FIRDAPSE

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

AMIFAMPRIDINE

から入手可能:

MEDISON PHARMA LTD

ATCコード:

N07XX05

医薬品形態:

TABLETS

構図:

AMIFAMPRIDINE 10 MG

投与経路:

PER OS

処方タイプ:

Required

製:

SERB S.A., BELGIUM

治療領域:

AMIFAMPRIDINE

適応症:

Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults

承認日:

2022-01-31

情報リーフレット

ךיראת
:
270/702/27
םושירה רפסמו תילגנאב רישכת םש
:
146-29-33301-01 FIRDAPSE TABLETS
םושירה לעב םש
:
מ"עב המראפ ןוסידמ
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE
Carcinogenicity risk
Amifampridine has not been fully tested in carcinogenicity
models, and the carcinogenicity risk associated with
treatment has not been determined.
The use of amifampridine in patients with the non-
paraneoplastic form of LEMS should only be commenced
following a thorough assessment of the risk-benefit to the
patient.
Carcinogenicity risk
Amifampridine has not been fully tested in carcinogenicity models,
and the carcinogenicity risk associated with treatment has not been
determined.
The use of amifampridine in patients with the non-paraneoplastic form
of LEMS should only be commenced following a thorough assessment
of the risk-benefit to the patient.
In a 2-year dietary carcinogenicity study, benign and malignant
Schwannomas have been observed in rats treated with amifampridine
(see section 5.3). Amifampridine was not genotoxic in a standard
battery of _in vitro_ and _in vivo_ tests. The correlation between the
use of
amifampridine and the development of tumours in humans is unknown
at this time.
Most Schwannomas are benign and asymptomatic. They can present in
many locations, therefore the clinical presentation can be varied. A
diagnosis of Schwannoma should be considered for patients who
present with symptoms such as a mass that is painful on palpation or
symptoms similar to a compressive neuropathy. Schwannomas are
generally slow-growing and can exist for months to years without
producing symptoms. The benefit of continuing treatment with
amifampridine should be reviewed for any patient who develops a
Schwannoma.
Amifampridine should be used with caution in patients with an
increased risk of Schwannomas, such as patients with past

製品の特徴

1
Physician Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
FIRDAPSE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amifampridine phosphate equivalent to 10 mg of
amifampridine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round tablet, flat-faced on one side and scored on the other
side.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under supervision of a physician
experienced in the treatment of the
disease.
Posology
FIRDAPSE should be given in divided doses, three or four times a day.
The recommended starting
dose is 15 mg amifampridine a day, which can be increased in 5 mg
increments every 4 to 5 days, to a
maximum of 60 mg per day. No single dose should exceed 20 mg.
Tablets are to be taken with food. Please see section 5.2 for further
information about bioavailability
of amifampridine in the fed and fasted state.
If treatment is discontinued, patients may experience some of the
symptoms of LEMS.
_Renal or hepatic impairment _
2
FIRDAPSE should be used with caution in patients with renal or hepatic
impairment. A starting dose
of 5 mg amifampridine (half tablet) once per day is recommended in
patients with moderate or severe
impairment of renal or hepatic function. For patients with mild
impairment of renal or hepatic
function, a starting dose of 10 mg amifampridine (5 mg twice a day)
per day is recommended. Patients
should be titrated more slowly than those without renal or hepatic
impairment with doses increased in
5 mg increments every 7 days. If any adverse reaction occurs, upward
dose titration should be
discontinued (see sections 4.4 and 5.2).
_Paediatric population_
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has
not been established. No data
are available.
Method of administration
For oral use only.
4.3
CONTRAIND