Do not use ADVATE<\/h2>\n\n\n\n- If you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6).<\/li>
- If you are allergic to mouse or hamster protein.<\/li><\/ul>\n\n\n\n
If you are not sure, ask your doctor.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using ADVATE. Tell your doctor if you have previously been treated with factor VIII products, especially if you have developed inhibitors, as there may be a greater risk of recurrence. Inhibitors are blocking antibodies to factor VIII, which reduce the effect of ADVATE in preventing or controlling bleeding. The development of inhibitors is a known complication in the treatment of hemophilia. Contact your doctor immediately if your bleeding is not controlled with ADVATE.
<\/p>\n\n\n\n
There is a small risk of you getting an anaphylactic reaction (a severe, sudden allergic reaction ) from ADVATE. You should be aware of early signs of allergic reactions such as rash, hives, general itching, swelling of the lips and tongue, difficulty breathing, pressure over the chest, general malaise, and dizziness. These symptoms can be an early symptom of anaphylactic shock, reactions that may also include severe dizziness, unconsciousness, and severe difficulty breathing.<\/p>\n\n\n\n
If you experience any of these symptoms, stop the injection\/infusion immediately, and contact your doctor. Severe symptoms, such as difficulty breathing and fainting, require immediate emergency treatment.<\/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 may 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 ADVATE, tell your doctor immediately.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
The information on warnings and precautions applies to both adults and children (from 0 to 18 years).<\/p>\n\n\n\n
Other medicines and ADVATE<\/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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ADVATE has no effect on the ability to drive and use machines.<\/p>\n\n\n\n
ADVATE contains sodium<\/h2>\n\n\n\n
This medicine contains 0.45 mmol sodium (10 mg) per vial. This should be considered by patients on a low-salt diet.<\/p>\n\n\n\n
Incorrect administration of ADVATE<\/strong><\/p>\n\n\n\nImproper administration ( injection into an artery or outside the vein) should be avoided, as mild, short-term reactions at the injection site, such as bruising and erythema, may occur.<\/p>\n\n\n\n
3. How to use ADVATE<\/h2>\n\n\n\n
Treatment with ADVATE will be initiated by a physician experienced in the management of patients with hemophilia A.<\/p>\n\n\n\n
Your doctor will calculate the dose of an ADVATE (in international units or IU) 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 ADVATE works on you. Replacement treatment with ADVATE is usually a lifelong treatment.<\/p>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.<\/p>\n\n\n\n
Prevention of bleeding<\/strong><\/p>\n\n\n\nThe usual dose is 20 – 40 IU octocog alfa per kg body weight given every two to three days. In some cases, especially in young patients, more frequent injections or higher doses may be necessary.<\/p>\n\n\n\n
Treatment of bleeding<\/strong><\/p>\n\n\n\nThe dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved. The desired factor VIII level depends on the location and severity of the bleeding.<\/p>\n\n\n\nDose (IU) = body weight (kg) x desired factor VIII increase (% of normal) x 0.5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\nIf you have the impression that ADVATE is not working properly, talk to your doctor.<\/p>\n\n\n\n
Your doctor will perform appropriate laboratory tests to ensure that you have adequate factor VIII levels. This is especially important if you are having major surgery.<\/p>\n\n\n\n
Use in children and adolescents (from 0 to 18 years)<\/h2>\n\n\n\n
When it comes to treating bleeding, the dose for children is the same as for adult patients. When it comes to preventing bleeding in children under 6 years of age, a dose of 20 to 50 IU per kg body weight is recommended 3 to 4 times a week. Administration of ADVATE to children ( intravenously ) does not differ from administration to adults. A central venous access device may be required to enable frequent infusion of factor VIII products.<\/p>\n\n\n\n
Due to the reduced injection volume of ADVATE reconstituted in 2 ml, there is even less time to react to hypersensitivity reactions. Therefore, caution is recommended when injecting ADVATE reconstituted in 2 ml, especially for children.<\/p>\n\n\n\n
How ADVATE is given<\/strong><\/p>\n\n\n\nADVATE is usually injected into a vein ( intravenously ) by your doctor or nurse. You or someone else can also give ADVATE 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 ADVATE than you should <\/h2>\n\n\n\n
Always take ADVATE exactly as your doctor has told you. Consult a doctor if you are unsure. If you inject more ADVATE than recommended, tell your doctor as soon as possible.<\/p>\n\n\n\n
If you forget to take ADVATE<\/h2>\n\n\n\n
Do not inject 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 taking ADVATE<\/h2>\n\n\n\n
Do not stop using ADVATE 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
If severe, sudden allergic (anaphylactic) reactions<\/strong> occur, discontinue injection immediately. <\/strong>You must contact your doctor immediately<\/strong> if you get any of the following early signs of allergic reactions:<\/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, unconsciousness.<\/li><\/ul>\n\n\n\n
Severe symptoms, such as difficulty breathing and fainting, require immediate emergency treatment.<\/p>\n\n\n\n
