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IMMUKIN 2 X 10 000 000 IU (0.1 MG) SOLUTION FOR INJECTION

Active substance: RECOMBINANT HUMAN INTERFERON GAMMA-1B

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PACKAGE LEAFLET:
INFORMATION FOR THE USER


Immukin® 2 x 106 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

abcd
Fertility, pregnancy and breast feeding
Based on the information available, effects
on fertility are not known but cannot be
excluded. You should not use IMMUKIN
during pregnancy, unless your doctor thinks
it is essential. You are recommended not to
breast-feed while using IMMUKIN.
Ask your doctor or pharmacist for advice
before using any medicine.
Driving and using machines
IMMUKIN can cause fatigue, fits (seizures),
confusion, disorientation or distorted or
imaginary sensations (hallucinations). These
side effects can reduce the ability to
respond and can thus have a negative effect
upon the ability to drive and use machines.
Do not drive or use machines if you realize
reduced responsiveness.
Important information about some of the
ingredients of IMMUKIN
This medicinal product contains less than
1 mmol sodium (23 mg) per 0.5 ml vial, i.e.
it is ‘sodium-free’. This may be important
for people with high blood pressure and
others wishing to maintain a low sodium
diet.

IMMUKIN contains a substance called
recombinant human interferon gamma-1b.
Interferons are so-called immunomodulators.
These are small proteins that can stimulate
3. HOW TO USE IMMUKIN
the body’s immune system defences. They
protect against micro-organisms (e.g.
IMMUKIN is for injection under the skin
bacteria, viruses and fungi) that can cause
(subcutaneous use) and can be administered
disease.
by a doctor or nurse. You or a family
IMMUKIN is for use by patients with chronic member could also administer IMMUKIN.
You or your family member should be
granulomatous disease (CGD). CGD is a
trained by a doctor or nurse in giving this
defect in the metabolism of neutrophils, a
type of white blood cell. These normally kill type of injection.
invading bacteria or fungi. The defect with
CGD makes neutrophils less able to prevent The recommended dosage of IMMUKIN for
the treatment of patients with CGD or
infections.
severe, malignant osteopetrosis is 50 mcg/m2
for patients whose body surface area is
IMMUKIN is used to reduce the number of
greater than 0.5 m2 and 1.5 mcg/kg for
serious infections that may occur with this
patients whose body surface area is equal to
disease.
or less than 0.5 m2.
IMMUKIN is also used in patients with
Your doctor will decide how much IMMUKIN
severe, progressive marble bone disease
(osteopetrosis). This is an inherited defect in you need to take to treat CGD or severe,
progressive osteopetrosis.
bone cells, which leads to excessive,
abnormal bone growth. It also affects the
Always use IMMUKIN as your doctor has
bone marrow and the blood cells that are
told you. Check with your doctor or
usually formed in it. As a result, patients
with osteopetrosis are also at risk of serious pharmacist if you are not sure how to use
IMMUKIN or if you need any other advice.
infections.
You should inject (or should have injected)
under your skin the exact amount of
IMMUKIN your doctor has told you that you
need. You should give the injections three
Do NOT use IMMUKIN
times per week (for example, Monday,
• if you are allergic (hypersensitive) to
Wednesday and Friday), preferably in the
interferon gamma or to other related
interferons or any of the other ingredients evening. The recommended injection sites
of IMMUKIN (please refer to section 6 for are the upper arm or the top of the thigh.
further ingredients). Ask your doctor or
• Always check the amount of IMMUKIN
pharmacist if you are unsure about
solution before giving the injection.
whether you are allergic to interferons.
2. BEFORE YOU USE IMMUKIN

Take special care with IMMUKIN
• if you have heart disease, because higher
than usual doses can make your heart
condition worse (see section 3 for dosage
information)
• if you have seizure disorder and/or

compromised central nervous system
function
• if your liver does not function as effectively
as normal (hepatic insufficiency)
• if your kidneys do not function as

effectively as normal (renal insufficiency)
• if your bone marrow does not produce as
many blood cells as normal (myelo-
suppression)
• if you are allergic to latex, because the
stopper of the glass vial contains natural
rubber (a derivative of latex) which may
cause allergic reactions
Consult your doctor if one of the warnings
above applies to you now or if it did in the
past.
You should avoid using IMMUKIN at the
same time as other types of protein-based
medicines. You should also avoid taking
IMMUKIN at the same time as you are given
a vaccine. If you have any questions about
this, ask your doctor.
You should continue to have the tests used
in the management of CGD and severe,
progressive osteopetrosis. Your blood
count, urine, kidney and liver function
should be carefully checked, both before
and during the treatment.
High interferon gamma-1b levels in the
body may possibly harm the fertility of men
and women.
Using other medicines
You may also require antibiotics to treat
infections that still occur while you are
taking IMMUKIN for the treatment of CGD.
There is no evidence that IMMUKIN affects
the efficacy of antibiotics or corticosteroids,
commonly used medications in CGD and
severe, malignant osteopetrosis patients.
Medicines that affect the liver or the kidneys
may affect the excretion of IMMUKIN from
the body.

