Do not use ADYNOVI<\/h2>\n\n\n\n- if you are allergic to rurioktokog alfa pegol, oktokog alfa, or any of the other ingredients of this medicine (listed in section 6)<\/li>
- if you are allergic to mouse or hamster proteins.<\/li><\/ul>\n\n\n\n
Consult a doctor if you are unsure.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using ADYNOVI.
<\/p>\n\n\n\n
There is a small risk that you may get an anaphylactic reaction (a severe, sudden allergic reaction ) when you use ADYNOVI. You should know the early signs of allergic reactions such as rash, hives, general itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general malaise, and dizziness. These may be early symptoms of anaphylactic shock. Other symptoms may include severe dizziness, unconsciousness and extreme difficulty breathing.<\/p>\n\n\n\n
If any of these symptoms occur, stop the injection immediately and consult a doctor. Severe symptoms, including difficulty breathing and (almost) fainting, require immediate urgent treatment.<\/p>\n\n\n\n
If you suffer from heart disease, tell your doctor about this, as there is an increased risk of complications related to coagulation (the ability of the blood to clot).<\/p>\n\n\n\n
Patients developing factor VIII inhibitors<\/em><\/p>\n\n\n\nThe development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent the treatment from working properly, especially at high levels. You or your child will be closely monitored for the development of inhibitors. If you or your child suffer from bleeding that cannot be controlled with ADYNOVI, tell your doctor immediately.<\/p>\n\n\n\n
Complications related to catheters<\/em><\/p>\n\n\n\nIf you need a central venous catheter (CVAD), your doctor should consider the risk of CVAD-related complications, including local infections, the presence of bacteria in the blood, and blood clots at the catheter site.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
ADYNOVI can only be used in adolescents and adults (12 years and older). The information about warnings and precautions also applies to young people.<\/p>\n\n\n\n
Other medicines and ADYNOVI<\/h2>\n\n\n\n
Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Hemophilia A is rare in women. Therefore, there is no experience with the use of ADYNOVI during pregnancy and lactation.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ADYNOVI has no effect on the ability to drive and use machines.<\/p>\n\n\n\n
ADYNOVI contains sodium<\/h2>\n\n\n\n
This medicine contains 0.45 mmol sodium (10 mg) per vial. This should be taken into consideration for patients prescribed a low-salt diet<\/p>\n\n\n\n
3. How to use ADYNOVI<\/h2>\n\n\n\n
Treatment with ADYNOVI will be initiated and supervised by a physician experienced in the management of patients with hemophilia A.<\/p>\n\n\n\n
Your doctor will calculate the dose of ADYNOVI that is right for you depending on your condition, your weight, and whether it is used to prevent or treat bleeding. How often the treatment is given depends on how well ADYNOVI works for you. Replacement treatment with ADYNOVI is usually a lifelong treatment.<\/p>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor if you are unsure.
<\/p>\n\n\n\n
Prevention of bleeding<\/strong><\/p>\n\n\n\nThe usual dose of ADYNOVI is 40 to 50 IU per kg body weight administered twice a week.
<\/p>\n\n\n\n
Treatment of bleeding<\/strong><\/p>\n\n\n\nDose one of ADYNOVI is calculated based on your body weight and the factor VIIIlevels to be achieved. The target levels for factor VIII depend on the severity of the bleeding and its occurrence.<\/p>\n\n\n\n
Talk to your doctor if you think the effect of ADYNOVI is not enough.<\/p>\n\n\n\n
Your doctor will perform appropriate laboratory tests to ensure that you have the correct factor VIII level. This is especially important if you are having major surgery.<\/p>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
ADYNOVI can only be used for adolescents and adults (12 years and older). Dose one for adolescents is also calculated by body weight and is the same as for adults.<\/p>\n\n\n\n
How ADYNOVI is given<\/h2>\n\n\n\n
ADYNOVI is usually injected into a vein ( intravenously ) by a doctor or nurse. You or someone else can also administer ADYNOVI as an injection, but only after the necessary training. Detailed instructions on how to give yourself the medicine can be found at the end of this leaflet.
<\/p>\n\n\n\n
If you use more ADYNOVI than you should<\/strong><\/p>\n\n\n\nAlways use ADYNOVI exactly as your doctor has told you. Consult a doctor if you are unsure. If you have been given more ADYNOVI than recommended, talk to your doctor as soon as possible.<\/p>\n\n\n\n
If you forget to use ADYNOVI<\/h2>\n\n\n\n
Do not take a double dose to make up for a forgotten dose. Take the next dose as planned and continue according to your doctor’s prescription.<\/p>\n\n\n\n
If you stop using ADYNOVI<\/h2>\n\n\n\n
Do not stop using ADYNOVI without consulting your doctor.
<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause side effects, although not everybody gets them.
<\/p>\n\n\n\n
A sudden and severe allergic reaction (anaphylactic shock ) must injection stopped immediately. If you get any of the following early symptoms of an allergic reaction<\/strong>, contact<\/strong> your doctor immediately<\/strong> :<\/p>\n\n\n\n- rash, hives, general itching<\/li>
- swelling of the lips and tongue<\/li>
- difficulty breathing, wheezing, pressure over the chest<\/li>
- general malaise<\/li>
- dizziness and unconsciousness.<\/li><\/ul>\n\n\n\n
Severe symptoms, including difficulty breathing and (almost) fainting, require immediate urgent treatment.
<\/p>\n\n\n\n
In patients previously treated with factor VIII (more than 150 days of treatment), inhibitory antibodies (inhibitors) may be formed (see section 2). This complication is classified as uncommon (affects less than 1 user in 100). If this happens, your medication may stop working properly and you may experience persistent bleeding. Contact a doctor immediately if this happens.
<\/p>\n\n\n\n
Common side effects are<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\nHeadache, nausea, diarrhea, rash
<\/p>\n\n\n\n
Less common side effects are<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\nRedness, allergic reaction (hypersensitivity)<\/p>\n\n\n\n
Antibodies (inhibitors) to factor VIII (in patients who have previously received factor VIII treatment (more than 150 days of treatment))<\/p>\n\n\n\n
Additional side effects in children<\/h2>\n\n\n\n
The frequency, type, and severity of side effects in children are expected to be the same as in adults.
<\/p>\n\n\n\n
Reporting of side effects<\/em><\/p>\n\n\n\nIf you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n
5. How to store ADYNOVI<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n
Do not freeze.
<\/p>\n\n\n\n
Store the blister pack in the outer carton. Sensitive to light.<\/p>\n\n\n\n
During the shelf life, the powder vial can be stored at room temperature (up to 30 \u00b0 C) for a maximum continuous period of 3 months. The expiry date for the medicine is then the end of this 3-month period, or alternatively the expiry date which is stated on the vial, whichever is the earlier. Note the end date of the 3-month period on the outer carton. The drug must not be stored in a refrigerator after it has been stored at room temperature. The solution must not be stored in the refrigerator after reconstitution.<\/p>\n\n\n\n
Use the medicine within 3 hours after the powder has completely dissolved.
<\/p>\n\n\n\n
This medicine is for single use only. Dispose of the remaining solution appropriately.
<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n- The active substance is rurioctococcal alpha pegol (pegylated human coagulation factor VIII produced by recombinant DNA technology). Each vial of powder nominally contains 250, 500, or 1000 IU rurioctococcal alpha pegol.<\/li>
- The solution for injection contains 2 ml of sterile water for injections.<\/li>
- The other ingredients are mannitol, trehalose dihydrate, histidine, glutathione, sodium chloride, calcium chloride dihydrate, tris (hydroxymethyl) aminomethane, polysorbate 80. ADYNOVI contains sodium, see section 2.<\/li><\/ul>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
ADYNOVI is supplied as a powder and solvent for solution for injection. The powder is white to an off-white granular powder. The solution liquid is a clear and colorless solution. After reconstitution, the solution is clear, colorless, and free of foreign particles.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Salesman<\/strong><\/p>\n\n\n\nBaxalta Innovations GmbH<\/p>\n\n\n\n
Industriestrasse 67<\/p>\n\n\n\n
A-1221 Vienna<\/p>\n\n\n\n
Tel: +44 (0) 1256 894 959<\/p>\n\n\n\n
Email: medinfoEMEA@shire.com
<\/p>\n\n\n\n
Manufacturer<\/strong><\/p>\n\n\n\nBaxalta Belgium Manufacturing SA<\/p>\n\n\n\n
Boulevard Ren\u00e9 Branquart 80<\/p>\n\n\n\n
B \u2011 7860 Lessines<\/p>\n\n\n\n
Belgium
<\/p>\n\n\n\n
This leaflet was last modified 03\/2018<\/p>\n\n\n\n
Other sources of information<\/h2>\n\n\n\n
Further information on this medicine is available on the European Medicines Agency web site: http:\/\/www.ema.europa.eu\/<\/p>\n\n\n\n
The following information is intended for healthcare professionals only:<\/h2>\n\n\n\n
Instructions for preparation and administration<\/strong>
<\/p>\n\n\n\nADYNOVI must not be mixed with any other medicinal product or solvent.
<\/p>\n\n\n\n
It is strongly recommended that the name and batch number of the medicine be recorded each time ADYNOVI is given. Detachable labels are on the blister pack.
<\/p>\n\n\n\n
Instructions for preparation<\/strong><\/p>\n\n\n\n- Do not use this medicine after the expiry date which is stated on the labels and carton.<\/li>
- Do not use unless the blister lid is completely closed<\/li>
- The solution must not be stored in the refrigerator after reconstitution.<\/li><\/ul>\n\n\n\n
- If the medicine is still stored in a refrigerator: remove the closed blister (containing vials of powder and solvent combined with the reconstitution system) from the refrigerator and allow it to reach room temperature (between 15 \u00b0 C and 25 \u00b0 C).<\/li>
- Wash your hands thoroughly with soap and warm water.<\/li>
- Open the blister pack with ADYNOVI by pulling off the top. Remove the BAXJECT III system from the blister.<\/li>
- Place the powder vial on a flat surface with the solvent vial on top (Fig. 1). The solvent vial has a blue stripe. Do not remove the blue cap until instructed to do so at a later stage.<\/li>
- Hold the powder vial in the BAXJECT III system with one hand and firmly push the solvent vial down with the other hand until the system is fully compressed and the solvent drains into the powder vial (Fig. 2). Do not tilt the system until all the solvent has drained into the powder vial.<\/li>
- Check that all solvent has been transferred. Gently swirl the bottle until all the powder has dissolved (Fig. 3). Make sure that the powder is completely dissolved, otherwise not all prepared solution can pass through the filter. The drug dissolves rapidly (usually in less than 1 minute). After reconstitution, the solution should be clear, colorless, and free of foreign particles.<\/li><\/ol>\n\n\n\n
Consult a doctor if you are unsure.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using ADYNOVI.
<\/p>\n\n\n\n
There is a small risk that you may get an anaphylactic reaction (a severe, sudden allergic reaction ) when you use ADYNOVI. You should know the early signs of allergic reactions such as rash, hives, general itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general malaise, and dizziness. These may be early symptoms of anaphylactic shock. Other symptoms may include severe dizziness, unconsciousness and extreme difficulty breathing.<\/p>\n\n\n\n
If any of these symptoms occur, stop the injection immediately and consult a doctor. Severe symptoms, including difficulty breathing and (almost) fainting, require immediate urgent treatment.<\/p>\n\n\n\n
If you suffer from heart disease, tell your doctor about this, as there is an increased risk of complications related to coagulation (the ability of the blood to clot).<\/p>\n\n\n\n
Patients developing factor VIII inhibitors<\/em><\/p>\n\n\n\n The development of inhibitors ( antibodies ) is a known complication that can occur during treatment with any factor VIII drug. The inhibitors prevent the treatment from working properly, especially at high levels. You or your child will be closely monitored for the development of inhibitors. If you or your child suffer from bleeding that cannot be controlled with ADYNOVI, tell your doctor immediately.<\/p>\n\n\n\n Complications related to catheters<\/em><\/p>\n\n\n\n If you need a central venous catheter (CVAD), your doctor should consider the risk of CVAD-related complications, including local infections, the presence of bacteria in the blood, and blood clots at the catheter site.<\/p>\n\n\n\n ADYNOVI can only be used in adolescents and adults (12 years and older). The information about warnings and precautions also applies to young people.<\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Hemophilia A is rare in women. Therefore, there is no experience with the use of ADYNOVI during pregnancy and lactation.<\/p>\n\n\n\n ADYNOVI has no effect on the ability to drive and use machines.<\/p>\n\n\n\n This medicine contains 0.45 mmol sodium (10 mg) per vial. This should be taken into consideration for patients prescribed a low-salt diet<\/p>\n\n\n\n Treatment with ADYNOVI will be initiated and supervised by a physician experienced in the management of patients with hemophilia A.<\/p>\n\n\n\n Your doctor will calculate the dose of ADYNOVI that is right for you depending on your condition, your weight, and whether it is used to prevent or treat bleeding. How often the treatment is given depends on how well ADYNOVI works for you. Replacement treatment with ADYNOVI is usually a lifelong treatment.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told you. Ask your doctor if you are unsure. Prevention of bleeding<\/strong><\/p>\n\n\n\n The usual dose of ADYNOVI is 40 to 50 IU per kg body weight administered twice a week. Treatment of bleeding<\/strong><\/p>\n\n\n\n Dose one of ADYNOVI is calculated based on your body weight and the factor VIIIlevels to be achieved. The target levels for factor VIII depend on the severity of the bleeding and its occurrence.<\/p>\n\n\n\n Talk to your doctor if you think the effect of ADYNOVI is not enough.<\/p>\n\n\n\n Your doctor will perform appropriate laboratory tests to ensure that you have the correct factor VIII level. This is especially important if you are having major surgery.