Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - novoeight

Document Subject

Generated Narrative: MedicinalProductDefinition mp6a4906798bb720b77ad2e34e8f5369c0

identifier: http://ema.europa.eu/identifier/EU/1/13/888/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NovoEight 250 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-6a4906798bb720b77ad2e34e8f5369c0

identifier: http://ema.europa.eu/identifier/EU/1/13/888/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - novoeight

Attesters

What is in this leaflet

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

NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein naturally found in the blood that helps it to clot.

NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups.

In patients with haemophilia A, factor VIII is missing or not working properly. NovoEight replaces this faulty or missing factor VIII and helps blood to form clots at the site of bleeding.

Do not use NovoEight:

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

Warnings and precautions

Talk to your doctor before using NovoEight.

There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to NovoEight. Early signs of allergic reactions are rash, hives, weals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.

If any of these symptoms occur, stop the injection immediately and contact your doctor.

Talk to your doctor if you think that your bleed is not being controlled with the dose you receive, as there can be several reasons for this. Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors make NovoEight less effective in preventing or controlling bleeding. If this happens you may need a higher dose of NovoEight or a different medicine to control your bleed. Do not increase the total dose of NovoEight to control your bleed without talking to your doctor. You should tell your doctor if you have been previously treated with factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child s bleeding is not being controlled with NovoEight, tell your doctor immediately.

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

NovoEight 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 dietary intake of sodium for an adult.

Talk to your doctor if you are on a controlled sodium diet.

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

Your doctor will calculate your dose for you. This will depend on your weight and what the medicine is being used for.

Prevention of bleeding The usual dose of NovoEight is 20 to 50 international units (IU) per kg of body weight. The injection is given every 2 to 3 days. In some cases, especially in younger patients, more frequent injections or higher doses may be needed.

Treatment of bleeding The dose of NovoEight 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.

Use in children and adolescents NovoEight can be used in children of all ages. In children (below the age of 12) higher doses or more frequent injections may be needed. Adolescents (above the age of 12) can use the same dose as adults. How NovoEight is given NovoEight is given as an injection into a vein. See Instructions on how to use NovoEight for more information.

If you use more NovoEight than you should If you use more NovoEight than you should, tell your doctor or go to a hospital straight away.

If you forget to use NovoEight You should contact your doctor if you have missed a dose and do not know how to compensate for this.

If you stop using NovoEight If you stop using NovoEight you may no longer be protected against bleeding or a current bleed may not stop. Do not stop using NovoEight without talking 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. The following side effects may occur with this medicine.

If severe, sudden allergic reactions (anaphylactic reactions) occur (very rare), the injection must be stopped immediately. You must contact your doctor immediately if you have one of the following early symptoms:

• difficulty in breathing, shortness of breath or wheezing
• chest tightness
• swelling of the lips and tongue
• rash, hives, weals or generalised itching
• feeling dizzy or loss of consciousness
• low blood pressure (having pale and cold skin, fast heartbeat).

Severe symptoms, including difficulty in swallowing or breathing and red or swollen face or hands, require prompt emergency treatment.

If you have a severe allergic reaction, your doctor may change your medicine.

For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in patients). If this happens to you or your child s medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.

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

• blood tests showing changes in the way the liver functions
• reactions (redness and itching) around the site where you injected the medicine.

Common side effects (may affect up to 1 in 10 people) in patients who have not previously treated with Factor VIII medicines

• blushing of the skin
• inflammation of vein
• bleeding into joint spaces
• bleeding in muscle tissue
• cough
• redness around the site where you placed catheter
• vomiting.

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

• feeling tired
• headache
• feeling dizzy
• difficulty sleeping (insomnia)
• fast heartbeat
• increased blood pressure
• rash
• fever
• feeling hot
• stiffness of muscles
• pain in muscles
• pain in legs and arms
• swelling of legs and feet
• joint disease
• bruising
• heart attack.

Side effects in children and adolescents The side effects observed in children and adolescents are the same as observed in adults.

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 and on the vial and the pre-filled syringe labels. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).
Do not freeze. Keep the vial in the outer carton in order to protect from light.

Before the NovoEight powder is reconstituted it may be kept at:

• room temperature ( 30 C) for a single period no longer than 9 months

or

• above room temperature (30 C up to 40 C) for a single period no longer than 3 months.

Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.

Please record the beginning of storage and the storage temperature on the product carton.

Once you have reconstituted NovoEight it should be used right away. If you cannot use the reconstituted NovoEight solution immediately, it should be used within:

• 24 hours stored at 2 C 8 C
• 4 hours stored at 30 C, for product which has been kept for a single period no longer than 9 months at room temperature ( 30 C)
• 4 hours stored up to 40 C, for product which has been kept for a single period no longer than 3 months at above room temperature (30 C up to 40 C).

Store the reconstituted product in the vial. If not used straight away the medicine may no longer be sterile and could cause infection. Do not store the solution without your doctor s advice.

The powder in the vial appears as a white or slightly yellow powder. Do not use the powder if the colour has changed.

The reconstituted solution will be clear to slightly opalescent. Do not use this medicine if you notice that it is cloudy or contains visible particles.

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 NovoEight contains

The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)). Each vial of NovoEight contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa.

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 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 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml, respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).

What NovoEight looks like and contents of the pack NovoEight is a powder and solvent for solution for injection. Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, 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: