200 mg\/ml injection solution for subcutaneous injection
normal human<\/p>\n\n\n\n
What Cuvitru is<\/strong> Cuvitru belongs to a group of medicines called “human normal immunoglobulins”.<\/p>\n\n\n\n Immunoglobulins are also called antibodies and are found in the blood of healthy people. Antibodies are part of the immune system (the body’s natural defense system) and help the body fight infections. How Cuvitru works<\/strong> Cuvier is made from the blood of healthy people. The drug works in the same way as immunoglobulins that are found naturally in the blood. What Cuvitru is used for<\/strong> Cuvier is used in patients with weak immune systems, who do not have enough antibodies in their blood and often get infections. Regular and adequate doses of Cuvitru can raise the abnormally low levels of immunoglobulin in the blood to normal levels ( substitution therapy ). Cuvier is prescribed to patients with the following conditions:<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before using Cuvitru.<\/p>\n\n\n\n If Cuvitru is stored in silicone-coated syringes for more than two hours, visible particles may form. The detailed instructions in “Method and route of administration” in section 3 of this leaflet must be followed carefully. Allergic reactions<\/em><\/p>\n\n\n\n You may be allergic to immunoglobulins without knowing it. Allergic reactions such as a sudden drop in blood pressure or anaphylactic shock (severe drop in blood pressure in combination with other symptoms such as swelling of the airways, difficulty breathing, and rash) are rare, but they can sometimes occur even if you have not had problems with similar treatments before. Signs or symptoms of these rare allergic reactions:<\/p>\n\n\n\n The first time you receive Cuvitru, the infusion is given slowly by a doctor or nurse, who monitors you so that any allergic reactions can be detected and treated immediately.<\/p>\n\n\n\n Monitoring during infusion<\/em><\/p>\n\n\n\n Some side effects may be more common if:<\/p>\n\n\n\n In all other cases, it is recommended that you be monitored during infusion one and for at least 20 minutes after the end of infusion one. Special patient groups<\/em><\/p>\n\n\n\n Your doctor will be especially vigilant if you are overweight, have diabetes, high blood pressure, low blood volume ( hypovolemia ), or blood vessel problems (vascular disease). In these conditions, immunoglobulins may increase the risk of heart attack, stroke, pulmonary embolism, or deep vein thrombosis, but only in very rare cases.<\/p>\n\n\n\n Your doctor will also check if you have or have had kidney problems before or if you are receiving medicines that can damage your kidneys (nephrotoxic medicines) as there is a rare risk of acute kidney failure. Meningitis (aseptic meningitis , AMS)<\/em><\/p>\n\n\n\n Infusion of immunoglobulin products can cause meningitis. Discontinuation of immunoglobulin therapy may reduce meningitis within a few days. Meningitis usually occurs a few hours up to 2 days after immunoglobulin treatment.<\/p>\n\n\n\n Contact your doctor if you experience the following symptoms: severe headache, stiff neck, drowsiness, fever, nausea, vomiting, and photosensitivity or discomfort of light after receiving Cuvitru.<\/p>\n\n\n\n The doctor will decide if more samples need to be taken and if treatment can continue. Degradation of red blood cells ( hemolysis )<\/em><\/p>\n\n\n\n Cuvitru contains antibodies that can cause red blood cell breakdown and hemolytic anemia ( anemia ). Effects on blood test analysis<\/em><\/p>\n\n\n\n Cuvitru contains several different antibodies and some of these may affect the results when the blood is analyzed (serological tests).<\/p>\n\n\n\n You and\/or your carer are trained to detect early signs of side effects, especially allergic reactions. During the infusion, you or your carer should be aware of the early signs of side effects are (further information in section 4, ” Possible side effects<\/strong> “).<\/p>\n\n\n\n Information about the original material in Cuvitru<\/em><\/p>\n\n\n\n Cuvier is made from human blood plasma (the liquid part of the blood). When medicines are made from human blood or plasma, certain measures are taken to prevent the transmission of infection to patients.<\/p>\n\n\n\n These include:<\/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 used. This also applies to unknown and new viruses or other types of infections. The measures taken are considered effective for enveloped viruses, e.g. human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, and for non-enveloped hepatitis A virus and parvovirus B19. No correlation between immunoglobulins and noted infection s with hepatitis A virus parvovirus B19, which may be because the antibody is present in Cuvitru against this infectious s is protective. The following information should be noted in the treatment diary, each time you receive a dose of Cuvitru:<\/p>\n\n\n\n The same warnings and precautions apply to both adults and children.<\/p>\n\n\n\n Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Vaccinations<\/em><\/p>\n\n\n\n Cuvitru may reduce the effectiveness of some vaccines with viruses such as measles, rubella, mumps, and chickenpox (live virus vaccines). Once you have received Cuvitru, you may have to wait up to 3 months before receiving certain vaccines. You may have to wait up to 1 year after receiving the last dose of Cuvitru before you can get the measles vaccine.