Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - esperoct

Document Subject

Generated Narrative: MedicinalProductDefinition mp4235a6fbbdf6cea7a0c9802b3f2102e6

identifier: http://ema.europa.eu/identifier/EU/1/19/1374/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Esperoct 500 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-4235a6fbbdf6cea7a0c9802b3f2102e6

identifier: http://ema.europa.eu/identifier/EU/1/19/1374/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - esperoct

Attesters

What is in this leaflet

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

What Esperoct is Esperoct contains the active substance turoctocog alfa pegol and is a long-acting recombinant coagulation factor VIII product. Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.

What Esperoct is used for Esperoct is used to treat and prevent bleeding in people 12 years and above with haemophilia A (inborn factor VIII deficiency).

In people with haemophilia A, factor VIII is missing or does not work properly. Esperoct replaces this faulty or missing factor VIII and helps blood to form clots at the site of bleeding.

Do not use Esperoct

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hamster proteins.

Do not use Esperoct if either of the above applies to you. If you are not sure, talk to your doctor before using this medicine.

Warnings and precautions

Previous use of factor VIII medicine
Tell your doctor if you have used factor VIII medicines before, especially if you developed inhibitors (antibodies) against the medicine, since there might be a risk that it happens again.

Allergic reactions There is a risk that you may experience a severe and sudden allergic reaction (e.g. anaphylactic reaction) to Esperoct.

Stop the injection and contact your doctor or an emergency unit immediately if you have early signs of allergic reactions. These early signs may include rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, or dizziness, headache, nausea and vomiting.

Development of factor VIII inhibitors (antibodies) Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines

• These inhibitors, especially at high levels, stop the treatment working properly
• You will be monitored carefully for development of these inhibitors
• If your bleeding is not being controlled with Esperoct, tell your doctor immediately
• Do not increase the total dose of Esperoct to control your bleed without talking to your doctor.

Catheter-related problems If you have a catheter where medicines can be injected into your blood (central venous access device), you may develop infections or blood clots at the site of the catheter.

Heart disease Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.

Children Esperoct can not be used in children below 12 years of age.

Other medicines and Esperoct Tell your doctor if you are taking, have recently taken or might take 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 taking this medicine.

Driving and using machines Esperoct has no influence on your ability to drive and use machines.

Esperoct contains sodium This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.

Decreased factor VIII activity in previously treated patients A decreased factor VIII activity may occur in the beginning of your treatment. If you think your medicine works less than expected, tell your doctor.

Treatment with Esperoct will be started by a doctor who is experienced in the care of people with haemophilia A. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure about how to use Esperoct.

How Esperoct is given Esperoct is given as an injection into a vein (intravenously), see Instructions on how to use Esperoct
for more information.

How much to use Your doctor will calculate your dose for you. This will depend on your body weight and whether it is used to prevent or to treat a bleeding.

To prevent bleeding Adults and adolescents (12 years of age and above): The recommended dose is 50 IU of Esperoct per kg body weight every 4 days. Your doctor may choose another dose or how often the injections should be given, based on your need.

To treat bleeding The dose of Esperoct is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding. If you experience that the effect of Esperoct is insufficient, talk to your doctor.

Use in children and adolescents Adolescents (12 years of age and above) can use the same dose as adults.

If you use more Esperoct than you should If you use more Esperoct than you should, contact your doctor straight away.

If you have to significantly increase your usage of Esperoct to stop a bleed, talk to your doctor immediately. For further information, see Development of factor VIII inhibitors (antibodies) in section 2. If you forget to use Esperoct If you forget a dose, inject the missed dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose. Proceed with the next injection as scheduled and continue as advised by your doctor. If you are in doubt, contact your doctor.

If you stop using Esperoct Do not stop using Esperoct without talking to your doctor. If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop. 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.

Allergic reactions (hypersensitivity) Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions). You must contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as:

• difficulty in swallowing or breathing
• wheezing
• chest tightness
• redness and/or swelling of the lips, tongue, face or hands
• rash, hives, weals or itching
• pale and cold skin, fast heartbeat, or dizziness (low blood pressure)
• headache, nausea or vomiting. Development of factor VIII inhibitors (antibodies) If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people). If this happens, your medicine may stop working properly and you may experience persistent bleeding. If this happens, you should contact your doctor immediately. See Development of factor VIII inhibitors (antibodies) in section 2. The following side effects have been observed with Esperoct

Very common side effects (may affect more than up to 1 in 10 people)

• factor VIII inhibitors (antibodies) in patients not previously treated with factor VIII.

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

• skin reactions where the injection is given
• itching (pruritus)
• redness of skin (erythema)
• rash.

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity). These may become severe and could be life-threatening, see Allergic reactions (hypersensitivity) above for more information
• factor VIII inhibitors (antibodies) in patients previously treated with factor VIII.

Other possible side effects (unknown frequency) Decreased factor VIII activity in the absence of factor VIII inhibitors.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 after EXP on the carton, on the vial, and on the pre-filled syringe labels. The expiry date refers to the last day of that month.

Before reconstitution (before the powder is mixed with the solvent): Store in a refrigerator (2 C - 8 C). Esperoct can be kept

• at room temperature ( 30 C) for a single period for up to 12 months within the shelf life of the product or
• above room temperature (> 30 C up to 40 C) for a single period for up to 3 months within the shelf life of the product.

When you start to store Esperoct outside the refrigerator, record the date and the storage temperature in the space provided on the carton.
Once you have taken the product out of the refrigerator for storage you must not store it again in the refrigerator.Do not freeze. Store in the original package in order to protect from light.

After reconstitution (after the powder has been mixed with the solvent 500 IU, 1 000 IU, 1 500 IU, 2 000 IU, 3 000 IU): Once you have reconstituted Esperoct, it should be used immediately. If you cannot use the reconstituted solution immediately, it should be used within

• 24 hours when stored in a refrigerator (2 C - 8 C) or
• 4 hours at 30 C or
• 1 hour between > 30 C and 40 C, only if the product was stored above room temperature (> 30 C up to 40 C) before reconstitution for no longer than 3 months.

After reconstitution (after the powder has been mixed with the solvent - 4 000 IU, 5 000 IU): Chemical and physical inuse stability have been demonstrated for:

• 24 hours when stored in a refrigerator (2 C - 8 C) or
• 4 hours at 30 C.

The powder in the vial appears as a white to off-white powder. Do not use the powder if the colour has changed.

The reconstituted solution must be clear and colourless. Do not use the reconstituted solution if you notice any particles or discolouration.

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 Esperoct contains

• The active substance is turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)). Each vial of Esperoct contains nominally 500, 1 000, 1 500, 2 000, 3 000, 4 000 or 5 000 IU turoctocog alfa pegol.
• The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
• The ingredients in the solvent are sodium chloride 9 mg/mL (0.9%) solution for injection and water for injections.

After reconstitution with the supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection), the prepared solution for injection contains 125, 250, 375, 500, 750, 1 000 or 1 250 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1 000, 1 500, 2 000, 3 000, 4 000 or 5 000 IU).

What Esperoct looks like and contents of the pack Esperoct is available in packs containing 500 IU, 1 000 IU, 1 500 IU, 2 000 IU, 3 000 IU, 4 000 IU or 5 000 IU. Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All
DK-2880 Bagsv rd, Denmark

This leaflet was last revised in
Other sources of information

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