500 IU powder and solvent for solution for injection Human prothrombin complex
1000 IU powder and liquid for infusion solution Human prothrombin complex<\/p>\n\n\n\n
Ocplex belongs to a group of medicines called\u00a0coagulation factors.\u00a0It contains the\u00a0vitamin\u00a0K-dependent human\u00a0coagulation factors\u00a0II, VII, IX, and X.<\/p>\n\n\n\n
Ocplex is used to treat and prevent bleeding:<\/p>\n\n\n\n
Virus security<\/strong><\/p>\n\n\n\n Children and young people<\/strong><\/p>\n\n\n\n There are no data available on the use of Ocplex in children and adolescents.<\/p>\n\n\n\n Ocplex should only be used during pregnancy and lactation if necessary.\u00a0Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n It is unknown whether Ocplex affects the ability to drive and use machines.<\/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 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.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Therefore, read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Treatment with Ocplex should be started under the supervision of a doctor who specializes in coagulation disorders.<\/p>\n\n\n\n How much Ocplex you get and how long depends on:<\/p>\n\n\n\n In case of overdose, the risk of developing increases<\/p>\n\n\n\n Like all medicines, Ocplex can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Blood vessel clot.<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Anxiety, high\u00a0blood pressure, asthma-like symptoms, bloody cough, nosebleeds, burning at the injection site, clot formation in the infusion unit.<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n Allergic reactions may occur. Temporarily elevated liver values \u200b\u200b( transaminases ) have been observed.<\/p>\n\n\n\n The use of this medication carries the risk of blood clots forming.<\/p>\n\n\n\n Has been reported (occurs in an unknown number of users)<\/em><\/p>\n\n\n\n Severe\u00a0allergic reaction\u00a0and\u00a0shock, hypersensitivity, tremor,\u00a0heart failure, increased heart rate,\u00a0circulatory failure, drop in blood pressure, respiratory failure, difficulty breathing, nausea,\u00a0hives, rash, chills.<\/p>\n\n\n\n The\u00a0heparin present\u00a0in the medicine may cause a sudden decrease in the number of platelets in the blood.\u00a0This is an\u00a0allergic reaction\u00a0called “heparin-induced\u00a0thrombocytopenia\u00a0type II”.\u00a0In patients who have not previously been hypersensitive to\u00a0heparin, in rare cases, the reduction in\u00a0platelet count\u00a0may occur 6-14 days after starting treatment.\u00a0In patients with a history of heparin hypersensitivity, the change may occur within a few hours after starting treatment.<\/p>\n\n\n\n Treatment with Ocplex must be stopped immediately in patients who experience this allergic reaction.\u00a0In the future, they must not be treated with medicines containing\u00a0heparin.<\/p>\n\n\n\n For information on virus security, see section 2.<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not store above 25 \u00b0 C. Do not freeze. Store in the original package. Sensitive to light.<\/p>\n\n\n\n The powder should only be dissolved just before\u00a0injection.\u00a0The stability of the solution has been demonstrated for up to 8 hours at + 25 \u00b0 C. Content declaration per\u00a0vial\u00a0and after\u00a0reconstitution\u00a0with 20 ml (500 IU) \/ 40 ml (1000 IU)\u00a0diluent\u00a0.\u00a0The active substances are:<\/strong><\/p>\n\n\n\n The specific activity is \u2265 0.6 IU \/ mg protein expressed as Factor IX activity. The other ingredients are\u00a0heparin, sodium citrate di (dihydrate), water for injections.<\/p>\n\n\n\n Ocplex is supplied as a powder and solvent for solution for\u00a0infusion\u00a0and is a moisture-absorbing, white to slightly colored powder or slightly crumbled dry substance in a\u00a0glass\u00a0vial.\u00a0The diluent is water for injections and is supplied in a\u00a0glass\u00a0vial.\u00a0The reconstituted solution is clear or slightly opalescent and may be colored.<\/p>\n\n\n\n Ocplex is delivered in a box containing:<\/p>\n\n\n\n – 1 vial of powder for solution for infusion<\/p>\n\n\n\n – 1 vial of water for injections ( diluent ).<\/p>\n\n\n\n – 1 transfer set Nextaro \u00ae<\/sup><\/p>\n\n\n\n Marketing Authorization Holder: 112 75 Stockholm<\/p>\n\n\n\n Tel. 08-566 43000<\/p>\n\n\n\n Customer contact: 020-311020<\/p>\n\n\n\n Manufacturer:<\/p>\n\n\n\n Octapharma Pharmazeutika Produktionsges.mbH<\/p>\n\n\n\n Oberlaaer Str. 235<\/p>\n\n\n\n A-1100 Vienna<\/p>\n\n\n\n Austria<\/p>\n\n\n\n Octapharma SAS<\/p>\n\n\n\n 72 Rue du Mar\u00e9chal Foch<\/p>\n\n\n\n 67380 Lingolsheim<\/p>\n\n\n\n France<\/p>\n\n\n\n This medicinal product is authorized under the European Economic Area under the names:<\/p>\n\n\n\n Optiplex<\/em>.\u00a0Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Holland, Ireland, Iceland, Croatia, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, UK, Germany, Hungary, Austria.<\/p>\n\n\n\n Ocplex<\/em>: Sweden, Czech Republic<\/p>\n\n\n\n Pronative<\/em> : Italy, Romania<\/p>\n","protected":false},"excerpt":{"rendered":" Ocplex belongs to a group of medicines called coagulation factors . It contains the vitamin K-dependent human coagulation factors II, VII, IX and X.<\/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":[2200,18526],"tags":[19670,19675,19666,19669,19671,19674,19668,19667,19672,19673],"class_list":["post-19470","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-human-prothrombin-complex","tag-benefits-of-ocplex","tag-human-prothrombin-complex","tag-human-prothrombin-complex-side-effects","tag-ocplex","tag-ocplex-side-effects","tag-what-human-prothrombin-complex-is-used-for","tag-what-is-human-prothrombin-complex","tag-what-is-ocplex","tag-what-ocplex-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19470","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=19470"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19470\/revisions"}],"predecessor-version":[{"id":19531,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19470\/revisions\/19531"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Warnings and Precautions<\/strong> :<\/p>\n\n\n\n
coagulation factor preparations should be used when available.<\/li>
You should therefore be closely monitored for signs or symptoms of intravascular coagulation or blood clots.
This is especially important if you have a history of coronary heart disease or liver disease, if you are having surgery and when Ocplex is given to very young children.<\/li>Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Important information about some of the ingredients of Ocplex<\/h2>\n\n\n\n
How to use Ocplex<\/h2>\n\n\n\n
If you take more Ocplex than you should<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Ocplex<\/h2>\n\n\n\n
However, the solution should be used immediately and only once in a while to prevent contamination.<\/p>\n\n\n\nContents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
Ingredient name<\/strong><\/td> Ocplex<\/strong>
Amount per\u00a0500 IU\u00a0injection bottle<\/strong><\/td>Ocplex <\/strong>Amount<\/strong>
per <\/strong>1000<\/strong> IU vial<\/strong>
<\/strong><\/strong><\/strong><\/td>Ocplex <\/strong>Amount per ml <\/strong>reconstituted <\/strong>solution<\/strong>
<\/strong><\/strong><\/strong><\/td><\/tr><\/thead>Total protein<\/td> 260-820 mg<\/td> 520-1640 mg<\/td> 13-41 mg \/ ml<\/td><\/tr> Active substances<\/em><\/td><\/tr> Human coagulation factor II<\/td> 280-760 IU<\/td> 560-1520 IU<\/td> 14-38 IU \/ ml<\/td><\/tr> Human coagulation factor VII<\/td> 180-480 IU<\/td> 360-960 IU<\/td> 9-24 IU \/ ml<\/td><\/tr> Human coagulation factor IX<\/td> 500 IU<\/td> 1000 IU<\/td> 25 IU \/ ml<\/td><\/tr> Human coagulation factor X<\/td> 360-600 IU<\/td> 720-1200 IU<\/td> 18-30 IU \/ ml<\/td><\/tr> Additional active ingredients<\/em><\/td><\/tr> Protein C<\/td> 260-620 IU<\/td> 520-1240 IU<\/td> 13-31 IU \/ ml<\/td><\/tr> Protein S<\/td> 240-640 IU<\/td> 480-1280 IU<\/td> 12-32 IU \/ ml<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
<\/p>\n\n\n\nWhat the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Octapharma AB<\/p>\n\n\n\n