500 IU FVIII \/ 1200 IU VWF and 1000 IU FVIII \/ 2400 IU VWF powder and solvent for solution for injection\/infusion
Human coagulation factor VIII\/von Willebrand factor (VWF)<\/p>\n\n\n\n
Haemate contains human coagulation factor VIII and von Willebrand factor. These factors are necessary for the blood to be able to coagulate. Haemate replaces the lack of body factor VIII and von Willebrand factor. Bleeding can then be stopped or prevented.<\/p>\n\n\n\n
Haemate is used to prevent and treat bleeding in patients with:<\/p>\n\n\n\n
Haemate is also used to treat patients with antibodies to factor VIII.<\/p>\n\n\n\n
As Haemate contains both factor VIII and von Willebrand factor, your doctor will consider which of these factors you need the most. If you have hemophilia A or other conditions with a factor VIII deficiency, your dose will be adjusted according to your need for factor VIII. If you have von Willebrand’s disease, your dose will be adjusted according to your need for the von Willebrand factor.<\/p>\n\n\n\n
Von Willebrand factor and human coagulation factor VIII contained in Haemate may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
If you are allergic to von Willebrand factor or coagulation factor VIII or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n
Traceability<\/em><\/strong><\/p>\n\n\n\n Each time you are given Haemate, it is recommended that the product name and batch number be registered to enable the tracking of the product used.<\/p>\n\n\n\n Tell your doctor or pharmacist if you experience a hypersensitivity reaction (for symptoms see section 4, Possible side effects ). Discontinue treatment and consult a physician.<\/p>\n\n\n\n Hemophilia A<\/em><\/p>\n\n\n\n The development of inhibitors ( antibodies ) is a known complication that may occur during treatment with any factor VIII drug. The inhibitors, especially at high levels, prevent the treatment from working properly. You or your child will be closely monitored for the development of such inhibitors. If you or your child has a haemorrhage that cannot be controlled with Haemate, tell your doctor immediately.<\/em><\/p>\n\n\n\n von Willebrand’s disease<\/em><\/p>\n\n\n\n During treatment with von Willebrand factor, antibodies to the coagulation factors may develop, which means that the bleeding cannot be controlled with normal doses. It is therefore important that the effect of the treatment is checked by your doctor.<\/p>\n\n\n\n Tell your doctor or pharmacist if you have a heart condition or have a risk factor for heart disease.<\/p>\n\n\n\n If you need a central venaccess device (CVAD) to deliver Haemate, there is a risk of CVAD-related complications in the form of local infections, bacteria in the blood ( bacteremia ), and the formation of a blood clot in the blood vessel ( thrombosis ) where the catheter is introduced.<\/p>\n\n\n\n If you have von Willebrand’s disease, there is an increased risk of getting a blood clot (including a blood clot in the lung) when using Haemate. This is especially true if you have a known risk factor for getting a blood clot such as a previous blood clot, periods in connection with surgery without preventive treatment for blood clots, severe obesity, prolonged bed rest, cancer, overdose. If you have any of these risk factors, consult your doctor before using Haemate.<\/p>\n\n\n\n Virus security<\/em><\/p>\n\n\n\n When medicines are made from human plasma or blood, 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 new, hitherto unknown viruses and other types of infections.<\/p>\n\n\n\n The measures taken are considered to be effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C virus, and the non-enveloped virus and hepatitis A virus. The measures may be of limited value against non-enveloped viruses such as parvovirus B19.<\/p>\n\n\n\n Parvovirus B19 infection can be serious in pregnant women ( fetal infection ), immunocompromised individuals, or in patients with certain types of anemia (eg, hemolytic anemia ).