REPLAGAL

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

AGALSIDASE ALFA

Tersedia dari:

TAKEDA ISRAEL LTD

Kode ATC:

A16AB03

Bentuk farmasi:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

AGALSIDASE ALFA 1 MG/ML

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

SHIRE HUMAN GENETIC THERAPIES INC., USA

Kelompok Terapi:

AGALSIDASE ALFA

Area terapi:

AGALSIDASE ALFA

Indikasi Terapi:

Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (alfa-galactosidase A deficiency).

Tanggal Otorisasi:

2021-11-30

Selebaran informasi

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
__
11/09/2014
_____
םש
רישכת
תילגנאב
רפסמו
םושירה
_
124-32-30382-00
REPLAGAL
__
םש
לעב
םושירה
___
ןוסידמ
המראפ
מ"עב
____
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.2
POSOLOGY AND
METHOD OF
ADMINISTRATION
_Paediatric Population_
The experience in children is limited.
No dosage regimen in children (0-6
years) can presently be recommended
as safety and efficacy have not yet
been sufficiently established. Limited
clinical data in children (7-18 years)
do not permit to recommend an
optimal dosage regimen presently (see
sections 5.1 and 5.2). Because no
unexpected safety issues were
encountered in the 6 month study with
Replagal administered at 0.2 mg/kg in
this population, this dose regimen is
suggested for children between 7- 18
years of age.
_Paediatric Population_
The experience in children is limited. No
dosage regimen in children (0-6 years) can
presently be recommended as safety and
efficacy haveof Replagal in children aged 0-
6 years has not yet been sufficiently
established. Currently available data are
described in section 5.1 but no
recommendation on posology can be made.
LimitedIn clinical data instudies of children
(7-18 years) do not permit to recommend an
optimal dosage regimen presently (see
sections 5.1 and 5.2). Becausewho received
Replagal 0.2 mg/kg every other week, no
unexpected safety issues were encountered in
the 6 month study with Replagal
administered at 0.2 mg/kg in this population,
this dose regimen is suggested for children
between 7- 18 years of age.(see section 5.1).
4.4
SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE
_Allergic-type hypersensitivity reactions_
As with any intravenous protein
product, allergic-type hypersensitivity
react

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Replagal
Concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
agalsidase alfa*. Each vial of 3.5 ml of concentrate
contains 3.5 mg of agalsidase alfa.
*agalsidase alfa is the human protein α-galactosidase A produced in a
human cell line by genetic engineering
technology.
Excipient(s) with known effect
This medicinal product contains 14.2 mg sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion. A clear and colourless
solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Replagal is indicated for long-term enzyme replacement therapy in
patients with a confirmed diagnosis of Fabry
Disease (α-galactosidase A deficiency).
4.2
Posology and method of administration
Replagal treatment should be supervised by a physician experienced in
the management of patients with Fabry
Disease or other inherited metabolic diseases.
Posology
Replagal is administered at a dose of 0.2 mg/kg body weight every
other week by intravenous infusion over 40
minutes.
_Special populations _
_Elderly patients_
_ _
Studies in patients over the age of 65 years have not been performed
and no dosage regimen can
presently be recommended in these patients as safety and efficacy have
not yet been established.
_Patients with hepatic impairment_
_ _
No studies have been performed in patients with hepatic impairment.
_Patients with renal impairment_
_ _
No dose adjustment is necessary in patients with renal impairment.
The presence of extensive renal damage (eGFR <60mL/min) may limit the
renal response to enzyme replacement
therapy. Limited data are available in patients on dialysis or
post-kidney transplantation, no dose adjustment is
recommended.
_Paediatric Population_
_ _
The safety and efficacy of Replagal in children aged 0-6 years has not
yet been established. Currently available data
are described in section