250 IU FVIII / 600 IU VWF (5 ml liquid), 500 IU FVIII / 1200 IU VWF (10 ml liquid), 500 IU FVIII / 1200 IU VWF (5 ml liquid), 1000 IU FVIII / 2400 IU VWF (10 ml liquid ) powder and liquid for injection/infusion, solution
human coagulation factor VIII, human von Willebrand factor
What Voncento is and what it is used for
The product is made from human plasma (the liquid part of the blood) and contains the active substances human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF).
Voncento is used in all age groups to prevent or stop bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in hemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective on its own or cannot given.
VWF and FVIII are involved in blood clotting. Lack of any of the factors means that the blood cannot clot as quickly as it should and therefore there is an increased tendency to bleed. Replacement of VWF and FVIII with Voncento temporarily repairs the coagulation mechanisms.
Because Voncento contains both FVIII and VWF, it is important to know which factor you need most. If you have hemophilia A, your doctor will prescribe Voncento with a specified number of units of FVIII. If you have VWD ( von Willebrand disease ), your doctor will prescribe Voncento with a specified number of units of VWF.
What you need to know before using Voncento
Do not use Voncento
- if you are allergic to VWF or FVIII or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Traceability
It is strongly recommended that you record the date of administration, batch number and volume injected in a treatment diary each time Voncento is given.
Talk to your doctor, nurse, or pharmacist before using Voncento.
- An allergic hypersensitivity reaction may occur. If symptoms of a hypersensitivity reaction occur, stop using the medicine immediately and contact your doctor. Your doctor should inform you about early signs of hypersensitivity reaction . These include hives, generalized skin rash, chest tightness, wheezing, drop in blood pressure and anaphylaxis (a severe allergic reaction causing severe difficulty breathing or dizziness).
- Development of inhibitors ( antibodies ) is a known complication that can occur with treatment with all factor VIII drugs. The inhibitors prevent, especially at high levels, the treatment from working as it should. You or your child will be closely monitored for the development of such inhibitors. If you or your child develop bleeding that cannot be controlled with Voncento, tell your doctor immediately.
- Tell your doctor or pharmacist if you have heart disease or have risk factors for heart disease
- If you need a central venous access device (CVAD) to deliver Voncento, the doctor should consider the risk of CVAD-related complications in the form of local infections , bacteria in the blood ( bacteraemia ) and formation of a blood clot in the blood vessel ( thrombosis ) where the catheter is inserted.
- von Willebrand diseaseIf you have a known risk of blood clots, you should be monitored for early signs of thrombosis (blood clot). Your doctor will give you treatment to prevent thrombosis .
Virus security
When medicines are made from human blood or plasma , special measures are taken by the manufacturer to prevent infection from being transmitted to patients. These include:
- Careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded,
- Testing each donation and plasma pool for signs of viruses/infections,
- Incorporation of steps in the handling of the blood or plasma that can inactivate or isolate viruses .
Despite these measures, the risk of transmission of infection cannot be completely excluded when medicines made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection .
The measures taken are considered to be effective against so-called “enveloped” viruses , such as human immunodeficiency virus ( HIV , AIDS virus), hepatitis B and hepatitis C viruses (which cause liver inflammation) and the “non-enveloped” virus et hepatitis A virus ( which also causes liver inflammation).
The measures may be of limited value against non-enveloped viruses such as parvovirus B19.
Parvovirus B19 infection can be serious
- for pregnant women (as there is a risk of the unborn child being infected) and
- for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anemia (eg sickle cell anemia or hemolytic anemia ).
Your doctor may suggest that you get vaccinated against Hepatitis A and B if you are regularly/repeatedly treated with plasma-derived medicines such as Voncento.
Children and young people
The warnings and precautions listed apply to adolescents and children.
Other medicines and Voncento
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- Voncento should only be used during pregnancy and breastfeeding when absolutely necessary.
Driving ability and use of machinery
Voncento does not affect the ability to drive or use machines.
Voncento contains sodium
The 250 IU FVIII /600 IU VWF (5 ml liquid) and 500 IU FVIII /1200 IU VWF (5 ml liquid) packages contain up to 14.75 mg sodium per bottle (the main ingredient in common/table salt). This corresponds to 0.74% of the maximum recommended daily intake of sodium for adults.
The 500 IU FVIII /1200 IU VWF (10 ml liquid) and 1000 IU FVIII /2400 IU VWF (10 ml liquid) packages contain up to 29.50 mg of sodium per bottle (the main ingredient in common/table salt). This corresponds to 1.48% of the maximum recommended daily intake of sodium for adults.
This should be taken into account if you have been prescribed a low-salt diet.
How to use Voncento
Your treatment must take place under the supervision of a doctor who has experience in the treatment of bleeding disorders.
If your doctor thinks you can administer Voncento yourself, your doctor will provide you with appropriate instructions. Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
Dosage
The amount of VWF and FVIII you need and the duration of treatment depends on:
- the severity of your illness
- where the bleeding is and how extensive it is
- your clinical condition
- your body weight
(see also section “The following information is only intended for healthcare professionals” ).
If you have been given Voncento for home use, your doctor will make sure that someone shows you how to inject it and that you know how much to use.
Follow the instructions of your doctor.
Use for children and adolescents
Dose one for children and adolescents aged < 18 years is based on body weight and is therefore generally based on the same instructions as for adults. In some cases, especially in younger patients, a higher dose may be needed.
If you use too much Voncento
Five cases of overdose have been reported from clinical trials . Those reports have not been associated with any side effects . However, the risk of forming blood clots ( thrombosis ) cannot be excluded at extremely high doses , especially in patients with VWD.
If you forget to use Voncento
- Take the next dose immediately and continue at regular intervals as recommended by your doctor.
- Do not take a double dose to make up for a missed dose .
If you stop using Voncento
Do not stop using Voncento without consulting a doctor.
Preparation and use
General instructions
- The powder should be mixed with the diluent (liquid) and withdrawn from the vial under aseptic conditions.
- Voncento cannot be mixed with other medicines, diluents or solutions except those mentioned in section 6.
- The solution should be clear and slightly opalescent (translucent), i.e. it may shimmer if held up to the light but must not contain any visible particles. After filtering or filling the syringe (see below), the solution should be seen (visually checked) before use. Do not use the solution if it is cloudy or contains flakes or particles.
- Any unused product or waste should be disposed of in accordance with local guidelines and as directed by your physician.
Preparation
Before opening the vials, Voncento powder and liquid should be warmed to room or body temperature. This can be done either by letting the bottles stand at room temperature for about an hour or by holding them in your hands for a few minutes.
DO NOT expose the vials to direct heat. The vials must not be heated above body temperature (37 ºC).
Carefully remove the plastic caps from the bottles and clean the surfaces of the rubber stoppers with an alcohol wipe. Allow the vials to dry before opening the Mix2Vial package (which contains the transfer set with filters). Then follow the instructions below.
Assignment and use
Using the supplied venipuncture set, insert the needle into a vein. Let the blood flow backwards to the end of the tube. Attach the syringe to the threaded locking device at the end of the venipuncture set. The use of disposable plastic syringes is recommended as solutions of this type often stick to the matte ground surfaces of whole glass syringes. Inject/infuse the reconstituted solution slowly (at a rate of no more than 6 ml/min) into the vein according to the instructions given to you by your doctor. Be careful not to get any blood into the syringe with ready-made solution.
In cases where large volumes of Voncento are required, it is possible to pool several vials of Voncento into a commercially available infusion set (eg, an injection pump for administering medication into a vein). In these cases, the initially prepared solution of Voncento should not be further diluted.
Feel for any immediate side effects . If you experience any side effects that may be due to the administration of Voncento, the injection or infusion should be discontinued (see also section 2).
If you have further questions about this medicine, contact your doctor or pharmacist .
Possible side effects
Like all medicines, Voncento can cause side effects , although not everybody gets them.
Contact your doctor immediately if:
- you get symptoms of an allergic reactionIn some cases, a severe allergic reaction ( anaphylaxis ) can develop, causing difficulty breathing, dizziness or shock . Allergic reactions may include the following symptoms: Swelling of the face, tongue, mouth or throat, difficulty breathing and swallowing, hives , wheezing, burning or stinging at the infusion site, chills, flushing, rash all over the body, headache, drop in blood pressure, restlessness , faster heartbeat, chest tightness (including chest pain and chest discomfort), back pain, tiredness (lethargy), nausea, vomiting, tingling.
- you notice that the medicine is no longer working properly (bleeding is not stopped).Among children who have not been treated with factor VIII medicines before, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment more than 150 days), the risk is lower and the complication is less common (occurring in fewer than 1 in 100 users). If you or your child develop antibodies , the medicines may stop working as they should, and you or your child may suffer from persistent bleeding.
You can develop an inhibitor (neutralizing antibody) against VWF, which means that VWF will no longer function properly. - you get symptoms of reduced blood flow in the arms and legs (e.g. if they become cold and pale) or internal organs (can manifest as severe chest pains)There is a risk of the formation of blood clots ( thrombosis ), especially in patients with known risk factors (see also section 2).
The following side effects have been observed as very common (may affect more than 1 in 10 people):
- Headache
The following side effects have been observed as common (may affect up to 1 in 10 people):
- Increased body temperature
The following side effects have been observed as uncommon (may affect up to 1 in 100 people):
- Taste changes ( dysgeusia )
- Abnormal liver function tests
Side effects in children and adolescents
Side effects in children and adolescents are expected to be the same as in adults.
How to store Voncento
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the label and carton after EXP.
- Store at a maximum of 25 ºC.
- Do not freeze.
- Voncento does not contain preservatives , so the ready-made product should be used immediately.
- If the reconstituted product is not administered immediately, storage time and conditions prior to use are the responsibility of the user.
- Store in the original packaging. Light sensitive.
- Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is:
250 IU FVIII and 600 IU VWF per vial; after reconstitution with 5 ml water for injections approximately 50 IU/ml FVIII and 120 IU/ml VWF.
500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 10 ml water for injections approximately 50 IU/ml FVIII and 120 IU/ml VWF.
500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml water for injections approximately 100 IU/ml FVIII and 240 IU/ml VWF.
1000 IU FVIII and 2400 IU VWF per vial; after reconstitution with 10 ml water for injections approximately 100 IU/ml FVIII and 240 IU/ml VWF.
For further information, see section “The following information is intended for healthcare professionals only “.
Other ingredients are:
Calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
See section 2 “Voncento contains sodium”.
Appearance and package sizes of the medicine
Voncento is supplied as a white powder and liquid for injection/infusion, solution.
The ready-made solution must be clear or slightly shimmering, i.e. it can shimmer if held up to the light, but it must not contain any visible particles.
The product’s inner packaging and liquid vials consist of glass with a stopper (rubber), a disc (plastic) and a cap (aluminium).
Packaging versions:
A pack of 250 IU/600 IU or 500 IU/1200 IU contains:
‑ 1 bottle of powder
‑ 1 bottle of 5 ml water for injections
– 1 transfer set with filter 20/20
The inner box contains:
1 disposable syringe 10 ml
1 venipuncture set
2 alcohol wipes
1 non-sterile patch
Pack of 500 IU/1200 IU or 1000 IU/2400 IU contains:
– 1 vial with powder
– 1 vial with 10 ml of water for injections
– 1 transfer set with filter 20/20
The inner box contains:
1 disposable syringe 10 ml
1 venipuncture set
2 alcohol wipes
1 non-sterile patch
Not all pack sizes may be marketed.
CSL Behring GmbH
Emil‑von‑Behring‑Straße 76
35041 Marburg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
Sweden
CSL Behring AB
Phone: +46 8 544 966 70