Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cevenfacta

Document Subject

Generated Narrative: MedicinalProductDefinition mpc4dcd27eb46fddef4eed0adfcbbf3b5e

identifier: http://ema.europa.eu/identifier/EU/1/22/1664/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CEVENFACTA 1 mg (45 KIU) 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c4dcd27eb46fddef4eed0adfcbbf3b5e

identifier: http://ema.europa.eu/identifier/EU/1/22/1664/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cevenfacta

Attesters

7. CEVENFACTA Instructions For Use

What is in this leaflet

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

CEVENFACTA contains the active substance eptacog beta (activated), a recombinant human coagulation Factor VIIa (rhFVIIa).

CEVENFACTA is used in adults and adolescents (12 years of age or older) who were born with haemophilia A or B and who have developed inhibitors (antibodies). It is used for:

• the treatment of bleeding episodes,

the management of bleeding during surgery.

How CEVENFACTA works This medicine works by making the blood clot at the site of bleeding, when the body s own clotting factors are not working.

Do not use CEVENFACTA

• if you are allergic to eptacog beta (activated), or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to rabbits or rabbit proteins.

Warnings and precautions
Before treatment with CEVENFACTA, tell your doctor:

• If you have a history of atherosclerosis (when your arteries are narrowed by disease), coronary artery disease (heart disease due to narrowing of the blood vessels supplying the heart), cerebrovascular disease (disease of the blood vessels supplying the brain), a crush injury, septicaemia (serious blood infection) or blood clots;
• If you have heart disease, heart failure, abnormal heart rhythms;
• If you had prior pulmonary (lungs) clots or heart surgery;
• If you have or have had any other medical condition.

Patients with known allergy to casein may be at a higher risk of hypersensitivity reactions. Should signs or symptoms of hypersensitivity occur, treatment should be discontinued and you should seek immediate medical attention. Symptoms may include hives (itchy swellings under the skin), itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, and low blood pressure.

Although the following conditions have not been observed, they may occur with CEVENFACTA:

• Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke), or in the lungs or deep veins. Symptoms may include swelling and pain in the arms, legs or abdomen, chest pain, shortness of breath, loss of feeling or movement, and altered consciousness or speech.
• Hypersensitivity or anaphylactic reactions. Symptoms may include hives (itchy swellings under the skin), itching, rash, difficulty breathing, swelling around the mouth and throat, tightness of the chest, wheezing, dizziness or fainting, and low blood pressure.
• Inhibitors (antibodies) which may cause bleeding problems.

If any of these conditions apply to you, talk to your doctor before using CEVENFACTA.

It is important to keep a record of the batch number of your CEVENFACTA. So, every time you get a new package of CEVENFACTA, note down the date and the batch number (which is on the packaging after Lot) and keep this information in a safe place. Adolescents
The listed warnings and precautions apply both to adults and adolescents (12 years of age and older).

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

You should talk to your doctor before using CEVENFACTA if

• you are taking or have recently taken another activated Factor VII, or activated or non-activated prothrombin complex concentrates,
• you are taking or have recently taken Factor XIII,
  since the combination of these medicines with CEVENFACTA may increase the risk of thromboembolic events (formation of blood clots in the veins).

You should talk to your doctor before using CEVENFACTA with these medicines.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines Dizziness might occur following administration of CEVENFACTA. You must avoid driving or using machines while experiencing this symptom.

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

Treatment with this medicine should be initiated and supervised by a physician experienced in the treatment of haemophilia and/or bleeding disorders. CEVENFACTA comes as a powder that must be made up (reconstituted) with its solvent and injected into a vein (intravenous injection). See instructions for use guide at the end of this leaflet (section 7).

When to treat yourself Injecting medicines requires special training. Do not attempt to self-inject unless you have been taught how to by your healthcare provider or haemophilia treatment centre.

Many people with inhibitors learn to self-inject or inject with the help of a family member: once trained, you will need additional injection equipment along with your CEVENFACTA kit so that you can successfully treat your bleeding episodes at home. Be sure to collect all necessary injection equipment before preparing the medicine for injection. This additional injection equipment will be provided by your healthcare professional (e.g., your pharmacist or haemophilia treatment centre).

CEVENFACTA may be injected at a haemophilia treatment centre, at your healthcare provider s office, or at home. Treating at the first sign of a bleed is important for bleed management.

