Thymoglobuline 5mgml Powder for concentrate for solution for infusion

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN

זמין מ:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

קוד ATC:

L04AA04

כמות:

25 mg/vial

טופס פרצבטיות:

INJECTION, POWDER, FOR SOLUTION

הרכב:

RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN 25 mg/vial

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

Genzyme Ireland Ltd

מצב אישור:

ACTIVE

תאריך אישור:

1990-03-07

עלון מידע

Colours Used
Black
Keyline (Does not print)
Genzyme
Thymoglobuline 5mg/ml Leaflet
502767
n/a
266 x 305mm (Folded size 30 x 102mm)
7pt
1 of 2
Singapore
English
Dave Petch
Two
11/10/10
Artwork Job No.
364768
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POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution with 5ml Water for Injection (WFI), the solution
contains 5mg
rabbit anti-human thymocyte immunoglobulin/ ml (concentrate).
Corresponding to 25mg / 5ml of rabbit anti-human thymocyte
immunoglobulin
per vial.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Thymoglobuline
®
is a creamy-white lyophilized powder.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
– Immunosuppression in transplantation: prophylaxis and treatment of
graft
rejection.
– Prophylaxis
of
acute
and
chronic
graft
versus
host
disease,
after
haematopoietic stem cell transplantation related non-HLA-identical
donors or
from unrelated HLA-identical donors
– Treatment of steroid-resistant, acute graft versus host disease
(GvHD).
– Haematology: treatment of aplastic anemia.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The posology

מאפייני מוצר

Thymoglobuline
®
must only be carried out after the benefits and
the risks have been carefully weighed up.
The serious and acute infusion-associated reactions (IARs)
correspond to a CRS attributed to the cytokine release by the
activated monocytes and lymphocytes.
In rare cases, these reactions are associated with serious
cardiorespiratory events and/or death.
_Infection_
Thymoglobuline
®
is routinely used in combination with other
immunosuppressive agents. Infections (bacterial, fungal, viral, and
protozoal), reactivation of infection (in particular cytomegalovirus
[CMV]), and sepsis have been reported after Thymoglobuline
®
administration in combination with multiple immunosuppressive
agents. In rare cases, these reactions have been fatal.
PRECAUTIONS
_General_
The dose adjustment of Thymoglobuline
®
differs from that of other
anti-thymocyte immunoglobulins insofar as protein composition
and concentrations vary depending on the source of anti-
thymocyte immunoglobulin used. Therefore, the doctors must
ensure that the dose prescribed is suitable for the anti-thymocyte
immunoglobulin administered.
Strict compliance with the recommended dosage and infusion
periods may reduce the incidence and the severity of IARs. In
addition, reducing the infusion rate allows a large number of these
IARs to be minimized. Premedication with antipyretic agents,
corticosteroids and/or antihistamines may reduce the incidence
and severity of these adverse reactions.
Rapid infusion rates have been associated with case reports
consistent with CRS.
In rare cases, a serious CRS can be fatal.
_Haematological effects_
Thrombocytopenia and/or leucopenia (in particular
lymphocytopenia and neutropenia) have been identified;
these conditions are reversible after dose adjustments. When
thrombocytopenia and/or leucopenia are not part of the
underlying condition or are not associated with the condition for
which Thymoglobuline
®
is being administered, dose reductions are
suggested.
Monitoring of white blood cells and platelet counts must be
c