Intron A Redipen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Interferon alfa-2b 15 MIU/mL

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Interferon alfa-2b 15 MIU/mL

Dosage:

18 MIU

Pharmaceutical form:

Solution for injection

Composition:

Active: Interferon alfa-2b 15 MIU/mL Excipient: Dibasic sodium phosphate Disodium edetate dihydrate Metacresol Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Units in package:

Cartridge, glass, 6x0.2mL doses of 3 million IU, 1.2 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH

Therapeutic indications:

INTRON A Redipen is used in the treatment of: · Hairy cell leukaemia in splenectomised or non-splenectomised patients; · Chronic myelogenous leukaemia;

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 6x0.2mL doses of 3 million IU - 1.2 mL - 15 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). With exposure to temperatures of up to 30 degrees C for up to 2 days 48 hours not refrigerated stored at or below 30°C. In-use, 4 weeks stored as directed between doses.

Authorization date:

1998-02-11

Patient Information leaflet

KEYTRUDA
®
1
INTRON A
®
_interferon alfa-2b _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Intron A.
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 response of
the body's immune system to help
fight infections, leukaemia and
tumours.
Your doctor may have prescribed
Intron A for another reason.
Ask your doctor if you have any
questions about why Intron A has
been prescribed for you.
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.

you are pregnant or breastfeeding
unless your doctor says so. Ask
your doctor about the risks and
benefits involved.

you are a woman of childbearing
age make sure you do not become
pregnant while using Intron A.

the 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 IF:

you are allergic to any other
medicines or any food, dyes or
preservativ

Summary of Product characteristics

_Page 1_
NEW ZEALAND DATA SHEET
1. INTRON A REDIPEN
INTRON A Redipen 18 MIU Solution for injection
INTRON A Redipen 30 MIU Solution for injection
INTRON A Redipen 60 MIU Solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INTRON A Redipen 18 MIU contains interferon alfa-2b 15 million
IU/mL (6 doses of 3
million IU, 0.2 mL per dose)
Each INTRON A Redipen 30 MIU contains interferon alfa-2b 25 million
IU/mL (6 doses of 5
million IU, 0.2 mL per dose)
Each INTRON A Redipen 60 MIU contains interferon alfa-2b 50 million
IU/mL (6 doses of 10
million IU, 0.2 mL per dose)
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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
INTRON A Redipen is a preloaded, multi-dose disposable injector and is
available in packs of
single pens. Each pack also contains 6 needles and 6 swabs.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTRON A Redipen is used in the treatment of:

Hairy cell leukaemia in splenectomised or non-splenectomised patients;

Kaposi's sarcoma in patients with acquired immune deficiency syndrome
(AIDS);

Chronic myelogenous leukaemia;

Multiple myeloma;

Follicular non-Hodgkin's lymphoma;

Malignant melanoma;

Chronic hepatitis B in adults;

Chronic hepatitis C in adults.
_Page 2_
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
HAIRY CELL LEUKAEMIA
The recommended dosage of INTRON A is 2 million IU/m
2
administered subcutaneously
three times a week (every other day). Higher doses are not
recommended. Normalisation of one
or more haemato