In children who have not been previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (affects more than 1 user in 10). However, for patients who have previously been treated with factor VIII(treatment for more than 150 days), the risk is less and the complication is less common (occurs in 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 suffer from persistent bleeding. If this happens, consult a doctor immediately.<\/p>\n\n\n\n
A very common side effect is<\/strong> (occurring in more than 1 in 10)<\/p>\n\n\n\nFactors VIII inhibitors (in children not previously treated with factor VIII medicines).<\/p>\n\n\n\n
Common adverse s<\/strong> (affects up to 1 in 10)<\/p>\n\n\n\nHeadache and fever.<\/p>\n\n\n\n
Less common side effects are<\/strong> (affects up to 1 in 100)<\/p>\n\n\n\nInhibitors of factor VIII (in patients who have been treated with factor VIII -previously (treatment for more than 150 days)), dizziness, influenza, fainting, abnormal heart rhythm, red itchy lumps on the skin, chest discomfort, bruising at the injection site, reaction to the injection site, itching, increased sweating, unusual taste in the mouth, swelling, migraine, memory problems, chills, diarrhea, nausea, vomiting, shortness of breath, sore throat, infection of the lymph vessels, pallor, eye inflammation, eczema, profuse sweating, swollen legs, feet decreased proportion of red blood cells in the blood, increased number of a certain type of white blood cells ( monocytes ) and pain in the upper abdomen or lower chest.<\/p>\n\n\n\n
In connection with surgery<\/em><\/p>\n\n\n\ncatheter-related infection, decreased red blood cell count, swelling of extremities joints, prolonged bleeding after drainage removal, decreased factor VIII level, and postoperative bruising.<\/p>\n\n\n\n
In connection with the device for central venous access<\/em><\/p>\n\n\n\nCatheter-related infection, systemic infection, and local blood clot at the catheter site.<\/p>\n\n\n\n
Adverse reactions with an unknown frequency<\/strong> (cannot be calculated from the available data).<\/p>\n\n\n\nPotentially life-threatening reactions ( anaphylaxis ) and other allergic reactions (hypersensitivity), general symptoms (fatigue, weakness).<\/p>\n\n\n\n
Additional side effects are in children<\/strong><\/p>\n\n\n\nIn addition to the development of inhibitors in pediatric patients not previously treated, as well as catheter-related complications, no age-specific differences in adverse reactions were observed during clinical trials.<\/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 ADVATE<\/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 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). Do not freeze.<\/p>\n\n\n\n
During the shelf life, the powder vial can be stored at room temperature (at a maximum of 25 \u00b0 C) for up to 6 months. The expiry date for the medicine is then the end of this 6-month period or the expiry date which is printed on the bottle, whichever is the earlier. Note the end date of the 6-month period on the outer carton. Once the medicine has been stored at room temperature, it must not be put back in the refrigerator.<\/p>\n\n\n\n
Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n
This product is for single use only. Dispose of the unused product appropriately.<\/p>\n\n\n\n
Use the product immediately when the powder is completely dissolved.<\/p>\n\n\n\n
Do not store the product in the refrigerator after preparation.<\/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 octocog alfa ( human coagulation factor VIII produced by recombinant DNA technology). Each vial of powder nominally contains 250, 500, 1000, or 1500 IU octocog alfa.<\/li>
- The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol<\/a>, polysorbate 80, and glutathione (reduced).<\/li><\/ul>\n\n\n\n
Vial with liquid:<\/em> 2 ml sterile water for injections<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
ADVATE is a white to off-white powder. After reconstitution, the solution is clear, colorless, and free of foreign particles. Each pack also contains a preparation aid (BAXJECT II).<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/strong><\/p>\n\n\n\nTakeda Manufacturing Austria AG<\/p>\n\n\n\n
Industriestrasse 67<\/p>\n\n\n\n
A \u2011 1221 Vienna<\/p>\n\n\n\n
Tel: +800 66838470<\/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 on 04\/2020<\/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: <\/p>\n\n\n\n
Instructions for preparation and administration<\/h2>\n\n\n\n
Aseptic technique is necessary during the preparation of the solution and during administration.<\/p>\n\n\n\n
Use only the sterile water for injections and the reconstitution aid provided with each package ADVATE. ADVATE must not be mixed with other medicines or solutions.<\/p>\n\n\n\n
It is strongly recommended to note the name and batch number of the product each time ADVATE is administered to a patient.<\/p>\n\n\n\n
Instructions for preparation<\/strong>
<\/p>\n\n\n\n
If you are not sure, ask your doctor.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using ADVATE. Tell your doctor if you have previously been treated with factor VIII products, especially if you have developed inhibitors, as there may be a greater risk of recurrence. Inhibitors are blocking antibodies to factor VIII, which reduce the effect of ADVATE in preventing or controlling bleeding. The development of inhibitors is a known complication in the treatment of hemophilia. Contact your doctor immediately if your bleeding is not controlled with ADVATE.
