INTRON A Interferon alfa-2b (HSA-free) 18 million IU/3mL injection

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Interferon alfa-2b

Dostupno od:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International ime):

Interferon alfa-2b

Status autorizacije:

Registered

Uputa o lijeku

INTRON A
_Interferon alfa-2b_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INTRON A. It does
not contain all of 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 using INTRON A
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT INTRON A IS
USED FOR
INTRON A belongs to a group of
medicines called interferons.
Interferons are a family of naturally
occurring, small protein molecules.
They are produced and secreted by
cells in response to viral infections or
various synthetic and biological
inducers.
Interferons modify the body's
immune system response.
INTRON A is used to treat patients
with the following conditions:
•
Hairy cell leukaemia
•
Kaposi's sarcoma in AIDS
•
Chronic myelogenous leukaemia
•
Multiple myeloma
•
Follicular non-Hodgkin's
lymphoma
•
Malignant melanoma
•
Chronic hepatitis B
•
Chronic hepatitis C
Your doctor, however, may prescribe
INTRON A for another purpose.
BEFORE YOU USE
INTRON A
_WHEN YOU MUST NOT USE IT:_
DO NOT USE INTRON A IF YOU ARE
ALLERGIC TO:
•
interferon alfa-2b or any of the
ingredients listed at the end of
this leaflet.
DO NOT USE INTRON A IF YOU ARE
PREGNANT OR BREASTFEEDING UNLESS
YOUR DOCTOR SAYS SO. ASK YOUR
DOCTOR ABOUT THE RISKS AND BENEFITS
INVOLVED.
IF YOU ARE A WOMAN OF CHILDBEARING
AGE MAKE SURE YOU DO NOT BECOME
PREGNANT WHILE USING INTRON A.
DO NOT USE INTRON A IF
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE INTRON A AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If you use it after the expiry date it
may have no effect at all, or worse,
an unexpected effect.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING INTRON A, TALK
TO YOUR DOCTOR.
_BEFORE YOU START TO USE IT_
YOU MUST TELL YOUR DOCTOR:
1.
IF

Svojstava lijeka

Page 1
PRODUCT INFORMATION
INTRON A
NAME OF THE MEDICINE
Interferon alfa-2b (rbe)
DESCRIPTION
INTRON A is a sterile, stable formulation of highly purified
interferon alfa-2b produced by
recombinant DNA techniques. Recombinant interferon alfa-2b is a water
soluble protein with
a molecular weight of approximately 19,300 daltons. It is obtained
from a clone of _ E. coli_
which has a genetically engineered plasmid containing an interferon
alfa-2 gene from human
leucocytes.
The activity of INTRON A is expressed in terms of International Units
(IU). The specific
activity of INTRON A is approximately 2.6 x 10
8
IU/mg protein.
INTRON A Injectable (HSA-free) Solution
INTRON A HSA-free Injectable Solution is a clear, colourless solution
and is available in
single dose vials. Each single dose vial of INTRON A HSA-free
Injectable Solution contains,
10 million IU/1 mL, 18 million IU/3 mL or 25 million IU/2.5 mL of
recombinant interferon alfa-
2b.
The
vials
also
contain
sodium
phosphate
dibasic,
sodium
phosphate
monobasic,
disodium edetate, sodium chloride, polysorbate 80, water for
injections and m-cresol.
PHARMACOLOGY
Interferons are
a family of naturally occurring, small protein molecules produced and
secreted by cells in response to viral infections or various synthetic
and biological inducers.
Interferons exert their cellular activities by binding to specific
membrane receptors on the cell
surface. Preliminary studies to characterise these membrane receptors
and to determine the
subsequent fate of the human interferon-receptor complex have been
carried out using
125
I-
labelled recombinant interferon alfa-2b. Human interferon receptors,
as isolated from human
lymphoblastoid (Daudi) cells, appear to be highly asymmetric membrane
proteins. They
exhibit selectivity for human but not murine interferons, suggesting
species specificity.
Studies with other interferons have demonstrated species specificity.
The results of several studies suggest that, once bound to the cell
membrane, the interferon
initiates a complex sequence of