50 g \/ l infusion solution
Human normal immunoglobulin (IVIg)<\/p>\n\n\n\n
Intratect is an extract of human blood that contains antibodies (the body’s defenses) against diseases, available as an infusion solution. The solution is ready to be administered via a vein (a drip).<\/p>\n\n\n\n
Intratect contains human immunoglobulin ( antibodies ) from blood donated by a wide range of the population and which is likely to contain antibodies against the most common infectious diseases. Appropriate doses of Intratect can restore normal levels of low levels of immunoglobulin G in the blood.<\/p>\n\n\n\n
Intratect is used in adults and children and adolescents (0-18 years) who do not have enough antibodies (replacement therapy) for:<\/p>\n\n\n\n
* patients with documented specific antibody deficiency or IgG level <4 g \/ l
Intratect is also used in adults and children and adolescents (0-18 years) for the treatment of inflammatory diseases (immune modulation) eg:<\/p>\n\n\n\n
Human normal immunoglobulin (IVIg) contained in Intratect may also be approved for the treatment of other conditions not mentioned in this product information. <\/strong>Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before using Intratect if you <\/strong><\/p>\n\n\n\n Your doctor should take extra care if you are overweight, elderly, diabetic, or have high blood pressure, if you have low blood volume ( hypovolemia ) or if your blood is thicker than normal (high blood viscosity) if you have been bedridden or immobile (immobile). for a long time or if you have problems with the blood vessels (vascular diseases) or if you have another risk factor for thrombotic events (blood clots).<\/p>\n\n\n\n Note – reactions<\/strong><\/p>\n\n\n\n You will be closely monitored during the infusion period with Intratect to check that you are not getting a reaction (eg anaphylaxis ). Your doctor will check that the infusion rate of Intratect is right for you.<\/p>\n\n\n\n If you notice any of the following signs of a reaction, ie. headache, flushing, chills, muscle aches, tingling, rapid heartbeat, low back pain, nausea, low blood pressure during infusion with Intratect, tell your doctor immediately. The infusion rate can be reduced or the infusion can be stopped completely.<\/p>\n\n\n\n After infusion one of Intratect, you may have a low concentration of white blood cells ( neutropenia ) which disappears spontaneously within 7 to 14 days. If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n In very rare cases, transfusion-related acute lung injury (TRALI) may occur after receiving immunoglobulins. This leads to non-cardiac accumulation of fluid in the airways of the lungs (non-cardiogenic pulmonary edema ) which causes severe difficulty breathing ( respiratory stress), rapid breathing ( tachypnea ), abnormally low levels of oxygen in the blood ( hypoxia ), and increased body temperature (fever). . The symptoms usually appear within 1 to 6 hours after you receive treatment. Contact a doctor immediately if you notice such reactions during infusion one of Intratect. The doctor will immediately discontinue the infusion.<\/p>\n\n\n\n Information on the transmission of infectious agents<\/strong><\/p>\n\n\n\n Intratect is made from human plasma (the part of the blood that is made up of fluid). When drugs are made from human blood or human plasma, it is important to prevent the transmission of infection to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, the risk of transmitting infection cannot be completely ruled out when administering medicinal products derived from human blood or human plasma.<\/p>\n\n\n\n The measures taken are considered to be effective for enveloped viruses e.g. human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus.<\/p>\n\n\n\n Measures taken may be of limited value against uncovered viruses, e.g. hepatitis A virus and parvovirus B19.<\/p>\n\n\n\n Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly due to the protective effect of the antibodies against these infections present in the product.<\/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 Intratect may reduce the effectiveness of certain vaccines, eg:<\/p>\n\n\n\n You may have to wait up to 3 months before you can get certain vaccines and up to a year before you can get the measles vaccine.<\/p>\n\n\n\n Do not use loop diuretics with Intratect.<\/p>\n\n\n\n Effects on blood tests<\/strong><\/p>\n\n\n\n Intratect may affect blood test results. If you have taken a blood sample after receiving Intratect, inform the person taking the blood sample or your doctor that you have received Intratect.<\/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.<\/p>\n\n\n\n Your doctor will decide if you can use Intratect during pregnancy and breastfeeding.<\/p>\n\n\n\n Intratect has little effect on the ability to drive and use machines. Patients who have experienced side effects during treatment should wait until they subside before driving or using machines. 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.<\/p>\n\n\n\n Intratect is for intravenous administration ( infusion into a vein). It is given by a doctor or nurse. Dose one depends on your condition and your body weight. Your doctor knows which is the right amount for you.<\/p>\n\n\n\n At the beginning of infusion one, you will receive Intratect at a low rate. Your doctor may then gradually increase the infusion rate.<\/p>\n\n\n\n The infusion rate and dosing frequency depend on the reason why you are receiving Intratect.