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Octaplex 500 IU powder and solvent for solution for infusion
Human prothrombin complex
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Octaplex is and what it is used for
2. What you need to know before you use Octaplex
3. How to use Octaplex
4. Possible side effects
5. How to store Octaplex
6. Contents of the pack and other information



Octaplex belongs to a group of medicines called clotting factors. It contains the human
vitamin K dependent blood coagulation factors II, VII, IX and X.
Octaplex is used to treat and prevent bleeding:
 caused by medicines called vitamin K antagonists (such as warfarin). These medicines
block the effect of vitamin K and cause a shortage of the vitamin K dependent clotting
factors in your body. Octaplex is used when rapid correction of the shortage is required.
 in people born with a shortage of the vitamin K dependent clotting factors II and X. It is
used when purified specific clotting factor product is not available.



Octaplex must not be used:
 if you are allergic to one of the ingredients of this product (listed in section 6).
 if you are allergic to heparin or if heparin has ever caused a reduction in the level of
platelets in your blood.
Warnings and precautions
 Take the advice of a doctor who specialises in clotting disorders, when receiving
 If you have an acquired deficiency of the vitamin K dependent clotting factors (for example
caused by treatment with vitamin K antagonist medicines), Octaplex should only be used
when rapid correction of the shortage is necessary such as major bleeding or emergency
surgery. In other cases, lowering the dose of the vitamin K antagonist medicine and/or
administration of vitamin K is usually sufficient.
 If you receive a vitamin K antagonist medicine (like warfarin) you may have an increased
risk of forming blood clots. In this case, treatment with Octaplex may enhance the risk.


 If you have been born with a shortage of any of the vitamin K dependent factors, specific
coagulation factor product should be used when available.
 If an allergic or anaphylactic- type reaction occurs, your doctor will stop the infusion
immediately and give appropriate treatment.
 There is a risk of thrombosis or disseminated intravascular coagulation (serious illness,
with clots forming all over the body) when you receive Octaplex (particularly if you receive
it regularly).You should be observed closely for signs or symptoms of intravascular
coagulation or thrombosis.
This is especially important if you have a history of coronary heart disease, liver disease, if
you are going to have an operation and also if Octaplex is given to very small babies
 No data are available regarding the use of Octaplex in case of bleeding during the birth
due to vitamin K deficiency in the new born.
Viral Safety
 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 virus
or other types of infections.
The measures taken are considered effective for enveloped viruses such as human
immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken
may be of limited value against non-enveloped viruses such as hepatitis A virus and
parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal
infection) and for individuals whose immune system is depressed or who suffer from a
type of anaemia (e.g. sickle cell disease or haemolytic anaemia).
It is strongly recommended that every time you receive a dose of Octaplex, the name and
batch number of the product are recorded in order to maintain a link to the batches used.
 Appropriate vaccination (hepatitis A and B) is recommended for you if you receive human
plasma-derived prothrombin complex products regularly/repeatedly.
Other medicines and Octaplex
Octaplex must not be mixed with other medicinal products.
Octaplex stops the effect of vitamin K antagonist medicines (like Warfarin), but no
interactions with other medicines are known.
Octaplex may affect the results of clotting tests which are sensitive to heparin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Pregnancy and breast-feeding
Octaplex should only be used during pregnancy and breast-feeding if clearly needed. Ask
your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is not known how Octaplex affects the ability to drive and use machines.
Important information about some of the ingredients of Octaplex
 Heparin may cause allergic reactions and reduced blood cell counts which may affect the
blood clotting system. Patients with a history of allergic reactions caused by heparin
should not use heparin-containing medicines.



 Octaplex contains 75 -125 mg sodium per vial. To be taken into consideration by patients
on a controlled sodium diet.



Treatment with Octaplex should be started under the supervision of a doctor who is
specialised in clotting disorders.
 First, the powder is dissolved in water
 Then the solution is given into a vein (the intravenous route).
How much Octaplex you receive, and for how long, depends on:
 how serious your illness is;
 where the bleeding is and how severe it is, and
 your general condition.
If you got more Octaplex than you should
In case of overdose, the risk is higher of developing
 clotting complications (such as heart attack and clots in your veins or lungs)
 disseminated intravascular coagulation (a serious illness where clots form all over the



Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Some patients may have allergic type reactions and fever.
Immune system problems:
Rare (more than 1 of 10,000, but less than 1 of 1,000 patients)
Rarely, patients treated with Octaplex for replacement therapy may develop neutralising
antibodies (inhibitors) against any of the contained clotting factors. If such inhibitors occur,
the replacement therapy will not be very effective.
General problems
Rare (more than 1 of 10,000, but less than 1 of 1,000 patients)
Increase in body temperature (fever) has not been observed but may rarely occur.
Vascular disorders
There is a risk of blood clotting following the administration of this medicine.
Nervous system disorders
Rare (more than 1 of 10,000, but less than 1 of 1,000 patients)
Headache may rarely occur.
Rare (more than 1 of 10,000, but less than 1 of 1,000 patients)
A temporary increase in liver test results (transaminases) has been rarely observed.
The heparin in the preparation may cause a sudden fall in the number of platelets in the
blood. This is an allergic reaction called “heparin-induced thrombocytopenia type II”. In rare


cases in patients not previously hypersensitive to heparin, this fall in the number of platelets
can occur 6-14 days after the start of treatment. In patients with a previous heparin
hypersensitivity, this alteration may develop within a few hours of starting treatment.
The treatment with Octaplex must be stopped immediately in patients showing this allergic
reaction. These patients must not receive heparin containing medicinal products in the future.
For information on viral safety see section 2.
Reporting of suspected adverse reactions
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 via the
national reporting system listed in Appendix V*. By reporting side effects you can help
provide more information on the safety of this medicine.
[*to be completed nationally]



Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
Do not store above 25 °C. Do not freeze. Store in the original package in order to protect
from light.
The powder should be dissolved only directly before injection. The stability of the solution
has been demonstrated for up to 8 hours at +2°C to +25°C. Nevertheless, to prevent
contamination, the solution should be used immediately and on one occasion only.



What Octaplex contains, per vial and after reconstitution with 20 ml solvent
The active substances are:
Name of ingredient
Total protein:
Active substances
Human coagulation factor II
Human coagulation factor VII
Human coagulation factor IX
Human coagulation factor X
Further active ingredients
Protein C
Protein S

Quantity per vial

Quantity per ml reconstituted solution

260 - 820 mg

13 - 41 mg/ml

280 - 760 IU
180 - 480 IU
500 IU
360 - 600 IU

14 - 38 IU/ml
9 - 24 IU/ml
25 IU/ml
18 - 30 IU/ml

260 - 620 IU
240 - 640 IU

13 - 31 IU/ml
12 - 32 IU/ml

The specific activity of the product is ≥ 0.6 IU/mg proteins, expressed as factor IX activity.
The other ingredients are:
Heparin, tri-sodium citrate dihydrate, Water for Injections.
What Octaplex looks like and contents of the pack
Octaplex is presented as a powder and solvent for solution for infusion.
Octaplex is sold in one carton containing
- 1 vial with powder for solution for infusion
- 1 vial with the solvent, 20 ml Water for Injections


- 1 transfer set Mix2Vial™
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
[To be completed nationally]

representative of the Marketing Authorisation Holder:
[To be completed nationally]>
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235
1100 Vienna
Octapharma Lingolsheim S.A.S.
72 Rue du Maréchal Foch
67380 Lingolsheim
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Portugal,
Republic of Slovenia, Slovak Republic, Spain, United Kingdom: Octaplex
Czech Republic, Sweden: Ocplex
Italy, Romania: Pronativ
This leaflet was last revised in MM/YYYY.

