CEVENFACTA 1 мг Порошок и раствор для инъекционного раствора

Содержание инструкции

1. CEVENFACTA 1 mg (45 KUI) powder and solvent for injectable solution, 2 mg (90 KUI) powder and solvent for injectable solution, 5 mg (225 KUI) powder and solvent for injectable solution
   1. What is CEVENFACTA and what is it used for
   2. What you need to know before using CEVENFACTA
   3. How to use CEVENFACTA
   4. Possible side effects
   5. How to store CEVENFACTA
   6. Contents of the pack and other information

CEVENFACTA 1 mg (45 KUI) powder and solvent for injectable solution, 2 mg (90 KUI) powder and solvent for injectable solution, 5 mg (225 KUI) powder and solvent for injectable solution

Eptacog beta (activated)
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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
• 7. Instructions for use of CEVENFACTA

1. What is CEVENFACTA and what is it used for

CEVENFACTA contains the active substance eptacog beta (activated), a recombinant human factor VIIa (rhFVIIa) of
coagulation.
CEVENFACTA is used in adults and adolescents (starting from 12 years of age) born with hemophilia A or B and
who have developed inhibitors (antibodies). It is used for:

• the treatment of bleeding episodes;
• the management of bleeding during surgical procedures.

How CEVENFACTA works
This medicine works by forming a blood clot at the site of bleeding, when the
body's coagulation factors are not effective.

2. What you need to know before using CEVENFACTA

DO NOT use CEVENFACTA

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

Warnings and precautions

Before treatment with CEVENFACTA, tell your doctor if:

• you suffer from atherosclerosis (a disease that causes narrowing of the arteries), coronary artery disease (heart disease due to narrowing of the vessels supplying blood to the heart), cerebrovascular disease (disease of the vessels supplying blood to the brain), crush injury, septicemia (a serious blood infection) or blood clot formation;
• you have a heart condition, suffer from heart failure or irregular heartbeat;
• you have had blood clots in the lungs in the past or have undergone heart surgery;
• you have had or have any other illness or medical condition.

Patients with a known allergy to casein may have a higher risk of developing hypersensitivity reactions. If you experience signs or symptoms of hypersensitivity, treatment should be discontinued and you should seek immediate medical attention. Symptoms may include: urticaria (itchy swelling under the skin), itching, rash, difficulty breathing, swelling of the mouth and throat, a feeling of tightness in the chest, wheezing, dizziness or fainting, and low blood pressure.
Even if they have not been observed, the following conditions may occur with CEVENFACTA:

• blood clots in the arteries of the heart (which can cause heart attack or angina), the brain (which can cause a stroke) or the lungs, or in the deep veins of the body. Symptoms may include: swelling and pain in arms, legs or abdomen, chest pain, shortness of breath, loss of sensation or ability to move, altered consciousness or ability to speak;
• hypersensitivity or anaphylactic reactions, with symptoms such as: urticaria (itchy swelling under the skin), itching, rash, difficulty breathing, swelling of the mouth and throat, a feeling of tightness in the chest, wheezing, dizziness or fainting, and low blood pressure;
• inhibitors (antibodies) that can cause bleeding problems.

If you have one or more of these conditions, talk to your doctor before using CEVENFACTA.
It is important to note the batch number of CEVENFACTA you are using. Therefore, each time you use a new package of CEVENFACTA, note the date and batch number (which you can find on the package, after the word "Lot") and keep this information in a safe place.

Adolescents
The warnings and precautions listed apply to both adults and adolescents (aged 12 years and over).

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

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

Talk to your doctor before using CEVENFACTA together with these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
Dizziness may occur after administration of CEVENFACTA. Avoid driving vehicles or using machines when you experience these symptoms.

CEVENFACTA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. essentially "sodium-free".

3. How to use CEVENFACTA

Treatment with this medicine must be started and carried out under the supervision of a
physician experienced in the treatment of hemophilia and/or coagulation disorders.
CEVENFACTA is marketed as a powder, which must be dissolved in the solvent (reconstitution) and
injected into a vein (intravenous injection). See the instructions for use at the end of this leaflet
(paragraph 7).