<\/p>\n\n\n\n Dosage one for children and adolescents (0\u201318 years) is no different than for adults, as dosage one for each indication is given by body weight and adjusted according to the clinical outcome of the above conditions.<\/p>\n\n\n\n As replacement therapy for patients with a weakened immune system (primary or secondary immunodeficiency) every three to four weeks.<\/p>\n\n\n\n To treat inflammatory diseases (immune modulation), an infusion can be given as follows.<\/p>\n\n\n\n Intratect is given in a hospital by a doctor or nurse, so it is unlikely that an infusion would be forgotten. However, tell your doctor if you think an infusion has failed.<\/p>\n\n\n\n An overdose can lead to fluid overload and thickening of the blood, especially in elderly patients or patients with impaired heart or kidney function. If you think you have been given too much Intratect, tell your doctor if your infusion should be stopped and alternative treatment given.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or nurse.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them.<\/p>\n\n\n\n The frequency groups listed below have generally been calculated based on the number of patients treated unless otherwise indicated, e.g. according to the number of infusions .<\/p>\n\n\n\n If you notice any of the following side effects , tell your doctor immediately:<\/strong><\/p>\n\n\n\n This can be an allergic or a severe allergic reaction (anaphylactic shock ) or a hypersensitivity reaction .<\/strong><\/p>\n\n\n\n The following adverse reactions have been reported during clinical trials with Intratect 50 g \/ l:<\/strong><\/p>\n\n\n\n Common:<\/strong> may occur with up to 1 in 10 infusions:<\/p>\n\n\n\n Uncommon<\/strong> : may occur in up to 1 in 100 infusions<\/p>\n\n\n\n The following side effects have been reported spontaneously with Intratect:<\/strong><\/p>\n\n\n\n No known frequency (can not be calculated from the available data)<\/strong><\/p>\n\n\n\n Preparations with human immunoglobulin generally cause the following side effects (in decreasing frequency):<\/strong><\/p>\n\n\n\n If a side effect occurs, the infusion rate is reduced or the infusion is stopped .<\/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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. 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 The pharmacy staff or the doctor knows how to store Intratect.<\/p>\n\n\n\n Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n Do not store above 25 \u00b0 C. Do not freeze.<\/p>\n\n\n\n The active substance in Intratect is human immunoglobulin for intravenous administration .<\/p>\n\n\n\n Intratect contains 50 g \/ l human plasma proteins , of which at least 96% are immunoglobulin G (IgG). The distribution of IgG subclasses is approximately 57% IgG1, 37% IgG2, 3% IgG3 and 3% IgG4. Maximum immunoglobulin A ( IgA ) content is 900 micrograms \/ ml.<\/p>\n\n\n\n The other ingredients are: glycine and water for injections.<\/p>\n\n\n\n Intratect is a solution for infusion . The solution is clear or slightly opalescent (milky, opalescent) and colorless to pale yellow.<\/p>\n\n\n\n 20 ml, 50 ml, 100 ml or 200 ml solution in a vial (type II glass) with a stopper (bromobutyl) and a cap (aluminum). Pack size: 3 vials with 200 ml solution.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Biotest Pharma GmbH<\/p>\n\n\n\n Landsteinerstrasse 5<\/p>\n\n\n\n 63303 Three<\/p>\n\n\n\n Germany<\/p>\n\n\n\n Tel: + 49 6103 801-0<\/p>\n\n\n\n Fax: + 49 6103 801-150<\/p>\n","protected":false},"excerpt":{"rendered":" Intratect is an extract of human blood that contains antibodies (the body’s defenses) against diseases, available as an infusion solution. The solution is ready to be administered via a vein (a drip).<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,12116],"tags":[12577,12582,12574,12579,12578,12583,12576,12581,12575,12580],"class_list":["post-14449","post","type-post","status-publish","format-standard","hentry","category-medicines","category-i","tag-benefits-of-human-normal-immunoglobulin-ivig","tag-benefits-of-intratect","tag-human-normal-immunoglobulin-ivig","tag-intratect","tag-side-effects-of-human-normal-immunoglobulin-ivig","tag-side-effects-of-intratect","tag-what-human-normal-immunoglobulin-ivig-is-used-for","tag-what-intratect-is-used-for","tag-what-is-human-normal-immunoglobulin-ivig","tag-what-is-intratect"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14449","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=14449"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14449\/revisions"}],"predecessor-version":[{"id":14861,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14449\/revisions\/14861"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=14449"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=14449"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=14449"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}2. What you need to know before using Intratect<\/h2>\n\n\n\n
Do not use Intratect<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Intratect<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
3. How to use Intratect<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If an infusion fails<\/h2>\n\n\n\n
If you take more Intratect than you should<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
5. How to store Intratect<\/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 contents of the pack<\/h2>\n\n\n\n
Pack size: 1 vial with 20 ml, 50 ml, 100 ml or 200 ml solution.<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n