250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection moroctocog
alfa ( recombinant human coagulation factor VIII)
What ReFacto AF is and what it is used for
ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII. Factor VIII is necessary for your blood to coagulate and stop bleeding. In patients with hemophilia A (congenital factor VIII deficiency), factor VIII is missing or not working properly.
ReFacto AF is used to treat and prevent bleeding ( prophylaxis ) in adults and children of all ages (including newborns) with hemophilia A.
What you need to know before using ReFacto AF
Do not use ReFacto AF
- if you are allergic to moroctocog alfa or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to protein you are from hamsters.
If you have any further questions, ask your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before using ReFacto AF
- if you get allergic reactions. Signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives, itching, tightness in the chest, wheezing, and low blood pressure. Anaphylaxis is a severe allergic reaction that can make it difficult to swallow and/or breathe, and make you red or swollen on the face and/or hands. If you get any of these signs, stop the infusion immediately and contact a doctor or go to the emergency department immediately. In case of severe allergic reactions, an alternative treatment must be considered.
- 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 ReFacto AF, tell your doctor immediately.
- if your bleeding does not stop as expected, contact a doctor or seek emergency care immediately.
Other medicines and ReFacto AF
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
ReFacto AF does not influence the ability to drive or use machines.
ReFacto AF contains sodium
After reconstitution, ReFacto AF contains 1.27 mmol (or 29 mg) sodium (the main ingredient in table salt / table salt) per vial . This corresponds to 1.5% of the maximum recommended daily intake of sodium for adults. Depending on your body weight and your dose of ReFacto AF, you may receive several vials. This should be considered if you have been prescribed a low-salt diet.
How to use ReFacto AF
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Treatment with ReFacto AF should be initiated by a doctor who has experience in caring for patients with hemophilia A. Your doctor will decide what dose of ReFacto AF you should have. The dose and duration of treatment depend on your individual need for factor VIII replacement therapy. ReFacto AF is given by injection into a vein lasting several minutes. The patient or their carer can give the injections with ReFacto AF, provided they have received appropriate training in this.
Your doctor may change the dose of ReFacto AF during treatment.
Consult healthcare professionals before making a trip. You should bring enough factor VIII product with you for expected treatment when you travel.
Each time you use ReFacto AF you should note the name of the carton and the product batch number. You can use one of the removable labels on the vial to document the batch number in your diary or to report any side effects.
Preparation and administration
The instructions below are guidelines for the preparation and administration of ReFacto AF. Follow your doctor’s instructions for the preparation and administration of ReFacto AF.
Use only the pre-filled syringe in the package for reconstitution. Other sterile disposable syringes may be used for administration.
ReFacto AF is given as an intravenous infusion after reconstitution of the lyophilized powder for injection with the supplied syringe of solvent [sodium chloride 9 mg/ml (0.9%) solution]. ReFacto AF must not be mixed with other infusion fluids.
Always wash your hands before performing the preparation and administration below. The aseptic technique (ie clean and germ-free) should be used during reconstitution.
Preparation:
Allow the vial of ReFacto AF powder and the pre-filled solvent syringe to reach room temperature.
2. Remove the plastic cap from the ReFacto AF bottle so that the middle part of the rubber stopper is visible.
3. Clean the stopper with the supplied alcohol swab or use another antiseptic solution and allow it to dry. Do not allow your hand to touch the stopper after cleaning and do not allow it to come in contact with any surface.
4. Remove the cap from the transparent plastic package of the bottle adapter. Do not remove the adapter from the package.
5. Place the bottle on a flat surface. Hold the adapter package and place the bottle adapter over the bottle. Press firmly down on the package until the adapter snaps onto the top of the bottle and the adapter needle goes through the rubber stopper of the bottle.
6. Lift the package of the adapter and discard the package.
7. Screw the piston rod onto the solvent syringe by inserting the rod into the opening of the syringe stopper and push and turn the rod firmly until it is securely attached to the stopper.
8. Break the safety plastic cap from the solvent syringe by breaking the perforation on the cap. This is done by bending upwards and downwards until the perforation is broken. Do not touch the inside of the cap or the top of the syringe. The cap may need to be used again (unless the reconstituted ReFacto AF is administered immediately), so set it aside by placing it on top.
9. Place the bottle on a flat surface. Attach the solvent syringe to the bottle adapter by placing the tip of the syringe in the adapter opening while pressing firmly and screwing the syringe clockwise until it is firmly seated.
10. Slowly push the plunger rod down so that all the solvent is injected into the ReFacto AF bottle.
11. Leave the syringe in the adapter and swirl the bottle gently until the powder has dissolved.
12. The finished solution should be inspected visually for particulate matter before administration. The solution should be ready to be slightly opalescent and colorless.
Note: If you use more than one bottle of ReFacto AF per infusion, each bottle should be prepared according to the previous instructions. The solvent syringe should be removed, the bottle adapter left in place, and a single large Luer syringe can be used to withdraw the reconstituted contents from each bottle.
13. Check that the plunger rod of the syringe is still fully depressed and turn the bottle upside down. Slowly pull up all the solution in the syringe through the bottle adapter.
14. Remove the syringe from the bottle adapter by gently pulling and screwing the syringe counterclockwise. Discard the bottle with its fitted adapter.
Note: If the solution is not to be used immediately, the spray cap should be carefully put back in place. Do not bring your fingers to the top of the syringe or the inside of the cap.
