rivacure is rivastigmine. 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,
Rivacure allows levels of
acetylcholine to be increased in the
brain, helping to reduce the
symptoms of Alzheimer’s disease.
BEFORE YOU USE RIVACURE PATCH
_WHEN YOU MUST NOT USE IT_
Do not apply Rivacure Patch

if you are allergic to
rivastigmine (the active
substance in Rivacure) or
any of the other ingredients
of this medicine.

If you have ever had an
allergic reaction to a similar
type of medicine
(carbamate derivatives).

If you have a skin reaction
spreading beyond the patch
size, if there is a more
intense local reaction (such
as blisters, increasing skin
inflammation, swelling)
and if it does not improve
within 48 hours after
removal of the transdermal
patch.
If this applies to you, tell your
doctor and do not apply Rivacure
Patch.
_BEFORE YOU START

Αρχείο Π.Χ.Π.

RIVACURE PATCH (RIVASTIGMINE)
DESCRIPTION:
Rivacure Patch 5:
5 cm
2
patch attached with quadrangle beige color protection film and release
paper on adhesive layer.
Rivacure Patch 10:
10 cm
2
patch attached with quadrangle beige color protection film and release
paper on adhesive layer.
COMPOSITION:
Rivacure Patch 5:
Each patch of 5 cm
2
contains 9 mg rivastigmine base, _in vivo_ release rate of 4.6 mg/24
hours.
Rivacure Patch 10:
Each patch of 10 cm
2
contains 18 mg rivastigmine base, _in vivo_ release rate of 9.5 mg/24
hours.
PHARMACEUTICAL FORM:
Transdermal Patch
PHARMACODYNAMICS:
Pharmacotherapeutic group: brain-selective cholinesterase inhibitor;
ATC-code: N06DA03.
Pathological changes in dementia such as Alzheimer’s Disease involve
cholinergic neuronal pathways
that project from the basal forebrain to the cerebral cortex and
hippocampus. These pathways are known
to be involved in attention, learning and memory and other cognitive
processes.
Rivastigmine, a brain-selective acetyl- and butyryl-cholinesterase
inhibitor of the carbamate type, is
thought to facilitate cholinergic neurotransmission by slowing the
degradation of acetylcholine released
by functionally intact cholinergic neurons. Data from animal studies
indicate that rivastigmine selectively
increases the availability of acetylcholine in the cortex and
hippocampus. Thus, rivastigmine may have an
ameliorative effect on cholinergic-mediated cognitive deficits
associated with Alzheimer’s Disease and
with Parkinson’s disease. In addition, there is some evidence that
cholinesterase inhibition could slow the
formation of amyloidogenic beta-amyloid-precursor protein (APP)
fragments, and thus of amyloid
plaques, which are one of the main pathological features of
Alzheimer’s Disease.
Rivastigmine interacts with its target enzymes by forming a covalently
bound complex that temporarily
inactivates the enzymes.
PHARMACOKINETICS:
Absorption of rivastigmine from rivastigmine transdermal patches is
slow. After the first dose, detectable
plasma concentratio