_____23/11/2014__ ‫תאריך‬
Fampyra 147-80-33543-00 ‫שם תכשיר באנגלית ומספר הרישום‬
____‫שם בעל הרישום ___מדיסון פארמה בע"מ‬
! ‫טופס זה מיועד לפרוט ההחמרות בלבד‬
‫רופא‬
‫בעלון ללרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
Other warnings and precautions
Other warnings and precautions
Fampyra should be administered with
caution to patients with cardiovascular
symptoms of rhythm and sinoatrial or
atrioventricular conduction cardiac
disorders (these effects are seen in
overdose). There is limited safety
information in these patients.
Fampyra should be administered with
caution to patients with cardiovascular
symptoms of rhythm and sinoatrial or
atrioventricular conduction cardiac
disorders (these effects are seen in
overdose). There is limited safety
information in these patients.
The increased incidence of dizziness and
balance disorder seen with Fampyra may
result in an increased risk of falls.
Therefore, patients should use walking aids
as needed.
The increased incidence of dizziness and
balance disorder seen with Fampyra in
the first 4 to 8 weeks of treatment may
result in an increased risk of falls.
Patients who are using walking aids
should continue to use these aids as
needed.
MedDRA SOC Adverse
Reaction
Infections and Urinary tract
infestations
infection
Immune system Anaphylaxis
disorders
Angioedema
Hypersensitivit
y
Psychiatric
Insomnia
disorders
Anxiety
Nervous system Dizziness
disorders
Headache
Balance
disorder
Paraesthesia
Tremor
Seizure
Exacerbation of
trigeminal
neuralgia
Vascular
Hypotension*
disorders
Respiratory,
Dyspnoea
thoracic and
Pharyngolaryng
mediastinal
eal pain
MedDRA SOC Adverse
Reaction
Infections and Urinary tract
infestations
infection
Immune system Anaphylaxis
disorders
Angioedema
Hypersensitivit
y
Psychiatric
Insomnia
disorders
Anxiety
Nervous system Dizziness
disorders
Headache
Balance
disorder
Paraesthesia
Tremor
Seizure
Vascular
Hypotension*
disorders
Respiratory,
Dyspnoea
thoracic and
Pharyngolaryn
mediastinal
geal pain
disorders
Frequency
category
Very Common
Uncommon
Uncommon
Uncommon
Common
Common
Common
Common
Common
Common
Common
Uncommon
Uncommon
Uncommon
Common
Common
Frequency
category
Very Common
Uncommon
Uncommon
Uncommon
Common
Common
Common
Common
Common
Common
Common
Uncommon
Uncommon
Common
Common
4.4
Special
warnings
and
precautions
for use
4.8
Undesirable
effects
disorders
Gastrointestinal Nausea
disorders
Vomiting
Constipation
Dyspepsia
Skin and
Rash
subcutaneous
Urticaria
tissue disorders
Musculoskeletal Back pain
and connective
tissue disorders
General
Asthenia
disorders and
Chest
administration discomfort*
site conditions
Gastrointestinal Nausea
disorders
Vomiting
Constipation
Dyspepsia
Skin and
Rash
subcutaneous Urticaria
tissue disorders
Musculoskeleta Back pain
l and
connective
tissue disorders
General
Asthenia
disorders and Chest
administration discomfort*
site conditions
Common
Common
Common
Common
Uncommon
Uncommon
Common
Common
Uncommon
Common
Common
Common
Common
Uncommon
Uncommon
Common
Common
Uncommon
‫לצרכן‬
‫בעלון לצרכן‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫על‬
‫ההחמרות המבוקשות‬
‫טקסט חדש‬
-‫תופעות לוואי המופיעות לעיתים רחוקות‬
‫ החמרה בכאב‬,)‫ רגישות יתר (אלרגיה‬,‫פרכוסים‬
.(trigeminal neuralgia( ‫עצבי בפנים‬
‫טקסט נוכחי‬
-‫תופעות לוואי המופיעות לעיתים רחוקות‬
.)‫ רגישות יתר (אלרגיה‬,‫פרכוסים‬
‫פרק בעלון‬
‫ תופעות‬.4
:‫לוואי‬
.‫ שבו מסומנות ההחמרות המבוקשות על רקע צהוב‬,‫מצ"ב העלון‬
‫ יש לסמן רק תוכן מהותי ולא שינויים במיקום‬.‫שינויים שאינם בגדר החמרות סומנו (בעלון) בצבע שונה‬
.‫הטקסט‬