Novoseven 1 mg (50 kui) polvo y disolvente para solucion inyectable
Introduction
Label: Information for the User
NovoSeven 1mg (50UI/mL) powder and diluent for injectable solution
NovoSeven 2mg (100UI/mL) powder and diluent for injectable solution
NovoSeven 5mg (250UI/mL) powder and diluent for injectable solution
NovoSeven 8mg (400UI/mL) powder and diluent for injectable solution
eptacog alfa (activated)
Read this label carefully before starting to use this medicine, as it contains important information for you.
•Keep this label, as you may need to read it again.
•If you have any questions, consult your doctor.
•This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
•If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.
1.What is NovoSeven and how is it used
2.What you need to know before starting to use NovoSeven
3.How to use NovoSeven
4.Possible adverse effects
5.Storage of NovoSeven
6.Contents of the package and additional information
Back: Instructions for use of NovoSeven
1. What is NovoSeven and what is it used for
NovoSeven is a blood coagulation factor.It acts by activating the blood coagulation system at the site of bleeding when the patient's own coagulation factors do not function.
NovoSeven is used forthe treatment of bleeding and the prevention of excessive bleeding after surgical interventions or other important treatments. Early treatment with NovoSeven reduces the amount and duration of bleeding. It works for all types of bleeding, including joint bleeding. This reduces the need for hospitalization and days of absence from work or school.
It is used in certain groups of people:
•If you havecongenital hemophiliaand do not respond normally to treatment with factors VIII or IX
•If you haveacquired hemophilia
•If you haveFactor VII deficiency
•If you haveGlanzmann's thrombasthenia(a bleeding disorder) and your condition cannot be effectively treated with platelet transfusions, or if platelets are not readily available.
NovoSeven may also be administered by a doctor to treat excessive bleeding after delivery, even if you do not have a bleeding disorder.
2. What you need to know before starting to use NovoSeven
No use NovoSeven
•If you are allergic to eptacog alfa (the active ingredient in NovoSeven) or to any of the other components of this medication (listed in section 6).
•If you are allergic to mouse, hamster, or bovine proteins (such as cow's milk).
?If this happens, do not use NovoSeven. Consult your doctor.
Warnings and precautions
Before starting treatment with NovoSeven, make sure your doctor knows:
•If you have recently undergone surgery
•If you have recently suffered a crushing injury
•If your arteries are narrower due to a disease (atherosclerosis)
•If you have a higher risk of blood clot formation (thrombosis)
•If you have severe liver disease
•If you have severe septicemia
•If you are prone to disseminated intravascular coagulation (DIC, a condition in which blood clots form in the bloodstream) you should be closely monitored.
?If this happens, inform your doctor before using this product.
Other medications and NovoSeven
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Do not use NovoSeven at the same time asprothrombin complex concentratesorrFXIII. You should consult with your doctor before using NovoSeven if you also use factor VIII or IX.
There is limited experience with the use of NovoSeven with other medications called antifibrinolytics (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding. You should consult with your doctor before using NovoSeven with these medications.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using NovoSeven.
Driving and operating machinery
There are no studies on the effects of NovoSeven on the ability to drive and operate machinery. However, there is no medical reason to think it could affect your ability.
NovoSeven contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per injection, which is essentially "sodium-free".
3. How to use NovoSeven
The NovoSeven powder must be reconstituted with the solvent and administered intravenously.See the detailed instructions on the back.
When to treat
Begin treatment for bleeding as soon as possible, ideally within the first 2 hours.
•In the case of mild or moderate bleeding, treat yourself as soon as possible, preferably at home.
•In the case of severe bleeding, contact your doctor. Normally, severe bleeding is treated in the hospital and you can administer the first dose of NovoSeven on the way there.
You should not treat for more than 24 hours without consulting your doctor.
•Each time you use NovoSeven, inform your doctor or hospital as soon as possible.
•If bleeding is not controlled within the first 24 hours, contact your doctor immediately.Generally, you will need hospital care.
Dose
The first dose should be administered as soon as possible after the onset of bleeding..Consult your doctor about when to administer injections and how long to continue using them.
Your doctor will set your dose based on your body weight, condition, and type of bleeding.
To achieve the best results, follow the prescribed dose carefully. Your doctor may change the dose.
If you have hemophilia:
The usual dose is 90 micrograms per kilogram of body weight; you can repeat the injection every 2-3 hours until bleeding is controlled.
Your doctor may recommend a single dose of 270 micrograms per kilogram of body weight. There is no clinical experience with this single dose in people over 65 years old.
If you have Factor VII deficiency:
The normal dose range is 15-30 micrograms per kilogram of body weight, per injection.
If you have Glanzmann's thrombasthenia:
The usual dose is 90 micrograms (range of 80 to 120 micrograms) per kilogram of body weight, per injection.
If more NovoSeven is injected than necessary
If an excess of NovoSeven is injected, consult your doctor immediately.
