Do not use ReFacto AF<\/h2>\n\n\n\n- if you are allergic to moroctocog alfa or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if you are allergic to\u00a0protein\u00a0you are from hamsters.<\/li><\/ul>\n\n\n\n
If you have any further questions, ask your doctor.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using ReFacto AF<\/p>\n\n\n\n
- if you get allergic reactions.\u00a0Signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives,\u00a0itching, tightness in the chest, wheezing, and low\u00a0blood pressure.\u00a0Anaphylaxis\u00a0is a severe\u00a0allergic reaction\u00a0that can make it difficult to swallow and\/or breathe, and make you red or swollen on the face and\/or hands.\u00a0If you get any of these signs, stop the\u00a0infusion\u00a0immediately and contact a doctor or go to the emergency department immediately.\u00a0In case of severe allergic reactions, an alternative treatment must be considered.<\/li>
- The development of inhibitors (\u00a0antibodies\u00a0) is a known complication that can occur during treatment with any\u00a0factor VIII\u00a0drug.\u00a0The inhibitors prevent, especially at high levels, that the treatment works properly.\u00a0You or your child will be closely monitored for the development of such inhibitors.\u00a0If you or your child suffer from bleeding that cannot be controlled with ReFacto AF, tell your doctor immediately.<\/li>
- if your bleeding does not stop as expected, contact a doctor or seek emergency care immediately.<\/li><\/ul>\n\n\n\n
Other medicines and ReFacto AF<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ReFacto AF does not influence the ability to drive or use machines.<\/p>\n\n\n\n
ReFacto AF contains sodium<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
How to use ReFacto AF<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Treatment with ReFacto AF should be initiated by a doctor who has experience in caring for patients with\u00a0hemophilia\u00a0A. Your doctor will decide what\u00a0dose\u00a0of ReFacto AF you should have.\u00a0The dose\u00a0and duration of treatment depend on your individual need for\u00a0factor VIII\u00a0replacement therapy.\u00a0ReFacto AF is given by\u00a0injection\u00a0into a vein lasting several minutes.\u00a0The patient or their carer can give the\u00a0injections\u00a0with ReFacto AF, provided they have received appropriate training in this.<\/p>\n\n\n\n
Your doctor may change the dose of ReFacto AF during treatment.<\/p>\n\n\n\n
Consult healthcare professionals before making a trip. You should bring enough factor VIII product with you for expected treatment when you travel.<\/p>\n\n\n\n
Each time you use ReFacto AF you should note the name of the carton and the product batch number.\u00a0You can use one of the removable labels on the vial to document the batch number in your diary or to report any\u00a0side effects.<\/p>\n\n\n\n
Preparation and administration<\/strong><\/p>\n\n\n\nThe instructions below are guidelines for\u00a0the preparation\u00a0and\u00a0administration\u00a0of ReFacto AF.\u00a0Follow your doctor’s instructions for\u00a0the preparation\u00a0and\u00a0administration\u00a0of ReFacto AF.<\/p>\n\n\n\n
Use only the pre-filled syringe in the package for\u00a0reconstitution.\u00a0Other sterile disposable syringes may be used for\u00a0administration.<\/p>\n\n\n\n
ReFacto AF is given as an\u00a0intravenous\u00a0infusion\u00a0after\u00a0reconstitution\u00a0of the lyophilized powder for\u00a0injection\u00a0with the supplied syringe of solvent [sodium chloride 9 mg\/ml (0.9%) solution].\u00a0ReFacto AF must not be mixed with other infusion fluids.<\/p>\n\n\n\n
Always wash your hands before performing the\u00a0preparation\u00a0and\u00a0administration\u00a0below.\u00a0The aseptic technique (ie clean and germ-free) should be used during\u00a0reconstitution.<\/p>\n\n\n\n
Preparation:<\/em><\/p>\n\n\n\nAllow the vial of ReFacto AF powder and the pre-filled solvent syringe to reach room temperature.<\/p>\n\n\n\n
2. Remove the plastic cap from the ReFacto AF bottle so that the middle part of the rubber stopper is visible.<\/p>\n\n\n\n![\"Remove](\"https:\/\/www.fass.se\/imaging\/resources\/05c3eb1f-abdc-4d55-ba52-cb0bda9e17f2\" "\\"Remove")
<\/a><\/figure>\n\n\n\n3. 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.<\/p>\n\n\n\n
4. Remove the cap from the transparent plastic package of the bottle adapter. Do not remove the adapter from the package.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n![\"Place](\"https:\/\/www.fass.se\/imaging\/resources\/7a64fea2-b052-4242-bd02-7f829c90846e\" "\\"Place")
