Immukin 2 x 106 IU (0.1mg) solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INTERFERON GAMMA

Available from:

Boehringer Ingelheim Limited Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom

ATC code:

L03AB03

INN (International Name):

INTERFERON GAMMA 2000000 IU

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INTERFERON GAMMA 2000000 IU

Prescription type:

POM

Therapeutic area:

IMMUNOSTIMULANTS

Authorization status:

Withdrawn

Authorization date:

2006-05-30

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
IMMUKIN
® 2 X 10
6 IU (0.1 MG)
SOLUTION FOR INJECTION
Active substance: recombinant human
interferon gamma-1b
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if the symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What IMMUKIN is and what it is used for
2. Before you use IMMUKIN
3. How to use IMMUKIN
4. Possible side effects
5. How to store IMMUKIN
6. Further information
1. WHAT IMMUKIN IS AND WHAT IT IS
USED FOR
IMMUKIN contains a substance called
recombinant human interferon gamma-1b.
Interferons are so-called immunomodulators.
These are small proteins that can stimulate
the body’s immune system defences. They
protect against micro-organisms (e.g.
bacteria, viruses and fungi) that can cause
disease.
IMMUKIN is for use by patients with chronic
granulomatous disease (CGD). CGD is a
defect in the metabolism of neutrophils, a
type of white blood cell. These normally kill
invading bacteria or fungi. The defect with
CGD makes neutrophils less able to prevent
infections.
IMMUKIN is used to reduce the number of
serious infections that may occur with this
disease.
IMMUKIN is also used in patients with
severe, progressive marble bone disease
(osteopetrosis). This is an inherited defect in
bone cells, which leads to excessive,
abnormal bone growth. It also affects the
bone marrow and the blood cells that are
usually formed in it. As a result, patients
with osteopetrosis are also at risk of serious
infections.
2. BEFORE YOU USE IMMUKIN
DO NOT USE IMMUKIN
• if you are allergic (hypersensitive) to
interferon gamma or to other related
interferons or any of the other ingredients
of IMMUKIN (

Summary of Product characteristics

Page 1 of 9 
1 
NAME OF THE MEDICINAL PRODUCT 
Immukin 2 x 10
6
 IU (0.1 mg) solution for injection 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial (0.5 ml) contains 2 x 10
6
 IU (0.1 mg) recombinant human interferon gamma-1b.  
Interferon gamma-1b is produced in an _E. coli_ expression system. 

For a full list of excipients, see section 6.1. 
3 
PHARMACEUTICAL FORM 
Solution for injection 

A clear, colourless solution 
4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Immukin is indicated for the reduction of the frequency of serious infections in patients with 
chronic granulomatous disease (CGD) (see also section 4.4).  

Immukin is indicated for the reduction in frequency of serious infections in patients with 
severe, malignant osteopetrosis (see also section 4.4 and 5.1). 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Immukin is for subcutaneous use.  The recommended dosage of Immukin for the treatment 
of patients with CGD or severe, malignant osteopetrosis is 50 mcg / m
2
 for patients whose 
body surface area is greater than 0.5 m
2
 and 1.5 mcg / kg / dose for patients whose body 
surface area is equal to or less than 0.5 m
2
.  The actually drawn volume has to be controlled 
before injection. Injections should be administered subcutaneously preferably in the evening 
three times weekly (for example, Monday, Wednesday, Friday).  The optimum sites of 
injection are the right and the left deltoid and anterior thigh.  Immukin can be administered 
by a physician, nurse, family member or patient when trained in the administration of 
subcutaneous injections. 

Although the most beneficial dose of Immukin is not known yet higher doses are not 
recommended.  Safety and efficacy has not been established for Immuk