Harshment form
PK-Merz Infusion/ Amantadine sulphate 200 mg
29/09/09
)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
______________________2990992009_ ‫תאריך‬
PK-Merz Infusion ___:‫שם תכשיר באנגלית‬
137 44 27102 00 :‫מספר רישום‬
‫ מגאפארם בע"מ‬:‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫לרופא‬
‫בעלון לרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
Suggested 09/2009
Section
Approved
4.1 Therapeutic
indication
Properties:PK Merz is a
therapeutic principle in the
treatment of Parkinsonism
which effects improvement of
the principal and troublesome
symptoms : rigor, tremor and
akinesia.
Indications :
For the intensive and initial treatment of
serious and critical cases of Parkinsonism
which do not respond to oral treatment
Deleted:
Properties:PK Merz is a
therapeutic principle in the
treatment of Parkinsonism which
effects improvement of the
principal and troublesome
symptoms : rigor, tremor and
akinesia.
Indications :
For the intensive and initial treatment of
serious and critical cases of Parkinsonism
which do not respond to oral treatment
Changed:
Intensive care and initial treatment
of akinetic crisis in acute
exacerbations of parkinsonian
symptoms.
Decreased vigilance in postcomatose states of varying
aetiology within a holistic concept
under hospital conditions.
Added:
4.3
Contraindications
4.4 Special warnings
and
special
precautions for use.
Reduced blood levels of Potassium or
Magnesium.
In the event of symptoms such as
palpitations, dizziness, or syncope,
amantadine treatment should be
immediately discontinued and the patient
checked within 24 hours for QT
prolongation. If no QT prolongation is
present, amantadine can be
recommenced, taking into account the
contraindications, interactions and
undesirable effects. (see section
Undesirable effects).
Deleted:
In the event of symptoms such as palpitations,
dizziness, or syncope, amantadine treatment
should be immediately discontinued and the
patient checked within 24 hours for QT
prolongation. If no QT prolongation is
present, amantadine can be recommenced,
taking into account the contraindications,
interactions and undesirable effects. (see
section Undesirable effects).
Added:
The patient should be examined by an
ophthalmologist as soon as symptoms such as
loss of visual acuity or blurred vision occur,
in order to rule out corneal oedema as a
possible cause. PK-Merz infusion should be
discontinued if corneal oedema is diagnosed.
Corneal oedema caused by PK-Merz infusion
is generally reversible with a month.
Added:
An infusion bottle with 500 ml solution for
infusion cantains 77 mmol Sodium (1770 mg
Sodium). This should be taken into account in
people on a low-salt diet.
4.5 Interaction with other
medicaments and other
forms of interaction
Added:
The simultaneous use of Amantadine and
drugs known to cause prolongation of the QT
interval is contraindicated.
For example:







Certain antiarrythmic agents of
class
1A
(e.g,
quinidine,
disopyramide and procainamide)
and class 3 (e.g. amiodarone and
sotalol)
Certain
antipsychotics
(e.g.
thioridazine,
chlorpromazine,
haloperidol and pimozide)
Certain tricyclic and tetracyclic
antidepressants (e.g. amitriptiline)
Certain
antihistamines
(e.g.
astemizole and terfenadine)
Certain macrolide antibiotics (e.g.
erythromycin and clarithromicin)
Certain gyrase inhibitors (e.g.
sparfloxacin)
Azole antimycotics and other
drugs
such
as
budipine,
halofantrine,
co-trimoxazole,
peptamidine,
cisapride
and
bepridil)
This list cannot be exhaustive.
Before commencing use of
amantadine concomitantly with
another drug, the SPC of the later
should be checked for potential
interactions, due to QT prolongation
between the drug and amantadine.
Use of PK-Merz infusion in combination with
other Parkinsonian drugs is possible.
To avoid undesirable effects (such as
psychotic reactions), it may be
necessary to reduce the dosage of the
other drug or of the combination.
4.8 Undesirable effects
Nervous
system
disorders
Common occurrences are motor
agitation.
Common occurrences are dizziness,
orthostatic dysregulation and rarely,
blurred vision.
Epileptic fits have also been triggered in
very rare cases, usually after treatment
in excess of the recommended dose.
Very rarely, myoclonus and symptoms
Deleted:
Common occurrences are motor agitation.
Common occurrences are dizziness,
orthostatic dysregulation and rarely, blurred
vision.
Epileptic fits have also been triggered in very
rare cases, usually after treatment in excess
of peripheral neuropathy have been
reported.
of the recommended dose.
Very rarely, myoclonus and symptoms of
peripheral neuropathy have been reported.
Changed:
Common: Dizziness
Very rare: Epileptic fits, usually after
treatment in excess of the recommended
dose; myoclonus, symptoms of peripheral
neuropathy
Added:
Common: Orthostatic dysregulation
Vascular disorders
Eye disorders
Very rarely, temporary loss of vision has
been reported.
Deleted:
Very rarely, temporary loss of vision has
been reported.
Added:
Rare: Blurred vision*
Very rare: Temporary loss of vision*,
increased photosensitivity
Not known: Corneal oedema, reversible after
discontinuation
* The patient should be examined by an
ophthalmologist as soon as loss of visual
acuity or blurred vision occur, in order to rule
out corneal oedema as a possible cause.
Added:
Blood and lymphatic
system disorders
Very rare: Haematological side effects such
as leukopenia and thrombocytopenia
5.2 Pharmacodynamic
properties
Deleted:
Amantadine has effects that
counteract the symptoms of
Parkinson’s disease.
The
antiparkinsonian
action
mechanism is complex and has not
yet been fully elucidated. Recent
studies of the action mechanism
confirm an antagonistic action on the
NMDA-ion-channel in the basal
ganglia. The action of NMDAantagonists is functionally analogous
to
that of dopamine, which may explain
the dopamine-like effects established
in behavioural drug studies. The
slight anticholinergic effects of
amantadine also play a part.
Amantadine has effects that counteract
the symptoms of Parkinson’s disease.
The antiparkinsonian action mechanism
is complex and has not yet been fully
elucidated. Recent studies of the action
mechanism confirm an antagonistic
action on the NMDA-ion-channel in the
basal ganglia. The action of NMDAantagonists is functionally analogous to
that of dopamine, which may explain the
dopamine-like effects established in
behavioural drug studies. The slight
anticholinergic effects of amantadine also
play a part.
Changed:
Amantadine has various pharmacological
effects. The agent has an indirectly
agonistic effect at the striatal dopamine
receptor. Animal studies have shown that
amantadine increases the extracellular
dopamine
concentration
both
by
increased dopamine release and through
blockade of rte-uptake into the presynaptic
neurons. At therapeutic concentrations,
amantadine inhibits the release of
acetylcholine
mediated
by
NMDA
receptors
and
can
thus
trigger
anticholinergic effects. The agent has
synergistic effects with L-dopa.