When to self-administer the medicine
To inject a medicine, you must have received specific training. Do not attempt to
inject yourself unless you have been taught how to do so by a healthcare professional
or at the hemophilia center.
Many people who have developed inhibitors learn to inject themselves or with the help of
a family member: after training, you will need to obtain other equipment in addition to the CEVENFACTA kit,
to effectively treat bleeding episodes at home. Make sure you have all the equipment available before
starting to prepare the medicine for injection. This
additional injection equipment will be provided by a healthcare professional (e.g. the pharmacist or the
hemophilia center).
CEVENFACTA can be injected at the hemophilia center, at the healthcare professional's clinic, or at home. For
adequate management of bleeding, it is important to start treatment at the
onset of the first signs of bleeding.
Start treatment of the bleeding promptly, if possible within 2 hours.

• In case of mild or moderate bleeding (e.g. at the level of the limbs, superficial muscles, soft tissues or mucous membranes), you should administer the treatment as soon as possible, ideally at home.
• In case of severe bleeding (e.g., life-threatening or limb-threatening [arm or leg] bleeding, intracranial [inside the skull] or gastrointestinal bleeding), you should contact your doctor.

Generally, severe bleeding is treated in hospital and a first dose of CEVENFACTA may
be administered while you are on your way to hospital.
Do not prolong treatment beyond 24 hours without consulting your doctor.

• Each time you use this medicine, you must inform your healthcare professional as soon as possible.
• If you do not control the bleeding within 24 hours, contact your healthcare professional immediately or go to the emergency room, as hospital care will generally be needed.

For instructions on reconstituting the medicine before administration, see the guide in
Inject the solution intravenously over a period of no more than 2 minutes.

Use this medicine exactly as your doctor has instructed.If you have any doubts, consult
your doctor.

Dose
Your healthcare professional will tell you the dose of CEVENFACTA to use and the timing, in
based on your body weight, the diseases you suffer from and the type of bleeding.

Treatment of bleeding episodes
Treatment with this medicine should be started as soon as a bleeding event occurs.
Mild and moderate bleeding
In mild to moderate bleeding episodes, home treatment should not exceed 24 hours.
Evaluate the continuation of home treatment beyond 24 hours only after consulting the
hemophilia center.
Severe bleeding
If you experience signs or symptoms of severe bleeding while at home, seek immediate medical attention.
To avoid any delay in treatment, you may administer the initial dose while on your way to the
hemophilia center or the healthcare professional's clinic.
Use this medicine exactly as stated in this leaflet or as instructed by your doctor. If you have any doubts, consult your doctor.

Route of administration
For instructions on reconstituting the medicine before administration and instructions for
administration, see the guide in the Instructions for usesection at the end of this leaflet
(paragraph 7).

If you use more CEVENFACTA than you should
If you use an excessive dose of CEVENFACTA, seek immediate medical attention.

If you forget to use CEVENFACTA
If you forget to use CEVENFACTA, contact your doctor.
If you have any doubts about using this medicine, contact your doctor.

4. Possible side effects

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
• Discomfort at the injection site
• Bruising at the injection site (hematoma)
• Increased body temperature
• Post-procedural hematoma
• Injection-related reaction

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CEVENFACTA

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 packaging after
"Exp.". The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Reconstitute CEVENFACTA only using the material provided in the kit.
After reconstitution, the product must be stored in the vial and administered within 4 hours.
Discard any unused solution after 4 hours from reconstitution.
Do not use this medicine if you notice that the solution is cloudy or contains particles after
mixing.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CEVENFACTA contains

• The active ingredient is recombinant coagulation factor VIIa (eptacog beta [activated]).
• The other ingredients 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 KUI/vial), 2
mg/vial (corresponding to 90 KUI/vial), 5 mg/vial (corresponding to 225
KUI/vial).
After reconstitution, the concentration of the solution is approximately 1 mg/mL (45 KUI/mL) of eptacog
beta (activated). 1 KUI is equivalent to 1000 IU (International Units).

Description of the appearance of CEVENFACTA and contents of the pack
The powder vial contains lyophilized powder ranging in color from white to off-white; the
pre-filled solvent syringe contains a clear and colorless solution. The reconstituted solution should be from
transparent to slightly opaque.
Each pack of CEVENFACTA contains:

• 1 glass vial containing powder for solution for injection
• 1 sterile vial adapter for reconstitution, equipped with a 5 µm filter
• 1 pre-filled syringe of water for injections
• 1 plunger with stop.

