ATGAM equine antithymocyte immunoglobulin 250mg/5mL injection ampoule

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Equine antithymocyte immunoglobulin, Quantity: 50 mg/mL

Հասանելի է:

Pfizer Australia Pty Ltd

Դեղագործական ձեւ:

Injection, solution

Կազմը:

Excipient Ingredients: sodium hydroxide; water for injections; glycine; hydrochloric acid

Կառավարման երթուղին:

Intravenous Infusion

Միավորները փաթեթում:

5 X 5 mL ampoules, 1 X 5 mL ampoule

Դաս:

Medicine Registered

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

INDICATIONS AS AT 11 APRIL 2002 : ATGAM is indicated for renal transplant patients in whom reduction of peripheral T-lympocyte function as measured by rosette-forming cell assay could be desirable. During controlled clinical trials, this immunosuppression has been demonstrated in renal allograft recipients treated with ATGAM. When it was administered prophylactically with conventional immunosuppressive therapy, ATGAM delayed the onset of the first rejection episode, and when it was administered at the time of the first rejection, ATGAM resolved the acute rejection episode more frequently than did conventional therapy alone.

Ապրանքի ամփոփագիր:

Visual Identification: Clear to straw coloured solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

1991-08-02

Տեղեկատվական թերթիկ

ATGAM
®
A
T
G
A
M
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH ATGAM?
Atgam contains the active ingredient, equine antithymocyte
immunoglobulin. It is a type of horse protein used to help control
your
body's immune system to foreign protein. Atgam is used after a kidney
transplant to stop your body's immune system from rejecting
the new kidney. For more information, see Section 1. Why am I being
treated with Atgam? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH ATGAM?
Do not use if you have ever had an allergic reaction to Atgam/equine
antithymocyte immunoglobulin or other horse proteins (equine
gamma globulins) or any of the ingredients listed at the end of the
CMI.
It is possible for products developed from horse or human blood to
carry infectious diseases like viral hepatitis and AIDS.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or if you are pregnant or plan to become
pregnant or are breastfeeding. For more information, see Section 2.
What should I know before treatment with Atgam? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Atgam and affect how it works.
More instructions can be found in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS ATGAM GIVEN?
Atgam will be given to you by your doctor usually after skin testing.
It is diluted and given by slow infusion into a vein over a period
of at least 4 hours. You will be monitored during treatment in case
you have an allergic reaction to Atgam. If you have an allergic
reaction, treatment with Atgam will be stopped. You may need to have
regular checks for new infections.
More instructions can be found in Section 4. How is Atgam given? in
the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH ATGAM?
THINGS YOU
SHOULD DO
•
Tell your doctor if you have previously been treat

Ապրանքի հատկությունները

Version: pfpatgai10421
Supersedes: pfpatgai10120
Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
ATGAM
®
(EQUINE
ANTITHYMOCYTE
IMMUNOGLOBULIN
)
1.
NAME OF THE MEDICINE
Equine antithymocyte immunoglobulin.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATGAM is the purified, concentrated and sterile gamma globulin,
primarily monomeric IgG,
from hyperimmune serum of horses immunised with human thymus
lymphocytes.
Before release for clinical use, each ATGAM lot is tested for its
ability to inhibit rosette
formation between human peripheral lymphocytes and sheep red blood
cells
_in vitro_
. The
potency of lots may vary over a twelve-fold range. The clinical
significance of this is unknown.
ATGAM is not solely anti-human thymocyte globulin.
ATGAM is likely to contain low levels of antibodies against other
formed elements of the
blood and also other antibodies raised by the horse in response to
prior antigenic exposure.
These may include pertussis, tetanus, influenza, mycobacterium, equine
encephalomyelitis or
strangles.
During processing, the drug is adsorbed with human erythrocyte stroma
and with IgG-free
human plasma proteins to reduce or remove antibodies against human red
blood cells and
human plasma proteins. Each lot is tested before release to assure
that antibody activity against
platelets is within acceptable limits. Each lot of ATGAM must also
test negative for anti-
human serum protein antibody and anti-glomerular basement membrane
before release.
Each ampoule of ATGAM contains 250 mg of horse gamma globulin
stabilised in 0.3 molar
glycine to a pH of approximately 6.8.
No preservative or antimicrobial agent added. For the full list of
excipients, see Section 6.1
List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
ATGAM is a transparent to slightly opalescent aqueous protein
solution, colourless to light
brown, and nearly odourless. It may develop a slight granular or flaky
deposit during storage.
For information about inline filters, see Section 4.2 Dose and method
of administration,
Method of