<\/p>\n\n\n\n Your doctor may suggest vaccination against Hepatitis A and B if you are regularly \/ repeatedly treated with plasma-derived factor VIII\/von Willebrand products.<\/p>\n\n\n\n Tell your doctor or pharmacist if you have recently taken or might take any other medicines.<\/p>\n\n\n\n Haemate should not be mixed with other drugs or diluents.<\/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 taking this medicine.<\/p>\n\n\n\n During pregnancy and lactation, Haemate should only be used after special consideration by the treating physician.<\/p>\n\n\n\n Haemate does not affect the ability to drive and use machines.<\/p>\n\n\n\n Haemate 500 IU FVIII \/ 1200 IU VWF contains 26 mg sodium (the main ingredient in common salt\/table salt) in each vial. This corresponds to 1.3% of the highest recommended daily intake of sodium for adults.<\/p>\n\n\n\n Haemate 1000 IU FVIII \/ 2400 IU VWF contains 52.5 mg sodium (the main ingredient in common salt\/table salt) in each vial. This corresponds to 2.6% of the maximum recommended daily intake of sodium for adults.<\/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 Treatment will be started by your doctor. The doctor will inform you thoroughly about the preparation of the solution for the injection\/infusion technique and the steps you should take in the event of a serious side effect s. As soon as you can treat yourself and if no side effects have occurred during the treatment, your doctor may allow you to continue treatment at home.<\/p>\n\n\n\n The doctor will adjust the dose individually for you. Do not change the dosage and injection rate prescribed by your doctor.<\/p>\n\n\n\n General instructions for preparation and administration<\/strong><\/p>\n\n\n\n The solution should be clear or slightly opalescent (semi-transparent). After filtration\/filling of the syringe (see below) but before administration, the solution should be inspected visually for particulate matter and discoloration. Even if the preparation instructions are followed exactly, it is not uncommon for any precipitates or particles to remain in the solution before filtration. The filter in the Mix2Vial set completely removes these particles. Do not use solutions that are still cloudy or contain particles or flakes after filtration.<\/p>\n\n\n\n Preparation and withdrawal in the syringe must be done under aseptic conditions (which prevents contamination with bacteria).<\/p>\n\n\n\n The solution should be used immediately after transferring it to the syringe.<\/p>\n\n\n\n Preparation of the solution and filling of the syringe<\/em><\/p>\n\n\n\n Heat the liquid to room temperature. Remove the plastic caps from both the powder vial and the vial with liquid. Treat the surfaces of the rubber stoppers with an antiseptic solution and allow them to dry before opening the Mix2Vial package. <\/p>\n\n\n\n Om st\u00f6rre m\u00e4ngder ska administreras kan detta ske med infusion (dropp i en ven). Den beredda l\u00f6sningen fr\u00e5n flera injektionsflaskor f\u00f6rs d\u00e5 \u00f6ver till en l\u00e4mplig infusionsp\u00e5se eller pump. Om l\u00e4kemedlet ska ges till dig som infusion g\u00f6rs det av sjukv\u00e5rdspersonal.<\/p>\n\n\n\n Om du f\u00e5tt i dig f\u00f6r stor m\u00e4ngd l\u00e4kemedel eller om t ex ett barn f\u00e5tt i sig l\u00e4kemedlet av misstag kontakta l\u00e4kare, sjukhus eller Giftinformationscentralen f\u00f6r bed\u00f6mning av risken samt r\u00e5dgivning.<\/p>\n\n\n\n Ta omedelbart n\u00e4sta dos och forts\u00e4tt med regelbundna intervall enligt din l\u00e4kares rekommendation.<\/p>\n\n\n\n Ta inte dubbel dos f\u00f6r att kompensera f\u00f6r gl\u00f6md dos.<\/p>\n\n\n\n Sluta inte att anv\u00e4nda Haemate utan att r\u00e5dfr\u00e5ga l\u00e4kare.<\/p>\n\n\n\n Om du har ytterligare fr\u00e5gor om detta l\u00e4kemedel, kontakta l\u00e4kare eller apotekspersonal.