JIVI 500 IU Порошок и раствор для инъекционного раствора

Содержание инструкции

1. Jivi 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 2000 IU powder and solvent for injectable solution, 3000 IU powder and solvent for injectable solution, 4000 IU powder and solvent for injectable solution
   1. What is Jivi and what is it used for?
   2. What you need to know before using Jivi
   3. How to use Jivi
   4. Possible side effects
   5. How to store Jivi
   6. Contents of the pack and other information

Jivi 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 2000 IU powder and solvent for injectable solution, 3000 IU powder and solvent for injectable solution, 4000 IU powder and solvent for injectable solution

recombinant human coagulation factor VIII, PEGylated, with B domain deletion
(damoctocog alfa pegol)

Read this leaflet carefully before you use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Jivi and what is it used for?

Jivi contains the active substance damoctocog alfa pegol. It is produced using recombinant DNA technology without the addition of any human or animal components during the manufacturing process.
Factor VIII is a protein normally present in the blood with the function of promoting
coagulation. The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its
action in the body.
Jivi is used for the treatment and preventionof bleedingin adults, adolescents and children
aged 7 years and older, previously treated, with haemophilia A (hereditary factor VIII deficiency). It is not indicated for use in children under 7 years of age.

2. What you need to know before using Jivi

Do not use Jiviif you

• are allergic to damoctocog alfa pegol or to any of the other ingredients of this medicine (listed in section 6)
• are allergic to murine or hamster proteins

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

• chest tightness, low blood pressure (which often manifests with dizziness when getting up quickly), hives with itching, shortness of breath, feeling unwell or weakness. These could be the symptoms of a rare and serious sudden allergic reaction

to this medicine. If this happens, stopthe infusion of the
medicineimmediately and see a doctor.

• bleeding that is not controlled with the usual dose of this medicine. If this happens, tell your doctor immediately. You may have developed antibodies directed against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG). These antibodies make Jivi less effective in preventing and controlling bleeding. Your doctor may perform tests to confirm the presence of these antibodies and verify that adequate levels of factor VIII are achieved with your dose of Jivi. If necessary, your doctor may return to previous treatment with factor VIII. Once the immune response has resolved, your doctor may consider resuming Jivi.
• previously developed inhibitors against factor VIII with other medicines.
• heart problems or are at risk of developing heart disease.
• need to use a central venous access device for this medicine. You may be at risk of complications related to the device at the catheter placement site, including
• local infections
• the presence of bacteria in the blood
• formation of a blood clot in the blood vessel

Children
Jivi is not indicated for use in children under 7 years of age.

Other medicines and Jivi
No effects of Jivi on other medicines or vice versa are known. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.

Driving and using machines
Jivi does not impair the ability to drive vehicles and use machines.

Jivi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

Jivi contains polysorbate 80 (E 433)
This medicine contains 0.2 mg of polysorbate 80 per vial of 250/500/1 000/2 000/3 000 IU
and 0.4 mg of polysorbate 80 per vial of 4 000 IU, equivalent to 0.08 mg/mL of injectable solution. Polysorbates can cause allergic reactions. Tell your doctor if you or your
child have known allergies.

3. How to use Jivi

Treatment with Jivi will be initiated by a physician who has experience in the treatment of patients with
hemophilia A. After adequate training, patients or those caring for them may be able to use Jivi at home.
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist. The number of Factor VIII units is expressed in International Units (IU).

Treatment of bleeding
To treat bleeding, the doctor will calculate and adjust the dose and frequency of
administration based on factors such as:

• your weight
• the severity of hemophilia A
• the location and severity of the bleeding
• if you have developed Factor VIII inhibitors and in what quantity
• the required levels of Factor VIII

Prevention of bleeding
To prevent bleeding, the doctor will define the appropriate dose and frequency based on your
needs. The doctor may adjust the dose and frequency of administration based on the levels of
Factor VIII achieved and your individual predisposition to bleeding.

• For adults and adolescents aged 12 years and over
• 45-60 IU per kg of body weight every 5 days or
• 60 IU per kg of body weight every 7 days or
• 30-40 IU per kg of body weight twice a week.
• For children from 7 to less than 12 years of age
• 40-60 IU per kg of body weight twice a week.
• 60 IU per kg of body weight twice a week as an initial dose.

Laboratory tests
Regular laboratory tests allow you to ensure adequate levels of Factor VIII at all times.
In particular, in the case of major surgery, your coagulation must be carefully
monitored.

Duration of treatment
Usually, Jivi therapy for hemophilia is necessary for life.

How Jivi is administered
Jivi is infused intravenously, over 2-5 minutes, depending on the total volume and the degree of well-being. The
maximum infusion rate is 2.5 mL per minute. Jivi must be used within 3 hours after
reconstitution.

How Jivi is prepared for infusion
Use only the components (the vial adapter, the pre-filled syringe containing the solvent
and the intravenous infusion set) supplied with each package of this medicine. If these components
cannot be used, contact your doctor. Do not use the medicine if a component of the
package is open or damaged.
Before infusion, the reconstituted medicine must be filtered using the
vial adapterto remove any particulate matter that may be present in the solution.
This medicine must notbe mixed with other injectable products. Do not use solutions
containing visible particles or that are cloudy. Follow the instructions for useprovided by the doctor and

If you use more Jivi than you should
If this happens, inform your doctor. No symptoms of overdose have been reported.

If you forget to use Jivi
Infuse the next dose immediately and continue at regular intervals as recommended by
your doctor.
Do not use a double dose to make up for a missed dose.

If you stop using Jivi
Do not stop therapy with this medicine without consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most seriousside effects are allergic reactionsor a severe allergic reaction. If
reactions of this type occur, stop the Jivi infusion immediately and
talk to your doctor.The following symptoms may be an early sign of these reactions:

• feeling of tightness in the chest/general feeling of discomfort
• burning and stinging pain at the infusion site
• hives, flushing
• low blood pressure which may make you feel weak when standing up
• nausea

In patients who have received previous factor VIII-based treatment (more than 150 days of
treatment), inhibitors (antibodies that block the effect of the medicine) may form, uncommonly (in less than 1 in 100 patients) (see section 2). If this happens, the medicine may stop working
properly and you may experience persistent bleeding. In this case, contact
your doctor immediately.
The following side effects may occur with this medicine:

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

• headache

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

• stomach pain
• nausea, vomiting
• fever
• allergic reactions (may occur as hives, widespread hives, feeling of tightness in the chest, shortness of breath, wheezing, low blood pressure; see above for early symptoms)
• local reactions at the infusion site such as bruising (bleeding under the skin), intense itching, swelling, burning sensation, temporary redness
• dizziness
• difficulty falling asleep
• cough
• skin rash, reddened skin

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

• inhibition of factor VIII of coagulation (FVIII)
• altered taste
• flushing
• itching

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Jivi

Keep this medicine out of the sight and reach of children.

Do not usethis medicine after the expiry date stated on the labels and the cartons. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do notfreeze.
Keep the vial and pre-filled syringe in the carton to protect them from light.
This medicine can be stored at room temperature (up to 25 °C) for a maximum of
6 months if stored in the outer carton. If you store the medicine at room temperature, the
expiry of the medicine will end after 6 months or at the expiry date, if this date is earlier.
The new expiry date must be noted on the outer carton when you take the medicine
out of the refrigerator.

Do notrefrigerate the solution after reconstitution. The reconstituted solution must be used within
3 hours.

Do not usethis medicine if you notice visible particles or if the solution is cloudy.
This medicine is for single use only. Any unused solution must be discarded.

Do notdispose of any medicine in wastewater or household waste. Ask your pharmacist or
doctor how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Jivi contains

• The active substance is recombinant human coagulation factor VIII, PEGylated and with the B domain deleted (damoctocog alfa pegol). Each vial of Jivi nominally contains 250, 500, 1,000, 2,000 or 3,000 or 4,000 IU of damoctocog alfa pegol. After reconstitution with the supplied solvent (water for injections), the resulting solutions have the following concentrations:
• The other ingredients are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), polysorbate 80 (E 433), glacial acetic acid (E 260) and water for injections. See section 2 “Jivi contains sodium” and “Jivi contains polysorbate 80 (E 433)”.

Description of Jivi and contents of the pack
Jivi is supplied as a powder and solvent for solution for injection. The powder is dry and of colour from
white to pale yellow. The solvent is a clear liquid. After reconstitution the solution is clear.

Each single pack of Jivi contains:

• one glass vial with powder
• one pre-filled syringe with solvent
• one separate plunger
• one vial adapter
• one infusion set for intravenous use.

Jivi is available in packs of:

• a single pack
• a 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +37 05 23 36 868

България
Байер България ЕООД
Tел.: +359-(0)2-424 72 80

Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária KFT
Tel:+36 14 87-41 00

Danmark
Bayer A/S
Tlf: +45 45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-23–799 1 000

Eesti
Bayer OÜ
Tel: +372 655 8565

Norge
Bayer AS
Tlf: +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30-210-61 87 500

Österreich
Bayer Austria Ges.m.b.H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel: +48 22 572 35 00

France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00

Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900

România
SC Bayer SRL
Tel: +40 21 529 59 00

Ireland
Bayer Limited
Tel: +353 1 216 3300

Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39 02 397 8 1

Suomi/Finland
Bayer Oy
Puh/Tel: +358- 20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/
-----------------------------------------------------------------------------------------------------------------

Detailed instructions for reconstitution and administration of Jivi
You will need alcohol swabs, dry swabs, plasters and a tourniquet. These
materials are not included in the Jivi pack.

z 1. Wash your hands thoroughly with soap and warm water.
n 2. Hold a vial closed and a syringe in your hands to warm them until they reach an adequate temperature (do not exceed 37 °C).
e g 3. Remove the protective closure cap from the vial (A). Clean the rubber stopper of the vial with an alcohol swab and let the stopper air dry before use. A

4. Place the vial containing the powder on a stable, non-slip surface. Remove the paper cap from the plastic casing of the vial adapter. Do not remove the adapter from the plastic casing. Grab the adapter casing, place it over the vial containing the powder and press down firmly (B). The adapter will snap onto the vial closure cap. Do not remove the adapter casing yet.	c o
m 5. Hold the pre-filled syringe with the solvent vertically. Grab the plunger as shown in the figure and attach it to the threaded cap by twisting firmly clockwise (C). r	a
a 6. Grab the body of the syringe and remove, by breaking off, the closure cap from the tip of the syringe (D). Do not touch the syringe tip F with your hands or any other surface. Set the syringe aside for later use.
l 7. Now remove and discard the adapter casing (E). e d
a 8. Attach the pre-filled syringe to the threaded vial adapter by twisting it clockwise (F). n
t 9. Inject the solvent by gently pushing down on the plunger (G). i l a
i z 10. Gently rotate the vial until all the powder has dissolved (H). I Do not shake the vial. Make sure the powder is completely dissolved. Check for any particles or colour change before using the solution. Do not use solutions containing visible particles or that are cloudy.
n 11. Grab the vial by the end above the vial adapter and the syringe (I). Fill the syringe by slowly and smoothly pulling back the plunger. Make sure the entire contents of the vial have been completely aspirated into the syringe. Keep the syringe in a vertical position and push the plunger until all the air has been expelled from the syringe.
g 12. Apply a tourniquet to your arm.
A 13. Identify the infusion site and clean the skin.
14. Insert the needle into a vein and secure the intravenous infusion set with a plaster.

15. Holding the vial adapter firmly, remove the syringe from the vial adapter (which must remain attached to the vial). Connect the syringe to the intravenous infusion set (J). Make sure no blood enters the syringe.	o
c 16. Remove the tourniquet.
a 17. Infuse the solution into a vein over a period of 2-5 minutes, monitoring the position m of the needle. The infusion rate should be based on the degree of well-being, but should not exceed 2.5 mL per minute.
r 18. If a further dose is required, use a new syringe with the reconstituted powder as described above.
F 19. If a further dose is not required, remove the intravenous infusion set and the syringe. Hold a dry swab firmly on the infusion site for about 2 minutes, keeping the arm outstretched. Finally, apply a small compress to the infusion site and, if necessary, a plaster.
l e 20. It is recommended to note the name and batch number of the medicinal product each time you use Jivi.
d 21. Do not dispose of any medicine in the drain or in household waste. Ask your pharmacist or doctor how to dispose of medicines you no longer use. This will help protect the environment.