<\/p>\n\n\n\n
There is a small risk of you getting an anaphylactic reaction (a severe, sudden allergic reaction ) from ADVATE. You should be aware of early signs of allergic reactions such as rash, hives, general itching, swelling of the lips and tongue, difficulty breathing, pressure over the chest, general malaise, and dizziness. These symptoms can be an early symptom of anaphylactic shock, reactions that may also include severe dizziness, unconsciousness, and severe difficulty breathing.<\/p>\n\n\n\n
If you experience any of these symptoms, stop the injection\/infusion immediately, and contact your doctor. Severe symptoms, such as difficulty breathing and fainting, require immediate emergency treatment.<\/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 may 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 ADVATE, tell your doctor immediately.<\/p>\n\n\n\n The information on warnings and precautions applies to both adults and children (from 0 to 18 years).<\/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.<\/p>\n\n\n\n ADVATE 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 considered by patients on a low-salt diet.<\/p>\n\n\n\n Incorrect administration of ADVATE<\/strong><\/p>\n\n\n\n Improper administration ( injection into an artery or outside the vein) should be avoided, as mild, short-term reactions at the injection site, such as bruising and erythema, may occur.<\/p>\n\n\n\n Treatment with ADVATE will be initiated by a physician experienced in the management of patients with hemophilia A.<\/p>\n\n\n\n Your doctor will calculate the dose of an ADVATE (in international units or IU) 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 ADVATE works on you. Replacement treatment with ADVATE is usually a lifelong treatment.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.<\/p>\n\n\n\n Prevention of bleeding<\/strong><\/p>\n\n\n\n The usual dose is 20 – 40 IU octocog alfa per kg body weight given every two to three days. In some cases, especially in young patients, more frequent injections or higher doses may be necessary.<\/p>\n\n\n\n Treatment of bleeding<\/strong><\/p>\n\n\n\n The dose of octocog alfa is calculated depending on your body weight and the factor VIII levels to be achieved. The desired factor VIII level depends on the location and severity of the bleeding.<\/p>\n\n\n\n If you have the impression that ADVATE is not working properly, talk to your doctor.<\/p>\n\n\n\n Your doctor will perform appropriate laboratory tests to ensure that you have adequate factor VIII levels. This is especially important if you are having major surgery.<\/p>\n\n\n\n When it comes to treating bleeding, the dose for children is the same as for adult patients. When it comes to preventing bleeding in children under 6 years of age, a dose of 20 to 50 IU per kg body weight is recommended 3 to 4 times a week. Administration of ADVATE to children ( intravenously ) does not differ from administration to adults. A central venous access device may be required to enable frequent infusion of factor VIII products.<\/p>\n\n\n\n Due to the reduced injection volume of ADVATE reconstituted in 2 ml, there is even less time to react to hypersensitivity reactions. Therefore, caution is recommended when injecting ADVATE reconstituted in 2 ml, especially for children.<\/p>\n\n\n\n How ADVATE is given<\/strong><\/p>\n\n\n\n ADVATE is usually injected into a vein ( intravenously ) by your doctor or nurse. You or someone else can also give ADVATE 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 Always take ADVATE exactly as your doctor has told you. Consult a doctor if you are unsure. If you inject more ADVATE than recommended, tell your doctor as soon as possible.<\/p>\n\n\n\n Do not inject 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 ADVATE 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 Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n If severe, sudden allergic (anaphylactic) reactions<\/strong> occur, discontinue injection immediately. <\/strong>You must contact your doctor immediately<\/strong> if you get any of the following early signs of allergic reactions:<\/p>\n\n\n\n In children who have not been previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (affects more than 1 user in 10). However, for patients who have previously been treated with factor VIII(treatment for more than 150 days), the risk is less and the complication is less common (occurs in 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 suffer from persistent bleeding. If this happens, consult a doctor immediately.<\/p>\n\n\n\n A very common side effect is<\/strong> (occurring in more than 1 in 10)<\/p>\n\n\n\n Factors VIII inhibitors (in children not previously treated with factor VIII medicines).