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

Marketing Authorisation Holder
Laboratoire français du Fractionnement et des Biotechnologies
Tour W
102 Terrasse Boieldieu, 19ème Étage
92800 Puteaux
France

Manufacturer
LFB Biotechnologies
Zone d'activité de Courtabœuf
3 Avenue des Tropiques
91940 Les Ulis
France
+33 1 69 82 70 10
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website, http://www.ema.europa.eu/
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.
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INSTRUCTIONS FOR USE
READ THE FOLLOWING INSTRUCTIONS CAREFULLY BEFORE USE
CEVENFACTA
CEVENFACTA is supplied as a powder. Before injection, the powder must be dissolved in its
solvent supplied in the syringe (reconstitution). The solvent is water for injections. Once
reconstituted, CEVENFACTA must be injected into a vein (for intravenous use only).
This kit contains the equipment necessary to reconstitute this medicinal product. Other equipment is also
required to inject the medicinal product after reconstitution, which will be provided by a healthcare
professional (e.g. the pharmacist or the haemophilia centre).

The doctor or nurse will teach you or the person caring for you how to reconstitute and
inject CEVENFACTA. Do not use this kit without receiving adequate training from a
healthcare professional or the haemophilia centre.
Prepare and inject the medicinal product with great care, ensuring cleanliness and the absence of germs
(aseptic technique).
The CEVENFACTA kit contains:

• 1 glass vial containing powder for solution for injection
• 1 sterile vial adapter for reconstitution, equipped with a 5 µm filter
• 1 pre-filled syringe of water for injections
• 1 plunger and stop

Powder vial

Vial adapters* and packaging

Vial adapter for 1 mg and 2 mgVial adapter for 5 mg

Plastic
cover
Plastic cover

Protective
paper

Protective
paper

Cap of the

Tip

(under the paper)

Tip (under the paper)

syringe

*NOTE. The CEVENFACTA kit contains only one vial adapter.

Syringe plungerPrefilled syringe with solvent

Thread Tip of

Stop of Cap of

Upper
widened
end

syringe

(Luer lock

under the cap)
plastic rubber
You will also need a sterile infusion set (tube and butterfly needle), a sterile plastic syringe,
sterile alcohol swabs and a sharps container in accordance with local rules and regulations.
This material is not included in the CEVENFACTA packand will be provided
by a healthcare professional (e.g. the pharmacist or the haemophilia centre).

Infusion setPlastic syringeAlcohol swabSharps
container

• 1)Preparation of equipment and preparation of the vial
• Take the number of CEVENFACTA kits needed to achieve the prescribed dose, a sterile infusion set (not supplied) and an alcohol swab (not supplied).

Do not use the kit if the tamper-evident seal is broken or if you suspect the kit may be
contaminated.Use a new kit instead.

• Check the expiry date on the side of the kit (Fig. A).

Do not use after the expiry date.

• Check the name, strength and colour of the pack to ensure it contains the correct product (the 1 mg pack is yellow, the 2 mg pack is green, the 5 mg pack is purple).
• Prepare a clean, flat surface before starting the reconstitution of CEVENFACTA.
• Wash your hands with soap and water and dry them with a clean towel or allow them to air dry (Fig. B).

• Remove the contents of one kit and an alcohol swab. Arrange the items on the clean surface (Fig. C).
• Inspect all the contents of the kit. Make sure that each vial has a syringe of the corresponding colour.

Do not use the contents of the kit if it has been dropped or damaged.Use a new kit instead.

• If necessary, bring the vial and pre-filled syringe to room temperature by holding them in your hands.

Do not heat the vial and pre-filled syringe in any other way.

• Remove the plastic cap from the vial (Fig. D).

If the plastic cap is loose or missing, do not use the vial.

• Clean the rubber stopper with an alcohol swab (Fig. E)and allow it to air dry for a few seconds to make it as germ-free as possible.

• After cleaning with alcohol, do not touch the rubber stopper with your fingers or allow it to come
  into contact with other objectsuntil the vial adapter is attached, as this could transfer germs.
• 2)Insertion of the vial adapter
• Remove the protective paper from the adapter cover (Fig. F).

If the protective paper is not perfectly sealed or is torn, do not use the adapter.

