Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - veyvondi

Document Subject

Generated Narrative: MedicinalProductDefinition mpa911acdcc16d3ea6bdce7272ad3df51a

identifier: http://ema.europa.eu/identifier/EU/1/18/1298/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VEYVONDI 650 IU powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a911acdcc16d3ea6bdce7272ad3df51a

identifier: http://ema.europa.eu/identifier/EU/1/18/1298/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - veyvondi

Attesters

What is in this leaflet

1. What VEYVONDI is and what it is used for
2. What you need to know before you use VEYVONDI
3. How to use VEYVONDI
4. Possible side effects
5. How to store VEYVONDI
6. Contents of the pack and other information

VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF). It behaves in the same way as natural human von Willebrand factor (VWF) in the body. VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot. Lack of VWF increases the tendency to bleed.

VEYVONDI is used to prevent and treat bleeding episodes, including bleeding during surgery, in adult patients (aged 18 years and older) with von Willebrand disease. It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.

Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor. In patients with the disease the blood does not clot normally leading to a prolonged bleeding time. Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.

Do not use VEYVONDI

• if you are allergic to vonicog alfa or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to mouse or hamster proteins

If you are unsure about this, ask your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using VEYVONDI.

There is a risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI. Your doctor should inform you about early signs of severe allergic reactions such as increased heart rate, rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, fast heartbeat, stuffy nose, red eyes,general feeling of being unwell, and dizziness. These could be early symptoms of a hypersensitivity reaction. If any of these symptoms occur, stop the infusion immediately and contact your doctor. Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.

Patients developing inhibitors Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly. You will be monitored carefully for the possibility of having developed these inhibitors.

• If your bleeding is not controlled with VEYVONDI, tell your doctor immediately.

If your plasma VWF or factor VIII fail to reach the expected levels with VEYVONDI based on the test results followed by your doctor, or if bleeding is not adequately controlled, it could be due to the presence of VWF or factor VIII antibodies. This will be checked by your doctor. You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings. Do not increase the total dose of VEYVONDI to control your bleeding without consulting your doctor.

If you have previously been treated with plasma-derived VWF concentrates you may have reduced response to VEYVONDI due to pre-existing antibodies. Your doctor may adjust the dose according to your laboratory results.

Thrombolism and embolism There is a risk of occurrence of thrombotic events if you have known clinical or laboratory risk factors. Therefore your doctor will monitor you for early signs of thrombosis.

FVIII products may contain varying amounts of VWF. Therefore, any FVIII product that would be administered in combination with VEYVONDI should be a pure FVIII product.

If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately.

Children and adolescents VEYVONDI is not approved for use in children or adolescents below 18 years.

Other medicines and VEYVONDI Tell your doctor, pharmacist or nurse if you are using, have recently used or might use 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, pharmacist or nurse for advice before taking this medicine.

Driving and using machines VEYVONDI is not likely to affect your ability to drive and use machines.

VEYVONDI contains sodium This medicine contains 5.2 mg sodium (main component of cooking/table salt) in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial.

This is equivalent to 2.2% of the recommended maximum daily dietary intake of sodium for an adult, assuming 70 kg body weight and 80 IU/kg body weight.

This should be taken into consideration if you are on a controlled sodium diet.

Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.

Your doctor will calculate your dose of VEYVONDI (in international units or IU). The dose depends on:

• body weight,
• the site of the bleeding
• intensity of the bleeding,
• your clinical condition,
• the required surgery
• the VWF activity levels in your blood after surgery
• the severity of your disease

Your doctor may test your blood to make sure that you have adequate levels of von Willebrand factor. This is particularly important if you are having major surgery.

Treatment of bleeding episodes

Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.

For minor bleeding (e.g. nose bleed, oral bleeding, menorrhagia), each initial dose is usually 40 to 50 IU/kg and for major bleeding (severe or refractory nose bleed, menorrhagia, gastrointestinal bleeding, Central nervous system trauma, haemarthrosis, or traumatic haemorrhage), each initial dose is 50 to 80 IU/kg. Subsequent doses (as clinically required) are 40 to 50 IU/kg every 8 to 24 hours for minor bleeds as long as deemed clinically necessary and for major bleeds 40 to 60 IU/kg for approximately 2-3 days.