<\/p>\n\n\n\n Liksom alla l\u00e4kemedel kan detta l\u00e4kemedel orsaka biverkningar, men alla anv\u00e4ndare beh\u00f6ver inte f\u00e5 dem.<\/p>\n\n\n\n Bland barn som inte behandlats med faktor VIII-l\u00e4kemedel tidigare \u00e4r det mycket vanligt att h\u00e4mmande antikroppar utvecklas (se avsnitt 2) (f\u00f6rekommer hos fler \u00e4n 1 av 10 patienter). F\u00f6r patienter som tidigare har behandlats med faktor VIII (behandling mer \u00e4n 150 dagar) \u00e4r dock risken mindre och komplikationen \u00e4r mindre vanlig (f\u00f6rekommer hos f\u00e4rre \u00e4n 1 av 100 anv\u00e4ndare). Om du eller ditt barn utvecklar antikroppar kan l\u00e4kemedlen upph\u00f6ra att fungera som de ska, och du eller ditt barn kan drabbas av ih\u00e5llande bl\u00f6dningar. Om detta h\u00e4nder ska du omedelbart kontakta l\u00e4kare.<\/p>\n\n\n\n Sluta ta Haemate och kontakta omedelbart l\u00e4kare om du f\u00e5r en \u00f6verk\u00e4nslighetsreaktion (anafylaktisk chock eller angio\u00f6dem). \u00d6verk\u00e4nslighetsreaktioner kan ge f\u00f6ljande symtom:<\/strong><\/p>\n\n\n\n \u00d6verk\u00e4nslighetsreaktioner \u00e4r mycket s\u00e4llsynta och f\u00f6rekommer hos f\u00e4rre \u00e4n 1 av 10 000 anv\u00e4ndare.<\/p>\n\n\n\n Mycket s\u00e4llsynta (f\u00f6rekommer hos f\u00e4rre \u00e4n 1 av 10 000 anv\u00e4ndare):<\/em><\/p>\n\n\n\n Har rapporterats (f\u00f6rekommer hos ett ok\u00e4nt antal anv\u00e4ndare) <\/em>:<\/em><\/p>\n\n\n\n Biverkningar hos barn och ungdomar<\/strong><\/p>\n\n\n\n Biverkningar hos barn f\u00f6rv\u00e4ntas vara samma som hos vuxna.<\/p>\n\n\n\n Rapportering av biverkningar<\/em><\/p>\n\n\n\n Om du f\u00e5r biverkningar, tala med l\u00e4kare, apotekspersonal eller sjuksk\u00f6terska. Detta g\u00e4ller \u00e4ven eventuella biverkningar som inte n\u00e4mns i denna information. Du kan ocks\u00e5 rapportera biverkningar direkt till L\u00e4kemedelsverket. Genom att rapportera biverkningar kan du bidra till att \u00f6ka informationen om l\u00e4kemedels s\u00e4kerhet. <\/p>\n\n\n\n F\u00f6rvara detta l\u00e4kemedel utom syn- och r\u00e4ckh\u00e5ll f\u00f6r barn.<\/p>\n\n\n\n Anv\u00e4nds f\u00f6re utg\u00e5ngsdatum som anges p\u00e5 kartongen efter EXP. Utg\u00e5ngsdatumet \u00e4r den sista dagen i angiven m\u00e5nad.<\/p>\n\n\n\n F\u00f6rvaras vid h\u00f6gst 25 \u00baC. F\u00e5r ej frysas.<\/p>\n\n\n\n F\u00f6rvara i ytterkartongen. Ljusk\u00e4nsligt.<\/p>\n\n\n\n Den f\u00e4rdigberedda l\u00f6sningen ska anv\u00e4ndas omedelbart.<\/p>\n\n\n\n Anv\u00e4nd inte l\u00f6sningen om den fortfarande \u00e4r grumlig eller inneh\u00e5ller partiklar eller flagor efter filtreringen.<\/p>\n\n\n\n All oanv\u00e4nd f\u00e4rdigberedd l\u00f6sning ska kasseras.<\/p>\n\n\n\n L\u00e4kemedel ska inte kastas i avloppet eller bland hush\u00e5llsavfall. Fr\u00e5ga apotekspersonalen hur man kastar l\u00e4kemedel som inte l\u00e4ngre anv\u00e4nds. Dessa \u00e5tg\u00e4rder \u00e4r till f\u00f6r att skydda milj\u00f6n.<\/p>\n\n\n\n De aktiva substanserna \u00e4r:<\/p>\n\n\n\n The other ingredients in the powder are human albumin, glycine , sodium chloride, sodium citrate, sodium hydroxide or hydroch,loric acid (for pH adjustment).<\/p>\n\n\n\n Liquid is water for injections.<\/p>\n\n\n\n The powder is white to pale yellow. The liquid is uncoloured and clear.<\/p>\n\n\n\n Pack size:<\/em><\/p>\n\n\n\n 500 IU coagulation factor VIII \/ 1200 IU von Willebrand factor: 1x (powder and 10 ml liquid)<\/p>\n\n\n\n 1000 IU coagulation factor VIII \/ 2400 IU von Willebrand factor: 1x (powder and 15 ml liquid)<\/p>\n\n\n\n The box contains:<\/em><\/p>\n\n\n\n CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany<\/p>\n\n\n\n Information provided by:<\/strong><\/p>\n\n\n\n CSL Behring AB, Box 712, 182 17 Danderyd<\/p>\n","protected":false},"excerpt":{"rendered":" Haemate contains human coagulation factor VIII and von Willebrand factor. These factors are necessary for the blood to be able to coagulate. Haemate replaces the lack of body factor VIII and von Willebrand factor. Bleeding can then be stopped or prevented.<\/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":[2200,2208],"tags":[14002,13998,13999,14003,13994,13997,14001,13996,14000,13995],"class_list":["post-13714","post","type-post","status-publish","format-standard","hentry","category-medicines","category-h","tag-benefits-of-haemate","tag-benefits-of-human-coagulation-factor-viii","tag-haemate","tag-haemate-side-effects","tag-human-coagulation-factor-viii","tag-human-coagulation-factor-viii-side-effects","tag-what-haemate-is-used-for","tag-what-human-coagulation-factor-viii-is-used-for","tag-what-is-haemate","tag-what-is-human-coagulation-factor-viii"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13714","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=13714"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13714\/revisions"}],"predecessor-version":[{"id":15350,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13714\/revisions\/15350"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=13714"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=13714"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=13714"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other drugs and Haemate<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Haemate contains sodium<\/h2>\n\n\n\n
3. How to use Haemate<\/h2>\n\n\n\n
<\/p>\n\n\n\n<\/a>1<\/td> 1. Open the Mix2Vial package by pulling off the closure. Do not<\/strong> remove the Mix2Vial kit from the blister pack.<\/td><\/tr> <\/a>
2<\/td>2. Place the bottle of liquid on a flat, clean surface and hold the bottle firmly. Take the blister pack with the Mix2Vial set and push the tip of the blue adapter part straight down<\/strong> through the stopper of the liquid bottle.<\/td><\/tr> <\/a>
3<\/td>Carefully remove the blister pack from the Mix2Vial set by grasping the edge from above and pulling it straight up. Make sure that only the blister pack is removed, not the Mix2Vial set.<\/td><\/tr> <\/a>
4<\/td>4. Place the powder bottle on a flat, firm surface. Turn the liquid bottle with the attached Mix2Vial set and push the tip of the transparent adapter part straight down<\/strong> through the stopper of the powder bottle. The liquid will automatically flow over to the powder bottle.<\/td><\/tr> <\/a>5<\/td> 5. Grasp the part of the Mix2Vial set where the powder bottle sits with one hand and the part of the Mix2Vial set where the liquid bottle sits with the other hand and carefully unscrew the set into two parts to avoid foaming. Dispose of the liquid bottle with the blue Mix2Vial part attached.<\/td><\/tr> <\/a>6<\/td> Carefully rotate the powder bottle with the attached transparent adapter until the powder is completely dissolved. Do not shake the bottle.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n <\/a>7<\/td> 7. Inhale air into an empty, sterile syringe. While the powder bottle is upright, the syringe is connected to the Luer-lock fitting on the Mix2Vial part. Inject air into the bottle.<\/td><\/tr> <\/a>8<\/td> With the syringe plunger depressed, turn the bottle (together with the set and syringe ) upside down. Withdraw the solution into the syringe by slowly returning the plunger.<\/td><\/tr> <\/a>9<\/td> 9. Once all the solution has been transferred to the syringe, grasp the syringe firmly (hold the syringe with the plunger down) and disconnect the transparent Mix2Vial adapter from the syringe.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Om du har anv\u00e4nt f\u00f6r stor m\u00e4ngd av Haemate<\/h2>\n\n\n\n
Om du har gl\u00f6mt att anv\u00e4nda Haemate<\/h2>\n\n\n\n
Om du slutar att anv\u00e4nda Haemate<\/h2>\n\n\n\n
4. Eventuella biverkningar<\/h2>\n\n\n\n
5. Hur Haemate ska f\u00f6rvaras<\/h2>\n\n\n\n
6. F\u00f6rpackningens inneh\u00e5ll och \u00f6vriga upplysningar<\/h2>\n\n\n\n
Inneh\u00e5llsdeklaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer:<\/h2>\n\n\n\n