Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - adynovi

Document Subject

Generated Narrative: MedicinalProductDefinition mp02998b2db7fd4b184d980a78d8dee404

identifier: http://ema.europa.eu/identifier/EU/1/17/1247/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ADYNOVI 250 IU / 5 ml 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-02998b2db7fd4b184d980a78d8dee404

identifier: http://ema.europa.eu/identifier/EU/1/17/1247/003

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - adynovi

Attesters

What is in this leaflet

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

ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII. The human coagulation factor VIII has been modified to prolong its duration of action. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.

ADYNOVI is used for the treatment and prevention of bleeding in patients from 12 years of age with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).

Do not use ADYNOVI

• if you are allergic to rurioctocog alfa pegol, octocog 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

It is important to keep a record of the batch number of your ADYNOVI. So, every time you get a new package of ADYNOVI, note down the date and the batch number (which is on the packaging after {abbreviation used for batch number}) and keep this information in a safe place.

Talk to your doctor before using ADYNOVI.

There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADYNOVI. You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. These could be early symptoms of anaphylactic shock; additional symptoms may include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.

If any of these symptoms occur, stop the injection immediately and contact your doctor. Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.

If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.

Patients developing factor VIII inhibitors The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child s bleeding is not being controlled with ADYNOVI, tell your doctor immediately.

Catheter-related complications
If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.

Children and adolescents

ADYNOVI can be used only in adolescents and adults (12 years and above). The listed warnings and precautions also apply to adolescents.

Other medicines and ADYNOVI

Tell your doctor 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 for advice before using this medicine. Haemophilia A occurs only rarely in women. Therefore no experience regarding the use of ADYNOVI during pregnancy and breast-feeding is available.

Driving and using machines

ADYNOVI has no or negligible influence on the ability to drive or use machines.

ADYNOVI contains sodium

ADYNOVI contains up to 12.42 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.62% of the recommended maximum daily dietary intake of sodium for an adult. Depending on your body weight and your dose of ADYNOVI, you could receive multiple vials. This should be taken into consideration if you are on a low salt diet.

Treatment with ADYNOVI will be started and supervised by a doctor who is experienced in the care of patients with haemophilia A.

Your doctor will calculate your dose of ADYNOVI depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding. The frequency of administration will depend on how well ADYNOVI is working for you. Usually, the replacement therapy with ADYNOVI is a life-long treatment.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Prevention of bleeding The usual dose of ADYNOVI is 40 to 50 IU per kg body weight, administered 2 times per week.

Treatment of bleeding The dose of ADYNOVI is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding. If you think that the effect of ADYNOVI is insufficient, talk to your doctor. Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels. This is particularly important if you are having major surgery.

Use in children and adolescents

ADYNOVI can be used only in adolescents and adults (12 years and above). The dose in adolescents is also calculated to body weight and is the same dose as for adults.

How ADYNOVI is given

ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse. You or someone else might also administer ADYNOVI as an injection, but only after receiving adequate training. Detailed instructions for self-administration are given at the end of this package leaflet.

If you use more ADYNOVI than you should

Always use ADYNOVI exactly as your doctor has told you. You should check with your doctor if you are not sure. If you inject more ADYNOVI than recommended, tell your doctor as soon as possible.

If you forget to use ADYNOVI

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

If you stop using ADYNOVI

Do not stop using ADYNOVI without consulting your doctor.

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

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

If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:

• rash, hives, wheals, generalised itching,
• swelling of lips and tongue,
• difficulty in breathing, wheezing, tightness in the chest,
• general feeling of being unwell,
• dizziness and loss of consciousness.

Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.

For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients). If this happens your medicine may stop working properly and you may experience persistent bleeding. If this happens, you should contact your doctor immediately.

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

Common side effects (may affect up to 1 in 10 people) Nausea Diarrhoea Rash Dizziness Hives

Uncommon side effects (may affect up to 1 in 100 people) Flushing, allergic reaction (hypersensitivity) Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment)) Increase in some type of white blood cells Infusion reaction Redness of the eye Adverse drug reaction of the skin

Side effects with unknown frequency (frequency cannot be estimated from the available data) Potentially life-threatening reactions (anaphylaxis)

Additional side effects in children

Frequency, type and severity of adverse reactions 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. 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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

During the shelf life the powder vial may be kept at room temperature (up to 30 C) for a single period not exceeding 3 months. In this case, this medicine expires at the end of this 3-month period or the expiry date printed on the product vial, whichever is earlier. Please record the end of the 3-month storage at room temperature on the outer carton. The product may not be returned to refrigerated storage after storage at room temperature. Do not refrigerate the solution after preparation.

Use the product within 3 hours once the powder is completely dissolved.

The product is for single use only. Discard any unused solution appropriately.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ADYNOVI contains

• The active substance is rurioctocog alfa pegol (pegylated human coagulation factor VIII produced by recombinant DNA technology). Each powder vial contains nominally 250, 500, 1 000, 2 000 or 3 000 IU rurioctocog alfa pegol.
• The solvent vial contains 5 ml of water for injections.
• The other ingredients are mannitol, trehalose dihydrate, histidine, glutathione, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane and polysorbate 80. See section 2 ADYNOVI contains sodium .

What ADYNOVI looks like and contents of the pack

ADYNOVI is provided as a powder and solvent for solution for injection (powder for solution for injection). The powder is a white to off-white crumbly powder. The solvent is a clear, colourless solution. After reconstitution, the solution is clear, colourless and free from foreign particles.

Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).

Marketing Authorisation Holder

Baxalta Innovations GmbH Industriestrasse A-1221 Vienna

Manufacturer

Baxalta Belgium Manufacturing SA Boulevard Ren Branquart B-7860 Lessines Belgium

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 T l: + 33 1 40 67 33 medinfoEMEA@takeda.com

Portugal Takeda Farmac uticos Portugal, Lda. 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

Proton Medical (Cyprus) Ltd : +357 22866admin@protoncy.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: