The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
IMMUNINE 600 IU POWDER FOR SOLUTION INJECTION/INFUSION
Powder and solvent for solution for injection or
Human blood coagulation factor IX
Read all of this leaflet carefully before you start using
– Keep this leaflet. You may need to read it again.
– If you have further questions, ask your doctor or
– This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their 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 IMMUNINE is and what it is used for
2. Before you use IMMUNINE
3. How to use IMMUNINE
4. Possible side effects
5. How to store IMMUNINE
6. Further information
1. WHAT IMMUNINE IS AND WHAT IT IS USED FOR
What IMMUNINE is
IMMUNINE is a coagulation factor IX concentrate. It
replaces the factor IX which is lacking or is not functioning
properly in hemophilia B. Hemophilia B is a sex-linked,
hereditary blood coagulation defect due to reduced
factor IX levels. This leads to severe bleeding in joints,
muscles and inner organs, either spontaneously or as a
consequence of accidental or surgical traumata.
The administration of IMMUNINE temporarily corrects the
factor IX deficiency and reduces the bleeding tendency.
What IMMUNINE is used for
IMMUNINE is used for the treatment and prophylaxis of
bleedings in patients born with hemophilia B.
2. BEFORE YOU USE IMMUNINE
Do not use IMMUNINE
– if you are hypersensitive (allergic) to human
coagulation factor IX or any of the other ingredients of
– if a consumption coagulopathy and/or a hyperfibrinolysis exists.
Consumption coagulopathy (DIC, disseminated intravascular coagulation) is a life threatening condition in
which excessive blood coagulation with pronounced
formation of blood clots in the blood vessels occurs. This
subsequently leads to the consumption of coagulation
factors in the entire body.
Hyperfibrinolysis is present when blood coagulation is
reduced because the important coagulation substance
fibrin is degraded.
After appropriate treatment of these conditions,
administer IMMUNINE in case of life threatening
Take special care with IMMUNINE
When allergic reactions occur:
• There is a rare possibility that you may experience a
severe, sudden allergic reaction (anaphylactic reaction)
Therefore you should be aware of the early signs of an
allergic reaction such as
– reddening of the skin
– formation of welts on the skin (urticaria)
– itching over the entire body
– swelling of lips and tongue
– breathing difficulties / dyspnea
– impaired breathing in and/or out due to constriction of
the air passages (wheezing)
– tightness in the chest
– general indisposition
– drop in blood pressure
– loss of consciousness
• If you detect one or more of the symptoms listed above
in yourself, stop the infusion immediately. Call your
doctor instantly. The symptoms listed above may be
early signs of an anaphylactic shock. Severe symptoms
require immediate emergency treatment.
When monitoring is required:
• Your doctor will test your blood regularly to ensure that
the current dosage is adequate and that your blood
receives sufficient factor IX.
• When factor IX concentrates are administered, blood
clots (thromboses) may develop and be washed into the
bloodstream (embolisms). Therefore the doctor will not
raise the factor IX level as high in patients who are prone
to thrombosis (not above 60 % of normal). Furthermore,
the doctor will monitor these patients, as well as patients
who receive high doses of IMMUNINE, with particular
care. With proper monitoring, possible complications
can be recognized in time and appropriate measures
can be taken. Among these complications are
thromboembolism and consumption coagulopathy, for
When the bleeding persists:
• If your bleeding is not controlled with IMMUNINE, please
inform your doctor immediately. You may have
developed inhibitors to factor IX. Factor IX inhibitors are
antibodies (inhibitors) in your blood which counteract the
effect of factor IX. This reduces the efficacy of
IMMUNINE in the treatment of bleeding. Your doctor will
carry out the necessary tests to ascertain this.
• There is a possible connection between the occurrence
of factor IX inhibitors and allergic reactions. Patients
with factor IX inhibitors may be at an increased risk of
anaphylaxis. Therefore patients who develop an allergic
reaction should be tested for the presence of a factor IX
There are insufficient data to recommend the use of
Immunine in children less than 6 years of age.
