5 mg\/ml\u00a0powder for\u00a0infusion liquid, solution
Rabbit anti-human\u00a0thymocyte\u00a0immunoglobulin<\/p>\n\n\n\n
Thymoglobuline is designed as a freeze-dried powder for\u00a0infusion solution, solution (25 mg \u2013 carton with 1 vial).<\/p>\n\n\n\n
After reconstitution with 5 ml water for\u00a0injections, the solution contains 5 mg rabbit ATG\/ml (concentrate).<\/p>\n\n\n\n
Thymoglobuline is a so-called anti-human thymocyte immunoglobulin, made from blood from rabbits that have received an injection of cells from the thymus gland from humans.<\/p>\n\n\n\n
When a patient receives an organ transplant, an immune reaction occurs (one of the body’s defense reactions that recognizes foreign substances entering the body) to get rid of the organ (reject it).<\/p>\n\n\n\n
Thymoglobuline belongs to a group of medicines called immunosuppressants, which help prevent transplanted organs from being rejected. These medications change the body’s defense mechanism and help it accept the transplanted organ. Immunosuppressive agents can also be used to treat other unwanted immune reactions.<\/p>\n\n\n\n
Thymoglobuline is used for immunosuppression in transplantation: to treat the rejection of a transplanted kidney when the rejection cannot be treated well enough with other medicines, called\u00a0corticosteroids.
<\/p>\n\n\n\n
Thymoglobuline must always be used under strict medical supervision in a hospital.<\/p>\n\n\n\n
During treatment with Thymoglobuline, the doctor will take regular blood tests and other tests to check your health. Because of the way this medicine works, it can affect your blood and other organs.<\/p>\n\n\n\n
Talk to a doctor or nurse before receiving Thymoglobuline if:<\/p>\n\n\n\n
Thymoglobuline is often used in combination with other immunosuppressive drugs.\u00a0Following the use of these combinations, there have been reports of\u00a0infection, reactivation of\u00a0infection, and\u00a0sepsis\u00a0(blood poisoning, a severe\u00a0infection\u00a0that is in the blood and spreads throughout the body).
In\u00a0aplastic anemia, the immunosuppressive treatment contributes to the risk of\u00a0infection\u00a0(especially fungal infection) associated with the aplastic anemia itself.<\/p>\n\n\n\n
The use of immunosuppressive drugs, including Thymoglobuline, may increase the risk of developing cancer<\/a>, including lymphoma or lymphoproliferative disorders (abnormal increase in the number of white blood cells).<\/p>\n\n\n\n The safety of immunization with live attenuated vaccines after thymoglobulin therapy has not been studied; therefore, immunization with attenuated live vaccines is not recommended if you have recently received Thymoglobuline (see also “Use of other medicines”).<\/p>\n\n\n\n Risk of transmission of infection<\/em><\/p>\n\n\n\n Components of human blood (formaldehyde-treated red blood cells), as well as thymus cells, are used in the manufacturing process for Thymoglobuline.\u00a0When medicines are prepared from human blood or\u00a0plasma, special measures are taken to prevent\u00a0infection\u00a0from being transmitted to patients.\u00a0These measures include carefully selecting blood and plasma donors to ensure that people at risk of being carriers are excluded, as well as testing individual donations and plasma pools (collection of blood plasma from several blood donors) for signs of virus\/infection.\u00a0The manufacturers of these products also include steps in the processing of blood and\u00a0plasma\u00a0that can inactivate or separate\u00a0viruses.\u00a0Despite these measures, the risk of transmission of infections when\u00a0administering\u00a0medicinal products made from components of human blood cannot be completely ruled out.\u00a0This risk also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection. When you are given Thymoglobuline, it is recommended that the product name and batch number be recorded to enable the tracking of the product used.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.<\/p>\n\n\n\n If you use Thymoglobuline together with other immunosuppressive drugs (e.g. combination treatment with ciclosporin, tacrolimus, or mycophenolate mofetil), there is a risk that the body’s defense system is weakened too much (so-called overimmunosuppression).\u00a0The doctor must therefore know if you are using any of these medicines.<\/p>\n\n\n\n Blood or blood products must not be administered together with Thymoglobuline.<\/p>\n\n\n\n Avoid vaccinating yourself during or soon after treatment with Thymoglobuline without first discussing it with your doctor as it may cause side effects or not work.<\/a><\/p>\n\n\n\n It is unlikely that food and drink will affect the medicine.<\/a><\/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 using this medicine.<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n Thymoglobuline should not be used by pregnant women, unless this is necessary, as the effects are unknown.<\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n Avoid breastfeeding if you receive Thymoglobuline because it can pass into the breast milk and affect the baby.<\/a><\/p>\n\n\n\n Avoid driving or using tools or machines because Thymoglobuline can make you feel sick, tired, or dizzy.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with a doctor or pharmacist if you are unsure.<\/p>\n\n\n\n This medicine contains 4 mg of\u00a0sodium\u00a0(the main ingredient in common\/table salt) per\u00a0vial.\u00a0This corresponds to 0.2% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults. Your medicine is given to you by a doctor or nurse in a hospital.\u00a0Thymoglobuline is given through a plastic tube (\u00a0catheter\u00a0) directly into the blood (\u00a0intravenous\u00a0infusion\u00a0) over at least 4 hours.\u00a0It may take longer to give the first\u00a0dose.<\/p>\n\n\n\n The dose you receive may vary and depends on your weight, and if you are receiving other medications at the same time. In general, patients receive 1.5 mg for each kilogram they weigh each day for 3 to 14 days, which equates to a total dose of 4.5 to 21 mg\/kg.<\/p>\n\n\n\n The doctor or nurse will check you regularly while you are receiving the first\u00a0dose\u00a0as this is when you are most likely to have\u00a0side effects.\u00a0They check if you have a rash, take\u00a0your pulse,\u00a0and blood pressure\u00a0and check your breathing.\u00a0Sometimes the doctor may also want to test your blood to check the number of blood cells.\u00a0If you have a low white blood cell count, the doctor may also give medicines to prevent or treat infections;\u00a0if you have a low\u00a0platelet count, your doctor may give you a platelet transfusion. Other medicines that the doctor may give you<\/strong><\/p>\n\n\n\n The doctor may give you certain other medicines before, or at the same time as you receive Thymoglobuline. These medicines are used to prevent or treat possible side effects and may include:<\/p>\n\n\n\n It is unlikely that you would receive too much Thymoglobuline, as you will be closely monitored by a doctor or nurse during treatment.\u00a0If this still happens, you may have\u00a0thrombocytopenia\u00a0(lower than a normal number of\u00a0platelets\u00a0) or\u00a0leukopenia\u00a0(lower than a normal number of white blood cells).\u00a0This means that you may have a fever, chills, sore throat<\/a>, and mouth ulcers and that you bleed or bruise more easily than usual.<\/p>\n\n\n\n The doctor gives the next\u00a0dose\u00a0at the usual time and does not give a double\u00a0dose\u00a0to compensate for forgotten single\u00a0doses.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Tell the doctor immediately if you get any of the following symptoms in connection with the infusion of Thymoglobuline:<\/p>\n\n\n\n This could be a sign of an allergic reaction or a serious, acute infusion-related reaction.<\/p>\n\n\n\n Side effects listed below have been reported:<\/p>\n\n\n\n Very common (may <\/em>affect <\/em>more than 1 in 10 users):<\/em><\/p>\n\n\n\n Common (may <\/em>affect <\/em>up to 1 in 10 <\/em>users):<\/em><\/p>\n\n\n\n Uncommon side effects (may affect up to 1 in 100 users)<\/em> :<\/p>\n\n\n\n Has been reported (occurring in an unknown number of users):<\/em><\/p>\n\n\n\n During treatment with Thymoglobuline, some patients experience a temporary, transient increase in certain liver values \u200b\u200bin laboratory tests that show how well the liver is working.<\/p>\n\n\n\n When Thymoglobuline has been administered in combination with other immunosuppressive drugs, there have been cases of\u00a0infection, activation of a previous\u00a0infection, and reduced number of certain\u00a0white blood cells\u00a0with concomitant fever, and\u00a0sepsis\u00a0(blood poisoning).\u00a0In rare cases, these\u00a0infections\u00a0have been fatal.\u00a0In rare cases, malignant diseases and\u00a0tumors\u00a0have also occurred, sometimes with fatal outcomes.\u00a0These\u00a0side effects\u00a0only occurred when several immunosuppressive drugs were combined.<\/p>\n\n\n\n Your medicine is kept in the hospital by a doctor or nurse, out of the sight and reach of children. Thymoglobuline contains 25 mg of the active substance, rabbit anti-human\u00a0thymocyte\u00a0immunoglobulin.\u00a0It also contains mannitol,\u00a0glycine,\u00a0and sodium chloride (salt).<\/p>\n\n\n\n Thymoglobuline is supplied in a glass bottle containing a creamy white powder.\u00a0Before using the powder, it must be mixed with 5 milliliters (ml) of sterile water so that it becomes a liquid.\u00a0Each milliliter (ml) contains 5 mg of rabbit anti-human\u00a0thymocyte\u00a0immunoglobulin.\u00a0The prepared solution is clear or slightly opalescent. Marketing Authorization Holder :<\/em> Paasheuvelweg 25<\/p>\n\n\n\n 1105 BP Amsterdam<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Manufacturer:<\/em> or<\/p>\n\n\n\n Genzyme Ireland Ltd.<\/p>\n\n\n\n IDA Industrial Park<\/p>\n\n\n\n Old Kilmeaden Road<\/p>\n\n\n\n Waterford<\/p>\n\n\n\n Ireland<\/p>\n","protected":false},"excerpt":{"rendered":" Thymoglobuline is designed as a freeze-dried powder for\u00a0infusion solution\u00a0, solution (25 mg \u2013 carton with 1 vial).<\/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":[2200,22500],"tags":[25859,25863,25856,25861,25858,25864,25855,25862,25857,25860],"class_list":["post-24992","post","type-post","status-publish","format-standard","hentry","category-medicines","category-t","tag-benefits-of-rabbit-anti-human-thymocyte-immunoglobulin","tag-benefits-of-thymoglobulin","tag-rabbit-anti-human-thymocyte-immunoglobulin","tag-rabbit-anti-human-thymocyte-immunoglobulin-side-effects","tag-thymoglobulin","tag-thymoglobulin-side-effects","tag-what-is-rabbit-anti-human-thymocyte-immunoglobulin","tag-what-is-thymoglobulin","tag-what-rabbit-anti-human-thymocyte-immunoglobulin-is-used-for","tag-what-thymoglobulin-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24992","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=24992"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24992\/revisions"}],"predecessor-version":[{"id":25043,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/24992\/revisions\/25043"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=24992"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=24992"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=24992"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (\u00a0HIV\u00a0), hepatitis B\u00a0virus, hepatitis C\u00a0virus,\u00a0and for non-enveloped\u00a0viruses, HAV and parvovirus B19.<\/p>\n\n\n\nOther medicines and Thymoglobuline<\/h2>\n\n\n\n
Thymoglobuline with food and drink<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Thymoglobuline contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Thymoglobuline<\/h2>\n\n\n\n
The doctor can change the\u00a0dose\u00a0of Thymoglobuline if you experience\u00a0side effects.<\/p>\n\n\n\nIf you have used too much Thymoglobuline<\/h2>\n\n\n\n
What should the doctor do if you have missed a dose of Thymoglobuline?<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How Thymoglobuline should be stored<\/h2>\n\n\n\n
Unopened vials of Thymoglobuline are stored in a refrigerator (2\u20138\u00b0C) and must not be frozen.
The doctor or nurse checks that the product has not passed the expiry date before diluting it.
Thymoglobuline should not be used if there are particles in the vial that do not disappear when the vial is rotated.<\/p>\n\n\n\nContents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n
This liquid is then mixed with sodium chloride or glucose solution so that it can be slowly given (infused) into the blood through a plastic tube (\u00a0catheter\u00a0) into a large vein.
Each pack contains one\u00a0vial.<\/p>\n\n\n\nMarketing authorization holder and manufacturer<\/h2>\n\n\n\n
Genzyme Europe BV<\/p>\n\n\n\n
Genzyme Polyclonals SAS
23 boulevard Chambaud de la Bruy\u00e8re
69007 Lyon
France<\/p>\n\n\n\n