200 mg\/ml injection for subcutaneous injection, solution
Human normal immunoglobulin (SCIg = subcutaneous immunoglobulin)<\/p>\n\n\n\n
What Hizentra is<\/strong><\/p>\n\n\n\n Hizentra belongs to a class of medicines called human normal immunoglobulins. Immunoglobulins are also called antibodies and are blood proteins that help your body fight infections.<\/p>\n\n\n\n How Hizentra works<\/strong><\/p>\n\n\n\n Hizentra contains immunoglobulins that have been produced from the blood of healthy people. Immunoglobulins are produced by the body’s immune system. They help your body fight infections caused by bacteria and viruses or maintain the balance of your immune system (called immunomodulation). The medicine works in the same way as the immunoglobulins that are naturally present in your blood.<\/p>\n\n\n\n What is Hizentra used for<\/strong><\/p>\n\n\n\n Substitution treatment (replacement treatment )<\/em><\/p>\n\n\n\n Hizentra is used to raise abnormally low levels of immunoglobulin in your blood to normal levels (replacement therapy). The medicine is used in adults and children Immunomodulatory therapy in CIDP patients<\/em><\/p>\n\n\n\n Hizentra is also used in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a type of autoimmune disease. CIDP is characterized by chronic inflammation in the peripheral nerves, which causes muscle weakness and\/or numbness mainly in the arms and legs. It is believed that the body’s defense attack amplifies such inflammation and that the immunoglobulins found in Hizentra help protect the nerves from the attack (immunomodulatory therapy ).<\/p>\n\n\n\n You may be allergic (hypersensitive) to immunoglobulin without knowing it. However, severe allergic reactions are uncommon. It can occur even if you have received human immunoglobulin before and tolerated it well. This may happen if you do not have enough immunoglobulin type A ( IgA ) in your blood ( IgA deficiency).<\/p>\n\n\n\n In such rare cases, allergic reactions such as a sudden drop in blood pressure or shock may occur (see also section 4 \u201cPossible side effects\u201d).<\/p>\n\n\n\n Your doctor\/nurse will avoid any complications by ensuring that:<\/strong><\/p>\n\n\n\n No clinical studies have been performed with Hizentra in pregnant women. However, drugs containing immunoglobulins have been used by pregnant or lactating women for many years and no adverse effects on the course of pregnancy, the fetus, or the newborn have been observed.<\/p>\n\n\n\n If you are breastfeeding and receiving Hizentra, the medicine’s immunoglobulins may also be present in breast milk. Therefore, your child may be protected against certain infections.<\/p>\n\n\n\n Patients may experience effects such as dizziness or nausea during treatment with Hizentra, which may affect their ability to drive or use machines. If this happens, do not drive or use machines until these effects have disappeared.<\/p>\n\n\n\n You should not take it if you suffer from hyperprolinaemia (see also section 2 \u201cWhat you need to know before using Hizentra\u201d). Tell your doctor before treatment.<\/p>\n\n\n\n Other important information about Hizentra<\/strong><\/p>\n\n\n\n Blood tests<\/strong><\/em><\/p>\n\n\n\n After receiving Hizentra, the results of certain blood tests (serological tests) may be affected for some time.<\/p>\n\n\n\n Information about what Hizentra is made of<\/strong><\/em><\/p>\n\n\n\n Hizentra is made from human blood plasma (the liquid part of the blood). When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. These include:<\/p>\n\n\n\n The manufacturers of these drugs also have stepped in the preparation of one of blood or plasma that can inactivate or remove viruses. Despite these measures, the risk of transmitting infectious agents can not be completely ruled out when medicinal products derived from human blood or plasma are given. This also applies to any unknown or new viruses and other types of infection.<\/p>\n\n\n\n Measures taken are considered effective against viruses with an envelope that human immunodeficiency virus ( HIV, AIDS – viruses et), hepatitis B virus and hepatitis C virus (liver inflammation), and against viruses without an envelope as hepatitis A virus and parvovirus B19.<\/p>\n\n\n\n Hizentra contains sodium<\/strong><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per vial, it is essential ‘sodium-free.<\/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 Dosage<\/strong><\/p>\n\n\n\n Your doctor will calculate the correct dose for you depending on your body weight and how you respond to treatment.<\/p>\n\n\n\n Do not change the dose or the time interval between doses without consulting your doctor.<\/p>\n\n\n\n If you have the impression that you are taking Hizentra more often or less often, talk to your doctor.<\/p>\n\n\n\n If you think you have missed a dose, talk to your doctor as soon as possible.<\/p>\n\n\n\n Substitution treatment<\/em><\/p>\n\n\n\n Your doctor will decide if you need a starting dose (for adults and children) of at least 1-2.5 ml\/kg bodyweight spread over several days. Thereafter, maintenance doses can be given at repeated intervals, from daily to once every two weeks, to achieve a total dose per month of approximately 2-4 ml\/kg body weight. Your doctor may adjust the dose based on how you respond to treatment.<\/p>\n\n\n\n Immunomodulatory therapy<\/em><\/p>\n\n\n\n Your doctor will start treatment with Hizentra 1 week after your last intravenous infusion of immunoglobulin by giving it under the skin ( subcutaneously ) with a weekly dose of 1.0 to 2.0 ml\/kg body weight. Your doctor will determine your weekly dose of Hizentra. The weekly maintenance doses can be divided into smaller doses and given as often as needed during the week. For dosing every two weeks, your doctor will double the weekly dose of Hizentra. Healthcare professionals can adjust the dose depending on how you respond to treatment.<\/p>\n\n\n\n Method of administration and route of administration<\/strong><\/p>\n\n\n\n If you receive treatment at home, it will be started by healthcare professionals experienced in the treatment of immunodeficiency \/ CIDP with subcutaneous immunoglobulin (SCIg) and in advising patients on treatment at home.<\/p>\n\n\n\n You will receive instructions and be trained in:<\/p>\n\n\n\n Infusion site (s)<\/strong><\/p>\n\n\n\n Infusion rate <\/strong>(s)<\/strong><\/p>\n\n\n\n Your doctor will determine the appropriate infusion technique and infusion rate for you based on your dose, dosing frequency, and your tolerance to the medicine.<\/p>\n\n\n\n Infusion with infusion equipment<\/em><\/p>\n\n\n\n The recommended initial infusion rate is up to 20 ml\/hour\/place. If well tolerated, you can gradually increase the infusion rate to 35 ml\/hour\/place for the following two infusions. Thereafter, the infusion rate may be further increased depending on how well you tolerate the treatment.<\/p>\n\n\n\n Manual infusion<\/em><\/p>\n\n\n\n The recommended initial infusion rate is up to 0.5 ml \/ min \/ place (30 ml \/ hour \/ place). If well tolerated, you can increase the infusion rate to up to 2.0 ml \/ min \/ place (120 ml \/ hour \/ place) for subsequent infusions . Thereafter, the infusion rate may be further increased depending on how well you tolerate it.<\/p>\n\n\n\n In INSTRUCTIONS for use<\/strong><\/p>\n\n\n\n
(0-18 years) in the following situations:<\/p>\n\n\n\n2. What you need to know before using Hizentra<\/h2>\n\n\n\n
Do NOT infuse Hizentra:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
This medicine should be infused slowly at first. The recommended infusion rate given in section 3 \u201cHow to use Hizentra\u201d should be followed carefully.<\/li>Other medicines and Hizentra<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Hizentra contains proline<\/h2>\n\n\n\n
3. How to use Hizentra<\/h2>\n\n\n\n