Do not use Immunine<\/h2>\n\n\n\n- if you are allergic<\/strong> to human coagulation factor IX or any of the other ingredients of Immunine.<\/li>
- if you have a condition called consumption coagulopathy,<\/strong> (also called DIC , disseminated intravascular coagulation ). This is a life-threatening condition where increased blood coagulation and pronounced formation of blood clots in the blood vessels occurs.<\/li>
- if you have a condition called hyperfibrinolysis<\/strong> . Hyperfibrinolysis occurs when blood coagulation is impaired because the important coagulant fibrin is degraded.<\/li>
- if you have a known allergy to heparin or if<\/li>
- you have had an abnormal decrease in the number of blood cells involved in the formation of blood clots, which is caused by the use of heparin ( heparin- induced thrombocytopenia<\/strong> ).<\/li><\/ul>\n\n\n\n
After treatment for any of these conditions, Immunine should only be used in case of life-threatening bleeding.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using Immunine.<\/p>\n\n\n\n
If allergic reactions occur:<\/em><\/strong><\/p>\n\n\n\nThere is a small risk that you may have a severe and sudden allergic reaction ( anaphylactic reaction ) to Immunine.<\/p>\n\n\n\n
Discontinue the infusion immediately and contact a doctor immediately<\/strong> if you experience any of the following symptoms. They may be a sign of an anaphylactic reaction and require immediate emergency care. <\/p>\n\n\n\n- redness of the skin<\/li>
- rash<\/li>
- elevations in the skin<\/li>
- itching all over the body<\/li>
- swelling of the lips and tongue<\/li>
- breathing difficulties \/ dyspnoea<\/li>
- impaired inhalation and \/ or exhalation due to narrowing of the airways (wheezing)<\/li>
- feeling of tightness in the chest<\/li>
- general well-being<\/li>
- dizziness<\/li>
- drop in blood pressure<\/li>
- unconsciousness<\/li><\/ul>\n\n\n\n
When monitoring is required:<\/em><\/strong><\/p>\n\n\n\n- Your doctor will check your blood regularly to make sure that the current dose is appropriate and that your blood is getting enough factor IX.<\/li>
- To detect possible complications, your doctor will specifically monitor you
- if you are taking high doses of Immunine.<\/li>
- if you are prone to thrombosis . In that case, you will receive a lower dose of factor IX, the active substance in Immunine.<\/li><\/ul><\/li><\/ul>\n\n\n\n
In case of persistent bleeding:<\/em><\/strong><\/p>\n\n\n\n- If your bleeding can not be controlled with Immunine, tell your doctor immediately<\/strong> . You may have developed factor IX inhibitors. Factor IX inhibitors are antibodies in the blood that counteract the effects of factor IX. This makes Immunine less effective in treating the bleeding. Your doctor will perform the necessary examinations to confirm this.<\/li>
- There is a possible link between the presence of factor IX inhibitors and allergic reactions. Patients with factor IX inhibitors may be at increased risk of sudden and severe allergic reactions ( anaphylaxis ). Therefore, patients who develop an allergic reaction should be tested for the presence of factor IX inhibitors.<\/li><\/ul>\n\n\n\n
Safety on communicable infection s<\/em><\/strong><\/p>\n\n\n\nWhen medicines are made from human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes:<\/p>\n\n\n\n
- careful selection of blood and plasma donors to ensure that people at risk of becoming carriers are excluded<\/li>
- testing of individual donations and plasma pools for signs of virus \/ infection<\/li>
- steps in the processing of blood and plasma that can inactivate and secrete viruses .<\/li><\/ul>\n\n\n\n
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infections.<\/p>\n\n\n\n
The measures taken are considered to be effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B, and hepatitis C virus, and against the uncovered virus and hepatitis A virus.<\/p>\n\n\n\n
The measures may be of limited value against non-enveloped viruses such as parvovirus B19 (the virus that causes reddening of the skin ( infectious erythema ).<\/p>\n\n\n\n
Parvovirus B19 infection can be serious in pregnant women ( fetal infection ), individuals with weakened immune systems, or patients with certain types of anemia (eg sickle cell anemia or haemolytic anemia ).<\/p>\n\n\n\n
Your doctor may suggest vaccination against Hepatitis A and B if you are regularly \/ repeatedly treated with plasma-derived products.<\/p>\n\n\n\n
When you are given Immunine, it is recommended that the product name and batch number be registered to enable the tracking of the used product.<\/p>\n\n\n\n
Children<\/h2>\n\n\n\n
There is insufficient information to recommend the use of Immunine in children under 6 years of age.<\/p>\n\n\n\n
Other medicines and Immunine<\/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
Immunine is\/is not affected by other drugs as far as is known.<\/p>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Hemophilia B is very uncommon in women. Therefore, to date, there is no experience with the use of Immunine during pregnancy and lactation, nor any experience with how Immunine affects fertility.<\/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 for advice before using this medicine. Your doctor will decide if you can use Immunine during pregnancy and breastfeeding.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