Using other medicines
Please tell your doctor or pharmacist if you are
taking / applying or have recently taken / applied any other
medicine, including medicines obtained without a
No interactions of IMMUNINE with other medicines are
IMMUNINE must not be mixed with other medicines before
administration. This may impair the efficacy and the safety
of the product. If you also receive other medicinal products
via your venous access, the venous access must be rinsed
with a suitable solution, e.g. with physiological saline
solution, before and after the administration of
Pregnancy and breast-feeding
Hemophilia B in women is very rare. Therefore there is no
experience regarding the use of IMMUNINE during
pregnancy and breast-feeding to date.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Inform your doctor if you are pregnant or breast-feeding.
Your doctor will decide if you may use IMMUNINE during
pregnancy and breast-feeding.
Driving and using machines
No effects on the ability to drive or use machines have
Important information about some of the ingredients
When medicines are made from human blood or plasma,
certain measures are put in place to prevent infections
being passed on to patients. These include careful
selection of blood and plasma donors to make sure those
at risk of carrying infections are excluded, and the testing
of each donation and pools of plasma for signs of virus/
infections. Manufacturers of these products also include
steps in the processing of the blood or plasma that can
inactivate or remove viruses. Despite these measures,
when medicines prepared from human blood or plasma are
administered, the possibility of passing on infection cannot
be totally excluded. This also applies to any unknown or
emerging viruses or other types of infections.
The measures taken are considered effective for enveloped
viruses such as human immuno deficiency virus (HIV, the
virus which causes AIDS), hepatitis B virus and hepatitis C
virus, and for the non-enveloped hepatitis A virus. The
measures taken may be of limited value against nonenveloped viruses, such as parvovirus B19 (virus which
causes infectious erythema). Parvovirus B19 infection may
be serious for pregnant women (fetal infection) and for
individuals whose immune system is depressed or who
have some types of anemia (i.e. sickle cell anemia or
Your doctor may recommend that you consider vaccination
against hepatitis A and B if you regularly / repeatedly
receive human plasma-derived products.
If you receive high daily doses of IMMUNINE, a sodium
amount of 200 mg may be exceeded. Please inform your
doctor, if you are on a low sodium diet. He needs to give
particular consideration to this.
It is strongly recommended that every time you receive a
dose of IMMUNINE the name and batch number of the
product are recorded in order to maintain a record of the
3. HOW TO USE IMMUNINE
Your treatment should be initiated and guided by doctors
with experience in the treatment of hemophilia B.
The doctor will determine the appropriate dose for you. He
will calculate it taking into consideration your special
requirements. Please talk to your doctor if you have the
impression that the effect of IMMUNINE is too strong or
Dosage for prophylaxis of bleeding
If you use IMMUNINE to prevent (prophylaxis) bleeding,
doses between 20 – 40 IU (IU = International Units) of
factor IX per kg body weight at an interval of 3 – 4 days are
usually given. In some cases shorter dosage intervals or
higher dosages may be required, especially in younger
Dosage for treatment of bleeding
If you use IMMUNINE to treat bleeding, your doctor will
calculate the appropriate dose for you, using the formula
Required IU = body weight (kg) x desired factor IX
increase (% of normal or IU/dl) x 1.1
Monitoring by your doctor
Your doctor will carry out appropriate laboratory tests at
regular intervals, to ensure that you have sufficient
amounts of factor IX in your blood. This is particularly
important in the case of major surgery.
Patients with inhibitors
If the expected factor IX levels in the blood are not reached
in spite of an appropriate dose, or if the bleeding does not
stop, inhibitors may be present. Your doctor will check this
using suitable tests.
If you have developed factor IX inhibitors, you may require
larger amounts of IMMUNINE to control the bleeding. If the
bleeding cannot be controlled even then, your doctor will
consider an alternative product. Do not increase the
dosage of IMMUNINE to control the bleeding without
consulting your doctor.
Frequency of administration
Your doctor will explain to you how often and at which
intervals you have to apply IMMUNINE. He will do this for
you personally, depending on your response to IMMUNINE.
Duration of treatment
Life-long treatment with IMMUNINE is usually required.
Method of administration
IMMUNINE is administered slowly into a vein (intravenously) after preparing the solution with the solvent
provided. Please follow your doctor’s instructions closely.
The rate of administration depends on your comfort level
and should not exceed 2 ml per minute.
• Use only the enclosed administration set. If other
injection sets are used, IMMUNINE may stick to the
inside of the infusion set, which may lead to an incorrect
• If you also receive other medicinal products via your
venous access, this venous access must be rinsed with
a suitable solution, e.g. with physiological saline solution,
before and after the administration IMMUNINE.