<\/a><\/figure>\n\n\n\n6. Lift the package of the adapter and discard the package.<\/p>\n\n\n\n![\"Lift](\"https:\/\/www.fass.se\/imaging\/resources\/4849e94c-e1a9-4a87-b176-87aaf5975c54\" "\\"Lift")
<\/a><\/figure>\n\n\n\n7. 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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n![\"Break](\"https:\/\/www.fass.se\/imaging\/resources\/22a611bc-6f11-4288-983a-f0fac0c41448\" "\\"Break")
<\/a><\/figure>\n\n\n\n9. Place the bottle on a flat surface.\u00a0Attach 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.<\/p>\n\n\n\n![\"Attach](\"https:\/\/www.fass.se\/imaging\/resources\/37930d8e-2f34-4345-ae17-1788337a7c92\" "\\"Attach")
<\/a><\/figure>\n\n\n\n10. Slowly push the plunger rod down so that all the solvent is injected into the ReFacto AF bottle.<\/p>\n\n\n\n![\"Slowly](\"https:\/\/www.fass.se\/imaging\/resources\/15c6e2c8-2e17-46fa-9016-8f97fa7dc795\" "\\"Slowly")
<\/a><\/figure>\n\n\n\n11. Leave the syringe in the adapter and swirl the bottle gently<\/strong> until the powder has dissolved.<\/p>\n\n\n\n![\"Gently](\"https:\/\/www.fass.se\/imaging\/resources\/9af7e32a-6eea-456b-aa23-f6e6cd24c357\" "\\"Gently")
<\/a><\/figure>\n\n\n\n12. The finished solution should be inspected visually for particulate matter before\u00a0administration.\u00a0The solution should be ready to be slightly opalescent and colorless.<\/p>\n\n\n\n
Note: If you use more than one bottle of ReFacto AF per\u00a0infusion, each bottle should be prepared according to the previous instructions.\u00a0The solvent syringe should be removed, the bottle adapter left in place, and a single large Luer\u00a0syringe\u00a0can be used to withdraw the reconstituted contents from each bottle.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n![\"Slowly](\"https:\/\/www.fass.se\/imaging\/resources\/850d2ec2-efc0-4cc8-a2ad-e28d5141a0b1\" "\\"Slowly")
<\/a><\/figure>\n\n\n\n14. Remove the syringe from the bottle adapter by gently pulling and screwing the syringe counterclockwise. Discard the bottle with its fitted adapter.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
ReFacto AF must be used within three hours after\u00a0reconstitution.\u00a0The reconstituted solution can be stored at room temperature before\u00a0administration.<\/p>\n\n\n\n
Administration ( Intravenous infusion ):<\/em><\/p>\n\n\n\nReFacto AF should be administered with the infusion set provided in the kit and the supplied pre-filled syringe with solvent or a single\u00a0sterile\u00a0disposable Luer lock model syringe.<\/p>\n\n\n\n
Attach the syringe to the lower end of the infusion set tubing.<\/p>\n\n\n\n
Attach a stasis tube and prepare the injection site by wiping the skin well with one of the alcohol compresses in the kit.<\/p>\n\n\n\n
If you have any further questions, ask your doctor.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using ReFacto AF<\/p>\n\n\n\n
- if you get allergic reactions.\u00a0Signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives,\u00a0itching, tightness in the chest, wheezing, and low\u00a0blood pressure.\u00a0Anaphylaxis\u00a0is a severe\u00a0allergic reaction\u00a0that can make it difficult to swallow and\/or breathe, and make you red or swollen on the face and\/or hands.\u00a0If you get any of these signs, stop the\u00a0infusion\u00a0immediately and contact a doctor or go to the emergency department immediately.\u00a0In case of severe allergic reactions, an alternative treatment must be considered.<\/li>
- The development of inhibitors (\u00a0antibodies\u00a0) is a known complication that can occur during treatment with any\u00a0factor VIII\u00a0drug.\u00a0The inhibitors prevent, especially at high levels, that the treatment works properly.\u00a0You or your child will be closely monitored for the development of such inhibitors.\u00a0If you or your child suffer from bleeding that cannot be controlled with ReFacto AF, tell your doctor immediately.<\/li>
- if your bleeding does not stop as expected, contact a doctor or seek emergency care immediately.<\/li><\/ul>\n\n\n\n
Other medicines and ReFacto AF<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ReFacto AF does not influence the ability to drive or use machines.<\/p>\n\n\n\n
ReFacto AF contains sodium<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
