NovoSeven 2 mg.

What NovoSeven is and what it is used for
NovoSeven is a coagulation factor. It works by forming a blood clot at the site of hemorrhage when the blood clotting factors of the body do not work.
NovoSeven is used to treat bleeding and to prevent large bleeding after surgery or other important treatment. Early treatment with NovoSeven reduces the severity and duration of haemorrhage. It is used in all types of bleeding, including joint bleeding. This reduces the need for hospitalization and the days of absence from work and school.
Used in some groups of people:
• If you are born with haemophilia and you are not responding to treatment with clotting factors VIII or IX
• If you have acquired hemophilia
• If you have Factor VII deficiency
• If you have Glanzmann's thrombasthenia (blood clotting disorder) and your condition can not be treated effectively by overflow of platelets.
2. What you need to know before using NovoSeven
Do not use NovoSeven
• If you are allergic to eptacog alfa (the active ingredient of NovoSeven) or any of the other ingredients in this medicine (described in section 6).
• If you are allergic to hamster, mouse or bovine protein (such as cow's milk).
If any of these apply to you, do not use NovoSeven. Talk to your doctor.
Warnings and precautions
Before treatment with NovoSeven, make sure that your doctor knows:
• If you have recently had surgery
• If you have recently suffered a tissue injury
• If your arteries are narrowed by disease (atherosclerosis)
• If you are at an increased risk of blood clots (thrombosis)
• If you have severe liver disease
• If you have a severe blood infection
• If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots are formed throughout your bloodstream), you should be monitored carefully.
If any of these conditions apply to you, tell your doctor before taking the injection.
Other medicines and NovoSeven
Tell your doctor or pharmacist if you are taking, have recently taken or can take any other medicines.
Do not use NovoSeven concomitantly with prothrombin complex or rFXIII concentrate. You should speak to your doctor before using NovoSeven if you also use Factor VIII or IX products.
There is limited experience with the concomitant use of NovoSeven and medicines called antifibrinolytic medicines (such as aminocaproic acid or tranexamic acid), which are also used to control bleeding. You should talk to your doctor before taking NovoSeven at the same time as these medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, talk to your doctor before using NovoSeven.
Driving and using machines
There are no studies on the effect of NovoSeven on the ability to drive and use machines. However, there is no medical reason to believe that it will affect your abilities.
3.How to use NovoSeven
NovoSeven powder should be reconstituted with the solvent and injected into a vein. See the other page of the leaflet for detailed instructions.
When to Treat
Start treating hemorrhage as early as possible, preferably within 2 hours.
• In case of mild or moderate hemorrhage, you should start treatment as early as possible, preferably at home.
• In the event of severe bleeding, you should contact your doctor. Usually severe hemorrhages are treated in a hospital and you can inject the first dose of NovoSeven on the way to the hospital.
Do not treat for more than 24 hours without consulting your doctor.
• Every time you use NovoSeven, tell your doctor or hospital as soon as possible.
• If bleeding is not controlled within 24 hours, contact your doctor immediately. Usually you will need hospital treatment.
Dosage
The first dose should be given as soon as possible after the onset of haemorrhage. Discuss with your doctor when and how long to use the injections.
Your dose will be determined by your doctor based on your body weight, condition and type of haemorrhage.
For the best results, follow carefully the prescribed dose. Your doctor may change the dose.
If you have haemophilia:
The usual dose is 90 micrograms per 1 kilogram body weight; You can repeat the injection every 2-3 hours to manage the bleeding. Your doctor may recommend a single dose of 270 micrograms per 1 kilogram of body weight. There is no clinical experience in people over 65 years of age using this single dose.
If you have a factor VII deficiency:
The usual dose ranges from 15 to 30 micrograms per 1 kilogram of body weight per injection.
If you have Glanzmann's thrombasthenia:
The usual dose is 90 micrograms (ranging from 80 to 120 micrograms) for every 1 kilogram of body weight for each injection
Blood clots in heart arteries (which can lead to heart attack or angina), in the brain (which can lead to a stroke) or in the gut and kidneys. Signs may include severe chest pain, shortness of breath, confusion, difficulty in speaking or movement (paralysis) or abdominal pain.
Uncommon (may affect up to 1 in 100 doses)
• Blood clots in the veins of the lungs, legs, liver, kidneys or injection site. Signs may include difficulty in breathing, reddening and painful swelling of the leg and abdominal pain.
• Lack of effect or reduced response to treatment.
