English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Voncento (human coagulation factor VIII / human...) – Package leaflet - B02BD06

Updated on site: 10-Oct-2017

Medication nameVoncento
ATC CodeB02BD06
Substancehuman coagulation factor VIII / human von willebrand factor
ManufacturerCSL Behring GmbH

Package Leaflet: Information for the user

Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent)

Voncento 500 IU FVIII / 1200 IU VWF (10 ml solvent)

Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent)

Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent)

Powder and solvent for solution for injection/infusion

Human coagulation factor VIII,

Human von Willebrand factor

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 further questions, ask your doctor, your nurse or your pharmacist.

This medicine has been prescribed for you. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Voncento is and what it is used for

2.What you need to know before you use Voncento

3.How to use Voncento

4.Possible side effects

5.How to store Voncento

6.Contents of the pack and other information

1. What Voncento is and what it is used for What is Voncento and what is it used for?

The product is made from human plasma (the liquid part of the blood) and contains the active substances called human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF).

Voncento is used to prevent or to halt bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in haemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective alone or cannot be given.

VWF and FVIII are involved in blood clotting. Lack of either factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed. The replacement of VWF and FVIII by Voncento will temporarily repair the blood clotting mechanisms.

As Voncento contains both FVIII and VWF, it is important to know which factor you most need. If you have haemophilia A your doctor will prescribe you Voncento with the number of units of FVIII specified. If you have VWD your doctor will prescribe you Voncento with the number of units of VWF specified.

2. What you need to know before you use 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

Talk to your doctor, nurse or pharmacist before taking Voncento.

Allergic (hypersensitivity) reactions are possible. If symptoms of hypersensitivity occur, you should stop using the medicine immediately and contact your doctor. Your doctor should inform you of the early signs of hypersensitivity reactions. These include hives, generalised skin rash, tightness of the chest, wheezing, fall in blood pressure and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, or dizziness).

The formation of inhibitors (antibodies) is a known complication that can occur during treatment, which stops the treatment working properly. If your bleeding is not being controlled with Voncento, tell your doctor immediately. You should be monitored carefully for the development of inhibitors.

If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.

If for the administration of Voncento you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.

von Willebrand disease

If you have a known risk of developing blood clots, you must be monitored for early signs of thrombosis (blood clotting). Your doctor should give you treatment to prevent thrombosis.

Virus safety

When medicines are made from human blood or plasma, certain measures are put in place by the manufacturer 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,

the testing of each donation and pools of plasma for signs of virus/infections,

inclusion of 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 so-called “enveloped” viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (which cause inflammation of the liver), and for the “non-enveloped” hepatitis A virus (which also causes inflammation of the liver).

The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.

Parvovirus B19 infection may be serious

for pregnant women (as there is a risk of infection of the unborn child) and

for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).

Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.

It is strongly recommended that every time Voncento is given, you record the date of administration, the batch number and the injected volume in your treatment diary.

Children and adolescents

The listed warnings and precautions apply to adults, children and adolescents.

Other medicines and Voncento

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

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 taking this medicine.

During pregnancy and breast-feeding, Voncento should be given only if it is clearly needed.

Driving and using machines

Voncento does not affect your ability to drive and use machines.

Voncento contains sodium

The presentations 250 IU FVIII /600 IU VWF (5 ml solvent) and 500 IU FVIII /1200 IU VWF (5 ml solvent) contain up to 14.75 mg (0.64 mmol) sodium per vial.

The presentations 500 IU FVIII /1200 IU VWF (10 ml solvent) and 1000 IU FVIII /2400 IU VWF (10 ml solvent) contain up to 29.50 mg (1.28 mmol) sodium per vial.

Please take this into account if you are on a controlled sodium diet.

3.How to use Voncento

Your treatment should be monitored by a doctor who is experienced in the treatment of blood clotting disorders.

If your doctor thinks you could administer Voncento yourself, appropriate instructions will be provided to you by your doctor. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Dose

The amount of VWF and FVIII you need to take and the duration of treatment depend on:

the severity of your disease

the site and intensity of the bleeding

your clinical condition

your body weight

(see also section “The following information is intended for healthcare professionals only”).

If you have been prescribed Voncento to use at home, your doctor will make sure that you are shown how to inject it and how much to use.

Follow the directions given to you by your doctor.

Use in children and adolescents

Dosing in 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, higher doses may be needed.

