Novoeight 2000 ui polvo y disolvente para solucion inyectable
Introduction
Product Information for the User
NovoEight250UI Powder and Diluent for Injectable Solution
NovoEight500UI Powder and Diluent for Injectable Solution
NovoEight1000UI Powder and Diluent for Injectable Solution
NovoEight1500UI Powder and Diluent for Injectable Solution
NovoEight2000UI Powder and Diluent for Injectable Solution
NovoEight3000UI Powder and Diluent for Injectable Solution
turoctocog alfa (human coagulation factor VIII (ADNr))
Read this entire leaflet carefully before you start using this medicine because it contains important information for you.
–Keep this leaflet, as you may need to read it again.
–If you have any questions, ask your doctor.
–This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
–If you experience any side effects, consult your doctor, even if they are not listed in this leaflet.See section 4.
1.What is NovoEight and what it is used for
2.What you need to know before starting to use NovoEight
3.How to use NovoEight
4.Possible side effects
5.Storage of NovoEight
6.Contents of the pack and additional information
1. What is NovoEight and what is it used for
NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein that is naturally found in the blood and helps to clot.
NovoEight is used to treat and prevent bleeding episodes in patients with hemophilia A (congenital deficiency of factor VIII) and can be used in all age groups.
In patients with hemophilia A, factor VIII is either lacking or does not function correctly.NovoEight replaces this “lacking or not functioning correctly factor VIII” and helps the blood to form clots at the bleeding site.
2. What you need to know before starting to use NovoEight
Do not use NovoEight:
•If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)
•If you are allergic to hamster proteins.
Do not use NovoEight in any of the above cases.If you are unsure, speak with your doctor before starting to use this medication.
Warnings and precautions
Consult your doctor before starting to use NovoEight.
There is a very small chance of anaphylactic reaction (a sudden and severe allergic reaction) to NovoEight.The first signs of allergic reaction are rash, hives, itching, generalized hives, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general feeling of discomfort, and dizziness.
If any of these symptoms occur, stop the injection immediately and contact your doctor.
Speak with your doctor if you believe the bleeding is not controlled with the dose you are given, as there may be different reasons for this.Some people who use this medication may develop antibodies against factor VIII (also known as inhibitors of factor VIII).Inhibitors of factor VIII reduce the effectiveness of NovoEight for preventing or controlling bleeding.If this happens, you may need a higher dose of NovoEight or another medication to control bleeding.Do not increase the total dose of NovoEight to control bleeding without speaking with your doctor.You must inform your doctor if you have been previously treated with factor VIII medications, especially if you have developed inhibitors, as the risk of this happening again is higher.
The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medications. These inhibitors, especially in large quantities, prevent the treatment from working correctly, so you and your child will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not being controlled with NovoEight, consult your doctor immediately.
Other medications andNovoEight
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you believe you may be pregnant or intend to become pregnant, consult your doctor before using this medication.
Driving and operating machinery
The influence of NovoEight on the ability to drive and operate machinery is none.
NovoEight contains sodium
This medication contains 30.5mg of sodium (main component of table salt/for cooking) per reconstituted vial. This is equivalent to 1.5% of the maximum daily sodium intake recommended for an adult.
If you follow a sodium-controlled diet, speak with your doctor.
3. How to Use NovoEight
A doctor experienced in treating patients with hemophilia A will initiate treatment with NovoEight. Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.
Your doctor will calculate the dose for you based on your weight and the intended use of the medication.
Prevention of Bleeding
The usual dose of NovoEight is 20 to 50 units per kilogram of body weight.The injection is administered every 2 or 3 days.In some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
Treatment of Bleeding
The dose of NovoEight is calculated based on body weight and desired factor VIII levels.The desired factor VIII levels 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 (under 12 years old), higher doses or more frequent injections may be necessary.Adolescents (over 12 years old) can use the same dose as adults.
How to Administer NovoEight
NovoEight must be injected into a vein.See “NovoEight Use Instructions” for more information.
If You Use More NovoEight Than You Should
If you use more NovoEight than you should, contact your doctor or go directly to the hospital.
If You Forget to Use NovoEight
If you have missed a dose and are unsure how to compensate, contact your doctor.
If You Interrupt Treatment with NovoEight
If you interrupt treatment with NovoEight, you will no longer be protected against bleeding, and it is possible that an existing bleeding episode will not stop.Do not interrupt treatment with NovoEight without first speaking with your doctor.
If you have any other questions about using this medication, ask your doctor.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.This medicine can cause the following side effects.
If anaphylactic reactions (severe and sudden allergic reactions) occur (rarely), the injection should be stopped immediately.If you experience any of the following symptoms, contact your doctor immediately:
•Difficulty breathing, difficult breathing, or wheezing
•Chest tightness
•Swelling of the lips and tongue
•Rashes, hives, generalized itching, or generalized prickling
•Dizziness or loss of consciousness
•Low blood pressure (pale and cold skin, palpitations)
Severe symptoms, including difficulty swallowing or breathing and facial or hand swelling, require immediate urgent treatment.
If you experience a severe allergic reaction, your doctor may change your medication.