<\/p>\n\n\n\n ADYNOVI can only be used for adolescents and adults (12 years and older). Dose one for adolescents is also calculated by body weight and is the same as for adults.<\/p>\n\n\n\n ADYNOVI is usually injected into a vein ( intravenously ) by a doctor or nurse. You or someone else can also administer ADYNOVI as an injection, but only after the necessary training. Detailed instructions on how to give yourself the medicine can be found at the end of this leaflet. If you use more ADYNOVI than you should<\/strong><\/p>\n\n\n\n Always use ADYNOVI exactly as your doctor has told you. Consult a doctor if you are unsure. If you have been given more ADYNOVI than recommended, talk to your doctor as soon as possible.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose. Take the next dose as planned and continue according to your doctor’s prescription.<\/p>\n\n\n\n Do not stop using ADYNOVI without consulting your doctor. If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. A sudden and severe allergic reaction (anaphylactic shock ) must injection stopped immediately. If you get any of the following early symptoms of an allergic reaction<\/strong>, contact<\/strong> your doctor immediately<\/strong> :<\/p>\n\n\n\n Severe symptoms, including difficulty breathing and (almost) fainting, require immediate urgent treatment. In patients previously treated with factor VIII (more than 150 days of treatment), inhibitory antibodies (inhibitors) may be formed (see section 2). This complication is classified as uncommon (affects less than 1 user in 100). If this happens, your medication may stop working properly and you may experience persistent bleeding. Contact a doctor immediately if this happens. Common side effects are<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Headache, nausea, diarrhea, rash Less common side effects are<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Redness, allergic reaction (hypersensitivity)<\/p>\n\n\n\n Antibodies (inhibitors) to factor VIII (in patients who have previously received factor VIII treatment (more than 150 days of treatment))<\/p>\n\n\n\n The frequency, type, and severity of side effects in children are expected to be the same as in adults. Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n Do not freeze. Store the blister pack in the outer carton. Sensitive to light.<\/p>\n\n\n\n During the shelf life, the powder vial can be stored at room temperature (up to 30 \u00b0 C) for a maximum continuous period of 3 months. The expiry date for the medicine is then the end of this 3-month period, or alternatively the expiry date which is stated on the vial, whichever is the earlier. Note the end date of the 3-month period on the outer carton. The drug must not be stored in a refrigerator after it has been stored at room temperature. The solution must not be stored in the refrigerator after reconstitution.<\/p>\n\n\n\n Use the medicine within 3 hours after the powder has completely dissolved. This medicine is for single use only. Dispose of the remaining solution appropriately. 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.<\/p>\n\n\n\n ADYNOVI is supplied as a powder and solvent for solution for injection. The powder is white to an off-white granular powder. The solution liquid is a clear and colorless solution. After reconstitution, the solution is clear, colorless, and free of foreign particles.<\/p>\n\n\n\n Salesman<\/strong><\/p>\n\n\n\n Baxalta Innovations GmbH<\/p>\n\n\n\n Industriestrasse 67<\/p>\n\n\n\n A-1221 Vienna<\/p>\n\n\n\n Tel: +44 (0) 1256 894 959<\/p>\n\n\n\n Email: medinfoEMEA@shire.com Manufacturer<\/strong><\/p>\n\n\n\n Baxalta Belgium Manufacturing SA<\/p>\n\n\n\n Boulevard Ren\u00e9 Branquart 80<\/p>\n\n\n\n B \u2011 7860 Lessines<\/p>\n\n\n\n Belgium This leaflet was last modified 03\/2018<\/p>\n\n\n\n Further information on this medicine is available on the European Medicines Agency web site: http:\/\/www.ema.europa.eu\/<\/p>\n\n\n\n Instructions for preparation and administration<\/strong> ADYNOVI must not be mixed with any other medicinal product or solvent. It is strongly recommended that the name and batch number of the medicine be recorded each time ADYNOVI is given. Detachable labels are on the blister pack. Instructions for preparation<\/strong><\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and ADYNOVI<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ADYNOVI contains sodium<\/h2>\n\n\n\n
3. How to use ADYNOVI<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nUse for children and adolescents<\/h2>\n\n\n\n
How ADYNOVI is given<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you forget to use ADYNOVI<\/h2>\n\n\n\n
If you stop using ADYNOVI<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nAdditional side effects in children<\/h2>\n\n\n\n
<\/p>\n\n\n\n5. How to store ADYNOVI<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nOther sources of information<\/h2>\n\n\n\n
The following information is intended for healthcare professionals only:<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n