Kovaltry 3000 ui polvo y disolvente para solucion inyectable
How to use Kovaltry 3000 ui polvo y disolvente para solucion inyectable
Introduction
Prospect: information for the user
Kovaltry 250 UI powder and solvent for injectable solution
Kovaltry 500 UI powder and solvent for injectable solution
Kovaltry 1000 UI powder and solvent for injectable solution
Kovaltry 2000 UI powder and solvent for injectable solution
Kovaltry 3000 UI powder and solvent for injectable solution
octocog alfa (human recombinant factor VIII coagulation factor)
Read this prospect carefully before starting to use this medication, as it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.
- What you need to know before starting to use Kovaltry
- How to use Kovaltry
- Possible adverse effects
- Storage of Kovaltry
- Contents of the package and additional information
1. What is Kovaltry and what is it used for
Kovaltry contains the active ingredient human recombinant factor VIII, also known as octocog alfa. Kovaltry is prepared using recombinant technology without the addition of any human or animal-derived components in the manufacturing process. Factor VIII is a protein that is naturally found in the blood and helps it to clot.
Kovaltry is used totreat and prevent bleeding
in adults, adolescents, and children of any age with hemophilia A (hereditary deficiency of factor VIII).2. What you need to know before starting to use Kovaltry
Do not use Kovaltryif you are
- allergic to octocog alfa or any of the other components of this medication (listed in section 6).
- allergic to mouse or hamster proteins.
Warnings and precautions
Consult your doctor or pharmacist if you have:
- chest tightness, dizziness (even when standing up from sitting or lying down), skin rash with itching, wheezing (whistling sound when breathing), feeling dizzy or faint. These may be signs of a rare and severe allergic reaction to Kovaltry.Stop administering the medication immediately and seek medical help if this occurs.
- uncontrolled bleeding with your usual dose of Kovaltry. The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII products. These inhibitors, especially in large quantities, prevent the treatment from working properly, so patients on Kovaltry treatment will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not controlled with Kovaltry, consult your doctor immediately.
- previously developed inhibitors to factor VIII with another product. If you switch to another factor VIII product, you may be at risk of developing inhibitors again.
- confirmed heart disease or are at risk of developing heart disease.
- using a central venous access device for Kovaltry administration. You may be at risk of complications related to the device, where the catheter has been inserted, such as:
- local infections
- bloodstream infections
- blood clot in the blood vessel
Children and adolescents
The warnings and precautions listed apply to patients of all ages, adults and children.
Using Kovaltry with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.
Kovaltry is unlikely to affect the fertility of male or female patients, as the active ingredient occurs naturally in the body.
Driving and operating machines
If you experience dizziness or other symptoms that affect your ability to concentrate and react, it is recommended that you do not drive or operate machines until the effect has worn off.
Kovaltry contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".
3. How to Use Kovaltry
The treatment with Kovaltry will be initiated by an experienced doctor in the care of patients with hemophilia A. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.
The number of factor VIII units is expressed in International Units (UI)
To treat bleeding, your doctor will calculate and adjust the dose and administration frequency, depending on factors such as:
- Your weight
- The severity of your hemophilia A
- The location and severity of the bleeding
- If you have factor VIII inhibitors and their level
- The required level of factor VIII.
Bleeding prevention
If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose that suits you. This dose will normally be 20 to 40 UI of octocog alfa per kg of body weight, injected two or three times a week. However, in some cases, especially in younger patients, shorter treatment intervals or higher doses may be required.
Laboratory tests
Regular laboratory tests help ensure that you always have the appropriate levels of factor VIII. In the case of major surgical interventions, your blood coagulation must be strictly monitored.
Use in children and adolescents
Kovaltry can be used in children of all ages. In children under 12 years, higher doses or more frequent injections may be required than those prescribed for adults.
Patients with inhibitors
If your doctor tells you that you have developed factor VIII inhibitors, you may need a higher dose of Kovaltry to control bleeding. If this higher dose does not control bleeding, your doctor may consider using another medication.
If you want more information, talk to your doctor.
Do not increase the dose of Kovaltry that your doctor has prescribed to control bleeding without consulting your doctor.
Treatment duration
Generally, treatment for hemophilia with Kovaltry will be necessary for life.
How to administer Kovaltry
Kovaltry is injected into a vein for 2-5 minutes, depending on the total volume and your comfort level, and should be used within 3 hours of reconstitution.
How to prepare Kovaltry for administration
Use only the components (vial adapter, pre-loaded syringe with solvent, and venous puncture equipment) included in the package for this medication. Please contact your doctor if it is not possible to use these components. Do not use it if any of the package components are open or damaged.
The reconstituted medicationmust be filtered using the vial adapterbefore administration to remove any particles present in the solution.
Do not use the venous puncture equipment supplied for blood extraction, as it contains an in-line filter.