ReFacto AF must be used within three hours after reconstitution. The reconstituted solution can be stored at room temperature before administration.
Administration ( Intravenous infusion ):
ReFacto AF should be administered with the infusion set provided in the kit and the supplied pre-filled syringe with solvent or a single sterile disposable Luer lock model syringe.
Attach the syringe to the lower end of the infusion set tubing.
Attach a stasis tube and prepare the injection site by wiping the skin well with one of the alcohol compresses in the kit.
Insert the needle of the infusion line into the vein according to the doctor’s instructions and remove the stasis tube. Remove air from the infusion set by pulling back on the syringe. The reconstituted product should be injected intravenously over several minutes. Your doctor may change your recommended infusion rate to make your infusion more comfortable.
Any unused solution, empty bottle, used needles, and syringes should be discarded in a suitable container for medical waste, as they may harm others if not disposed of properly.
If you use more ReFacto AF than you should
Consult a doctor or pharmacist.
If you stop using ReFacto AF
Do not stop using ReFacto AF without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If severe, sudden allergic reactions (anaphylactic) occur, the infusion must be stopped immediately. You must contact a doctor immediately if you get any of the following early symptoms of an allergic reaction:
- rash, hives, general itching
- swelling of the lips and tongue
- difficulty breathing, wheezing, feeling of tightness in the chest
- general malaise
- dizziness, unconsciousness
Severe symptoms, such as difficulty breathing and (almost) fainting, require immediate medical attention. Severe, sudden allergic reactions (anaphylactic) are less common (may affect up to 1 in 100 people).
Inhibitor development
In children who have not been previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less common (less than 1 in 100 users). If you or your child develop antibodies, the medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, consult a doctor immediately.
Very common side effects ( may affect more than 1 user in 10)
- inhibitor development in patients who have not been previously treated with factor VIII products
- headache
- cough
- joint pain
- fever.
Common side effects ( may affect up to 1 in 10 people)
- bleeding
- dizziness
- decreased appetite, diarrhea, vomiting, abdominal pain, nausea
- hives, rash, itching
- muscle pain
- chills, reaction at the catheter site
- Some blood tests may show an increase in the number of antibodies to factor VIII.
Uncommon side effects ( may affect up to 1 in 100 people)
- inhibitor development in patients who have previously been treated with factor VIII products (less than 1 in 100 users)
- severe allergic reaction
- numbness, drowsiness, altered taste experience
- chest pain, fast heart rate, palpitations
- low blood pressure, pain, and redness in a vein associated with a blood clot, hot flashes
- shortness of breath
- heavy sweating
- weakness, injection site reactions including pain
- slight increase in cardiac enzymes
- increased liver enzyme values increased bilirubin.
How to store ReFacto AF
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 ° C-8 ° C). Do not freeze (to avoid damaging the pre-filled syringe with solvent).
If necessary, the drug can be taken out of the refrigerator and stored for a continuous period of a maximum of three months at room temperature (maximum 25 ° C). At the end of the storage period at room temperature, the product must not be put back in the refrigerator but must be used or discarded. Make a note on the outer carton of the date when the ReFacto AF is removed from the refrigerator and stored at room temperature (maximum 25 ° C).
Keep the vial in the outer carton. Sensitive to light.
Use the reconstituted solution within three hours after reconstitution.
The solution should be clear to slightly opalescent and colorless. Do not use this medicine if you notice that it is cloudy or contains visible particles.
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 moroctocog alfa ( recombinant coagulation factor VIII). One bottle of ReFacto AF nominally contains 250, 500, 1000, or 2000 IU moroctocog alfa.
- The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, and sodium chloride (see section 2 “ReFacto AF contains sodium”). A solvent [sodium chloride 9 mg / ml (0.9%) solution for injection ] is provided for reconstitution .
- After reconstitution with the supplied solvent [sodium chloride 9 mg / ml (0.9%) solution], one vial contains 62.5, 125, 250 and 500 IU respectively (based on the potency of moroctocog alfa, ie 250, 500, 1000 or 2000 IU). IU) moroctocog alfa per 1 ml reconstituted solution for injection.
What the medicine looks like and the contents of the pack
ReFacto AF is supplied as a powder for injection in a glass vial and a solvent is supplied in a pre-filled syringe.
The package contains:
- one bottle of moroctocog alfa 250, 500, 1000, or 2000 IU powder
- a pre-filled syringe of solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9%) solution for injection, with a plunger rod
- a sterile bottle adapter device for reconstitution
- a sterile infusion set
- two alcohol compresses
- a patch
- a compress
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Wyeth Farma SA
Autovia del Norte A-1 Km 23
Desvio Algete Km 1
28700 San Sebastian de los Reyes
Madrid
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000 |
| BulgariaPfizer Luxembourg SARE, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | HungaryPfizer Kft.Tel .: + 36 1 488 37 00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 | The NetherlandsPfizer bvTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 526 100 |
| GreecePFIZER ΕΛΛΑΣ Α.Ε:Ηλ: +30 210 678 5800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp. z oo,Tel .: +48 22 335 61 00 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: +385 1 3908 777 | RomaniaPfizer România SRLTel: +40 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: + 386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: + 354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel: + 421-2-3355 5500 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 43 00 40 |
| .ΠροςPFIZER ΕΛΛΑΣ Α.Ε.(CYPRUS BRANCH):Ηλ: +357 22 817690 | SwedenPfizer ABTel: + 46 (0) 8 550 520 00 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel: +371 670 35 775 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |