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OCTAPLEX 500 IU POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active substance(s): FACTOR VII / HUMAN BLOOD COAGULATION FACTOR II / HUMAN BLOOD COAGULATION FACTOR X / HUMAN COAGULATION FACTOR IX / PROTEIN C / PROTEIN S

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Dose
Bleeding and prevention of bleeding during vitamin K antagonist treatment:
The dose will depend on the International 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
Approximate dose*
0.9 –1.3
1.3 – 1.6
1.6 – 1.9
(mL Octaplex/kg body weight)
*The single dose should not exceed 3,000 IU (= 120 mL Octaplex).

> 3.5
> 1.9

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 dosage for factor X:
Required units = body weight (kg) x desired factor X rise (IU/mL) × 60
where 60 (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) × 50
where 50 (mL/kg) is the reciprocal of the estimated recovery.
If the individual recovery is known that value should be used for calculation.

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.
5. With both vials still attached, gently swirl the powder vial
until the product is dissolved.
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™.
If the powder fails to dissolve completely or an aggregate is
formed, do not use the preparation.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Octaplex 500 IU powder and solvent for solution for infusion
Human prothrombin complex
Octaplex 1000 IU powder and solvent for solution for infusion
Human prothrombin complex

Fig. 1

Fig. 2

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 reconstitution. 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

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 the 20 mL (for 500 IU) or 40 mL (for 1000 IU)
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
Fig. 3
Fig. 4
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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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 gets 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
1. WHAT OCTAPLEX IS AND WHAT IT IS USED FOR
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.

• if you have IgA deficiency with known antibodies
against IgA.
Warnings and precautions
Take the advice of a doctor who specialises in clotting
disorders, when receiving Octaplex.
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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAPLEX
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.

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 (HBV) and hepatitis C virus (HCV). The
measures taken may be of limited value against non-enveloped viruses such as hepatitis
A virus (HAV) and parvovirus B19. Parvovirus B19 infection may be serious for pregnant

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women (fetal 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
medicines.
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 500 IU vial/ 150 – 250 mg sodium per 1000 IU
vial. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE OCTAPLEX
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.

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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
body).
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Clots in blood vessels.
Uncommon (may affect up to 1 in 100 people)
Anxiety, increase in blood pressure, asthma-like symptoms, coughing up blood, bleeding
from the nose, injection site burning, clots in device.
Rare (may affect up to 1 in 1,000 people)
Allergic type reactions may occur. A temporary increase in liver test results (transaminases)
has been rarely observed.
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.
Very rare (may affect up to 1 in 10,000 people)
Increase in body temperature (fever) has been observed.
There is a risk of blood clotting following the administration of this medicine.
Not known (frequency cannot be estimated from the available data)
Serious allergic reaction and shock, hypersensitivity, tremor, failure of the heart, increase
in heart rate, failure of the blood circulation, drop in blood pressure, respiratory failure,
difficulty in breathing, nausea, hives, rash, chills.
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.

www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE OCTAPLEX
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 +25°C. Nevertheless, to prevent contamination,
the solution should be used immediately and on one occasion only.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Octaplex contains, per vial and after reconstitution with 20 mL (500 IU)/
40 mL (1000 IU) solvent
The active substances are:
Name of ingredient

Octaplex
Quantity per 500 IU
vial

Octaplex
Quantity per
1000 IU vial

Octaplex
Quantity per mL
reconstituted solution

260 – 820 IU

520 – 1640 mg

13 – 41 mg/mL

Human coagulation factor II

280 – 760 IU

560 – 1520 IU

14 – 38 IU/mL

Human coagulation factor VII

180 – 480 IU

360 – 960 IU

9 – 24 IU/mL

Human coagulation factor IX

500 IU

1000 IU

25 IU/mL

Human coagulation factor X

360 – 600 IU

720 – 1200 IU

18 – 30 IU/mL

Protein C

260 – 620 IU

520 – 1240 IU

13 – 31 IU/mL

Protein S

240 – 640 IU

480 – 1280 IU

12 – 32 IU/mL

Total protein:
Active substances

Octaplex is sold in one carton containing:
• 1 vial with powder for solution for infusion
• 1 vial with the solvent, Water for Injections
• 1 Mix2Vial™ transfer device
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Octapharma Limited
The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom
Manufacturers:
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235, 1100 Vienna, Austria
Octapharma Lingolsheim S.A.S.
72 Rue du Maréchal Foch, 67380 Lingolsheim, France
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 05/2017
INFORMATION FOR HEALTHCARE PROFESSIONALS
General information about how to use Octaplex is provided in section 3.
The following information is intended for medical or healthcare professionals only:

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

What Octaplex looks like and contents of the pack
Octaplex is presented as a powder and solvent for solution for infusion and is a hygroscopic,
white or slightly coloured powder or friable solid in a glass vial. The solvent is water for
injections and is provided in a glass vial. The reconstituted solution is clear or slightly
opalescent and may be coloured.

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
requirements.

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Further active ingredients

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.

+ Expand Transcript

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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