If you feel that VEYVONDI is not working well enough, talk to your doctor. Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor. If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.

Prevention of bleeding in case of elective surgery

For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery. If your FVIII level is inadequate your doctor may give you a dose of 40-60 IU/kg VEYVONDI 12-24 hours (pre-operative dose) prior to initiating elective surgery in order to raise FVIII levels to the target level (0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery). Within 1 hour prior to surgery, you will receive a dose of VEYVONDI based on the assessment 3 hours before surgery. The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.

Prophylaxis treatment

The usual starting dose for long term prophylaxis against bleeding episodes is 40 to 60 IU/kg twice weekly. The dose can be adjusted to a maximum of 80 IU/kg one to three times per week, depending on your condition and how well VEYVONDI is working for you. Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.

How VEYVONDI is given VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse. Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet.

Use in children and adolescents VEYVONDI is not approved for use in children and adolescents below 18 years.
If you use more VEYVONDI than you should Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If you infuse more VEYVONDI than recommended, tell your doctor as soon as possible. There may be a risk of developing blood clots (thrombosis) in case of an accidental high dose.

If you forget to use VEYVONDI

• Do not infuse a double dose to make up for a forgotten dose.
• Proceed with the next infusion as scheduled and continue as advised by your doctor.

If you stop using VEYVONDI Do not stop using VEYVONDI without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everybody gets them.

You can have a serious allergic reaction to VEYVONDI.

You must stop the infusion and contact your doctor immediately if you have any of the following early symptoms of severe allergic reactions:

• rash or hives, itching all over the body,
• tightness of the throat, chest pain or chest tightness,
• difficulty breathing, light headedness, fast heartbeat,
• dizziness, nausea or fainting.

The following side effects have been reported with VEYVONDI:

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• nausea
• vomiting
• tingling or burning at infusion site
• chest discomfort
• dizziness
• vertigo
• blood clots
• hot flushes
• itching
• high blood pressure
• muscle twitching
• unusual taste
• increased heart rate

Reporting of side effects 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.

• 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 carton and the vial label after EXP. The expiry date refers to the last day of that month.
• Store below 30 C.
• Do not freeze.
• Store in the original package in order to protect from light.
• Do not refrigerate the solution after preparation.
• Use the reconstituted product within 3 hours to avoid the risk of microbial contamination, because the product does not contain preservatives.
• This medicine is for single use only. Discard any unused solution appropriately.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What VEYVONDI contains
The active substance is vonicog alfa (recombinant human von Willebrand factor).

VEYVONDI 650 IU powder and solvent for solution for injection

Each vial of powder contains nominally 650 International Units (IU) vonicog alfa. After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.

VEYVONDI 1300 IU powder and solvent for solution for injection

Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa. After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.

The other ingredients are:

• Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80 and water for injections.
• See section 2 VEYVONDI contains sodium .

What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder. After reconstitution, when drawn into the syringe, the solution is clear, colourless in appearance and free from flakes or other foreign particles.

Each pack of VEYVONDI 650 IU contains:

• powder in a glass vial with a rubber stopper
• 5 mL of solvent in a glass vial with a rubber stopper
• one reconstitution device (Mix2Vial)

Each pack of VEYVONDI 1300 IU contains:

• powder in a glass vial with a rubber stopper
• 10 mL of solvent in a glass vial with a rubber stopper
• one reconstitution device (Mix2Vial)

Marketing Authorisation Holder
Baxalta Innovations GmbH Industriestrasse 1221 Vienna Austria

Manufacturer Takeda Manufacturing Austria AG Industriestrasse 1221 Vienna Austria

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

Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com

Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com

Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com

Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com

Malta akeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com

Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com

Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com

Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com

Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com

sterreich Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com

Espa a Takeda Farmac utica Espa a, S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com

Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com

France Takeda France SAS Portugal Takeda Farmac uticos Portugal, Lda. T l: + 33 1 40 67 33 medinfoEMEA@takeda.com

Tel: + 351 21 120 1medinfoEMEA@takeda.com

Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com

Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com

Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com

Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com

sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com

Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com

Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com

Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

akeda . . : +30 210 6387medinfoEMEA@takeda.com

Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com

Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com

This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site: