Thymoglobuline

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Antithymocyte immunoglobulin 25mg (Rabbit)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Antithymocyte immunoglobulin 25 mg (Rabbit)

Dosage:

25 mg

Pharmaceutical form:

Powder for infusion

Composition:

Active: Antithymocyte immunoglobulin 25mg (Rabbit) Excipient: Glycine Mannitol Sodium chloride

Units in package:

Vial, glass, 10 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Genzyme Polyclonals SAS

Therapeutic indications:

Thymoglobuline® (rabbit anti - human thymocyte immunoglobulin) is indicated for the prophylaxis of graft rejection in renal transplantation; treatment of steroid - resistant or moderate to severe renal transplant rejection and in the prophylaxis of graft rejection in heart transplantation.

Product summary:

Package - Contents - Shelf Life: Vial, glass, - 10 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2007-08-29

Patient Information leaflet

THYMOGLOBULINE
®
1
THYMOGLOBULINE
®
_Rabbit anti-human thymocyte immunoglobulin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Thymoglobuline.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Thymoglobuline against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR, NURSE
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THYMOGLOBULINE
IS USED FOR
ORGAN TRANSPLANTATION
You have been given a new
transplanted kidney from another
person because your own was no
longer healthy. Your body recognises
that this new organ is different from
your organs and will try to reject it
by attacking it in the same way it
would attack germs that enter your
body. This could make you ill again.
The name of your medicine is
Thymoglobuline. It belongs to a
group of medicines called
immunosuppressants (anti-rejection
medicines). These medicines
suppress your immune system and
can help prevent your body from
rejecting the transplanted kidney.
_HOW IT WORKS _
ORGAN TRANSPLANTATION:
Thymoglobuline works by lowering
certain cells within your body's
immune system which are likely to
attack your transplanted organ
BEFORE YOU ARE GIVEN
THYMOGLOBULINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT TAKE THYMOGLOBULINE IF YOU
HAVE AN ALLERGY TO:
•
Thymoglobuline
•
rabbit proteins
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching, hives or
redness of the skin
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
•
blood or bleeding problems not
related to aplastic anaemia
•
lowered immunity due to dis

Summary of Product characteristics

New Zealand Data Sheet
Thymoglobuline – rabbit antithymocyte immunoglobulin
thymo-ccdsv2-dsv8-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
THYMOGLOBULINE 25 MG POWDER FOR INFUSION
Thymoglobuline 25 mg powder for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains rabbit antithymocyte immunoglobulin (rATG) 25 mg.
Reconstituted solution contains rATG 5 mg/mL.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for infusion
Thymoglobuline is a sterile creamy white lyophilised powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thymoglobuline (rabbit antithymocyte immunoglobulin) is indicated for
the prophylaxis of graft
rejection in renal transplantation; treatment of steroid-resistant or
moderate to severe renal
transplant rejection and in the prophylaxis of graft rejection in
heart transplantation.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Thymoglobuline must always be used under strict medical supervision
and prescribed by
physicians with experience in using immunosuppressive agents. The
dosage depends on the
indication, the administration regimen and the combination with other
immunosuppressive agents.
The following dosage may be used as a reference. Treatment can be
discontinued without gradual
tapering of the dose.
New Zealand Data Sheet
Thymoglobuline – rabbit antithymocyte immunoglobulin
thymo-ccdsv2-dsv8-20jun22
Page 2
_TRANSPLANTATION _
_Prophylaxis of Graft Rejection in Renal Transplantation _
1 to 1.5 mg/kg/day for 3 to 9 days after transplantation corresponding
to a cumulative dose of 3 to
13.5 mg/kg.
_Treatment of Steroid-Resistant or Moderate to Severe Renal Transplant
Rejection _
1.5 mg/kg/day for 7 to 14 days after transplantation of a kidney,
corresponding to a cumulative
dose of 10.5 to 21 mg/kg.
_Prophylaxis of Rejection in Heart Transplantation _
1 to 2.5 mg/kg/day for 3 to 5 days after transplantation corresponding
to a cumulative dose of 3 to
12.5 mg/kg.
_Dose Modifications _
Obese Patients
For obese patients dosing should be based on ideal