No effect on the ability to drive and use machines has been observed.<\/p>\n\n\n\n
Immunine contains sodium and sodium citrate<\/h2>\n\n\n\n
Immunine 600 IU contains 20 mg sodium (the main ingredient in table salt \/ table salt) per vial. This corresponds to 1% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n
Immunine 1200 IU contains 41 mg sodium (the main ingredient in table salt \/ table salt) per vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n
3. How to use Immunine<\/h2>\n\n\n\n
Your treatment should be instituted and administered by a doctor experienced in the treatment of haemophilia B.<\/p>\n\n\n\n
Your doctor will decide on the dose that is right<\/em> for you. The doctor will calculate the dose according to your special needs. Talk to your doctor if you think the effect of Immunine is too strong or too weak.<\/p>\n\n\n\nUse for children<\/strong><\/p>\n\n\n\nThere is insufficient information to recommend the use of Immunine in children under 6 years of age.<\/p>\n\n\n\n
Control of the amount of factor IX in the blood<\/strong><\/p>\n\n\n\nYour doctor will regularly take the necessary samples to make sure you have enough factor IX in your blood. This is especially important in major surgical procedures for life-threatening bleeding.<\/p>\n\n\n\n
If the amount of factor IX in the blood is too low<\/strong><\/p>\n\n\n\nIf the expected factor IX value in the blood is not reached despite the appropriate dose, or if the bleeding does not stop, it may be due to the presence of inhibitors (inhibitors). Your doctor will check for the presence of inhibitors with appropriate samples. When developing inhibitors, contact a specialist center for haemophilia .<\/p>\n\n\n\n
If you have developed factor IX inhibitors, you may need a larger dose of your Immunine to keep your bleeding under control. If the bleeding still cannot be controlled, your doctor will consider alternative medicine. Do not increase the dose of Immunine to get the bleeding under control without consulting your doctor.<\/p>\n\n\n\n
How often to take Immunine<\/strong><\/p>\n\n\n\nYour doctor will tell you how often and at what intervals to administer Immunine. This is a personal evaluation based on how you react to Immunine.<\/p>\n\n\n\n
Method or method of administration<\/strong><\/p>\n\n\n\nImmunine is administered slowly <\/strong>into a vein ( intravenously )<\/em> after reconstitution of the solution with the diluent provided. Follow your doctor’s instructions carefully.<\/p>\n\n\n\nImmunine must not be mixed with other medicines before it is given. This may affect the effect and safety of the medicine.<\/p>\n\n\n\n
The rate of administration can be adjusted according to what you think is convenient, but it should not exceed 2 ml per minute.<\/p>\n\n\n\n
- Use only the supplied infusion set. If other infusion sets are used, Immunine may get stuck on the inside of the infusion set, which may result in incorrect dosing .<\/li>
- If you are also receiving other medicines via your venous entrance, the venous entrance must be<\/strong> rinsed with a suitable solution, e.g. a physiological saline solution, before and after <\/strong>administration of Immunine.<\/li>
- Immunine should only be mixed immediately before administration , after which the liquid must be used immediately. (The solution does not contain preservatives .)<\/li>
- Injection solution is clear or slightly “milky” (opalescent). Do not use solutions that are more cloudy or have visible particles.<\/li>
- Dispose of leftover liquid according to standard procedures.<\/li><\/ul>\n\n\n\n
Adding the powder to a solution for injection:<\/strong><\/p>\n\n\n\nBe sure to mix with the liquid under as clean and sterile conditions as possible!<\/p>\n\n\n\n
- Heat the rubber stoppered, unopened vial of diluent (sterile water for injections) to room temperature (max. 37 \u00b0 C).<\/li>
- Remove the protective caps on the rubber stoppered bottles with the powder and diluent (Fig. A) and clean both rubber stoppers.<\/li>
- Remove the protective cover from one end of the supplied transfer needle by twisting and pulling. Insert the needle through the rubber stopper of the diluent bottle (Figs. B and C).<\/li>
- Remove the protective cover from the other end of the transfer needle and be careful not to touch the exposed end.<\/li>
- Hold the bottle of liquid upside down over the powder bottle, and insert the other end of the transfer needle through the rubber stopper of the powder bottle (Fig. D). The diluent will be sucked in by the vacuum in the powder bottle.<\/li>
- Separate the two bottles when all the diluent has been transferred to the powder bottle by pulling the transfer needle out of the powder bottle (Fig. E). Gently shake the powder bottle to speed up the dissolution.<\/li>
- When the powder has completely dissolved, insert the supplied aeration needle (fig. F) so that any foam disappears. Pull out the aeration needle.<\/li><\/ol>\n\n\n\n
Injection \/ infusion:<\/strong><\/p>\n\n\n\nBe sure to mix with the liquid under as clean and sterile conditions as possible!<\/p>\n\n\n\n
After treatment for any of these conditions, Immunine should only be used in case of life-threatening bleeding.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before using Immunine.<\/p>\n\n\n\n