In children not previously treated with Factor VIII medications, inhibitors (see section 2) may form with high frequency (more than 1 in 10 patients); however, in patients who have received previous treatment with Factor VIII (more than 150 days of treatment), the risk is rare (less than 1 in 100 patients). If this happens to you or your child, the treatment may not work properly and you or your child may experience persistent bleeding. If this happens, contact your doctor immediately.
Frequent side effects (may affect up to 1 in 10 people)
•Liver function changes indicated by blood tests
•Reactions (redness and itching) at the site where the medication was injected.
Frequent side effects (may affect up to 1 in 10 people) in patients not previously treated with Factor VIII medications
•Skin redness
•Vein inflammation
•Bleeding in the joints
•Bleeding in the muscle tissue
•Cough
•Redness around the site where the catheter was placed
•Vomiting.
Rare side effects (may affect up to 1 in 100 people)
•Feeling tired
•Headache
•Dizziness
•Difficulty sleeping (insomnia)
•Palpitations
•Increased blood pressure
•Rash
•Fever
•Sensation of heat
•Muscle stiffness
•Muscle pain
•Pain in arms and legs
•Swelling in arms and legs
•Joint disease
•Cardinal signs
•Myocardial infarction.
Side effects in children and adolescents
The side effects observed in children and adolescents are the same as those observed in adults.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the 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 medication.
5. Conservation of NovoEight
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date that appears on the packaging and on the vial and pre-filled syringe labels after CAD.The expiration date is the last day of the month indicated.
Store in refrigerator (between 2°C and 8°C).
Do not freeze.
Store the vial in the outer packaging to protect it from light.
Before reconstituting, NovoEight powder can be stored at:
•room temperature (≤30°C) for a single period not exceeding 9months
or
•above room temperature (from 30°C to 40°C) for a single period not exceeding 3months.
Once the product is removed from the refrigerator, it should not be re-refrigerated.
Please note the start of storage date and storage temperature on the product packaging.
Once reconstituted, NovoEight must be used immediately.If you cannot use the reconstituted NovoEight solution immediately, you should use it in:
•24hours stored between 2°C and 8°C
•4hours stored at ≤ 30ºC, for the product that has been stored for a single period not exceeding 9months at room temperature (≤30°C).
•4hours stored up to 40ºC, for the product that has been stored for a single period not exceeding 3months above room temperature (from 30°C to 40°C).
If you are not going to use the reconstituted medication immediately, store it in the vial. Otherwise, it will no longer be sterile and could cause an infection. Do not store the solution unless you follow your doctor's advice.
The powder in the vial is a white or slightly yellow powder. If the powder color has changed, do not use it.
The reconstituted solution will be transparent to slightly opalescent.Do not use this medication if you observe that it is cloudy or contains visible particles.
Medicines should not be thrown away through drains or in the trash.Ask your pharmacist how to dispose of the packaging and medications that you no longer need.This will help protect the environment.
6. Contents of the packaging and additional information
Composition of NovoEight
–The active ingredient is turoctocog alfa (human coagulation factor VIII (ADNr)).Each vial of NovoEight contains 250, 500, 1000, 1500, 2000 or 3000UI of turoctocog alfa.
–The other components are L-histidine, sucrose, polisorbate 80, sodium chloride, L-methionine, dihydrate calcium chloride, sodium hydroxide, and hydrochloric acid.
–The components of the solvent are sodium chloride and water for injection.
After reconstitution with the supplied solvent (sodium chloride 9mg/ml (0.9%)), the prepared injectable solution contains 62.5, 125, 250, 375, 500 or 750UI of turoctocog alfa per ml respectively (based on the concentration of turoctocog alfa, that is, 250, 500, 1000, 1500, 2000 or 3000UI).
Appearance of the product and contents of the package
NovoEight is a powder and solvent for injectable solution. Each package of NovoEight contains a vial with white or slightly yellow powder, a pre-filled syringe with 4ml of a colorless and transparent solution, a plunger rod, and a vial adapter.
