500 IU powder and solvent for solution for injection Human prothrombin complex
1000 IU powder and liquid for infusion solution Human prothrombin complex
What Ocplex is and what it is used for
Ocplex belongs to a group of medicines called coagulation factors. It contains the vitamin K-dependent human coagulation factors II, VII, IX, and X.
Ocplex is used to treat and prevent bleeding:
- caused by so-called vitamin K antagonists (eg warfarin ), drugs that block the effect of vitamin K and lead to a lack of vitamin K-dependent coagulation factor in the body. Ocplex is used when such a deficiency needs to be remedied quickly.
- in persons born with a deficiency of vitamin K-dependent coagulation factors II and X, when purified, specific coagulation factor preparations are not available.
What you need to know before using Ocplex
Do not use Ocplex
- if you are allergic (hypersensitive) to any of the ingredients of this product (listed in section 6).
- if you are allergic (hypersensitive) to heparin or if you have previously had heparin cause a decrease in the number of platelets in your blood.
- if you have IgA deficiency and expensive antibodies to IgA .
Warnings and Precautions :
- Consult a physician who specializes in coagulation disorders when using Ocplex.
- If your vitamin K-dependent coagulation factor deficiency is acquired (eg when it is caused by treatment with medicines that are vitamin K antagonists ), Ocplex should only be used when the deficiency needs to be remedied quickly, e.g. in case of major bleeding or emergency surgery. In other cases, it is usually sufficient to reduce the dose one of vitamin K antagonist one and / or give vitamin K.
- If you are being treated with a vitamin K antagonist (eg warfarin ) this may be because you are at increased risk of blood clots. Treatment with Ocplex can then reinforce that risk.
- If you were born with a deficiency of any vitamin K-dependent factor, specific
coagulation factor preparations should be used when available. - If an allergic or anaphylactic reaction occurs, your doctor should immediately discontinue the infusion and give appropriate treatment.
- When you receive Ocplex, especially if you receive it regularly, there is a risk of thrombotic disease or so-called disseminated intravascular coagulation (a serious disease in which blood clots form throughout the body).
You should therefore be closely monitored for signs or symptoms of intravascular coagulation or blood clots.
This is especially important if you have a history of coronary heart disease or liver disease, if you are having surgery and when Ocplex is given to very young children. - No data are available on the use of Ocplex in case of postpartum haemorrhage due to vitamin K deficiency in the newborn.
Virus security
- When medicines are made from human blood or plasma , special measures are taken to prevent the transmission of infection to patients. This includes a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, as well as testing of individual donations and plasma pools for signs of virus / infection. The manufacturers of these products also include steps in the handling of blood and plasma that can inactivate or possibly separate. virus . Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown virusesand other types of infection you.
- The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus (HBV) and hepatitis C virus ( HCV ). The measures may be of limited value against non-enveloped viruses , such as hepatitis A and parvovirus B19. Parvovirus B19 infection can be serious in pregnant women (fetal infection ), individuals with weakened immune systems or patients with certain types of anemia (eg hemolytic anemia ).
- When you are given Ocplex, it is recommended that the product name and batch number be registered to maintain a link to the used batch.
- Your doctor may suggest vaccination against hepatitis A and B if you are regularly / repeatedly treated with plasma-derived prothrombin complex preparations.
Children and young people
There are no data available on the use of Ocplex in children and adolescents.
Pregnancy and breastfeeding
Ocplex should only be used during pregnancy and lactation if necessary. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unknown whether Ocplex affects the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of Ocplex
- Heparin can cause allergic reactions and reduce the number of blood cells , which can affect the blood’s ability to coagulate. Patients who have previously had allergic reactions triggered by heparin should avoid the use of medicines containing heparin .
- This medicine contains 75-125 mg (500 IU vial ) or 150-250 mg (1,000 IU vial ) of sodium (the main ingredient in common salt / table salt) per vial . This corresponds to 3.8% –6.3% or 7.5% –12.5% of the highest recommended daily intake of sodium for adults.
How to use Ocplex
Treatment with Ocplex should be started under the supervision of a doctor who specializes in coagulation disorders.
- The powder is first dissolved in water
- The solution is then given into a vein ( intravenously )
How much Ocplex you get and how long depends on:
- How serious is his illness
- Where you bleed, how much you bleed and
- Your general condition
If you take more Ocplex than you should
In case of overdose, the risk of developing increases
- thrombotic diseases (eg heart attack and blood clots in veins or lungs)
- disseminated intravascular coagulation (a serious disease with the formation of blood clots throughout the body)
Possible side effects
Like all medicines, Ocplex can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Blood vessel clot.
Uncommon (may affect up to 1 in 100 people)
Anxiety, high blood pressure, asthma-like symptoms, bloody cough, nosebleeds, burning at the injection site, clot formation in the infusion unit.
Rare (may affect up to 1 in 1,000 people)
Allergic reactions may occur. Temporarily elevated liver values ( transaminases ) have been observed.
The use of this medication carries the risk of blood clots forming.
Has been reported (occurs in an unknown number of users)
Severe allergic reaction and shock, hypersensitivity, tremor, heart failure, increased heart rate, circulatory failure, drop in blood pressure, respiratory failure, difficulty breathing, nausea, hives, rash, chills.
The heparin present in the medicine may cause a sudden decrease in the number of platelets in the blood. This is an allergic reaction called “heparin-induced thrombocytopenia type II”. In patients who have not previously been hypersensitive to heparin, in rare cases, the reduction in platelet count may occur 6-14 days after starting treatment. In patients with a history of heparin hypersensitivity, the change may occur within a few hours after starting treatment.
Treatment with Ocplex must be stopped immediately in patients who experience this allergic reaction. In the future, they must not be treated with medicines containing heparin.
For information on virus security, see section 2.
How to store Ocplex
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 expiration date is the last day of the specified month.
Do not store above 25 ° C. Do not freeze. Store in the original package. Sensitive to light.
The powder should only be dissolved just before injection. The stability of the solution has been demonstrated for up to 8 hours at + 25 ° C.
However, the solution should be used immediately and only once in a while to prevent contamination.
Contents of the pack and other information
Content declaration
Content declaration per vial and after reconstitution with 20 ml (500 IU) / 40 ml (1000 IU) diluent . The active substances are:
| Ingredient name | Ocplex Amount per 500 IU injection bottle | Ocplex Amount per 1000 IU vial | Ocplex Amount per ml reconstituted solution |
| Total protein | 260-820 mg | 520-1640 mg | 13-41 mg / ml |
| Active substances | |||
| 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 |
| Additional active ingredients | |||
| Protein C | 260-620 IU | 520-1240 IU | 13-31 IU / ml |
| Protein S | 240-640 IU | 480-1280 IU | 12-32 IU / ml |
The specific activity is ≥ 0.6 IU / mg protein expressed as Factor IX activity.
The other ingredients are heparin, sodium citrate di (dihydrate), water for injections.
What the medicine looks like and contents of the pack
Ocplex is supplied as a powder and solvent for solution for infusion and is a moisture-absorbing, white to slightly colored powder or slightly crumbled dry substance in a glass vial. The diluent is water for injections and is supplied in a glass vial. The reconstituted solution is clear or slightly opalescent and may be colored.
Ocplex is delivered in a box containing:
– 1 vial of powder for solution for infusion
– 1 vial of water for injections ( diluent ).
– 1 transfer set Nextaro ®
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Octapharma AB
112 75 Stockholm
Tel. 08-566 43000
Customer contact: 020-311020
Manufacturer:
Octapharma Pharmazeutika Produktionsges.mbH
Oberlaaer Str. 235
A-1100 Vienna
Austria
Octapharma SAS
72 Rue du Maréchal Foch
67380 Lingolsheim
France
This medicinal product is authorized under the European Economic Area under the names:
Optiplex. Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Holland, Ireland, Iceland, Croatia, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, UK, Germany, Hungary, Austria.
Ocplex: Sweden, Czech Republic
Pronative : Italy, Romania