If you forget to administer a NovoSeven injection
If you forget to administer a NovoSeven injection or want to interrupt treatment, consult your doctor immediately.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
Severe side effects
Rare(may affect up to 1 in 1,000 episodes treated)
•Allergy, hypersensitivity, or anaphylactic reactions. Symptoms may include skin rashes, itching, redness, and urticaria; sounds in the chest or difficulty breathing; feeling of dizziness or vertigo, and intense swelling of the lips or throat, or at the injection site.
•Blood clots in the arteries of the heart (which may lead to a heart attack or angina pectoris), in the brain (which may lead to a stroke) or in the intestines and kidneys. Symptoms may include intense chest pain, difficulty breathing, confusion, difficulty with speech or movement (paralysis) or abdominal pain.
Poorly frequent(may affect up to 1 in 100 episodes treated)
•Blood clots in the veins of the lungs, legs, liver, kidneys, or at the injection site. Symptoms may include difficulty breathing, red and painful swelling in the leg, and abdominal pain.
•Lack of efficacy or reduced response to treatment.
?If you experience any of these severe side effects, seek medical help immediately. Explain that you have been using NovoSeven.
Remember to inform your doctorif you have a history of allergic reactionsas you may need more thorough monitoring.In the vast majority of reported thrombosis cases, patients had a predisposition to suffer thrombotic disorders.
Other rare side effects
(may affect up to 1 in 1,000 episodes treated)
•Nausea (feeling dizzy)
•Headache
•Changes in some blood and liver test results.
Other poorly frequent side effects
(may affect up to 1 in 100 episodes treated)
•Skin rashes, including hives, itching, and urticaria
•Fever.
Reporting of side effects
If you experience any type of side effect, consultyour doctor, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of NovoSeven
•Keep this medication out of the sight and reach of children.
•Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.
•Store the powder and solvent below 25°C.
•Store the powder and solvent protected from light.
•Do not freeze.
•Use NovoSeven immediately after mixing the powder with the solvent to prevent infections. If you cannot use it immediately, after mixing, it must be stored in the vial with the vial adapter and the syringe still attached, in the refrigerator between 2°C and 8°C, for a maximum of 24hours. Do not freeze the reconstituted NovoSeven solution and keep it protected from light. Do not store the solution without consulting your doctor or nurse.
•Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of NovoSeven
•The active ingredientis recombinant activated factor VIIa (eptacog alfa activated).
•The other componentsin the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polisorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide. The components of the solvent are histidine, hydrochloric acid, sodium hydroxide, and water for injection.
The powder for injectable solution contains: 1mg/vial (which corresponds to 50UI/vial), 2mg/vial (which corresponds to 100UI/vial), 5mg/vial (which corresponds to 250UI/vial), or 8mg/vial (which corresponds to 400UI/vial).
After reconstitution, 1ml of the solution contains 1mg of eptacog alfa (activated).
1UI is equal to 1,000UI (International Units).
Appearance of NovoSeven and contents of the package
The vial of powder contains white powder, and the pre-filled syringe contains a transparent and colorless solution. The reconstituted solution is colorless. Do not use the reconstituted solution if it contains particles or is discolored.
Each package of NovoSeven contains:
•1vial with white powder for injectable solution
•1 adapter for the vial
•1pre-filled syringe with solvent for reconstitution
•1 plunger
Presentation:1mg (50UI), 2mg (100UI), 5mg (250UI), and 8mg (400UI).
The current presentation is indicated on the outer packaging.
Holder of the marketing authorization and responsible for manufacturing
Novo Nordisk A/S
Novo Allé
DK‑2880 Bagsværd, Denmark
Date of the last review of this leaflet:
Other sources of information
The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
Instructions for use of NovoSeven READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN NovoSeven is presented in powder form. Before injection (administration), it must be reconstituted with the solvent that comes with the syringe. The solvent is a histidine solution. The reconstitution of NovoSeven must be injected into a vein (intravenous injection). The equipment in this package is designed to reconstitute and inject NovoSeven. You will also need administration equipment (catheter and butterfly needle, sterile alcohol wipes, gauze pads, and bandages). These materials are not included in the NovoSeven package. Do not use the equipment without proper training from your doctor or nurse. Wash your hands and make sure the area around you is clean. When preparing and injecting a medicine directly into a vein, it is essentialto use a clean and germ-free technique (aseptic).A non-sterile technique can introduce germs that can infect the blood. Do not open the equipment until you are ready to use it. Do not use the equipment if it has fallen or is damaged.In that case, use a new package. Do not use the equipment if it has expired.In that case, use a new package.The expiration date is printed after CAD on the carton box, on the vial, on the vial adapter, and on the pre-filled syringe. Do not use the equipment if you suspect it is contaminated.In that case, use a new package. Do not dispose of any of the materials until the reconstituted solution has been injected. The equipment is for single use only. | |
Contents The package contains: •1vial with NovoSeven powder •1 vial adapter •1 pre-filled syringe with solvent •1 plunger (placed below the syringe) | |
