Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kovaltry

Document Subject

Generated Narrative: MedicinalProductDefinition mp8467bc8586a2da87e0b1d648339b10b3

identifier: http://ema.europa.eu/identifier/EU/1/15/1076/002 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL))

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kovaltry 250 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-8467bc8586a2da87e0b1d648339b10b3

identifier: http://ema.europa.eu/identifier/EU/1/15/1076/002 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL))

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - kovaltry

Attesters

What is in this leaflet

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

Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa. Kovaltry is prepared by recombinant technology without addition of any human- or animal derived components in the manufacturing process. Factor VIII is a protein naturally found in the blood that helps to clot it.

Kovaltry is used to treat and prevent bleeding in adults, adolescents and children of all ages with haemophilia A (hereditary factor VIII deficiency).

Do not use Kovaltry if you are

• allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6).
• allergic to mouse or hamster proteins.

Warnings and precautions
Talk to your doctor or pharmacist if you have:

• tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy nettle-rash, wheezing, feeling sick or faint. These may be signs of a rare severe sudden allergic reaction to Kovaltry. Stop administering the product immediately and seek medical advice if this occurs.
• bleeding that is not being controlled with your usual dose of Kovaltry. 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, patients receiving Kovaltry will be monitored carefully for the development of these inhibitors. If your or your child s bleeding is not being controlled with Kovaltry, tell your doctor immediately.
• previously developed factor VIII inhibitors to a different product. If you switch factor VIII products, you may be at risk of your inhibitor coming back.
• a confirmed heart disease or are at risk of heart disease.
• to use a central venous access device for the administration of Kovaltry. You may be at risk of device related complications where the catheter is inserted including:

• local infections
• bacteria in the blood
• a blood clot in the blood vessel.

Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.

Other medicines and Kovaltry Tell your doctor or pharmacist 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.

Kovaltry is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.

Driving and using machines If you experience dizziness or any other symptoms affecting your ability to concentrate and react, do not drive or use machines until the reaction subsides.

Kovaltry contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The number of factor VIII units is expressed in International Units (IU).

Treatment of bleeding To treat a bleed, your doctor will calculate and adjust your dose and how often it should be given, depending on factors such as:

• your weight
• the severity of your haemophilia A
• where the bleed is and how serious it is
• whether you have inhibitors and how high their level is
• the factor VIII level that is needed.

Prevention of bleeding If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose for you. This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, injected two or three times per week. However, in some cases, especially for younger patients, shorter dose intervals or higher doses may be necessary.

Laboratory tests Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels. For major surgery in particular, your blood clotting must be closely monitored.

Use in children and adolescents Kovaltry can be used in children of all ages. In children below the age of 12 higher doses or more frequent injections than prescribed for adults may be needed.

Patients with inhibitors If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger dose of Kovaltry to control bleeding. If this dose does not control your bleeding your doctor may consider giving you another product. Speak to your doctor if you would like further information on this. Do not increase the dose of Kovaltry to control your bleeding without checking with your doctor.

Duration of treatment Usually, Kovaltry treatment for haemophilia is needed life-long.

How Kovaltry is given Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.

How Kovaltry is prepared for administration Use only the components (vial adapter, pre filled syringe containing solvent and venipuncture set) provided with each package of this medicine. Please contact your doctor if these components cannot be used. Do not use if any component of the package is opened or damaged.

The reconstituted product must be filtered by using the vial adapter before administration to remove any possible particles in the solution.

Do not use the venipuncture set provided for drawing blood because it contains an in-line filter.

This medicine must not be mixed with other infusion solutions. Do not use solutions containing visible particles or that are cloudy. Follow the instructions for use given by your doctor and provided at the end of this leaflet.

If you use more Kovaltry than you should Tell your doctor if this occurs. No cases of overdose have been reported.

If you forget to use Kovaltry Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Do not use a double dose to make up for a forgotten dose.

If you stop using Kovaltry Do not stop using this medicine without checking with 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.

The most serious side effects are allergic reactions which may be severe allergic reaction. Stop injecting Kovaltry immediately and speak to your doctor at once if such reactions occur. The following symptoms could be an early warning of these reactions:

• chest tightness/general feeling of being unwell
• dizziness
• feeling faint upon standing indicating a reduction in blood pressure
• feeling sick (nausea)

For children not previously treated with factor VIII medicines, inhibitors (see section 2) may form very commonly (more than 1 in 10 patients). 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, please contact your doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 users):

• stomach pain or discomfort
• indigestion
• fever
• local reactions where you injected the medicine (e.g. bleeding under the skin, intense itching, swelling, burning sensation, temporary redness)
• headache
• trouble sleeping
• hives
• rash/itchy rash

Uncommon (may affect up to 1 in 100 users):

• lymph nodes enlarged (swelling under the skin of the neck, armpit or groin)
• heart palpitations (feeling your heart beating hard, rapidly, or irregularly)
• rapid heartbeat
• dysgeusia (strange taste)
• flushing (redness of the face)

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 labels and cartons. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze. Store this medicine in the original package in order to protect from light.

This medicine may be stored at room temperature (up to 25 C) for up to 12 months when you keep it in its outer carton. If you store it at room temperature it expires after 12 months or at the expiry date if this is earlier. The new expiry date must be noted on the outer carton when the medicine is removed from the refrigerator.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 3 hours. This product is for single use only. Any unused solution must be discarded.

Do not use this medicine if you notice any particles in the solution or if the solution is cloudy.

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 Kovaltry contains

The active substance is octocog alfa (human coagulation factor VIII). Each vial of Kovaltry contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa. The other ingredients are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections.

What Kovaltry looks like and contents of the pack

Kovaltry is provided as a powder and solvent for solution for injection. The powder is dry and white to slightly yellow . The solvent is a clear liquid.

Each single pack of Kovaltry contains

• a glass vial with powder
• a pre filled syringe with solvent
• a separate plunger rod
• a vial adapter
• a venipuncture set (for injection into a vein).

Kovaltry is available in pack sizes of:

1 single pack

1 multipack with 30 single packs Not all pack sizes may be marketed.

Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany

Manufacturer Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany

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

Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-535 63 Lietuva UAB Bayer Tel. +37 05 23 36

T .: +359-(0)2-424 72 Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel:+36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-(0)297-28 06 Eesti Bayer O
Tel: +372 655 8Norge Bayer AS Tlf: +47 23 13 05
Bayer
: +30-210-61 87 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer SRL Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785
NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3This leaflet was last revised in

Detailed information on this medicine is available on the website of the European Medicines Agency