IMUKIN Interferon Gamma-1b recombinant human (2 million IU)/100microgram/0.5mL

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Interferon gamma-1b, Quantity: 4 million IU/mL

Tersedia dari:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: succinic acid; sodium succinate hexahydrate; mannitol; water for injections; polysorbate 20

Rute administrasi :

Subcutaneous

Unit dalam paket:

6 x 0.5mL vial, 1 x 0.5mL vial

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

As an adjunct for reduction of the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD). The benefits of Imukin have been most marked in children with CGD although Imukin may be used in adult patients.

Ringkasan produk:

Visual Identification: Colourless to pale yellow, clear to slightly opalescent solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Registered

Tanggal Otorisasi:

1994-04-08

Selebaran informasi

Imukin CMI
1
IMUKIN®
_Interferon gamma-1b _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Imukin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Imukin against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IMUKIN IS USED
FOR
Interferons are substances which are
normally produced by the body and
which play a role in the body's
response to infection. Interferon
gamma-1b is just one of several types
of interferon. Imukin contains
interferon gamma-1b which is
produced in the laboratory by
recombinant technology. It modifies
the body's response to infection in
the same way as naturally-occurring
interferon gamma.
Chronic Granulomatous Disease
(CGD) is a rare disorder in which the
body's own natural defence against
infection is not working properly.
Imukin is used with other treatments
to reduce the frequency of serious
infections in people with CGD.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE IMUKIN
_WHEN YOU MUST NOT USE IT _
DO NOT USE IMUKIN IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
interferons
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breat

Karakteristik produk

Imukin Product Information v4.0
1
1 NAME OF THE MEDICINE
Interferon Gamma-1b recombinant human.
2 QUALITATIVE AND QUANTITATIVE INFORMATION
Vials containing 2 x 10
6
IU (100

g) interferon gamma-1b (rbe) per 0.5mL.
Imukin
(interferon
gamma
-
1b
[rbe]),
a
biologic
response
modifier,
is
a
single-chain
polypeptide containing 140 amino acids. Production of Imukin is
achieved by fermentation of
a genetically engineered _Escherichia coli _bacterium containing the
DNA which encodes the
human
protein.
Purification
of
the
product
is
achieved
by
conventional
column
chromatography.
Imukin is a highly purified sterile solution consisting of
non-covalent dimers of two identical
16,465 Dalton monomers, with a specific activity of 20 million IU/mg.
List of excipients: For the full list of excipients see SECTION 6.1
LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imukin is indicated as an adjunct for reduction of the frequency of
serious infections in patients
with Chronic Granulomatous Disease (CGD).
The benefits of Imukin have been most marked in children with CGD
although Imukin may be
used in adult patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage of Imukin for injection for the treatment of
patients with CGD is 1
x 10
6
IU (50

g)/m
2
for patients whose body surface area is greater than 0.5m
2
, and 3 x
10
4
IU (1.5

g)/kg/dose for patients whose body surface area is equal to or less
than 0.5m
2
.
Care should be taken to ensure accurate adjustment of the volume of
solution drawn into the
syringe prior to injection. Injections should be administered
subcutaneously three times weekly
(for example, Monday, Wednesday, Friday). The optimum sites of
injection are the right and
the left deltoid region and anterior thigh.
Imukin can be administered by a physician, nurse,
family member or patient once they are trained in the administration
of subcutaneous
injections.
Treatment with Imukin should continue in the event of infectious
compl