Do not pull the adapter out of the plastic cover with your fingers.Touching the tip of the adapter
could transfer germs from your fingers to the tip.

• Place the vial on a clean surface and hold it with one hand; with the other hand, hold the cover (with the adapter inside) directly above the vial, aligning the tip of the adapter with the centre of the grey rubber stopper.
• Press the plastic cover firmly downwards so that the tip of the adapter penetrates the rubber stopper (you will be able to see or feel a click when the adapter is in place) (Fig. G).

• Gently press the plastic cover and lift it to remove it from the adapter (Fig. H).

Do not touch the top of the adapter until you have removed the plastic cover,
to avoid transferring germs from your fingers onto it.
NOTE.The 5 mg vial adapter may not be completely flat against the vial,
but it is still fully functional. As explained previously, the CEVENFACTA kit
contains only one vial adapter, which is the one suitable for the vial included in the kit.

• 3)Attaching the pre-filled syringe and inserting the plunger
• Remove the cap from the pre-filled syringe by gripping the body of the syringe with one hand and unscrewing the cap with the other hand (rotate to the left) (Fig. I).

Do not touch the tip of the syringe under the cap to avoid transferring germs from your
fingers.
Do not use the pre-filled syringe if the cap is loose or missing.

• Hold the adapter by the edges and simultaneously screw the pre-filled syringe (rotating to the right) several times until you meet resistance (Fig. J).

Do not tighten excessively, as you will need to remove the syringe at a later
stage.

• To insert the plunger into the syringe, hold the widened upper end of the plunger with one hand and the body of the syringe with the other hand.
• Insert the plunger into the syringe, then screw (rotate to the right) so that the plunger is fixed to the grey rubber stopper of the syringe (Fig. K).

• 4)Mixing the medicine in the vial
• Slowly push the plunger all the way down into the syringe, to transfer all the liquid from the syringe into the vial (Fig. L).

Do not push too quickly as this may cause foaming and excess air in the vial.

• Rotate or gently turn the vial upside down until all the powder has dissolved (Fig.M).

Do not shake the vial to avoid creating foam and air.

• Visually inspect the mixed solution (Fig. N), which should appear from transparent to slightly opaque. All the powder must be dissolved and there must be no particles in the liquid.

Do not use the medicine if, after mixing, the liquid contains particles or is cloudy.
Start the procedure again with a new kit.

• 5)Removing the empty syringe from the vial adapter
• Without drawing medicine into the syringe, unscrew the syringe from the vial adapter (rotating to the left) until it is completely detached (Fig. O).

• Dispose of the empty syringe in a suitable sharps container (Fig. P).

Do not remove the vial adapter.
Do not touch the Luer tip of the adapter, as this may transfer germs from your fingers to the adapter.

• 6)Mixing other vials and injecting the dose
• If more than one vial is needed to reach the dose to be administered, repeat the previous steps with other kits until the required dose is obtained.
• Draw the liquid medicine from the vial(s) using a sterile syringe provided by the pharmacy; the syringe must have a capacity sufficient to contain the prescribed dose.
• CEVENFACTA must be administered within 4 hours of reconstitution (Fig. Q).

If more than 4 hours have passed since reconstitution, the medicine should not be used.

• CEVENFACTA can be administered by injecting it into a vein over a period of no more than 2 minutes, according to the instructions provided by the healthcare professional.
• 7)Disposal of empty medicine vials
• After reconstitution and injection, safely dispose of the vials with the adapter inserted, the injection syringe, and any other waste material, placing everything in the sharps container (Fig. R).

Do not throw this material into household waste.
Do not separate the vial and adapter after disposal.
Do not reuse the kit components.

Dispose of the sharps container according to local rules and regulations.

Storage
CEVENFACTA is supplied in a kit to be stored at a temperature below 30 °C.
Do not open the contents of the kit until you are ready to use it.
Do not freeze or store syringes containing the reconstituted CEVENFACTA solution.
Avoid exposure of the reconstituted CEVENFACTA solution to direct light.

Important information
CEVENFACTA is for intravenous injection (intravenous administration) only. Do not inject in
any other way, for example under the skin (subcutaneously) or into the muscle (intramuscularly).
If you have any problems, contact your doctor, nurse or pharmacist.