THYMOGLOBULINE

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

IMMUNOGLOBULIN RABBIT ANTI-HUMAN THYMOCYTE

Tersedia dari:

SANOFI ISRAEL LTD

Kode ATC:

L04AA04

Bentuk farmasi:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

IMMUNOGLOBULIN RABBIT ANTI-HUMAN THYMOCYTE 25 MG/VIAL

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

GENZYME EUROPE B.V., THE NETHERLANDS

Kelompok Terapi:

ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)

Area terapi:

ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)

Indikasi Terapi:

Immunosuppression in transplantation: prevention and treatment of graft rejection. Treatment of acute graft versus host disease (GvHD). Hematology treatment of aplastic anemia.

Tanggal Otorisasi:

2021-08-31

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
________
05.05.2015
_______________
םש
רישכת
תילגנאב
THYMOGLOBULINE
רפסמ
םושיר
123-24-25723-00
םש
לעב
םושירה
סיטנווא-יפונאס__
לארשי
__________________________
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE ןמוסמ הרמחה הווהמו ףסוותהש עדימ
ב
בוהצ ,
אלמ עדימ
:)אלמה ןולעב אוצמל ןתינ הז ףיעס לש
Thymoglobulin should be used under strict
medical supervision in a hospital setting, and
patients should be carefully monitored during
the infusions.
Infusion-Associated Reactions (IARs) may
occur following the administration of
Thymoglobulin and may occur as soon as the
first or second infusion during a single course
of Thymoglobulin treatment
.
UNDESIRABLE EFFECTS ןמוסמ הרמחה הווהמו ףסוותהש עדימ
ב
בוהצ , אלמ עדימ
אלמה ןולעב אוצמל ןתינ הז ףיעס לש):
In addition:
HEPATOCELLULAR INJURY,
HEPATOTOXICITY, HEPATIC FAILURE (cases have
been reported secondary to allergic hepatitis
and reactivation of
hepatitis in patients with hematologic disease
and/or stem cell transplant as confounding
factors)…
…
…………………………………………………………………
In addition:
DISSEMINATED INTRAVASCULAR
COAGULOPATHY AND COAGULOPATHY
have also
been reported.
.
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
עבצב
קורי
וא ,
םודא
םע
וק
הקיחמ
רובע(
עדימ
ונאש
םישקבמ
.)דירוהל
רבעוה
ראודב
ינורטקלא
.......ךיראתב
05.0

Karakteristik produk

THYM-SPC-15.1
1
Thymoglobuline
Powder for concentrate for solution for infusion
1.
NAME OF THE MEDICINAL PRODUCT
Thymoglobuline
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml
reconstituted solution
contains 5 mg rabbit, anti-human thymocyte immunoglobulin.
Excipient(s) with known effect:
Each 10 ml vial contains 0.171 mmol of sodium, which is 4 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Immunosuppression in transplantation: prevention and treatment of
graft rejection.
Treatment of acute graft versus host disease (GvHD).
Hematology treatment of aplastic anemia.
4.2 Posology and method of administration
Posology
The posology depends on the indication, the administration regimen and
the possible
combination with other immunosuppressive agents.
The following dosage recommendations may be used as reference.
Treatment can be
discontinued without gradual tapering of the dose.
Immunosuppression in transplantation
Prophylaxis of acute graft rejection:
1 to 1.5 mg/kg/day for 2 to 9 days after transplantation of a kidney,
pancreas or liver and for 2
to 5 after heart transplantation, corresponding to a cumulative dose
of 2 to 7.5 mg/kg in heart
transplantation and 2 to 13.5 mg/kg for other organs.
THYM-SPC-15.1
2
Treatment of acute graft rejection:
1.5 mg/kg/day for 3 to 14 days, corresponding to a cumulative dose of
4.5 to 21 mg/kg.
Treatment of acute graft versus host disease
The dosage must be defined depending on individual basis. It is
usually between 2 and 5
mg/kg/day for 5 days.
Treatment of aplastic anaemia
2.5 to 3.5 mg/kg/day for 5 consecutive days, corresponding to a
cumulative dose of 12.5 to
17.5mg/kg.
The indication for aplastic anaemia has not been established by
controlled trials carried out
with this medicinal product.
Method of administration
Thymoglobuline is usually administered within the context of a