If you notice any of these serious side effects, seek medical attention immediately. Explain that you have used NovoSeven.
Tell your doctor if you have a history of allergic reactions, as you may need more careful monitoring. In most cases of blood clots, patients were predisposed to blood clotting disorders.
Other rare side effects
(May affect up to 1 in 1,000 doses)
• Nausea (feeling sick)
•Headache
• Changes in some liver and blood tests.
Other Uncommon Side Effects
(May affect up to 1 per 100 doses)
• Allergic skin reactions, including rash, pruritus and urticaria
• Fever.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, nurse or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5.How to store NovoSeven
• Keep this medicine out of the reach and sight of children.
• Store NovoSeven in a refrigerator (2 ° C - 8 ° C).
Store in the original package in order to protect from light.
• Do not freeze to prevent damage to the solvent vial.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Use NovoSeven immediately after mixing the solvent powder to avoid infection. If you can not use it immediately after mixing, you should store it in the vial with the attached needle in a refrigerator at 2 ° C to 8 ° C for up to 24 hours. Do not store the solution for injection without advice from your doctor or nurse.
• Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Package Contents and Additional Information
What NovoSeven contains
• The active substance is a recombinant coagulation factor VIIa (activated eptacog alfa).
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, hydrochloric acid and sodium hydroxide. The solvent is water for injections.
The powder for the solution for injection contains: 1.2 mg / vial (corresponding to 60 KIU / vial), 2.4 mg / vial (corresponding to 120 KIU / vial) or 4.8 mg / vial (corresponding to
240 KIU / vial).
After reconstitution, 1 ml of solution contains 0.6 mg of eptacog alfa (activated).
1 KIU corresponds to 1 000 IU (International Units).
What NovoSeven looks like and contents of the pack
The powder vial contains white powder and the water vial contains a clear, colorless solution. The reconstituted solution for injection is colorless. Do not use the reconstituted product if particles and discoloration are observed.
Each NovoSeven pack contains:
• 1 vial of white powder (NovoSeven) for solution for injection
• 1 vial of water (water for injections) to be reconstituted
• 1 sterile adapter for the reconstitution vial
• 1 sterile disposable syringe for reconstitution and administration
• 1 sterile infusion set
• 2 alcohol wipes wiped.
Packages: 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU).
Please look at the outer package for the quantity in this package.
Preparation of the solution
Wash your hands. Heat the vials with NovoSeven powder and water to room temperature (but not higher than 37 ° C). You can do this by holding them in your palms. Remove the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers of the vials with the alcohol wipes and let them dry before use.
A
Remove the protective label from the vial adapter without removing the adapter from the protective cap. Attach the vial adapter to the water vial. Be careful not to touch the blade adapter blade.
Then remove the protective cap from the vial adapter.
B
Pull the plunger to enter air in a volume equivalent to the amount of water in the water vial (ml is equivalent to cs on the syringe).
C
Screw the syringe firmly to the adapter attached to the water vial. Inject air into the vial by pushing the plunger until you feel sharp resistance.
D
Hold the syringe with the water vial back and pull the plunger to draw water into the syringe.
E
Remove the empty vial from the water by tapping the syringe with the vial adapter.
F
Insert the vial adapter, still attached to the syringe, onto the powder vial. Keep the syringe slightly sloping with the vial pointing down. Slowly push the plunger to inject water into the powder vial. Make sure that the jet of water is not directed directly to the NovoSeven powder as this will cause frothing.
G
Carefully rotate the vial until all the powder has dissolved. Do not shake the vial as this will cause frothing. Check the solution for visible particles and discoloration. If you notice any of the two, do not use it.
Although NovoSeven is stable for 24 hours after mixing, you should inject it immediately to avoid infection. If you do not use it immediately after mixing, you should store the vial with the attached needle in the refrigerator at 2 ° C to 8 ° C for up to 24 hours. Do not store the solution for injection without your doctor's recommendation.
Injecting the solution
H
Make sure that the plunger is fully depressed before inverting the syringe (may have been pushed out of the syringe pressure). Hold the syringe with the vial upside down and pull the plunger to withdraw the entire solution in the syringe.
I
Unscrew the vial adapter from the empty vial.
NovoSeven is already ready for injection. Follow the instructions for injection given to you by your healthcare professional.

 

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