250 IU, 1250 IU Powder, and solvent for solution for injection\/infusion
Human coagulation factor XIII<\/p>\n\n\n\n
What is Cluvot?<\/em><\/strong><\/p>\n\n\n\n Cluvot consists of a white powder and a diluent which is prepared into a finished solution. The solution is given as an injection into a vein. Cluvot contains coagulation factor XIII (FXIII) from human plasma (the fluid part of the blood) and has an important hemostatic function (stops bleeding). What is Cluvot used for?<\/strong><\/em><\/p>\n\n\n\n Cluvot is used in adults and children<\/p>\n\n\n\n Human coagulation factor XIII contained in Cluvot may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. The following sections provide information that your doctor should consider before taking Cluvot.<\/p>\n\n\n\n Tell your doctor if you have any drug or food allergies.<\/strong><\/p>\n\n\n\n Talk to your doctor before using Cluvot:<\/p>\n\n\n\n A known complication of the treatment is the formation of inhibitors (neutralizing antibodies )<\/em>, which means that the treatment stops working. If your bleeding can not be controlled with Cluvot, consult your doctor immediately. You should then be closely monitored for the formation of antibodies. Your doctor will carefully consider the benefits of Cluvot treatment compared to the risk of the above complications. Virus security<\/strong><\/em><\/p>\n\n\n\n When medicines are made from human blood or plasma, 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 unknown or new viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B, and hepatitis C virus, and against non-enveloped viruses a hepatitis A and parvovirus B19. It is strongly recommended that your doctor record the product name and batch number of the medicine (indicated on the carton) each time you receive Cluvot. Your doctor may suggest vaccination against hepatitis A and B if you are regularly \/ repeatedly treated with drugs made from human plasma.<\/p>\n\n\n\n No studies on the ability to drive and use machines have been performed. 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 Be aware that Cluvot contains sodium. This should be considered if you have been prescribed a low-salt diet. Cluvot contains 124.4-195.4 mg (5.41\u20118.50 mmol) of sodium per dose (40 IU \/ kg body weight – for normal weight of 70 kg) if the recommended dose is one (2800 IU = 44.8 ml) ges. Your doctor will calculate the dose you need and how often Cluvot should be given to you, taking into account how well the treatment is working.<\/p>\n\n\n\n For more information, see the section “The following information is intended for healthcare professionals only”.<\/p>\n\n\n\n No cases of overdose have been reported and this is not expected as healthcare professionals are giving the medicine.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed in rare cases (affects more than 1 user in 10,000 and less than 1 in 1,000 users):<\/p>\n\n\n\n The following side effects have been observed in very rare cases (affects less than 1 user in 10,000):<\/p>\n\n\n\n If allergic reactions occur, administration of Cluvot must be stopped immediately and appropriate treatment initiated. In the event of a medical shock, the applicable standard medical treatment must be applied. Side effects are in children and adolescents<\/strong><\/p>\n\n\n\n Side effects in children and adolescents are expected to be the same as in adults. Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address<\/p>\n\n\n\n The active substance is:<\/em><\/strong><\/p>\n\n\n\n Human coagulation factor XIII, 250 IU, and 1250 IU, respectively, per vial.<\/p>\n\n\n\n IU = IE (International Units) Other ingredients are:<\/em><\/strong><\/p>\n\n\n\n Human albumin, glucose monohydrate, sodium chloride, sodium hydroxide (in small amounts for pH adjustment ).<\/p>\n\n\n\n Diluent<\/em>: Water for injections.<\/p>\n\n\n\n Cluvot is supplied as a white powder together with a diluent (water for injections). The reconstituted solution should be colorless, clear to slightly opalescent. When held against the light, it should not be cloudy or contain precipitates\/particles. Packaging:<\/em><\/strong><\/p>\n\n\n\n One pack of 250 IU contains<\/p>\n\n\n\n Accessories for administration (inner carton):<\/p>\n\n\n\n One pack of 1250 IU contains<\/p>\n\n\n\n Accessories for administration (inner carton):<\/p>\n\n\n\n CSL Behring GmbH<\/p>\n\n\n\n Emil-von-Behring-Strasse 76<\/p>\n\n\n\n 35041 Marburg<\/p>\n\n\n\n Germany Further information on this medicine can be obtained from the representative of the marketing authorization holder:<\/strong><\/p>\n\n\n\n CSL Behring AB<\/p>\n\n\n\n Box 712<\/p>\n\n\n\n 182 17 Dande<\/p>\n","protected":false},"excerpt":{"rendered":" Cluvot consists of a white powder and a diluent which is prepared into a finished solution. The solution is given as an injection into a vein.<\/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":[2203,2200],"tags":[6858,6861,6860,6862,6854,6857,6856,6859,6855],"class_list":["post-6949","post","type-post","status-publish","format-standard","hentry","category-c","category-medicines","tag-cluvot","tag-cluvot-injection","tag-cluvot-side-effects","tag-cluvot-uses","tag-human-coagulation-factor-xiii","tag-human-coagulation-factor-xiii-dose","tag-human-coagulation-factor-xiii-uses","tag-what-is-cluvot","tag-what-is-human-coagulation-factor-xiii"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6949","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=6949"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6949\/revisions"}],"predecessor-version":[{"id":11328,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6949\/revisions\/11328"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6949"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6949"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6949"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/p>\n\n\n\n2. What you need to know before using Cluvot<\/h2>\n\n\n\n
Do not use Cluvot:<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and Cluvot<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nCluvot contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Cluvot<\/h2>\n\n\n\n
Dosage<\/h2>\n\n\n\n
If you use more Cluvot then you should <\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Cluvot<\/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
<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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