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 NovoEight READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT. NovoEight is supplied as a powder.Before injection (administration), it must be reconstituted with the supplied solvent in the syringe.The solvent is a sodium chloride 9mg/ml (0.9%) solution.NovoEight reconstituted must be injected into a vein (intravenous injection).The elements of this package are designed to reconstitute and inject NovoEight. You will also need a perfusion set (tubes and butterfly needle), sterile alcohol wipes, gauze, and bandages.These devices are not included in the NovoEight package. Do not use the equipment without having received proper training from your doctor or nurse. Wash your hands and make sure the area around you is clean. When preparing and injecting the medication directly into the veins, it is essentialto use a clean and germ-free (aseptic) technique.A poor technique may introduce germs capable of infecting the blood. Do not open the equipment until you are ready to use it. Do not use the equipment if it has fallen or been damaged.Use a new package instead. Do not use the equipment if it has expired.Use a new package instead.The expiration date is printed on the outer packaging, the vial, the vial adapter, and the pre-filled syringe after CAD. Do not use the equipment if you suspect it is contaminated.Use a new package instead. Do not dispose of any element until the reconstituted solution has been injected. The equipment is for single use only. | |
Contents The package contains: •1vial with NovoEight powder •1vial adapter •1pre-filled syringe with solvent •1plunger rod (located under the syringe) | |
1.Prepare the vial and syringe •Prepare the number of NovoEight packages you need.. •Check the expiration date. •Check the name, concentration, and colorof the package to ensure it contains the correct product. •Wash your handsand dry them properly with a clean towel or air. •Remove the vial, vial adapter, and pre-filled syringe from the package.Leave the plunger rod untouched in the package. •Take the vial and pre-filled syringe to room temperature.You can do this by holding both 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 stopper with a sterile alcohol wipeand let it dry in the air for a few seconds before using it to ensure it is as free of germs as possible. •Do not touch the rubber stopper with your fingers, as this may transfer germs. | |
2.Place the vial adapter •Remove the protective paperfrom the vial adapter. If the protective paperis not fully sealed or is torn, do not use the vial adapter. Do not remove the vial adapter from its protective covering with your fingers.If you touch the spike of the vial adapter, you may transfer germs from your fingers. | |
•Place the vial on a flat, hard surface. •Place the protective covering of the vial adapter upside downand place the vial adapter firmly onto the vial. Once attached, do not remove the vial adapter from the vial. | |
•Compressgentlythe protective coveringbetween your thumb and index finger as shown. Remove the protective coveringfrom the vial adapter. Do not remove the vial adapterwhen removing the protective covering. | |
3.Mount the plunger rod and syringe •Hold the plunger rod by the wide end and remove it from the package.Do not touch the sides or the threads of the plunger rod.If you touch the sides or threads, you may transfer germs from your fingers. •Immediately connect the plunger rod to the syringe by turning it to the right inside the plunger in the syringe until you feel resistance. | |
•Remove the syringe capby bending it down until the perforation breaks. •Do not touch the tip of the syringe below the syringe cap.If you touch the tip of the syringe, you may transfer germs from your fingers. If the syringe cap is loose or missing, do not use the syringe. | |
•Tighten the syringefirmlyonto the vial adapter until you feel resistance. | |
4.Reconstitute the powder with the solvent •Hold the syringe slightly tiltedwith the vial pointing downwards. •Press the plunger rodto inject all the solvent into the vial. | |
•Keep the plunger rod pressed and gently removethe vial until the powder has dissolved. Do not shake the vial, as this would produce foam. •Check the reconstituted solution.It should be transparent or slightly opalescent (slightly less transparent).If it appears cloudy or contains visible particles, do not use it.Use a new package instead. | |
It is recommended to use NovoEight immediately after reconstituting it,as, if left, the medication may no longer be sterile and could cause infections. If you cannot use the reconstituted NovoEight solution immediately, you must use it within 4hours if it is stored at room temperature or up to 40°C, and within 24hours if it is stored between 2°C and 8°C.Store the reconstituted product in the vial. Do not freeze the reconstituted NovoEight solution or store it in syringes. Do not store the solution without consulting your doctor. Store the reconstituted NovoEight solution away from direct light. If your dose requires more than one vial, repeat stepsAtoJwith additional vials, vial adapters, and pre-filled syringes until you reach the required dose. | |
•Keep the plunger rod pushed all the way in. •Place the syringewith the vial upside down. •Release the plunger rod and let it returnby itself while the reconstituted solution fills the syringe. •Pull the plunger rod slightly downwardsto make the reconstituted solution flow into the syringe. •If you only need a portion of the vial, use the syringe scale to see the amount of reconstituted solution you have removed, as instructed by your doctor or nurse. If there is too much air in the syringe at any time, inject the air back into the vial. •While holding the vial upside down,gently tap the syringeto allow any bubbles to rise to the top. •Slowly push the plunger roduntil all the bubbles have been removed. | |
•Remove the vial adapterfrom the vial. •Do not touch the tip of the syringe.If you touch the tip of the syringe, you may transfer germs from your fingers. | |
5.Inject the reconstituted solution Now NovoEight is ready to be injected into a vein. •Inject the reconstituted solution according to the instructions of your doctor or nurse. •Inject slowly over 2 to 5minutes. •Do not mix NovoEight with any other infusion or medication by intravenous injection. Injection of NovoEight through connectors without needles 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 medication and/or damage the needleless connector. Injection of the solution through acentral venous access device (DAVC)such as a central venous catheter or subcutaneous port: • Use a clean and germ-free (aseptic) technique. Follow the instructions for the proper use of your connector andDAVCwith the guidance of your doctor or nurse. •The injection into aDAVCmay require using a sterile 10ml plastic syringe to extract the reconstituted solution. This should be done immediately after step J. •If it is necessary to flush theDAVCline before or after the injection of NovoEight, use a sodium chloride 9mg/ml solution for injection. | |
Disposal •After injection, dispose of the unused NovoEight solution, syringe with perfusion set, vial with vial adapter, and other residues safely, following the instructions of your pharmacist. Do not dispose of them as ordinary household waste. | |
Do not disassemble the equipment before disposing of it. Do not reuse the equipment. |
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