250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection turoctococcal
alpha ( human coagulation factor VIII (rDNA))
What NovoEight® is and what it is used for
NovoEight contains the active substance turoctococcal alpha, human coagulation factor VIII. Factor VIII is a protein found naturally in the blood that helps it to coagulate.
NovoEight is used to treat and prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency) and can be used for all age groups.
In patients with hemophilia A, factor VIII is missing or does not work properly. NovoEight replaces the factor VIII that does not work or is missing and helps the blood to form clots where it bleeds.
What you need to know before using NovoEight®
Do not use NovoEight®
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to protein you from hamster.
Do not use NovoEight if any of these apply to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and cautions
Talk to your doctor before using NovoEight.
There is a risk, although rare, that you may experience an anaphylactic reaction (a severe sudden allergic reaction ) to NovoEight. Early signs of allergic reactions are skin rash, hives, general itching, swollen lips or tongue, difficulty breathing, wheezing, tightness of the chest, general malaise, and dizziness.
If any of these symptoms occur, stop the injection immediately and consult a doctor.
Talk to your doctor if you think that the bleeding is not sufficiently regulated with the dose you use, as there can be many reasons for this. Some people who use this medicine may develop antibodies to factor VIII (also called factor VIII inhibitors). These make NovoEight less effective in preventing or controlling bleeding. If this happens, you may need a higher dose of NovoEight or another medicine to keep your bleeding under control. Do not increase the total dose of NovoEight to control bleeding without talking to a doctor. You should tell your doctor if you have previously been treated with factor VIIIpreparations, especially if you have developed inhibitors, as there is an increased risk of it happening again.
The development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent, especially at high levels, that the treatment works properly. You or your child will be closely monitored for the development of such inhibitors. If you or your child suffer from bleeding that cannot be 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 you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
NovoEight does not affect the ability to drive or use machines.
NovoEight contains sodium
This medicine contains 30.5 mg sodium (the main ingredient in table salt/table salt) per reconstituted vial. This corresponds to 1.5% of the maximum recommended daily intake of sodium for adults.
Tell your doctor if you are on a diet with a limited salt intake.
3. How to use NovoEight®
Treatment with NovoEight is started by a doctor who has experience in the treatment of patients with hemophilia A. Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor will calculate your dose for you. It depends on your weight and what the medicine is used for.
Prevention of bleeding
The usual dose of NovoEight is 20 to 50 International Units (IU) per kilogram bodyweight. Injection one is taken every two or three 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 taking into account your body weight and the factor VIII level to be achieved. The level depends on how severe the bleeding is and where it is bleeding.
How NovoEight is given
NovoEight is given as an injection into a friend. See the “NovoEight User Guide” for more information.
Use for children and adolescents
NovoEight can be used for children of all ages. For children (under 12 years of age), higher doses or more frequent injections may be needed. Adolescents (over 12 years of age) can use the same dose as adults.
If you use more NovoEight than you should
If you inject too much NovoEight, talk to a doctor or go to a hospital straight away.
If you forget to take NovoEight
Contact a doctor if you forget to take a dose and do not know how to compensate for it.
If you stop using NovoEight®
If you stop using NovoEight, you may no longer be protected against bleeding or ongoing bleeding may stop. Do not stop using NovoEight without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
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), injection must be stopped immediately. You must contact a doctor immediately if you get any of the following early symptoms:
- difficulty breathing, shortness of breath or wheezing
- tightness in the chest
- swollen lips and tongue
- skin rash, hives or general itching
- dizziness or unconsciousness
- low blood pressure (gives pale and cold skin, palpitations).
Severe symptoms, including difficulty swallowing or breathing and red or swollen face or hands, require immediate urgent treatment.
If you get a severe allergic reaction, your doctor may change your medication.
In children not previously treated with Factor VIII medicines, inhibitory antibodies (see section 2) may form. This complication is classified as very common (affects more than 1 patient in 10). In patients who have previously been treated with Factor VIII (more than 150 days of treatment), the risk is classified as unusual (occurs in less than 1 in 100 patients). If this happens, your or your child’s medication may stop working properly, and you / your child may experience persistent bleeding. Contact a doctor immediately if this happens.
Common side effects (affects up to 1 in 10 people)
- changes in liver function that appear in blood tests
- reactions ( redness and itching ) around the injection site where you injected the medicine
Common side effects (affects up to 1 in 10 people) in patients not previously treated with Factor VIII medicines
- reddening of the skin
- inflammation in the vein
- bleeding inside the joint
- bleeding into muscle tissue
- cough
- redness around the site where the catheter was placed
- vomiting.
Uncommon side effects (affects up to 1 in 100 people)
- fatigue
- headache
- dizziness
- difficulty falling asleep (insomnia)
- fast heartbeat
- increased blood pressure
- rash
- fever
- feeling of warmth
- stiff muscles
- pain in muscles
- pain in legs and arms
- swollen legs and feet
- joint disease
- bruise
- myocardial infarction.
Side effects in children and adolescents
Side effects observed in children and adolescents are the same as in adults.
How to store NovoEight®
Keep this medicine out of the sight and reach of children.
Use this medicine before the expiry date which is stated on the carton and label of the EXP bottle and the pre-filled syringe label. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Before diluting the NovoEight powder, it can be stored:
At room temperature (≤ 30 ° C) for a single continuous period not exceeding 9 months
or
• above room temperature (30 ° C up to 40 ° C) for a single continuous period of not more than 3 months
Once the medicine has been removed from the refrigerator, it must not be put back in the refrigerator.
Make a note of the date when storage begins and the storage temperature on the outer carton.
Once you have prepared the NovoEight solution, use it immediately. If you can not use the solution immediately, it should be used within:
• 24 hours when stored at 2 ° C – 8 ° C
• 4 hours for storage at ≤ 30 ° C, for medicinal products stored for a single continuous period of not more than 9 months at room temperature (≤ 30 ° C)
• 4 hours when stored up to 40 ° C, for medicines that have been stored for a single continuous period of no more than 3 months above room temperature (30 ° C up to 40 ° C).
Store the reconstituted solution in the vial. If not used immediately, it may lose its sterility and infect you. Do not save a solution without consulting a doctor.
The powder in the vial is white or slightly yellowish. Do not use the powder if the color has changed.
The prepared solution is ready for something unclear. Do not use this medicine if it is cloudy or you see particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is turoctococcal alpha ( human coagulation factor VIII (rDNA)). Each vial of NovoEight nominally contains 250, 500, 1000, 1500, 2000 or 3000 IU turoctococcal alpha.
- 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 diluent are sodium chloride and water for injections.
After reconstitution with the diluent (9 mg / ml sodium chloride (0.9%) solution for injection ) , the reconstituted solution contains 62.5; 125; 250; 375; 500 and 750 IU turoktokog alfa per ml respectively (based on the strength of turoktokog alfa, ie 250, 500, 1000, 1500, 2000 or 3000 IU).
What the medicine looks like and contents of the pack
NovoEight is a powder and solvent for solution for injection.
Each pack of NovoEight contains a vial of white or slightly yellowish powder, a 4 ml pre-filled syringe with a clear, colorless solution, a plunger rod, and a bottle adapter.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd, Denmark