ReFacto AF – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine ReFacto AF, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefu lly before you start using this medicine because it contains important information for you.
- Keep this leaflet. You ma y need to read it again.
- If you have further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. 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 the blood to form clots and stop bleedings. In pa tients with haemophilia A (inborn factor VIII deficiency), it is missing or not working properly.
ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in adults and children of all ages (including newb orns) with haemophilia A.
⚠️ 2. What you need to know before you use ReFacto AF
Do not use ReFacto AF
- if you are allergic to mo roctocog alfa or any of the other ingr edients of this medicine (listed in section 6).
- if you are allergic to hamster proteins.
If you are unsure about this, ask your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using ReFacto AF – if you experience alle rgic reactions. Some of the signs of allergic reactions are difficulty in breathing, shortness of breath, sw elling, hives, itching, tightness of the chest, wheezing, and low blood pressure. Anaphylaxis is a severe allergic reaction that can cause difficulty in swallowing 41 and/or breathing, red or swollen face and/or hands. If any of these signs occur, stop the infusion immediately and contact a doctor or seek immediate emergency care. In case of severe allergic reactions, alternative ther apy must be considered.
- the formation of inhib itors (antibodies) is a known complica tion that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored caref ully for the development of these inhibitors. If your or your child’s bleeding is not being controlled with ReFacto AF, tell your doctor immediately.
- if your bleeding does not stop as expected and contact your doctor or seek immediate emergency care.
Other medicines and ReFacto AF
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
ReFacto AF has no influence on the ability to drive or use machines.
ReFacto AF contains sodium
After reconstitution, ReFacto AF contains 1.27 mmol (or 29 mg) sodium (main component of cooking/table salt) per pre-filled syringe. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult. Depe nding on your body weight and your dose of ReFacto AF, you could receive multiple pre-filled syringes. Th is should be taken into consideration if you are on a low salt diet.
💊 3. How to use ReFacto AF
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with ReFacto AF should be started by a doctor who is ex perienced in the care of patients with haemophilia A. Your doctor will decide the dose of ReFacto AF you w ill receive. This dose and duration will depend upon yo ur individual needs for replacement f actor VIII therapy. ReFacto AF is given by injection into a vein las ting several minutes. Pa tients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
During your treatment, your doctor may decide to change the dose of ReFacto AF you receive. Consult with your health care provider before you travel. You should bring enough of your factor VIII product for anticipated trea tment when travelling.
It is recommended that every time you use ReFacto AF, you record the name on the carton and batch number of the product. You can use one of the peel -off labels found on th e pre-filled syringe to document the batch number in your diary or for reporting any side effects.
42 Reconstitution and administration The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF provided in a pre-filled sy ringe. Patients should follow the specific reconstitution and administration procedures provided by their doctors.
ReFacto AF is administered by intravenous (IV) infusion after reconstitution. The pre-filled syringe consists of 2 chambers, one chamber contains the ReFacto AF lyophilised powder and the other chamber contains the solvent [sodium chloride 9 mg /ml (0.9%) solutio n]. For the purposes of these instructions, this device will be re ferred to as a pre-filled syringe.
Use only the pre-filled syri nge provided in the box fo r reconstitution. Other ster ile disposable syringes may be used for administration.
ReFacto AF should not be mixed with other infusion solutions.
Note : If you need to use more than one pre-filled syringe of ReFact o AF per infusion , each syringe should be reconstituted according to the specific directions. A separate 10 cc or larger luer lock syringe (not included in this kit) may be used to draw back the reco nstituted contents of each syringe (see Additional Instructions ) Preparation 1. Always wash your hands before pe rforming the following procedures.
2. Aseptic technique (meaning clean and germ-fr ee) should be used du ring the reconstitution procedure.
3. All components used in the reconstitution and admi nistration of this product should be used as soon as possible after opening their sterile containers, to minimise unnecessary exposure to the air.
Reconstitution 1. Allow the pre-filled syringe to reach room temperature.
2. Remove the contents of the ReFacto AF pre-f illed syringe kit and place on a clean surface, making sure you have all the supp lies you will need.
3. Grasp the plunger rod as shown in the following diagram. Screw the plunger rod firmly into the opening in the finger rest of the ReFact o AF pre-filled syringe by pushing and turning clockwise firmly until resistance is felt (approximately 2 turns).
Throughout the reconstitution process, it is important to keep the ReFacto AF pre-filled syringe upright (with the white powder above the clear solution) to prevent possible leakage.
43 4. Holding the pre-filled syringe up right, remove the wh ite tamper-evident seal by bending the seal right to left (or a gentle rocking motion) to break the perforation of the cap and expose the grey rubber ti p cap of the ReFacto AF pre-filled syringe.
5. Remove the protective blue vented sterile cap from its packaging.
Whilst continuing to hold the ReFacto AF pre-filled syringe upright, remove the grey rubber tip cap and replace it with the protective blue vented cap. This vented cap has tiny holes that allow air to escape in order to prevent pressure build-up. Avoid touching the open end of the syringe or the protective blue vented cap.
