Refixia 1000 ui polvo y disolvente para solucion inyectable
Introduction
Product Information for the User
Refixia500UI Powder and Solvent for Injectable Solution
Refixia 1000UI Powder and Solvent for Injectable Solution
Refixia 2000UI Powder and Solvent for Injectable Solution
Refixia 3000UI Powder and Solvent for Injectable Solution
nonacog beta pegol
This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4includes information on how to report these adverse effects.
Read this entire prospectus carefully before starting to use this medicine, as it contains important information for you.
•Keep this prospectus, as you may need to refer to it again.
•If you have any doubts, consult your doctor.
•This medicine has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
•If you experience adverse effects, consult your doctor, even if they are not listed in this prospectus. See section4.
1.What is Refixia and what is it used for
2.What you need to know before starting to use Refixia
3.How to use Refixia
4.Possible adverse effects
5.Storage of Refixia
6.Contents of the package and additional information
1. What is Refixia and how is it used
What is Refixia
Refixiacontains the active ingredientnonacog beta pegol. It is a prolonged-acting version of the factorIX. FactorIX is a protein naturally found in the blood that helps to stop bleeding.
How Refixia is usedRefixia
Refixia is used to treat and prevent bleeding episodes in patients of all age groups with hemophiliaB (congenital deficiency of factorIX).
In patients with hemophiliaB, the factorIX is either lacking or does not function correctly. Refixia replacesthis missing or non-functioning factorIX and helps the blood to form clots at the site of bleeding.
2. What you need to know before starting to use Refixia
No use Refixia
•If you are allergic to the active ingredient or to any of the other components of this medication (listed in section6).
•If you are allergic to hamster proteins.
If you find yourself in any of the above situations or are unsure, consult your doctor before using this medication.
Warnings and Precautions
Traceability
It is essential to maintain a record of the batch number of Refixia. Therefore, each time you obtain a new box of Refixia, you must note the date and batch number (which appears on the packaging after Lot) and store this information in a safe place.
Allergic Reactions and Inhibitor Development
A minimal risk exists of a sudden and severe allergic reaction (e.g., anaphylactic reaction) to Refixia. Stop the injection and contact your doctor or emergency services immediately if you experience signs of an allergic reaction, such as:
•Rash, hives, itching in large areas of the skin, redness, and/or swelling of the lips, tongue, face, or hands
•Difficulty swallowing or breathing, shortness of breath, wheezing, chest tightness, pale and cold skin, palpitations, and/or dizziness
Your doctor may need to treat these reactions quickly. Your doctor may also perform a blood test to check if you have developed inhibitors of factorIX (neutralizing antibodies) against your medication, as inhibitors can develop along with allergic reactions. If you develop these inhibitors, you may have a higher risk of experiencing sudden and severe allergic reactions (e.g., anaphylactic reaction) during future treatment with factorIX.
Due to the risk of experiencing allergic reactions with factorIX, your initial treatment with Refixia should be carried out in a healthcare setting or in the presence of a healthcare professional who can provide appropriate medical attention if necessary.
Inform your doctor immediately if bleeding does not stop as expected or if you need to significantly increase the amount of Refixia to stop bleeding. Your doctor will perform a blood test to check if you have developed inhibitors (neutralizing antibodies) against Refixia. The risk of developing inhibitors is higher in individuals who have not been treated with factorIX medications before, generally in young children.
Blood Clots
Inform your doctor if you experience any of the following circumstances, as the risk of blood clot formation increases during treatment with Refixia:
•You have recently undergone surgery
•You have another serious illness, such as liver disease, heart disease, or cancer
•You have risk factors for developing heart disease, such as high blood pressure, obesity, or smoking.
Renal Disease (Nephrotic Syndrome)
A minimal risk exists of developing a specific renal disease called “nephrotic syndrome” after administration of high doses of factorIX in patients with hemophiliaB and inhibitors of factorIX, as well as a history of allergic reactions.
Complications Related to the Catheter
If you have a central venous access device (DAVC), you may develop infections or blood clots at the catheter insertion site.
Other Medications and Refixia
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, breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using Refixia.
Driving and Operating Machines
Refixia has no influence on the ability to drive and operate machines.
Refixia Contains Sodium
This medication contains less than 1mmol of sodium (23mg) per vial; it is essentially “sodium-free.” In the case of treatment with multiple vials, the total sodium content should be considered.
3. How to use Refixia
A doctor with experience in treating patients with hemophilia will initiate treatment with Refixia. Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor again on how to use Refixia.
Your doctor will calculate your suitable dose based on your weight and the purpose for which the medication is being used.
Prevention of bleeding
The normal dose of Refixia is40units per kilogram of body weight. It is administered via injection once a week. Your doctor may choose another dose or change the frequency of injections according to your needs.
Treatment of bleeding
The normal dose of Refixia is40units per kilogram of body weight. It may be necessary to administer a higher dose (80units per kilogram) or additional injections depending on the location and severity of the bleeding. Consult with your doctor about the dose and number of injections you need.
Use in children and adolescents
Refixia can be used in children and adolescents of all ages. The dose in children and adolescents is also calculated based on body weight and is the same dose as for adults.
How Refixia is administered
Refixia is available in powder and solvent to prepare a solution (reconstitution) and must be injected into a vein.See “Instructions for using Refixia” for more information.
If you use more Refixia than you should
If you use more Refixia than you should, contact your doctor.
If you need to significantly increase the amount of Refixia you need to stop bleeding, inform your doctor immediately. For more information, see section2“Allergic reactions and development of inhibitors”.
If you forget to use Refixia
If you forget a dose, inject the missed dose as soon as you remember. Do not administer a double dose to compensate for the missed dose. If you have any doubts, contact your doctor.
If you interrupt treatment with Refixia
If you interrupt treatment with Refixia, you will no longer be protected against bleeding or it is possible that an existing bleeding will not stop. Do not interrupt treatment with Refixia without first speaking with your doctor.
If you have any other doubts about the use of this medication, ask your doctor.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is possible to experience allergic reactions with this medicine.
If severe and sudden allergic reactions (anaphylactic reactions) occur, the injection should be stopped immediately. If you experience any of the following early symptoms of a severe allergic reaction (anaphylaxis), contact your doctor or emergency services immediately:
•Difficulty swallowing or breathing
•Lack of air or wheezing
•Chest tightness
•Redness and/or swelling of the lips, tongue, face, or hands
•Rashes, hives, itching, or prickling
•Pale and cold skin, palpitations, and/or dizziness (low blood pressure).
For children not previously treated with factor IX medications, the generation of inhibitors (see section 2) is common (up to 1 in 10 patients). If this occurs, the medication may not work properly and your child may experience persistent bleeding. If this occurs, you should contact your doctor immediately.
The following side effects have been observed with Refixia:
Frequent side effects(may affect up to1in10people)
•Allergic reactions (hypersensitivity). This can be severe and life-threatening (anaphylactic reactions)
•Itching (pruritus)
•Skin reactions at the injection site
•Nausea
•Feeling extremely tired
•Hives
•Children not previously treated with factor IX medications: neutralizing antibodies (inhibitors), anaphylactic reactions.
Rare side effects(may affect up to1in100people)
•Palpitations
•Headaches.
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.
5. Refixia Storage
Keep this medication out of the sight and reach of children.
Do not use Refixia after the expiration date that appears on the packaging and on the vial and preloaded syringe labels after “CAD”. The expiration date is the last day of the month indicated.
Store in the refrigerator (between 2°C and 8°C). Do not freeze. Store the vial in the outer packaging to protect it from light.
Refixia can be out of the refrigerator for a maximum period of 1 year and stored at room temperature (up to 30°C). Note on the packaging the date when you removed Refixia from the refrigerator and put it at room temperature. The new expiration date should never be later than the one on the carton. Discard this medication if you have not used it before the new expiration date. After storing the medication at room temperature, do not put it back in the refrigerator.
Use the injection immediately after preparing the solution (reconstitution). If you cannot use it immediately, you must use it within 24 hours if you store it in the refrigerator between 2°C and 8°C or within 4 hours if you store it out of the refrigerator at a maximum temperature of 30°C.
The powder in the vial is a white to off-white powder. If the color of the powder has changed, do not use it.
The reconstituted solution is transparent and colorless to slightly yellow. Do not use the reconstituted solution if you observe that it contains particles or discoloration.
Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Refixia
•The active principle is nonacog beta pegol (human coagulation factor IX [ADNr] pegylated). Each vial of Refixia contains 500 UI, 1,000 UI, 2,000 UI or 3,000 UI of nonacog beta pegol, which correspond to approximately 125 UI/ml, 250 UI/ml, 500 UI/ml or 750 UI/ml respectively after reconstitution with histidine solvent.
•The other components of the powder are sodium chloride, histidine, sucrose, polisorbate 80, mannitol, sodium hydroxide and hydrochloric acid. See section 2 “Refixia contains sodium”.
•The components of the sterilized solvent are histidine, water for injection, sodium hydroxide and hydrochloric acid.
Appearance of Refixia and contents of the package
•Refixia is supplied as a powder and solvent for injectable solution (500 UI, 1,000 UI, 2,000 UI or 3,000 UI of powder in a vial and 4 ml of solvent in a pre-filled syringe, a plunger rod with a vial adapter; package size 1).
•The powder is white to off-white and the solvent is transparent and colourless.
Holder of the marketing authorization and responsible for manufacturing
Novo Nordisk A/S
Novo Allé
DK-2880Bagsværd, 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 useRefixia Read these instructions carefully before using Refixia. Refixia is supplied as a powder. Before injection, a solution (reconstituted) must be prepared with the solvent supplied in the syringe. The solvent is a histidine solution. The reconstituted solution must be injected into a vein (intravenous injection [IV]). The elements of this package are designed to reconstitute and inject Refixia. You will also need an intravenous infusion equipment (tubes and butterfly needle), sterile alcohol wipes, gauze and bandages. These materials are not included in the Refixia package. Do not use the equipment without having received proper training from your doctor or nurse. Wash your hands and always ensure that the area around you is clean. When preparing and injecting the medicine directly into the veins, it is essential to use a clean and germ-free technique (aseptic). A wrong 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 is 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. 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: •1 vial with Refixia powder •1 vial adapter •1 pre-filled syringe with solvent •1 plunger rod (located under the syringe) | |
1. Prepare the vial and syringe •Prepare the number of Refixia packages you need. •Check the expiration date. •Check the name, concentration and colour of the package to ensure it contains the correct product. •Wash your hands and dry them correctly 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 heat the vial and pre-filled syringe. | |
•Remove the plastic cap from the vial.If the plastic cap is loose or missing, do not use the vial. •Clean the rubber stopper of the vial 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 paper from the vial adapter. If the protective paper is not fully sealed or is torn, do not use the vial adapter. Do not remove the vial adapter from the protective cover with your fingers. | |
•Place the vial on a flat and hard surface. •Place the protective cover upside downand place the vial adapter firmly onto the vial. Once attached, do not remove the vial adapter from the vial. | |
•Compresslightlythe protective coverbetween your thumb and index finger, as shown. Remove the protective coverfrom the vial adapter. Do not remove the vial adapter from the vialwhen removing the protective cover. | |
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 thread of the plunger rod.If you touch the sides or thread, you may transfer germs from your fingers. •Immediately connect the plunger rod to the syringeby turning it clockwiseinside the plunger rod in the syringe until you feel resistance. | |
•Remove the syringe cap by bending it downwards 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 thesyringe cap is loose or missing, do not use the syringe. | |
•Tighten the syringe firmlyin 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 and colourless or slightly yellow and not have any visible particles.If you observe particles or a colour change, do not use it.Use a new package instead. | |
It is recommended to use Refixia immediately after reconstitution,as, if left, the medicine may no longer be sterile and could cause infections. If you cannot use the reconstituted Refixia solution immediately,you must use it within4hours if it is stored at room temperature (up to30°C) and within24hours if it is stored in the refrigerator (between2°C and8°C). Store the reconstituted product in the vial. Do not freeze the reconstituted Refixia solution or store it in syringes. Store the reconstituted Refixia solution away from direct light. If your dose requires more than one vial, repeat stepsAtoJwith more vials, vial adapters and pre-filled syringes until you reach the required dose. | |
•Keep the plunger rod fully pressed inside. •Turn the syringe with the vial pointing downwards. •Stop pushing the plunger rod and let it go backby itself while the reconstituted solution fills the syringe. •Pull the plunger rod slightly downwardsto make the reconstituted solution pass into the syringe. •If you only need a part of the vial, use the syringe scale to see the amount of reconstituted solution you have removed, as indicated by your doctor or nurse. If there is air in the syringe at any time, inject the air back into the vial. •While holding the vial pointing downwards,gently tap the syringeto make any bubbles rise to the top. •Slowly push the plunger roduntil all the bubbles have been eliminated. | |
•Remove the vial adapter from 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 Refixia is ready to be injected into a vein. •Inject the reconstituted solution according to the instructions of your doctor or nurse. •Inject slowly over1to3minutes. •Do not mix Refixia with any other infusion solution or medication administered intravenously. Injection of Refixia 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 connectors without needles that have an internal spike are incompatible with the pre-filled syringe. This incompatibility may prevent the administration of the medicine and/or cause damage to the connector without needle. Injection of the solution 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 advice of your doctor or nurse. •The injection into a DAVC may require using a sterile plastic syringe of10ml to extract the reconstituted solution. This should be done immediately after step J. •If it is necessary to flush the DAVC before or after the injection of Refixia, use a sodium chloride solution9mg/ml. | |
Disposal •After injection, dispose of the unused Refixia solution, the syringe with the intravenous infusion equipment, the vial with the vial adapter and other residues safely, following the instructions of your pharmacist. Do not throw it away in household waste. | |
Do not disassemble the equipment before disposing of it. Do not reuse the equipment. |
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