• Only reconstitute IMMUNINE immediately before
administration, then use the solution straight away. (The
solution does not contain preservatives.)
• The solution for injection is clear or slightly milky
(opalescent). Do not use solutions which are more turbid
or have visible particles.
• Dispose of unused dissolved product appropriately.
Reconstitution of powder to prepare a solution for
Take care to prepare the solution under conditions which
are as clean and as sterile as possible!
1. Warm the unopened rubber-capped vial containing the
solvent (Water for Injections) to room temperature (max.
2. Remove protective caps from the rubber-capped vials
containing the powder and the solvent (fig. A) and
cleanse the rubber stoppers of both.
3. Remove protective covering from one end of the
enclosed transfer needle by twisting and pulling. Insert
the needle through the rubber stopper of the solvent vial
(fig. B and C).
4. Remove protective covering from the other end of the
transfer needle taking care not to touch the exposed
5. Invert the solvent vial over the powder vial, and insert
the free end of the transfer needle through the rubber
stopper of the powder vial (fig. D). The solvent will be
drawn in by the vacuum in the powder vial.
6. After the entire solvent has flowed into the powder vial,
disconnect the two vials by removing the transfer needle
from the powder vial (fig. E). Gently agitate the powder
vial to accelerate dissolution.
7. Upon complete reconstitution of the powder, insert the
enclosed aeration needle (fig. F) and any foam will
collapse. Remove the aeration needle.
Injection / infusion:
Take care to prepare the solution under conditions which
are as clean and as sterile as possible!
1. Remove protective covering from the enclosed filter
needle by twisting and pulling and fit the needle onto the
sterile disposable syringe. Draw the solution into the
syringe (fig. G).
2. Disconnect the filter needle from the syringe and slowly
(max. 2 ml per minute) administer the solution
intravenously with the enclosed infusion set (or the
enclosed disposable needle).
When administering by infusion, use a disposable winged
infusion set with an appropriate filter.
If you use more IMMUNINE than you should
Please inform your doctor. Symptoms through over dosage
with factor IX are not known.
If you forget to use IMMUNINE
• Do not take a double dose to make up for a forgotten
• Proceed with the next administration immediately and
continue at regular intervals as advised by your doctor.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, IMMUNINE can have side effects,
although not everybody gets them. 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.
The side effects are listed according to the following
frequency criteria: very common: (≥ 1/10), common
(≥ 1/100; < 1/10), uncommon (≥ 1/1,000; < 1/100), rare
(≥ 1/10,000; < 1/1,000), very rare (1/10,000).
The following side effects were observed uncommonly
within clinical studies:
Skin and the subcutaneous tissue disorders: skin rash,
Respiratory, thoracic and mediastinal disorders:
irritation in the throat, sore throat, dry cough.
The following side effects were observed very rarely
within the framework of monitoring after market
Blood and the lymphatic system disorders: factor IX
neutralising antibodies (inhibitors), consumption coagulopathy (DIC).
Immune system disorders: anaphylactic reactions
including shock, angioneurotic edema (a suddenly
occurring swelling of the skin or mucous membranes, with
or without difficulty in swallowing and/or breathing),
flushing, skin rash, nettle rash over the entire body
Nervous system disorders: headache, restlessness,
Cardiac disorders: tachycardia, (myocardial) infarction
Vascular disorders: low blood pressure, thromboembolic
events, pulmonary embolism, venous thrombosis.
Respiratory, thoracic and mediastinal disorders:
impaired breathing in and/or out due to constriction of the
respiratory passages (wheezing)
Gastrointestinal disorders: nausea, vomiting.
Skin and the subcutaneous tissue disorders: skin rash.
Renal and urinary disorders: nephrotic syndrome (a
certain kidney disorder with symptoms such as swelling of
lids, face and lower legs with weight gain and loss of
protein via the urine).
General disorders and administration site conditions:
chills, fever, hypersensitivity reactions, burning and
stinging at the injection site, lethargy, tightness of the
The following side effects have been observed with
products of the same product group:
Hypersensitivity or allergic reactions including angioneurotic syndrom, burning and stinging at the injection site,
chills, flushing, generalised urticaria, headache, itching,
low blood pressure, lethargy, nausea, restlessness,
tachycardia, tightness of the chest, tingling, vomiting and
In individual cases, the side effect may progress to a
severe anaphylactic reaction, including shock. Severe
allergic reactions were observed mostly in chronological
connection with inhibitors to factor IX.