<\/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 or pharmacist for advice before taking this medicine. No clinical trials have been performed with Cuvitru in pregnant or lactating women. However, experience with immunoglobulins suggests that no harmful effects are expected during pregnancy or in the infant. If you are breast-feeding and receiving Cuvitru, the antibodies from the medicine will also be present in your breast milk and may protect your baby from certain infections. Experience with immunoglobulins shows that there are no expected detrimental effects on fertility.<\/p>\n\n\n\n Patients may experience side effects (such as dizziness or nausea) during treatment with Cuvitru that may affect their ability to drive and use machines. If this happens, wait until the reactions have passed.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist. Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Cuvitru must be given under the skin ( subcutaneous administration ). Cuvitru treatment is started by a doctor or nurse, but you can use the medicine at home once you have received the first infusions under medical supervision and you (and\/or your carer) have received appropriate training. You and your doctor will decide if you can use Cuvitru at home. Do not start treatment with Cuvitru at home until you have received complete instructions. Dosage<\/em><\/p>\n\n\n\n Your doctor will calculate the correct dose for you, based on your body weight, any previous treatment, and how you respond to the treatment.<\/p>\n\n\n\n Your doctor will decide if you need a loading dose (for adults or children) of at least 1.0 to 2.5 ml\/kg bodyweight spread over several days. After this, you will receive Cuvitru regularly, from daily to once every two weeks. The total dose one per month will be about 1.5 to 5 ml\/kg body weight. Your doctor may adjust your dose depending on how you respond to treatment. Do not change the dose or dosing interval without consulting your doctor. If you think you should get Cuvitru more often or less often, talk to your doctor. If you think you have missed a dose, talk to your doctor as soon as possible. Start treatment<\/em><\/p>\n\n\n\n Your treatment is started by a doctor or nurse who has experience in treating patients with weak immune systems and instructing patients for treatment at home. You will be closely monitored throughout infusion one and for at least 1 hour after the end of infusion one to see how well you tolerate the medicine.<\/p>\n\n\n\n Initially, the doctor or nurse uses a slow infusion rate and gradually increases it during the first infusion and subsequent infusions. Once the doctor or nurse has arrived at the right dose and infusion rate for you, you can give the treatment to yourself at home. Treatment at home<\/em><\/p>\n\n\n\n You or your carer can administer Cuvitru on their own. You will be trained by a doctor or nurse who has experience in instructing and treating patients in your situation. The doctor or nurse will be with you during the first treatments. You or your carer will be instructed in:<\/p>\n\n\n\n You must follow the doctor’s instructions regarding the dose, infusion rate, and the frequency of infusion of Cuvitru so that the treatment will work for you. Method of administration and route of administration<\/strong> Choice of infusion site (s): <\/em><\/p>\n\n\n\n The following sites are recommended for subcutaneous infusion of Cuvitru: abdomen, thighs, upper arms, and lumbar spine. Cuvitru can be infused at several infusion sites. The infusion sites should be at least 10 cm apart. Avoid bony areas, visible blood vessels, scars, and areas that may be inflamed (irritated) or infected.<\/p>\n\n\n\n Switch between different places for each administration according to the instructions given to you by your doctor or nurse. Multiple subcutaneous infusion sites can be used simultaneously with a set of multiple needles. The amount of medicine given depends on the infusion site and doses over 30 ml can be divided into several infusion sites. Infusion rate: <\/em><\/p>\n\n\n\n The recommended initial infusion rate is 10 ml per hour per infusion site. If well tolerated, it can be increased at intervals of at least 10 minutes to 20 ml per hour per site for the first two infusions. For subsequent infusions, the infusion rate may be increased as tolerated. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse Detailed instructions for use can be found in the section below:<\/em><\/p>\n\n\n\n Do not use Cuvitru at home until you have received instructions and training from your doctor or nurse.<\/p>\n\n\n\n Prepare the Cuvitru bottle (s):<\/p>\n\n\n\n
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<\/p>\n\n\n\n2. What you need to know before using Cuvitru<\/h2>\n\n\n\n
DO NOT use Cuvitru:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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The risk that you will get allergic reactions is higher if you have IgA deficiency with anti- IgA – antibody s. Tell your doctor or nurse before treatment if you have IgA deficiency. Cuvitru contains residual amounts of IgA which may increase the risk of an allergic reaction.
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Treatment at home<\/em><\/p>\n\n\n\n
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<\/p>\n\n\n\n3. How to use Cuvitru<\/h2>\n\n\n\n
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