General information about how to use Octaplex is provided in section 3.
The following information is intended for medical or healthcare professionals only:
Instructions for Treatment
Please read all the instructions and follow them carefully!
During the procedure described below, aseptic technique must be maintained!
The product reconstitutes quickly at room temperature.
The reconstituted solution should be clear or slightly opalescent.
Do not use solutions that are cloudy or have deposits.
Reconstituted products should be inspected visually for particulate matter and discoloration
prior to administration.
After reconstitution the solution must be used immediately.
Any unused product or waste material should be disposed of in accordance with local
Bleeding and prevention of bleeding during vitamin K antagonist treatment:
The dose will depend on the Internal normalised ratio (INR) before treatment and the
targeted INR. In the following table approximate doses (ml/kg body weight of the


reconstituted product) required for normalisation of INR ( 1.2 within 1 hour) at different initial
INR levels are given.
Initial INR

2 – 2.5

2.5 – 3

3 – 3.5

> 3.5

Approximate dose* (ml
Octaplex/kg body weight)

0.9 –1.3

1.3 – 1.6

1.6 – 1.9

> 1.9

*The single dose should not exceed 3.000 IU (= 120 ml Octaplex).
As these recommendations are empirical and recovery and the duration of effect may vary,
monitoring of INR during treatment is mandatory.
Bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent
coagulation factors II and X when specific coagulation factor product is not available:
The calculated required dosage for treatment is based on the empirical finding that
approximately 1 IU of factor II or X per kg body weight raises the plasma factor II or X activity
by 0.02 and 0.017 IU/ml, respectively.
 Required units = body weight (kg) x desired factor X rise (IU/ml) x 59
where 59 (ml/kg) is the reciprocal of the estimated recovery.
 Required dosage for factor II:
Required units = body weight (kg) x desired factor II rise (IU/ml) x 50
If the individual recovery is known that value should be used for calculation.
Instructions for reconstitution:
1. If necessary, allow the solvent (Water for Injections) and the powder in the closed
vials to reach room temperature. This temperature should be maintained during
If a water bath is used for warming, care must be taken to avoid water coming into
contact with the rubber stoppers or the caps of the vials. The temperature of the
water bath should not exceed 37°C.
2. Remove the caps from the powder vial and the water vial and clean the rubber
stoppers with an alcohol swab.
3. Peel away the lid of the outer package of the Mix2Vial™. Place the solvent vial on an
even surface and hold it firmly. Place the blue part of the Mix2Vial™ on top of the
solvent vial and press firmly down until it snaps (Fig. 1). While holding onto the
solvent vial, carefully remove the outer package from the Mix2Vial™, being careful to
leave the Mix2Vial™ attached firmly to the solvent vial (Fig. 2).




4. Place the powder vial on an even surface and hold it firmly. Take the solvent
vial with the attached Mix2Vial™ and turn it upside down. Place the
transparent part on top of the powder vial and press firmly down until it snaps
(Fig. 3). The solvent flows automatically into the powder vial.

Fig. 3

5. With both vials still attached, gently swirl the powder vial until the product is
Octaplex dissolves quickly at room temperature to a colourless to slightly blue
solution. Unscrew the Mix2Vial™ into two parts (Fig. 4).
Dispose the empty solvent vial with the blue part of the Mix2Vial™.

Fig. 4

If the powder fails to dissolve completely or an aggregate is formed, do not use the
Instructions for infusion:
As a precautionary measure, the patients pulse rate should be measured before and during
the infusion. If a marked increase in the pulse rate occurs the infusion speed must be
reduced or the administration must be interrupted.
1. Attach a 20 ml syringe to the transparent part of the Mix2Vial™. Turn the vial upside down
and draw the solution into the syringe.
Once the solution has been transferred, firmly hold the plunger of the syringe (keeping it
facing down) and remove the syringe from the Mix2Vial™.
Dispose the Mix2Vial™ and the empty vial.
2. Disinfect the intended injection site with an alcohol swab.
3. Inject the solution intravenously at a slow speed: Initially 1 ml per minute, not faster than
2 - 3 ml per minute.
No blood must flow into the syringe due to the risk of formation of fibrin clots. The Mix2Vial™
is for single use only.



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