This medicationshould notbe mixed with other infusion solutions. Do not use solutions if you observe particles or if the solution is cloudy. Follow the administration instructions given by your doctorand collected at the end of this leaflet.
If you use more Kovaltry than you should
Inform your doctor if this occurs. No cases of overdose have been reported.
If you forgot to use Kovaltry
Administer the next dose immediately and continue at regular intervals following your doctor's instructions.
Do not use a double dose to compensate for missed doses.
If you interrupt treatment with Kovaltry
Do not stop using this medication without consulting your doctor.
If you have any other questions about the use of this medication, ask your doctor.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The mostseriousside effects areallergic reactionsthat may include a severe allergic reaction.Stopimmediately the Kovaltry injection and speak right away with your doctor if this reaction occurs.The following symptomsmaybe an early sign of these reactions:
- chest tightness or a general feeling of discomfort
- dizziness
- sensation of dizziness when standing, indicating a decrease in blood pressure
- nausea
In children not previously treated with factor VIII medications, inhibitors may form very frequently (more than 1 in 10 patients) (see section 2). In patients who have received previous treatment with factor VIII (more than 150 days of treatment), inhibitors may form with low frequency (less than 1 in 100 patients) (see section 2). If this happens,the medicine you take may not work properly and you may experience persistent bleeding. In that case, please contact your doctor immediately.
Other possible side effects:
Frequent(may affect up to 1 in 10 people):
- stomach pain or discomfort
- indigestion
- fever
- local reactions at the site where the medicine has been injected (e.g., bleeding under the skin, strong itching, swelling, burning sensation, transient redness)
- headache
- difficulty sleeping
- hives
- urticaria with or without itching
Infrequent(may affect up to 1 in 100 people):
- enlargement of lymph nodes (swelling under the skin of the neck, armpit, or groin)
- palpitations (sensation of a strong, rapid, or irregular heartbeat)
- accelerated heart rate
- disturbance of taste
- flushing (redness of the face)
Reporting of side effects
If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Kovaltry Storage
Keep this medication out of the sight and reach of children.
Do notuse this medication after the expiration date that appears on the labels and boxes.
The expiration date is the last day of the month indicated.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Store this medication in the original packaging to protect it from light.
This medication can be stored at room temperature (up to 25 °C) for a maximum of 12 months, if it is kept in its original packaging. If you store the medication at room temperature, it expires after 12 months or on the expiration date indicated, whichever comes first.
You must note the new expiration date on the outer packaging when the medication is removed from the refrigerator.
Do notrefrigerate the solution after reconstitution. The reconstituted solution must be used within a maximum of 3 hours. Use the contents only once. Discard unused solution.
Do notuse this medication if you observe particles in the solution or if the solution is cloudy.
Medicationsmust notbe disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Kovaltry
The active principle is octocog alfa (human coagulation factor VIII). Each vial of Kovaltry contains 250, 500, 1000, 2000 or 3000 UI of octocog alfa.
The other components are sucrose, histidine, glycine (E 640), sodium chloride, dihydrate calcium chloride (E 509), polisorbate 80 (E 433), glacial acetic acid (E 260) and water for injection.
Appearance of the product and contents of the package
Kovaltry is presented in the form of a powder and a solvent for injectable solution. The powder is dry and white to slightly yellowish in color. The solvent is a clear liquid.
Each individual package of Kovaltry contains
- a glass vial with powder
- a preloaded syringe with solvent
- an independent plunger
- a vial adapter
- a venous puncture device (for injection into a vein).
Kovaltry is available in sizes of:
- 1 individual package
- 1 multiple package with 30 individual packages
Not all sizes may be marketed.
Marketing Authorization Holder
Bayer AG
51368 Leverkusen
Germany
Responsible for manufacturing
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11 | Lietuva UAB Bayer Tel. +37 05 23 36 868 |
???????? ????? ???????? ???? T??.: +359-(0)2-424 72 80 | Luxembourg/Luxemburg Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11 |
Ceská 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 5000 | 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-(0)297-28 06 66 |
Eesti Bayer OÜ Tel: +372 655 8565 | Norge Bayer AS Tlf: +47 23 13 05 00 |
Ελλ?δα Bayer Ελλ?ς 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 81 | Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785 21 |
Κ?προς NOVAGEM Limited Tηλ: +357 22 48 38 58 | Sverige Bayer AB Tel: +46 (0) 8 580 223 00 |
Latvija SIA Bayer Tel: +371 67 84 55 63 | United Kingdom (Irlanda del Norte) Bayer AG Tel: +44-(0)118 206 3000 |
Last review date of this leaflet:
For detailed information about this medicine, please visit the website of the European Medicines Agencyhttp://www.ema.europa.eu
--------------------------------------------------------------------------------------------------------------------IInstructions for reconstitution and administration of Kovaltry
You will need sterile gauze pads soaked in alcohol, sterile gauze, adhesive strips and a tourniquet. These items are not included in the Kovaltry package.
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