If allergic reactions occur:<\/em><\/strong><\/p>\n\n\n\n There is a small risk that you may have a severe and sudden allergic reaction ( anaphylactic reaction ) to Immunine.<\/p>\n\n\n\n Discontinue the infusion immediately and contact a doctor immediately<\/strong> if you experience any of the following symptoms. They may be a sign of an anaphylactic reaction and require immediate emergency care. <\/p>\n\n\n\n When monitoring is required:<\/em><\/strong><\/p>\n\n\n\n Safety on communicable infection s<\/em><\/strong><\/p>\n\n\n\n When medicines are made from human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes:<\/p>\n\n\n\n Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infections.<\/p>\n\n\n\n The measures taken are considered to be effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B, and hepatitis C virus, and against the uncovered virus and hepatitis A virus.<\/p>\n\n\n\n The measures may be of limited value against non-enveloped viruses such as parvovirus B19 (the virus that causes reddening of the skin ( infectious erythema ).<\/p>\n\n\n\n Parvovirus B19 infection can be serious in pregnant women ( fetal infection ), individuals with weakened immune systems, or patients with certain types of anemia (eg sickle cell anemia or haemolytic anemia ).<\/p>\n\n\n\n Your doctor may suggest vaccination against Hepatitis A and B if you are regularly \/ repeatedly treated with plasma-derived products.<\/p>\n\n\n\n When you are given Immunine, it is recommended that the product name and batch number be registered to enable the tracking of the used product.<\/p>\n\n\n\n There is insufficient information to recommend the use of Immunine in children under 6 years of age.<\/p>\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 Immunine is\/is not affected by other drugs as far as is known.<\/p>\n\n\n\n Hemophilia B is very uncommon in women. Therefore, to date, there is no experience with the use of Immunine during pregnancy and lactation, nor any experience with how Immunine affects fertility.<\/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 for advice before using this medicine. Your doctor will decide if you can use Immunine during pregnancy and breastfeeding.<\/p>\n\n\n\n No effect on the ability to drive and use machines has been observed.<\/p>\n\n\n\n Immunine 600 IU contains 20 mg sodium (the main ingredient in table salt \/ table salt) per vial. This corresponds to 1% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n Immunine 1200 IU contains 41 mg sodium (the main ingredient in table salt \/ table salt) per vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n Your treatment should be instituted and administered by a doctor experienced in the treatment of haemophilia B.<\/p>\n\n\n\n Your doctor will decide on the dose that is right<\/em> for you. The doctor will calculate the dose according to your special needs. Talk to your doctor if you think the effect of Immunine is too strong or too weak.<\/p>\n\n\n\n Use for children<\/strong><\/p>\n\n\n\n There is insufficient information to recommend the use of Immunine in children under 6 years of age.<\/p>\n\n\n\n Control of the amount of factor IX in the blood<\/strong><\/p>\n\n\n\n Your doctor will regularly take the necessary samples to make sure you have enough factor IX in your blood. This is especially important in major surgical procedures for life-threatening bleeding.<\/p>\n\n\n\n If the amount of factor IX in the blood is too low<\/strong><\/p>\n\n\n\n If the expected factor IX value in the blood is not reached despite the appropriate dose, or if the bleeding does not stop, it may be due to the presence of inhibitors (inhibitors). Your doctor will check for the presence of inhibitors with appropriate samples. When developing inhibitors, contact a specialist center for haemophilia .<\/p>\n\n\n\n If you have developed factor IX inhibitors, you may need a larger dose of your Immunine to keep your bleeding under control. If the bleeding still cannot be controlled, your doctor will consider alternative medicine. Do not increase the dose of Immunine to get the bleeding under control without consulting your doctor.<\/p>\n\n\n\n How often to take Immunine<\/strong><\/p>\n\n\n\n Your doctor will tell you how often and at what intervals to administer Immunine. This is a personal evaluation based on how you react to Immunine.<\/p>\n\n\n\n Method or method of administration<\/strong><\/p>\n\n\n\n Immunine is administered slowly <\/strong>into a vein ( intravenously )<\/em> after reconstitution of the solution with the diluent provided. Follow your doctor’s instructions carefully.<\/p>\n\n\n\n Immunine must not be mixed with other medicines before it is given. This may affect the effect and safety of the medicine.<\/p>\n\n\n\n The rate of administration can be adjusted according to what you think is convenient, but it should not exceed 2 ml per minute.<\/p>\n\n\n\n Adding the powder to a solution for injection:<\/strong><\/p>\n\n\n\n Be sure to mix with the liquid under as clean and sterile conditions as possible!<\/p>\n\n\n\n Injection \/ infusion:<\/strong><\/p>\n\n\n\n Be sure to mix with the liquid under as clean and sterile conditions as possible!<\/p>\n\n\n\n
In case of persistent bleeding:<\/em><\/strong><\/p>\n\n\n\nChildren<\/h2>\n\n\n\n
Other medicines and Immunine<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Immunine contains sodium and sodium citrate<\/h2>\n\n\n\n
3. How to use Immunine<\/h2>\n\n\n\n