if you are allergic to coagulation factor VIII from human blood or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Octanate.<\/p>\n\n\n\n
Octanate contains very small amounts of other human\u00a0proteins.\u00a0All medicines containing\u00a0proteins\u00a0injected into a vein (\u00a0intravenous\u00a0administration\u00a0) may cause allergic reactions (See section 4 – “Possible side effects”).<\/p>\n\n\n\n
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 Octanate, tell your doctor immediately.<\/p>\n\n\n\n
Information on blood and plasma used to make Octanate<\/strong><\/p>\n\n\n\n When medicines are made from human blood or\u00a0plasma, special measures are taken to prevent the transmission of\u00a0infection\u00a0to patients.\u00a0This includes<\/p>\n\n\n\n Nevertheless, the risk of transmission of\u00a0infection\u00a0can not be completely ruled out when drugs made from human blood or\u00a0plasma\u00a0are given.\u00a0This also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n The measures taken are considered effective against enveloped\u00a0viruses\u00a0such as\u00a0HIV,\u00a0Hepatitis\u00a0B, and\u00a0Hepatitis\u00a0C\u00a0virus\u00a0and for the non-enveloped\u00a0virus\u00a0et\u00a0Hepatitis\u00a0A. The measures may be of limited value against non-enveloped\u00a0viruses\u00a0such as parvovirus B19.\u00a0Parvovirus B19\u00a0infection\u00a0can be serious in pregnant women ( fetal\u00a0infection\u00a0) and individuals with weakened immune systems or patients with certain types of\u00a0anemia\u00a0(eg sickle cell anemia or\u00a0hemolytic anemia\u00a0).<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n There are no known interactions between products containing coagulation factor VIII from human blood and other medicinal products. However, octanate should not be combined with other drugs during infusion one.<\/p>\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 No effects have been observed on the ability to drive and use machines.<\/p>\n\n\n\n per 250 IU \/ bottle:<\/strong><\/p>\n\n\n\n less than 1 mmol\u00a0sodium\u00a0(23 mg) (the main ingredient in table salt\/table salt) is per\u00a0vial, ie essentially ‘sodium-free’.<\/p>\n\n\n\n per 500 and 1000 IU \/ bottle:<\/strong><\/p>\n\n\n\n up to 40 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 2% of the maximum recommended daily\u00a0sodium\u00a0intake for adults.<\/p>\n\n\n\n Octanate should be given intravenously after dilution with the supplied liquid.<\/p>\n\n\n\n Treatment should be started under the supervision of a physician.<\/p>\n\n\n\n Dosage to prevent bleeding<\/strong><\/p>\n\n\n\n If you have severe\u00a0hemophilia\u00a0A, inject 20 to 40 IU\u00a0factor VIII\u00a0per kg body weight every two or three days for long-term preventive treatment.\u00a0Dosage\u00a0one should be adjusted according to your answer.\u00a0In some cases, shorter dosing intervals or higher\u00a0doses\u00a0may be required.<\/p>\n\n\n\n Dose calculation<\/strong><\/p>\n\n\n\n Always use Octanate exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.<\/p>\n\n\n\n Factor VIII\u00a0activity refers to the amount of\u00a0factor VIII\u00a0in\u00a0plasma.\u00a0It is expressed either as a percentage (relative to normal\u00a0human\u00a0blood plasma) or in international units (IU).\u00a0Dose\u00a0one of\u00a0factor VIII\u00a0is expressed in IU.<\/p>\n\n\n\n One IU of factor VIII activity corresponds to the amount of factor VIII in one ml of normal human blood plasma. One IU factor VIII per kg body weight increases the factor VIII activity in plasma by 1.5% – 2% of normal activity. To calculate dose one, the level of factor VIII activity in your blood plasma is measured. This shows how much the activity needs to be increased. Talk to your doctor if you are unsure about how much your factor VIII activity needs to be increased or how to calculate dose one.<\/p>\n\n\n\n The required dose is calculated using the following formula:<\/p>\n\n\n\n Units needed = body weight (kg) x desired increase of factor VIII (%) (IU \/ dl) x 0.5<\/strong><\/p>\n\n\n\n The size of the dose and how often it should be given (frequency) should always be guided by the clinical effect in the individual patient.<\/p>\n\n\n\n In the following bleeding events, the\u00a0factor VIII\u00a0activity should not fall below the level of\u00a0plasma\u00a0activity (in% of normal activity) given in the table below for the corresponding period.\u00a0The table can be used for guidance regarding\u00a0dosing\u00a0in case of bleeding and surgical procedures:<\/p>\n\n\n\nOther medicines and Octanate<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Octanate contains excipients<\/h2>\n\n\n\n
How to use Octanate<\/h2>\n\n\n\n