6. Gently and slowly advance the plunger rod by pushing until the two plungers inside the pre-filled syringe meet, and all of the solvent is tran sferred to the top ch amber containing the ReFacto AF powder.
Note: To prevent the escape of fluid from the tip of the syringe, do not push the plunger rod with excessive force.
44 7. With the ReFacto AF pre-filled sy ringe remaining upright, swirl gently several times until the powder is dissolved.
Look at the final solution to check for particulat e matter or discolouration. The solution should appear clear to slightly opales cent and colourless. Discard th e pre-filled syringe if visible particulate matter or discolouration is observed.
8. Continuing to hold the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the (top) chamber.
ReFacto AF should be infused with in 3 hours after either reconstitution or rem oval of the grey tip cap from the pre- filled syringe.
If you are not going to use the ReFacto AF solution immediately, you should store the syringe in an upright position, with the protectiv e blue vented cap on the pre-fille d syringe until you are ready to infuse. The reconstituted solution may be stored at room temperature fo r up to 3 hours. If you have not used it within 3 hours, throw it away.
Administration (Intravenous Infusion) Your doctor or other healthcare professional should teach you how to infuse ReFacto AF. Once you learn how to self-infuse, you can follow the instructions in this Package Leaflet.
ReFacto AF is administered by intravenous (IV) infusion after reconstitution of the powder with the solvent (0.9% sodium chloride). Once reconstituted, ReFacto AF shou ld be inspected for particulate matter and discolouration pr ior to administration.
ReFacto AF should be administered using the infusion set included in the kit, unless otherwise advised by your doctor or other healthcare professional.
45 1. Remove the protective blue vented cap and firmly attach the intravenous infusion set provided onto the ReFacto AF pre-filled syringe.
2. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
3. Remove the protective needle cove r and insert the butterfly needle of the infusi on set tubing into your vein, as instructed by your doctor or other healthcare professional. Remove the tourniquet. The reconstituted ReFacto AF product should be injected intravenously over several minutes. Your doctor may change your recommended infusion rate to make the infusion more comfortable. Disc uss your intravenous infusion procedure with your doctor or other healthcare professional. Do not atte mpt self-infusion unless properly trained.
Reconstituted ReFacto AF must not be administered in the same tubing or container with other medicinal products.
46 4. After infusing ReFacto AF, remove the infusion set and discard. The amount of drug product left in the infusion set will not affect your treatment.
Note: Please dispose of all unused solution, the em pty pre-filled syringe, and the used medical supplies in an appropriate container for throwing away medical waste, as these materials may hurt others if not disposed of properly.
It is recommended to record the lot number from the ReFact o AF pre-filled syringe label every time you use ReFacto AF. You can use the peel-off labe l found on the ReFacto AF pre-filled syringe to record the lot number.
Additional Instructions:
Multiple ReFacto AF in Pre-f illed Syringe Reconstitution to a 10 cc or Larger Luer Lock Syringe (10 cc or larger luer lock syringes not provided) The instructions below are for the use of multiple ReFacto AF pre-fille d syringe kits with a 10 cc or larger luer lock syringe.
1. Reconstitute all ReFacto AF pre- filled syringes according to instructions shown above in the reconstitution directions (see Reconstitution and Administration).
Holding the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the ai r is removed from the drug product chamber.
2. Remove the luer-to-luer syringe connector from its package (luer-to-luer syringe connectors are not provided).
47 3. Connect a sterile 10 cc or larger luer lock syringe to one opening (port) in the syringe connector and the ReFacto AF pre-filled sy ringe to the remainin g open port on the opposite end.
4. With the ReFacto AF pre-filled syringe on t op, slowly depress the plunger rod until the contents empty into the 10 cc or larger luer lock syringe.
5. Remove the empty ReFacto AF pre-filled syring e and repeat procedures 3 and 4 above for any additional reco nstituted syringes.
6. Remove the luer-to-luer syringe connector from the 10 cc or larger luer lock syringe and attach the infusion set, as described above in the directions for administration of the pre-filled syringe [see Administra tion (Intravenous Infusion)].
Note: Please dispose of all unused solution, the em pty pre-filled syringe, and the used medical supplies in an appropriate container for throwing away medical waste, as these materials may hurt others if not disposed of properly.
If you use more ReFacto AF than you should
Check with your doctor or pharmacist.
48 If you stop using ReFacto AF Do not stop using ReFacto AF without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. 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 your doctor immediately if you have any of the following early symptoms of allergic reactions:
- rash, hives, wheals, generalised itching
- swelling of lips and tongue
- difficulty in breathing, wheezing, tightness in the chest
- general feeling of being unwell
- dizziness and loss of consciousness Severe symptoms, including difficu lty in breathing and (nearly) fa inting, require prompt emergency treatment. Severe, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 people).
Inhibitor development For children not previously treated with factor VIII medicines, inhibitor anti bodies (see section 2) may form very commonly (more than 1 in 10 patients) ; however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is unco mmon (less than 1 in 100 patients). If this happens, your or your child’s medicines may stop working properly and you or your child may experience persistent bleeding. If this ha ppens, you should contact your doctor immediately.
