IMMUKIN International Unit Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INTERFERON GAMMA

Available from:

Boehringer Ingelheim Limited

ATC code:

L03AB03

INN (International Name):

INTERFERON GAMMA

Dosage:

International Unit

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Interferons

Authorization status:

Transfer Pending

Authorization date:

1993-01-14

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  
 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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. Immukine 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 Immukine given in doses greater or less than the recommended dose o