<\/p>\n\n\n\n Common adverse s<\/strong> (affects up to 1 in 10)<\/p>\n\n\n\n Headache and fever.<\/p>\n\n\n\n Less common side effects are<\/strong> (affects up to 1 in 100)<\/p>\n\n\n\n Inhibitors of factor VIII (in patients who have been treated with factor VIII -previously (treatment for more than 150 days)), dizziness, influenza, fainting, abnormal heart rhythm, red itchy lumps on the skin, chest discomfort, bruising at the injection site, reaction to the injection site, itching, increased sweating, unusual taste in the mouth, swelling, migraine, memory problems, chills, diarrhea, nausea, vomiting, shortness of breath, sore throat, infection of the lymph vessels, pallor, eye inflammation, eczema, profuse sweating, swollen legs, feet decreased proportion of red blood cells in the blood, increased number of a certain type of white blood cells ( monocytes ) and pain in the upper abdomen or lower chest.<\/p>\n\n\n\n In connection with surgery<\/em><\/p>\n\n\n\n catheter-related infection, decreased red blood cell count, swelling of extremities joints, prolonged bleeding after drainage removal, decreased factor VIII level, and postoperative bruising.<\/p>\n\n\n\n In connection with the device for central venous access<\/em><\/p>\n\n\n\n Catheter-related infection, systemic infection, and local blood clot at the catheter site.<\/p>\n\n\n\n Adverse reactions with an unknown frequency<\/strong> (cannot be calculated from the available data).<\/p>\n\n\n\n Potentially life-threatening reactions ( anaphylaxis ) and other allergic reactions (hypersensitivity), general symptoms (fatigue, weakness).<\/p>\n\n\n\n Additional side effects are in children<\/strong><\/p>\n\n\n\n In addition to the development of inhibitors in pediatric patients not previously treated, as well as catheter-related complications, no age-specific differences in adverse reactions were observed during clinical trials.<\/p>\n\n\n\n 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 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). Do not freeze.<\/p>\n\n\n\n During the shelf life, the powder vial can be stored at room temperature (at a maximum of 25 \u00b0 C) for up to 6 months. The expiry date for the medicine is then the end of this 6-month period or the expiry date which is printed on the bottle, whichever is the earlier. Note the end date of the 6-month period on the outer carton. Once the medicine has been stored at room temperature, it must not be put back in the refrigerator.<\/p>\n\n\n\n Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n This product is for single use only. Dispose of the unused product appropriately.<\/p>\n\n\n\n Use the product immediately when the powder is completely dissolved.<\/p>\n\n\n\n Do not store the product in the refrigerator after preparation.<\/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 Vial with liquid:<\/em> 2 ml sterile water for injections<\/p>\n\n\n\n ADVATE is a white to off-white powder. After reconstitution, the solution is clear, colorless, and free of foreign particles. Each pack also contains a preparation aid (BAXJECT II).<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Takeda Manufacturing Austria AG<\/p>\n\n\n\n Industriestrasse 67<\/p>\n\n\n\n A \u2011 1221 Vienna<\/p>\n\n\n\n Tel: +800 66838470<\/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 on 04\/2020<\/p>\n\n\n\n Further information on this medicine is available on the European Medicines Agency web site: <\/p>\n\n\n\n Aseptic technique is necessary during the preparation of the solution and during administration.<\/p>\n\n\n\n Use only the sterile water for injections and the reconstitution aid provided with each package ADVATE. ADVATE must not be mixed with other medicines or solutions.<\/p>\n\n\n\n It is strongly recommended to note the name and batch number of the product each time ADVATE is administered to a patient.<\/p>\n\n\n\n Instructions for preparation<\/strong>Children and young people<\/h2>\n\n\n\n
Other medicines and ADVATE<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
ADVATE contains sodium<\/h2>\n\n\n\n
3. How to use ADVATE<\/h2>\n\n\n\n
Dose (IU) = body weight (kg) x desired factor VIII increase (% of normal) x 0.5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Use in children and adolescents (from 0 to 18 years)<\/h2>\n\n\n\n
If you use more ADVATE than you should <\/h2>\n\n\n\n
If you forget to take ADVATE<\/h2>\n\n\n\n
If you stop taking ADVATE<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Severe symptoms, such as difficulty breathing and fainting, require immediate emergency treatment.<\/p>\n\n\n\n5. How to store ADVATE<\/h2>\n\n\n\n
6. 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 the 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
Instructions for preparation and administration<\/h2>\n\n\n\n
<\/p>\n\n\n\n