Grafalon 20 mg/ml concentrate for solution for infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Anti-human t-lymphocyte immunoglobulin from rabbits

Tersedia dari:

Neovii Biotech GmbH

Kode ATC:

L04AA; L04AA04

INN (Nama Internasional):

Anti-human t-lymphocyte immunoglobulin from rabbits

Dosis:

20 milligram(s)/millilitre

Bentuk farmasi:

Concentrate for solution for infusion

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Selective immunosuppressants; antithymocyte immunoglobulin (rabbit)

Status otorisasi:

Marketed

Tanggal Otorisasi:

2001-06-05

Selebaran informasi

Grafalon, PIL Ireland, Version 2019-07 adaption frequency_update acc.
to PVAR
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GRAFALON 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
anti-human T-lymphocyte immunoglobulin from rabbits
READ ALL OF THIS LEAFLET CAREFULLY

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Grafalon is and what it is used for
2.
What you need to know before Grafalon is given to you
3.
How Grafalon is given to you
4.
Possible side effects
5
How to store Grafalon
6.
Contents of the pack and other information
1.
WHAT GRAFALON IS AND WHAT IT IS USED FOR
Grafalon belongs to a group of medicines called immunosuppressants.
Immunosuppressants are used
to prevent the body from rejecting a transplanted organ.
You may be given Grafalon if you have had or are going to have an
ORGAN
TRANSPLANT
. This is to
prevent your body’s immune system from rejecting a new organ.
Grafalon helps to prevent or to stop
this rejection response by blocking the development of special cells,
which would normally attack the
transplanted organ.
Grafalon is used as part of
IMMUNOSUPPRESSIVE THERAPY
, together with other immunosuppressive
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE GRAFALON S IS GIVEN TO YOU
DO NOT HAVE GRAFALON AT ALL AND TELL YOUR DOCTOR …

if you are
ALLERGIC
to anti-human T-lymphocyte immunoglobulin from rabbits or any of the
other
ingredients of this medicine (listed in section 6)

if you are suffering from an
INFECTION
, where treatment is not working;

if you have difficulty stopping
BLEEDING
;

if you have a
TUMOR
.
WARNINGS AND PRECAUTIONS
IT IS IMPORTANT TO TELL YOUR DOCTOR
if you suffer from the following. You may be able to have
Grafalon, but need to discuss with your doctor first.

If you have previously had
ALLERGIC REACTIONS
to these medicines (immu

Karakteristik produk

Health Products Regulatory Authority
01 April 2022
CRN00CVV5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Grafalon 20 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 mg anti-human T-lymphocyte immunoglobulin from rabbits per 1 ml
Grafalon (100mg/5ml vial or 200mg/10ml vial).
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,
pH = 3.4 – 4.0
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 methyl-prednisolone
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).
Unless otherwise prescribed, the recommended daily dose of Grafalon
is:
Prophylaxis following organ transplantation:
0.1-0.25 ml (=2-5 mg) Grafalon/kg BW. The most common daily dosages
are in the range of 3-