There are reports about the occurrence of nephrotic
syndrome, a certain kidney disorder with symptoms such
as swelling of lids, face and lower legs with weight gain
and loss of protein via the urine.
On rare occasions, fever has been observed.
The formation of neutralising antibodies (inhibitors) to
factor IX can manifest as insufficient response to the
The use of Factor IX concentrates may lead to thromboses,
which may be washed into the bloodstream. The
consequences may be myocardial infarction, disseminated
intravascular coagulation, venous thrombosis and
5. HOW TO STORE IMMUNINE
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the original package in order to protect
Do not use IMMUNINE after the expiry date which is stated
on the label and the carton. The expiry date refers to the
last day of that month.
During its shelf life, IMMUNINE may be stored at below
25°C. However, this is restricted to 3 months only. Record
the beginning and the end of storage at below 25°C on the
product box. You must use IMMUNINE within these three
months. If you do not need the medicinal product, you must
dispose of it after the 3 months have expired. Do not
refrigerate IMMUNINE again.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What IMMUNINE contains
– The active substance is human blood coagulation
factor IX. 1 vial with powder for solution for injection
contains 600 IU human coagulation factor IX.
1 ml of solution contains 120 IU human coagulation
factor IX, when reconstituted with 5 ml of water for
– The other ingredients are sodium chloride and sodium
– Water for Injections
What IMMUNINE looks like and contents of the
IMMUNINE is a white or light yellow powder for preparing a
solution for injection. After reconstitution with the solvent
provided (Water for Injections) the solution is clear or
slightly milky (opalescent).
Pack size: 1 x 600 IU
Each package contains: – 1 rubber-capped vial
IMMUNINE 600 IU
– 1 rubber-capped vial with 5 ml
Water for Injections
– 1 transfer needle
– 1 aeration needle
– 1 filter needle
– 1 disposable needle
– 1 disposable syringe (5 ml)
– 1 infusion set
Marketing Authorisation Holder:
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk,
IP24 3SE, United Kingdom
Industriestrasse 72, A-1221 Vienna, Austria
Marketing Authorisation Number:
PL 00116/0631 (UK)
PA 167/132/2 (Ireland)
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria: Immunine 600 I.E. – Pulver und Lösungsmittel zur
Herstellung einer Injektionslösung
Bulgaria: Immunine 600 IU
Cyprus: Immunine 600 IU
The following information is intended for medical
or health professionals only:
The following table contains guidance values for the
minimum content of factor IX in the blood.
In the following hemorrhagic events, the factor IX activity
should not fall below the specified content (in % of normal
or in IU/dl) within the specified period of time. Under
certain conditions, especially at the beginning of the
treatment, higher dosages than calculated may be
bleeding / Type
Early hemarthrosis, muscle
bleeding or oral
20 – 40
24 hours for at least
1 day, until the
bleeding episode as
indicated by pain is
resolved or healing
30 – 60
every 24 hours for
3 – 4 days or more
until pain and acute
60 – 100
every 8 to 24 hours
until the threat to the
patient is resolved.
30 – 60
Every 24 hours for
at least 1 day, until
healing is achieved.
every 8 – 24 hours
wound healing, then
continue therapy for
at least another
7 days to maintain a
factor IX activity of
30 % to 60 % (IU/dl).
Czech Republic: Immunine Baxter 600 IU
Estonia: Immunine 600 IU
Germany: Immunine 600 IE
Greece: Immunine 600 IU
Ireland: Immunine 600 IU
Latvia: Immunine 600 IU powder and solvent for solution
Lithuania: Immunine 600 TV milteliali ir tirpiklis injeciniam
Netherlands: Immunine Baxter
Norway: Baxnine 600 IE
Poland: Immunine 600 IU
Portugal: Immunine 600 IU
Romania: Immunine 600 IU
Slovakia: Immunine 600 IU
Slovenia: Immunine 600 IU
Spain: Immunine 600 IU
Sweden: Baxnine 600 IE
United Kingdom: Immunine 600 IU
This leaflet was last approved in October 2007.
dosage (hours) /
80 – 100