Start treatment of a bleed as early as possible, ideally within 2 hours.
In cases of a mild or moderate bleed (e.g., joint, superficial muscle, soft tissue, and mucous membranes), you should treat yourself as early as possible, ideally at home.
In case of a severe bleed (e.g., life or limb [arm or leg] threatening haemorrhage, intracranial [within the skull] or gastrointestinal [in the stomach or gut] haemorrhage) you should contact your doctor.

Usually, severe bleeds are treated at the hospital and a dose of CEVENFACTA can be given on the way there.

Do not treat yourself for longer than 24 hours without consulting your doctor.
Each time you use this medicine tell your healthcare provider as soon as possible.
If bleeding is not controlled within 24 hours, contact your healthcare provider or emergency services immediately. You will usually need hospital care.

For instructions on reconstitution of the medicinal product before administration, follow the Instructions For Use guide at the end of this leaflet (section 7).
Inject the solution into your vein over 2 minutes or less.

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

Dose Your healthcare provider will tell you how much CEVENFACTA to use, and when to use this medicine based on your weight, condition and type of bleed.

Treatment of bleeding episodes Treatment with this medicine should be started as soon as a bleeding event occurs.

Mild and moderate bleeding

For mild to moderate bleeding episodes, treatment at home should not last longer than 24 hours. Continuing home treatment after 24 hours can only be considered after consultation with the haemophilia treatment centre.

Severe bleeding

You should seek immediate medical care if signs or symptoms of severe bleeding occur at home.
An initial dose can be administered on your way to the haemophilia treatment centre or your healthcare provider s office to avoid any treatment delay.

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

Method of administration For instructions on reconstitution of the medicinal product before administration and instructions on administration, follow the Instructions For Use guide at the end of this leaflet (section 7).

If you use more CEVENFACTA than you should If you use too much CEVENFACTA, get medical advice at once.

If you forget to use CEVENFACTA,
If you forget to use CEVENFACTA, talk to 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.

Common side effects
(may affect up to 1 in 10 people)

• Dizziness
• Headache
• Injection site discomfort
• Injection site bruising (haematoma)
• Body temperature increased
• Post procedural haematoma
• Injection related reaction

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 the carton after EXP. The expiry date refers to the last day of that month.

Store below 30 C. Do not freeze.

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

To reconstitute CEVENFACTA only use the material provided in the kit.

After reconstitution, the product must be stored in the vial and given within 4 hours. Any unused solution should be thrown away 4 hours after reconstitution. Do not use this medicine if you notice the liquid has particles or is cloudy after mixing.

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 CEVENFACTA contains

• The active substance is recombinant coagulation factor VIIa (eptacog beta (activated))
• The other excipients are: Powder: arginine hydrochloride, isoleucine, trisodium citrate dihydrate, glycine, lysine hydrochloride, polysorbate 80, hydrochloric acid (for pH adjustment). Solvent: water for injections.
  See section 2 CEVENFACTA contains sodium .

The powder for solution for injection contains: 1 mg/vial (corresponding to 45 KIU/vial), 2 mg/vial (corresponding to 90 KIU/vial), 5 mg/vial (corresponding to 225 KIU/vial). After reconstitution the solution concentration is approximately 1 mg/ mL (45 KIU/ mL) eptacog beta (activated). 1 KIU equals 1 000 IU (International Units).

What CEVENFACTA looks like and contents of the pack The powder vial contains a white to off-white lyophilised powder and the prefilled syringe of solvent contains clear and colourless solution. The reconstituted solution should be clear to slightly opaque.

Each CEVENFACTA pack contains:

• 1 glass vial with powder for solution for injection,
• 1 sterile vial adapter for reconstitution equipped with a 5 m filter,
• 1 prefilled syringe of water for injections,
• 1 plunger rod and backstop.

Pack sizes: 1 mg (45 KIU), 2 mg (90 KIU), and 5 mg (225 KIU).

Marketing Authorisation Holder
Laboratoire fran ais du Fractionnement et des Biotechnologies Tour W 102 Terrasse Boieldieu 19 me tage 92800 Puteaux
France

Manufacturer LFB Biotechnologies Zone d activit de Courtab uf 3 Avenue des Tropiques 91940 Les Ulis France +33 1 69 82 70 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in

Other sources of information

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