GRAFALON 20 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RABBIT ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

L04AA04

Dosage:

20 mg/ml

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

RABBIT ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN 20 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

NEOVII BIOTECH GMBH

Authorization status:

ACTIVE

Authorization date:

1991-05-27

Patient Information leaflet

A0500401/ Exp. (SPC)
1. NAME OF THE MEDICINAL PRODUCT
ATG-Fresenius 20 mg/ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the concentrate contains 20 mg anti-human T-lymphocyte
immunoglobulin from
rabbits.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATG-Fresenius is indicated in combination with other immunosuppressive
medicinal products
for the suppression of immune competent cells, which are the cause for
acute rejection. It is
usually administered for the following indications:
Prevention of acute transplant rejection in patients receiving
allogeneic solid organ transplants
ATG-Fresenius is indicated in combination with other immunosuppressive
medicinal products
(e.g. glucocorticosteroids, purin antagonists, calcineurin inhibitors
or mTOR inhibitors) to
enhance immunosuppression following allogeneic solid organ
transplantation.
Therapy of acute corticosteroid-resistant rejection after allogeneic
solid organ transplantation
ATG-Fresenius is indicated for the treatment of acute
corticosteroid-resistant rejection episodes
after allogeneic solid organ transplantation if the therapeutic effect
of methyl-
prednisolone treatment has proven unsatisfactory.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ATG-Fresenius should be prescribed only by physicians who are
experienced in the use of
immunosuppressive therapies. ATG-Fresenius must be administered under
qualified medical
supervision.
RECOMMENDED DOSE
The dose of ATG-Fresenius is dependent on the indication. Dose
recommendations are based
on body weight. 
Prevention of acute transplant rejection in patients receiving
allogeneic solid organ transplants
The recommended dose range is 2 to 5 mg/kg/d ATG-Fresenius. The most
common doses are
in the range of 3 to 4 mg/kg/d. Therapy should commence on the day of
transplantation 
pre-, intra-, or immediately post-operatively. Depending on the
patient's conditio

Summary of Product characteristics

Page 1 of 10
INSTRUCTION FOR USE
Page 2 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Grafalon 20 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the concentrate contains 20 mg anti-human T-lymphocyte
immunoglobulin from rabbits.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Grafalon is indicated in combination with other immunosuppressive
medicinal products for the suppression
of immune competent cells, which are the cause for acute rejection. It
is usually administered for the
following indications:
Prevention of acute transplant rejection in patients receiving
allogeneic solid organ transplants
Grafalon is indicated in combination with other immunosuppressive
medicinal products (e.g.
glucocorticosteroids, purine antagonists, calcineurin inhibitors or
mTOR inhibitors) to enhance
immunosuppression following allogeneic solid organ transplantation.
Therapy of acute corticosteroid-resistant rejection after allogeneic
solid organ transplantation
Grafalon is indicated for the treatment of acute
corticosteroid-resistant rejection episodes after allogeneic
solid organ transplantation if the therapeutic effect of
methylprednisolone treatment has proven
unsatisfactory.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Grafalon should be prescribed only by physicians who are experienced
in the use of immunosuppressive
therapies. Grafalon must be administered under qualified medical
supervision.
Posology
The dose of Grafalon is dependent on the indication. Dose
recommendations are based on body weight
(BW).
Prevention of acute transplant rejection in patients receiving
allogeneic solid organ transplants
The recommended dose range is 2 to 5 mg/kg BW/d Grafalon. The most
common doses are in the range of
3 to 4 mg/kg BW/d. Therapy should commence on the day of
transplantation pre-, intra-, or immediately
pos