Very common side effects (may affect more than 1 in 10 people)
- inhibitor development for patients who have neve r 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, diar rhoea, vomiting, stomach pain, nausea
- hives, rash, itching
- muscular pain
- chills, catheter site reaction
- certain blood tests may show an in crease in antibodie s to factor VIII
Uncommon side effects ( may affect up to 1 in 100 people)
- inhibitor development for patients who have been previously treated with factor VIII products (less than 1 in 100 patients)
- severe allergic reaction 49 • numbness, sleepiness, altered taste
- chest pain, rapid hear t beat, palpitations
- low blood pressure, pain and redness of veins associated with a blood clot, flushing
- shortness of breath
- excessive sweating
- weakness, injection site reactions including pain
- slight increase in heart enzymes
- increased liver enzymes, increas ed bilirubin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help pr ovide more informatio n on the safety of this medicine.
🌡️ 5. 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 th e outer carton and pre-filled syringe label after EXP. The expiry date refers to the la st day of that month.
Store and transport refrigerated (2 °C – 8 °C). Do not freeze, in order to prevent damage to the pre-filled syringe.
For your convenience, the medicine can be removed from such storage for one single period of maximum 3 months at room temperature (up to 25°C). At the end of this room temperature storage period, the product must not be put back in the refrigerator, but must be used or discarded. Record on the outer carton the date ReFacto AF pre-filled syringe is removed fr om the refrigerator and set at room temperature (up to 25 oC).
Keep the pre-filled syringe in the outer carton in orde r to protect from light.
Use the reconstituted solution w ithin 3 hours of reconstitution or removal of the grey tip cap.
The solution will be clear to sligh tly opalescent and colourless. Do no t use this medicine if you notice that it is cloudy or contains visible particles.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Thes e measures will help protect the environment.
📦 6. Contents of the pack and other information
What ReFacto AF contains – The active substance is moroctoc og alfa (recombinant coagulation factor V III). Each pre-filled
syringe of ReFacto AF contains nominally 250, 500, 1000, 2000, or 3000 IU of moroctocog
alfa.
A solvent [sodium chloride 9 mg/ml (0.9%) solution for injec tion] is included within the ReFacto AF pre-filled syringe fo r reconstituting moroctocog alfa.
- The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and
sodium chloride (see section 2 “ReFacto AF contains sodium”).
- After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], the prepared solution for injection contains either 62.5, 125, 250, 500 or 750 IU of moroctocog alfa per ml, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, 2000, or 3000 IU).
What ReFacto AF looks like and contents of the pack
ReFacto AF is provided as a powd er and solvent for solution for inj ection in a pre-filled syringe that contains the ReFacto AF powder in the top chamber and the solvent [sodium chloride 9 mg/ml (0.9%) solution] in the bottom chamber.
The contents of the pack are:
- one pre-filled syringe containing moroctocog alfa 250, 500, 1000, 2000, or 3000 IU powder and solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for in jection for reconstitution
- one plunger rod
- one protective blue vented sterile cap
- one sterile in fusion set
- two alcohol swabs
- one plaster
- one gauze pad
Marketing Authorisation Holder
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Manufacturer
Wyeth Farma S.A. Autovia del Norte A-1 Km 23 Desvio Algete Km 1 28700 San Sebastian de los Reyes Madrid Spain For any information about this medicine, please c ontact the local represen tative of the Marketing 51 Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11 Lietuva Pfizer Luxembourg SA RL filialas Lietuvoje Tel: +370 5 251 4000 България Пфайзер Люксембург САРЛ , Клон България Тел.: +359 2 970 4333 Magyarország Pfizer Kft.
Tel.: + 36 1 488 37 00 Česká republika Pfizer, spol. s r.o.
Tel: +420 283 004 111 Malta Vivian Corporation Ltd.
Tel: +356 21344610 Danmark Pfizer ApS Tlf.: +45 44 20 11 00 Nederland Pfizer bv Tel: +31 (0)800 63 34 636 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51000 Norge Pfizer AS Tlf: +47 67 52 61 00 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500 Österreich Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0 Ελλάδα Pfizer Ελλάς Α.Ε.
Τηλ: +30 210 6785800 Polska Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 00 España Pfizer S.L.
Tel: +34 91 490 99 00 Portugal Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500 France Pfizer Tél: +33 (0)1 58 07 34 40 România Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00 Hrvatska Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777 Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s podro čja farmacevtske dejavn osti, Ljubljana Tel: + 386 (0) 1 52 11 400 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) Tel: +44 (0)1304 616161 Slovenská republika Pfizer Luxembourg SARL, organiza čná zložka Tel: + 421 2 3355 5500 52 Ísland Icepharma hf.
Sími: +354 540 8000 Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Italia Pfizer S.r.l. Tel: +39 06 33 18 21 Sverige Pfizer AB Tel: + 46 (0)8 550 520 00 Κύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22817690 Latvija Pfizer Luxembourg SARL fili āle Latvijā Tel: +371 670 35 775
This leaflet was last revised in
Detailed information on this me dicine is available on European Medicines Agency website: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information ReFacto AF (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/99/103).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.