If you use more Voncento than you should

Five cases of overdose have been reported from clinical trials. No side effects have been associated with these reports. The risk of developing blood clots (thrombosis) cannot be excluded in case of an extremely high dose, especially in patients with VWD.

If you forget to use Voncento

Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.

Do not take a double dose to make up for a forgotten dose.

If you stop using Voncento

Do not stop using Voncento without consulting your doctor.

Reconstitution and application

General Instructions

The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.

Voncento must not be mixed with other medicines, diluents or solvents except those mentioned in section 6.

The solution should be clear or slightly opalescent, i.e. it might be sparkling when held up to the light but must not contain any obvious particles. After filtering or withdrawal (see below) the solution should be checked by eye, before it is used. Do not use the solution if it is visibly cloudy or if it contains flakes or particles.

Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.

Reconstitution

Without opening the vials, warm the Voncento powder and the liquid to room or body temperature. This can be done either by leaving the vials 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 protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab. Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.

1. Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package!

2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.

3. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.

4. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.

5. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces to avoid excessive build-up of foam when dissolving the product. Discard the solvent vial with the blue Mix2Vial adapter attached.

6.Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise. Inject air into the product vial.

Withdrawal and Application

8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.

Use the venipuncture kit supplied with the product, insert the needle into a vein. Let blood flow back to the end of the tube. Attach the syringe to the threaded, locking end of the venipuncture kit. The use of plastic disposable syringes is recommended as the ground glass surfaces of all-glass syringes tend to stick with solutions of this type. Inject/infuse the reconstituted solution slowly (at a rate not more than 6 ml per minute) into the vein following the instructions given to you by your doctor. Take care not to get any blood in the syringe containing the product.

In case large volumes of Voncento are required, it is possible to pool several vials of Voncento together, via a commercially available infusion set (e.g. a syringe pump for giving medicines into a vein). However, in these cases the initially reconstituted solution of Voncento should not be diluted any further.

Check yourself for any side effects that might happen straight away. If you have any side effects that might be related to the administration of Voncento, the injection or infusion should be stopped (see also section 2).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Voncento can cause side effects, although not everybody gets them.

Please contact your doctor immediately in case of emergency:

if you notice symptoms of allergic reactions (see below)

if you notice that the medicine stops working properly

if you notice any symptoms of an impaired perfusion in your extremities (e.g. cold and pale extremities) or vital organs (e.g. severe chest pain)

The following side effect has been observed very commonly (may affect more than 1 in 10 people):

Headache

The following side effects have been observed commonly (may affect up to 1 in 10 people):

FVIII inhibition: the medicine stops working properly (continuous bleeding). You may develop an inhibitor (neutralising antibody) to FVIII, in which case FVIII will not work properly any more. If this happens, you should stop using the medicine immediately and contact your doctor.

Allergic reactions have been observed and may in some cases progress to a serious allergic reaction (anaphylaxis) that causes severe difficulty in breathing, dizziness or shock. Allergic reactions may include the following symptoms:

Swollen face, tongue, mouth or throat, difficulty in breathing and swallowing, hives, wheezing, burning and stinging where the infusion was given, chills, flushing, skin rash over the whole body, headache, fall in blood pressure, restlessness, faster heart beat, tightness of the chest (including chest pain and chest discomfort), back pain, tiredness (lethargy), nausea, vomiting, tingling. If this happens, you should stop using the medicine immediately and contact your doctor.

Increase in body temperature

The following side effects have been observed uncommonly (may affect up to 1 in 100 people):

Taste alteration (dysgeusia)

There is a risk of formation of blood clots (thrombosis), particularly in patients with known risk factors (see also section 2).

Abnormal liver function test

The following side effect may occur but it is not known how many people may be affected:

VWF inhibition: the medicine stops working properly (continuous bleeding). You may develop an inhibitor (neutralising antibody) to VWF, in which case VWF will not work properly any more. If this happens, you should stop using the medicine immediately and contact your doctor.

Side effects in children and adolescents

Side effects in children are expected to be the same as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

5.How to store Voncento

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 and carton.

Do not store above 25 °C.

Do not freeze.

The reconstituted product should preferably be used immediately.

If the reconstituted product is not administered immediately, storage times and conditions prior to use are the responsibility of the the user and should not exceed 24 hours at 2 to 8 °C.

Keep the vial in the outer carton in order to protect from light.

6.Contents of the pack and other information

What Voncento contains

The active substance is:

250 IU FVIII and 600 IU VWF per vial; after reconstitution with 5 ml of water for injection approx. 50 IU/ml FVIII and 120 IU/ml VWF.

500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 10 ml of water for injection approx. 50 IU/ml FVIII and 120 IU/ml VWF.

500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml of water for injection approx. 100 IU/ml FVIII and 240 IU/ml VWF.

1000 IU FVIII and 2400 IU VWF per vial; after reconstitution with 10 ml of water for injection approx. 100 IU/ml FVIII and 240 IU/ml VWF.

See section “The following information is intended for healthcare professionals only” for further information.

The other ingredients are:

Calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol. See last paragraph of section 2.

Solvent: Water for injections

What Voncento looks like and contents of the pack

Voncento is presented as a white powder and is supplied with water for injection as solvent.

The reconstituted solution should be clear to slightly opalescent, i.e. it might sparkle when held up to the light but must not contain any obvious particles.

Presentations

One pack with 250 IU/600 IU or 500 IU/1200 IU containing:

-1 vial with powder

-1 vial with 5 ml water for injections

-1 filter transfer device 20/20

One inner box containing: 1 disposable 10 ml syringe 1 venipuncture set

2 alcohol swabs

1 non-sterile plaster

One pack with 500 IU/1200 IU or 1000 IU/2400 IU containing:

-1 vial with powder

-1 vial with 10 ml water for injections

-1 filter transfer device 20/20

One inner box containing: 1 disposable 10 ml syringe 1 venipuncture set

2 alcohol swabs

1 non-sterile plaster

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Straße 76

35041 Marburg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

CSL Behring NV

CSL Behring GmbH

Tél/Tel: +32 15 28 89 20

Tel: +49 69 30584437

България

Luxembourg/Luxemburg

Новимед EООД

CSL Behring NV

Тел: +359 2 850 8617

Tél/Tel: +32 15 28 89 20

Česká republika

Magyarország

CSL Behring s.r.o.

CSL Behring Kft.

Tel: + 420 702 137 233

Tel.: +36 1 213 4290

Danmark

Malta

CSL Behring AB

AM Mangion Ltd.

Tel: +46 8 544 966 70

Tel: +356 2397 6333

Deutschland

Nederland

CSL Behring GmbH

CSL Behring BV

Tel: +49 69 30584437

Tel: + 31 85 111 96 00

Eesti

Norge

CSL Behring GmbH

CSL Behring AB

Tel: +49 69 30584437

Tlf: +46 8 544 966 70

Ελλάδα

Österreich

CSL Behring ΕΠΕ

CSL Behring GmbH

Τηλ: +30 210 7255 660

Tel: +43 1 80101 2463

España

Polska

CSL Behring S.A.

CSL Behring sp. z o.o.

Tel: +34 933 67 1870

Tel: +48 22 213 22 65

France

Portugal

CSL Behring S.A.

CSL Behring Lda

Tél: + 33 –(0)-1 53 58 54 00

Tel: +351 21 782 62 30

Hrvatska

România

PharmaSwiss d.o.o.

Prisum International Trading srl

Tel: +385 (1) 631-1833

Tel: +40 21 322 0171

Ireland

Slovenija

CSL Behring UK Ltd.

MediSanus d.o.o.

Tel: +44 1444 447405

Tel: +386 1 25 71 496

Ísland

Slovenská republika

CSL Behring AB

CSL Behring s.r.o.

Sími: +46 8 544 966 70

Tel: +421 911 653 862

Italia

Suomi/Finland

CSL Behring S.p.A.

CSL Behring AB

Tel: +39 02 34964 200

Puh/Tel: +46 8 544 966 70

Κύπρος

Sverige

CSL Behring ΕΠΕ

CSL Behring AB

Τηλ: +30 210 7255 660

Tel: +46 8 544 966 70

Latvija

United Kingdom

CSL Behring GmbH

CSL Behring UK Ltd.

Tel: +49 69 30584437

Tel: +44 1444 447405

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

----------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Posology

von Willebrand disease

It is important to calculate the dose using the number of IU of VWF:RCo specified. Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %).

Levels of VWF:RCo of > 0.6 IU/ml (60 %) and of FVIII:C of > 0.4 IU/ml (40 %) should be achieved.

On-demand treatment

Usually 40 - 80 IU/kg of VWF (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.

An initial dose of 80 IU/kg VWF:RCo may be required, especially in patients with type 3 VWD where maintenance of adequate levels may require greater doses than in other types of VWD.

Prevention of haemorrhage in case of surgery:

For prevention of excessive bleeding during or after surgery the application should start 1 - 2 hours before the surgical procedure.

An appropriate dose should be re-administered every 12 - 24 hours. The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of the bleeding, and both VWF:RCo and FVIII:C levels.

When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. After 24 - 48 hours of treatment, in order to avoid an excessive rise in FVIII:C, reduced doses and/or prolongation of the dose interval or the use of a VWF product containing a low level of FVIII should be considered.

Prophylaxis treatment

For long term prophylaxis in patients with VWD, a dose of 25 - 40 IU VWF:RCo /kg body weight should be considered at a frequency of 1 to 3 times per week. In patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary. The dose and duration of treatment will depend on the clinical status of the patient, as well as their VWF:RCo and FVIII:C plasma levels.

Paediatric VWD population

Treatment of bleeding

Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended in paediatric patients to treat a bleed.

Prophylaxis treatment

Patients aged 12 to 18 years old: Dosing is based on the same guidelines as for adults.

Patients aged <12 years old: Based on results from a clinical trial in which paediatric patients under 12 years of age were shown to have lower exposure of VWF, a prophylactic dose range of 40 – 80 IU VWF:RCo/kg body weight 1 to 3 times a week should be considered.

The dose and duration of treatment will depend on the clinical status of the patient, as well as their VWF:RCo and FVIII:C plasma levels.

Haemophilia A

It is important to calculate the dose using the number of IU of FVIII:C specified.

The dose and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and on the patient’s clinical condition.

The number of units of FVIII administered is expressed in International Units (IU), which is related to the current WHO standard for FVIII products. FVIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for FVIII in plasma).

1 IU of FVIII activity is equivalent to that quantity of FVIII in 1 ml of normal human plasma.

On demand treatment

The calculation of the required dose of FVIII is based on the empirical finding that 1 IU FVIII per kg body weight raises the plasma FVIII activity by about 2 % of normal activity (in vivo recovery 2 IU/dl). The required dose is determined using the following formula:

Required units = body weight [kg] x desired FVIII rise [% or IU/dl] x 0.5.

The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, the FVIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) within the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery:

Degree of haemorrhage / Type

Factor VIII level required

Frequency of doses (hours) /

of surgical procedure

(% or IU/dl)

Duration of therapy (days)

Haemorrhage

 

 

Early haemarthrosis, muscle

20 - 40

Repeat infusion every 12 to 24

bleeding or oral bleeding

 

hours for at least 1 day, until the

 

 

bleeding episode as indicated by

 

 

pain is resolved or healing is

 

 

achieved.

More extensive haemarthrosis,

30 - 60

Repeat infusion every 12-24

muscle bleeding or haematoma

 

hours for 3 - 4 days or more

 

 

until pain and acute disability

 

 

are resolved.

Life-threatening haemorrhages:

60 - 100

Repeat infusion every 8 to 24

 

 

hours until threat is resolved.

Surgery

 

 

Minor

30 - 60

Repeat infusion every 24 hours

including tooth extraction

 

for at least 1 day, until healing is

 

 

achieved.

Major

80 - 100

Repeat infusion every 8-24

 

(pre- and

hours until adequate wound

 

postoperative)

healing, then continue therapy

 

 

for at least another 7 days to

 

 

maintain a factor VIII activity of

 

 

30% - 60% (IU/dl).

Treatment monitoring

During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight may require adjustment in underweight or overweight patients. In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable..

Prophylaxis treatment

For long term prophylaxis in patients with severe haemophilia A, the usual dose is 20 to 40 IU of FVIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.

Previously untreated patients

The safety and efficacy of Voncento in previously untreated patients have not yet been established. No data are available.

Paediatric haemophilia A population

Dosing in in haemophilia A in children and adolescents aged ˂ 18 years is based on body weight and is therefore generally based on the same guidelines as for adults. In some cases shorter dose intervals or higher doses may be necessary. The frequency of administration should always be oriented to the clinical effectiveness in the individual case.

Older people

No dose adjustment is necessary for the older people.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed