Atgam
Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Foglio illustrativo
(PIL)
01-12-2022
Scheda tecnica
(SPC)
01-12-2022
Principio attivo:
Antithymocyte immunoglobulin 50 mg/mL (Equine)
Commercializzato da:
Pfizer New Zealand Limited
INN (Nome Internazionale):
Antithymocyte immunoglobulin 50 mg/mL (Equine)
Dosaggio:
250 mg/5mL
Forma farmaceutica:
Concentrate for injection
Composizione:
Active: Antithymocyte immunoglobulin 50 mg/mL (Equine) Excipient: Glycine Hydrochloric acid Sodium hydroxide Water for injection
Confezione:
Ampoule, glass, 5 mL
Classe:
Prescription
Tipo di ricetta:
Prescription
Prodotto da:
Pharmacia and Upjohn Company LLC
Indicazioni terapeutiche:
ATGAM is indicated for the management of allograft rejection, including delay of onset of first rejection episode, in patients who have undergone renal transplantation.
Dettagli prodotto:
Package - Contents - Shelf Life: Ampoule, glass, - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Ampoule, glass, 5 x 5mL - 25 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
Data dell'autorizzazione:
1983-09-26
Foglio illustrativo
ATGAM®
1
ATGAM
®
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 treated
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Scheda tecnica
Version: pfdatgai11122
Supersedes: pfdatgai10722
Page 1 of 14
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ATGAM
®
250 mg/5 mL concentrate injection for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
5
mL
ampoule
of
ATGAM
contains
250 mg
of
horse
gamma
globulin
(equine
antithymocyte immunoglobulin) stabilised in 0.3 molar glycine to a pH
of approximately 6.8 (pH
range of 6.4 – 7.2).
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.
ATGAM contains no preservatives or antimicrobial agents.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate injection. To be diluted prior to intravenous infusion.
ATGAM is a transparent to slightly opalescent, colourless to light
brown solution. It may
develop a slight granular or flaky deposit during storage.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATGAM is in
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