How to use ReFacto AF<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Treatment with ReFacto AF should be initiated by a doctor who has experience in caring for patients with\u00a0hemophilia\u00a0A. Your doctor will decide what\u00a0dose\u00a0of ReFacto AF you should have.\u00a0The dose\u00a0and duration of treatment depend on your individual need for\u00a0factor VIII\u00a0replacement therapy.\u00a0ReFacto AF is given by\u00a0injection\u00a0into a vein lasting several minutes.\u00a0The patient or their carer can give the\u00a0injections\u00a0with ReFacto AF, provided they have received appropriate training in this.<\/p>\n\n\n\n
Your doctor may change the dose of ReFacto AF during treatment.<\/p>\n\n\n\n
Consult healthcare professionals before making a trip. You should bring enough factor VIII product with you for expected treatment when you travel.<\/p>\n\n\n\n
Each time you use ReFacto AF you should note the name of the carton and the product batch number.\u00a0You can use one of the removable labels on the vial to document the batch number in your diary or to report any\u00a0side effects.<\/p>\n\n\n\n
Preparation and administration<\/strong><\/p>\n\n\n\n
The instructions below are guidelines for\u00a0the preparation\u00a0and\u00a0administration\u00a0of ReFacto AF.\u00a0Follow your doctor’s instructions for\u00a0the preparation\u00a0and\u00a0administration\u00a0of ReFacto AF.<\/p>\n\n\n\n
Use only the pre-filled syringe in the package for\u00a0reconstitution.\u00a0Other sterile disposable syringes may be used for\u00a0administration.<\/p>\n\n\n\n
ReFacto AF is given as an\u00a0intravenous\u00a0infusion\u00a0after\u00a0reconstitution\u00a0of the lyophilized powder for\u00a0injection\u00a0with the supplied syringe of solvent [sodium chloride 9 mg\/ml (0.9%) solution].\u00a0ReFacto AF must not be mixed with other infusion fluids.<\/p>\n\n\n\n
Always wash your hands before performing the\u00a0preparation\u00a0and\u00a0administration\u00a0below.\u00a0The aseptic technique (ie clean and germ-free) should be used during\u00a0reconstitution.<\/p>\n\n\n\n
Preparation:<\/em><\/p>\n\n\n\n
Allow the vial of ReFacto AF powder and the pre-filled solvent syringe to reach room temperature.<\/p>\n\n\n\n
2. Remove the plastic cap from the ReFacto AF bottle so that the middle part of the rubber stopper is visible.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
4. Remove the cap from the transparent plastic package of the bottle adapter. Do not remove the adapter from the package.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
6. Lift the package of the adapter and discard the package.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
9. Place the bottle on a flat surface.\u00a0Attach 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.<\/p>\n\n\n\n
10. Slowly push the plunger rod down so that all the solvent is injected into the ReFacto AF bottle.<\/p>\n\n\n\n
11. Leave the syringe in the adapter and swirl the bottle gently<\/strong> until the powder has dissolved.<\/p>\n\n\n\n
12. The finished solution should be inspected visually for particulate matter before\u00a0administration.\u00a0The solution should be ready to be slightly opalescent and colorless.<\/p>\n\n\n\n
Note: If you use more than one bottle of ReFacto AF per\u00a0infusion, each bottle should be prepared according to the previous instructions.\u00a0The solvent syringe should be removed, the bottle adapter left in place, and a single large Luer\u00a0syringe\u00a0can be used to withdraw the reconstituted contents from each bottle.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
14. Remove the syringe from the bottle adapter by gently pulling and screwing the syringe counterclockwise. Discard the bottle with its fitted adapter.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
ReFacto AF must be used within three hours after\u00a0reconstitution.\u00a0The reconstituted solution can be stored at room temperature before\u00a0administration.<\/p>\n\n\n\n
Administration ( Intravenous infusion ):<\/em><\/p>\n\n\n\n
ReFacto AF should be administered with the infusion set provided in the kit and the supplied pre-filled syringe with solvent or a single\u00a0sterile\u00a0disposable Luer lock model syringe.<\/p>\n\n\n\n
Attach the syringe to the lower end of the infusion set tubing.<\/p>\n\n\n\n
Attach a stasis tube and prepare the injection site by wiping the skin well with one of the alcohol compresses in the kit.<\/p>\n\n\n\n