1. Prepare the vial and syringe •Take out the number of NovoSeven packages you will need. •Check the expiration date. •Check the name, concentration, and colorof the package, to make sure it contains the correct product. •Wash your handsand dry them well with a clean towel or air. •Take out the vial, vial adapter, and pre-filled syringe from the package.Leave the plunger untouched in the package. •Take the vial and pre-filled syringe to room temperature(not above 37°C). You can do this by holding them in your hands until you feel they are at the same temperature as your hands. •Do not use any other system to heatthe vial and pre-filled syringe. | |
•Remove the plastic capfrom the vial. If the plastic cap is loose or missing, do not use the vial. •Clean the rubber stopperwith a sterile alcohol wipe and let it dry for a few seconds before use to make sure it is as free of germs as possible. •Do not touch the rubber stopper with your fingers, as this can transfer germs from your fingers. | |
2. Place the vial adapter •Remove the paper sealfrom the vial adapter. If the paper seal is not completely sealed or is torn, do not use the vial adapter. Do not remove the vial adapter from the protective cap with your fingers.If you touch the spike of the vial adapter, you can transfer germs from your fingers. | |
•Place the vial on a flat and solid surface. •Turn the protective capover, and insert the vial adapter into the vial. Once they are connected, do not remove the vial adapter from the vial. | |
•Pressgentlythe protective capbetween your thumb and index finger as shown in the drawing. Remove the protective capfrom the vial adapter. Do not remove the vial adapter from the vialwhen removing the protective cap. | |
3. Place the plunger in the syringe •Hold the plunger by the wide end and take it out of the package.Do not touch the sides or the threads of the plunger. If you touch the sides or threads, you can transfer germs from your fingers. Connectimmediatelythe plunger with the syringe by turning itclockwise in the piston inside the pre-filled syringe until you feel resistance. | |
•Remove the syringe capfrom the pre-filled syringedoubling it down until the perforation breaks. Do not touch the tip of the syringe under the syringe cap.If you touch the tip of the syringe, you can transfer germs from your fingers. If the syringe cap is loose or missing, do not use the pre-filled syringe. | |
•Tightenthe pre-filled syringe firmlyin the vial adapter until you feel resistance. | |
4. Reconstitute the powder with the solvent •Hold the pre-filled syringe slightly inclinedwith the vial downwards. •Press the plungerto inject all the solvent into the vial. | |
•Keep the plunger pressed and make gentle circularmovements with the vial until all the powder is dissolved. Do not shake the vial, as this can produce foam. •Check the reconstituted solution.It should be colorless.If you see particles or a change in color, do not use it.In that case, use a new package. | |
Use the reconstituted NovoSeven immediatelyto avoid infections. If you cannot use it immediately,see section 5Storage of NovoSevenon the other side of this leaflet. Do not store the reconstituted solution without consulting your doctor or nurse. (I) If your dose requires more than one vial, repeat the steps from A to J with additional vials, vial adapters, and pre-filled syringes until you reach the required dose. | |
•Keep the plunger pressed all the way down. •Turn the syringewith the vial upside down. •Release the plunger and letit slide on its ownwhile the reconstituted solution passes into the syringe. •Pull the plunger slightly downwardsto pass all the reconstituted solution into the syringe. •On the syringe scale, see how much reconstituted solution you extract, as your doctor or nurse has taught you. •If, at any time, there is too much air in the syringe, inject the air back into the vial. •While holding the vial upside down,gently tapthe syringe to make the air bubbles rise. •Press the plunger slowlyuntil there are no air bubbles left | |
•Loosen the vial adapterfrom the vial. •Do not touch the tip of the syringe.If you touch the tip of the syringe, you can transfer germs from your fingers. | |
Injection of NovoSeven with pre-filled syringe through needleless connectors for intravenous catheters (IV) Warning:The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connectors. Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility may prevent the administration of the drug and/or damage the needleless connector. Follow the instructions for use of the needleless connector. Administration through a needleless connector may require extracting the reconstituted solution with a sterile 10ml luer-lock syringe. This should be done immediately after step J. | |
5. Inject the reconstituted solution NovoSeven is now ready to be injected into a vein. •Inject the reconstituted solution according to your doctor's or nurse's instructions. •Inject slowly over 2 to 5minutes. Administration through a central venous access device (DAVC) such as a central venous catheter or subcutaneous port: • Use a clean and germ-free technique (aseptic). Follow the instructions for the proper use of your connector and DAVC with the guidance of your doctor or nurse. • Administration through a DAVC may require using a sterile 10ml syringe to extract the reconstituted solution. • If it is necessary to flush the DAVC line before or after injecting NovoSeven, use sodium chloride 9mg/ml for injection. | |
Disposal •After injection, disposeof the syringe with the administration equipment, the vial with the vial adapter, the unused NovoSeven, and other waste according to your doctor's or nurse's instructions. • Do not throw it away with household waste. | |
Do not disassemble the equipment before disposing of it. Do not reuse the equipment. |
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