• Do not use IMMUKIN if you can see small
particles or discolouration of the solution.
• Do not mix IMMUKIN with other medicines.
• Do not strongly shake IMMUKIN vials.
If you use more IMMUKIN than you should
Immediately consult your doctor if you have
administered more IMMUKIN than your
doctor has told you.
Symptoms after having administered too
much IMMUKIN can include the following:
• central nervous system side effects such as
difficulty in thinking, difficulty in walking,
and dizziness
• if you have heart disease, this may get
worse for a short time
• blood disorders can occur during

treatment with IMMUKIN


These include:
- temporary changes in the number of
some blood cells
- increases in blood levels of certain
substances (liver enzymes and

triglycerides)
These changes can be detected by your
doctor with a blood test.
These symptoms resolve with reduction in
dose or with discontinuing IMMUKIN.
If you forget to use IMMUKIN
Have your injections at the times your
doctor has recommended. If you forget to
take a dose, do not inject a double dose to
make up for it. You can still administer it on
the same or following day. Contact your
doctor if you think you have gone too long
without taking a dose.
If you stop using IMMUKIN
Please inform your doctor if you stop using
IMMUKIN.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

It is possible that IMMUKIN might prolong
the activity of other medicines that are
broken down and removed from the body
by the liver.
If you use IMMUKIN at the same time as
medicines or vaccines that have effects
upon the heart, blood, bone marrow,
nervous system or immune system, the risk
of side effects may be increased.
Please tell your doctor or pharmacist if you
are taking or have recently taken or regularly
take any medicines, including medicines
obtained without a prescription.

Mandatory in

File information

TD

A

Printfile

Issue date of TD:

15.11.2012

Yes

P004535

No

Yes

PPM SKU version: 

011

No

Yes

Issue date of artwork:

09.04.2015

No

Yes

Print colors:

PAN Black

No

Yes

Mat. No. Pack. Site:

304345-02

No

Yes

Min. font size:

10.2 pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

B

Yes

PPM SKU:

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Gluepoints

Additional Requirements of Packaging site
Template name: TD-PI_160x630

Index: b

C
Mass
Mass
Mass

A
B
C

8,5 mm
2,2 mm
max. 42,5 mm

4. POSSIBLE SIDE EFFECTS
Like all medicines, IMMUKIN can cause side
effects, although not everybody gets them.
The risk of side effects occurring depends
on the dose and the dosing schedule you
have been given.
The most common side effects are flu-like
symptoms such as fever, headache, cold
chills, and fatigue.
These may become less severe over time as
the treatment is continued. Some of these
symptoms can be reduced by administering
IMMUKIN just before going to sleep. A
medicine such as paracetamol can be used
to reduce some of these side effects.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly (see details below). By reporting
side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
Some people who take IMMUKIN may
develop short-term skin problems, such as a e-mail: medsafety@hpra.ie
temporary skin rash, spotty skin rash, the
Malta
sudden formation of blisters on the skin,
ADR Reporting
and reddening of the skin at the injection
The Medicines Authority
site. However, these are rarely severe
Post-Licensing Directorate
enough to stop treatment with IMMUKIN.
203 Level 3, Rue D’Argens
The side effects listed below are grouped by GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
how likely they are to happen.
e-mail: postlicensing.medicinesauthority@gov.mt
Very common side effects (more than 1 in
10 patients treated) are:
5. HOW TO STORE IMMUKIN
• fever
• headache
Keep out of the reach and sight of children.
• chills
• pain at the injection site
Do not use IMMUKIN after the expiry date
• vomiting
which is stated on the carton and vial, after
• nausea (feeling sick)
‘Do not use after’ or ‘EXP’. The expiry date
• diarrhoea
refers to the last day of that month.
• fatigue
• raised levels of liver enzymes
Store in a refrigerator (2°C – 8°C). Do not
• rash
freeze.
Common side effects (less than 1 in 10
IMMUKIN solution for injection vials are for
patients treated) are:
single use only.
• muscle pain
• joint aching or pain
IMMUKIN contains no preservatives. Once
• back pain
opened, you should use the contents of a
• stomach pain
vial immediately. Dispose of any unused
• depression
contents of the vial.
Not known (cannot be estimated from the
Do not use IMMUKIN if you notice particles
available data):
• shortage of white blood cells (neutropenia) or discolouration in it before use.
• shortage of blood platelets (thrombo-
cytopenia) which might be associated with Medicines should not be disposed of via
wastewater or household waste. Ask your
bruises and a tendency towards bleeding
pharmacist how to dispose of medicines no
• proteins in the urine
longer required. These measures will help to
Side effects have also been seen in patients protect the environment.
with conditions other than CGD or
malignant osteopetrosis. These events have
6. FURTHER INFORMATION
not been seen in clinical trials involving
CGD or osteopetrosis.
What IMMUKIN contains
The following side effects have been reported
in clinical trials with patients suffering from Each vial (0.5 ml) contains 2 x 106 IU (0.1 mg)
other diseases/conditions than CGD or
recombinant human interferon gamma-1b.
osteopetrosis. Often the doses used in these This is a substance produced using E. coli
studies were higher than the recommended bacteria modified by gene technology.
dose for CGD and osteopetrosis. For this
reason it is not possible to say accurately
The other ingredients are D-mannitol,
how often they occurred.
disodium succinate hexahydrate,
polysorbate 20, succinic acid and water for
Not known (cannot be estimated from the
injections.
available data):
• low blood levels of sodium which can
The stopper of the glass vial contains
cause tiredness and confusion, muscle
natural rubber (a derivative of latex).
twitching, fits or coma (hyponatraemia)
• high levels of a sugar called glucose
What IMMUKIN looks like and contents of
(hyperglycaemia)
the pack
• fatty acids called triglycerides (hyper-
triglyceridaemia) in the blood
IMMUKIN is a clear, colourless solution for
injection. IMMUKIN is available in 3 ml vials
The following nervous system disorders
containing 0.5 ml solution for injection.
have been observed:
- confusion
Pack sizes: 1, 3, 5, 6 and 12 vial(s) in one
- disorientation
folding box.
- effects on ability to walk such as

Parkinsonian gait
Not all pack sizes may be marketed.
- trembling
- fits (seizures)
Marketing Authorisation Holder and
- distorted or imaginary sensations

Manufacturer
(hallucinations)
Marketing Authorisation Holder
The following heart disorders have also
Boehringer Ingelheim Limited
been seen to occur:
Ellesfield Avenue
- additional and irregular heart beats
Bracknell
- disturbance in the heart rate, such as
Berkshire
faster or slower heart rate
RG12 8YS
- heart problems which can cause

United Kingdom
shortness of breath or ankle swelling
(heart failure)
Manufacturer
- heart attack
Boehringer Ingelheim RCV GmbH & Co KG
Dr. Boehringer-Gasse 5-11
The following blood system disorders have
1121 Vienna
been reported:
Austria
- low blood pressure
- fainting
Tel: +43 1 80 105-0

- mild, temporary stroke (transient
Fax: +43 1 804 08 23
ischemic attack)
- blood clot or blockage of a lung artery
This medicinal product is authorised in the
(deep venous thrombosis and

Member States of the EEA under the
pulmonary embolism); symptoms can
following names:
include shortness of breath
Austria:
Imukin® Latvia:
Belgium: Immukine® Liechtenstein: The following respiratory disorders have
Bulgaria: Lithuania: occurred:
Cyprus:
Imukin® Luxembourg: Immukine®
- rapid breathing
Czech
Malta: Immukin®
- chest tightness (bronchospasm or
Republic: Netherlands: Immukine®
interstitial lung disease)
Denmark: Imukin® Norway: Imukin®
Estonia:
Poland: • bleeding in the digestive system
• inflammation of the pancreas, which can Finland: Imukin® Portugal: Imukin®
France:
Imukin® Romania: lead to death
Germany: Imukin® Slovakia: • damage to the liver that affects its function
Greece:
Imukin® Slovenia: (liver failure)
Hungary: Imukin® Spain: Imukin®
• damage to the kidneys that affect their
Iceland:
Sweden: Imukin®
function but can be treated effectively
Ireland:
Immukin® United
(reversible kidney failure)
Italy:
Imukin® Kingdom: Immukin®
• pains in the chest
• worsening of a skin condition called
dermatomyositis (seen as a skin rash
This leaflet was last approved in April 2015.
accompanying muscle weakness)
• development of the long-term disease
© Boehringer Ingelheim Limited 2015
called systemic lupus erythematosus (i.e.
the patient’s own immune system attacks
various parts of the body)
• autoimmune reaction (Autoantibody
response)

304345-02

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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