Infusion solution. ABO blood group-specific human plasma protein<\/p>\n\n\n\n
octaplasLG is\u00a0human\u00a0plasma, which has been pooled and treated for virus inactivation.\u00a0Human\u00a0plasma\u00a0is the liquid part of human blood that transports cells.\u00a0It contains human\u00a0plasma protein, which is important for maintaining normal coagulation properties.\u00a0octaplasLG is used in the same way as normal, fresh frozen\u00a0plasma\u00a0(FFP).<\/p>\n\n\n\n
octaplasLG is used in complex coagulation factor deficiency that can be caused by severe liver failure or massive\u00a0transfusion.\u00a0octaplasLG can also be given in acute situations when no coagulation factor concentrate (such as factor V or factor XI) is available or when a necessary laboratory diagnosis is not possible.<\/p>\n\n\n\n
octaplasLG can also be given to quickly counteract the effects of oral anticoagulants (coumarin or indanedione type) when vitamin K levels are too low due to hepatic impairment or in an emergency.<\/p>\n\n\n\n
octaplasLG can be given to patients undergoing plasma exchanges to restore the balance between coagulation factors.
<\/p>\n\n\n\n
Talk to your doctor before using octaplasLG.<\/p>\n\n\n\n
Tell your doctor if you have any other illnesses.<\/p>\n\n\n\n
Take special care with octaplasLG<\/strong><\/p>\n\n\n\n octaplasLG is not normally recommended for the treatment of\u00a0von Willebrand’s disease.<\/p>\n\n\n\n Virus security<\/strong><\/p>\n\n\n\n When medicines are made from human blood or\u00a0human\u00a0plasma\u00a0or blood, special measures are taken to prevent the transmission of\u00a0infection\u00a0to patients.\u00a0This includes careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, as well as testing of individual donations and plasma pools for signs of virus\/infection.\u00a0The manufacturers of these products also include steps in the processing of blood and\u00a0plasma\u00a0that can inactivate and secrete\u00a0viruses.\u00a0Nevertheless, the risk of transmission of\u00a0infection\u00a0can not be completely ruled out when drugs are made from human blood or\u00a0plasmas.\u00a0This also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n The measures taken are considered to be effective against enveloped\u00a0viruses, such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0and\u00a0hepatitis\u00a0C\u00a0virus.<\/p>\n\n\n\n The measures may be of limited value against non-enveloped\u00a0viruses\u00a0such as\u00a0hepatitis\u00a0A\u00a0virus,\u00a0hepatitis\u00a0E\u00a0virus,\u00a0and parvovirus B19.<\/p>\n\n\n\n It is strongly recommended that each time octaplasLG is given to a patient, the product name and batch number should be noted to record which batch was used for the patient.<\/p>\n\n\n\n Your doctor may suggest hepatitis A and B vaccination if you are regularly \/ repeatedly treated with plasma-derived products.<\/p>\n\n\n\n Some cases of low calcium, possibly due to citrate binding, have been observed during therapeutic plasma exchange in children. Monitoring of calcium is recommended during such use of octaplasLG.<\/p>\n\n\n\n In\u00a0clinical trials, octaplasLG has been given in combination with many other medicines and no\u00a0interaction\u00a0has been observed. octaplasLG must not be mixed with other intravenous fluids or medicines other than\u00a0red blood cells\u00a0and\u00a0platelets.<\/p>\n\n\n\n To avoid blood clots, a solution containing calcium should not be administered in the same vein as octaplasLG.<\/p>\n\n\n\n Interactions of octaplasLG with other drugs are not known.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n No effects were observed.<\/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.\u00a0octaplasLG will only be given to you if your doctor considers it important for you.<\/p>\n\n\n\n There is no evidence that octaplasLG can affect the ability to drive or 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 attention.\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.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n For a list of the other ingredients, see section 6. octaplasLG will be given to you by a doctor or nurse. It is given to you by infusion into a vein.<\/p>\n\n\n\n Your dose depends on your clinical situation and how much you weigh. Your doctor will determine the appropriate dose for you.<\/p>\n\n\n\n Before an octaplasLG\u00a0infusion\u00a0can be given, and ABO blood group determination must be made.<\/p>\n\n\n\n – In emergencies, octaplasLG for blood group AB can be given to all patients.<\/p>\n\n\n\n The infusion rate mustn’t exceed 1 mL octaplasLG per kilogram body weight per min.<\/p>\n\n\n\n To minimize the negative effects of the citrate contained in octaplasLG, calcium gluconate may be given into another vein.<\/p>\n\n\n\n You will be monitored during treatment and for at least 20 minutes after treatment in the event of an\u00a0allergic reaction\u00a0(\u00a0anaphylactic reaction\u00a0) or\u00a0shock.\u00a0Infusion\u00a0one is then stopped immediately.<\/p>\n\n\n\n Data for children and adolescents (0-16 years) are limited.<\/p>\n\n\n\n High\u00a0doses\u00a0can cause fluid overload, accumulation of fluid in the lungs, and\/or heart problems.<\/p>\n\n\n\n Your doctor is responsible for monitoring your medication supply and ensuring that your laboratory values \u200b\u200bare appropriate.<\/p>\n\n\n\n Your doctor is responsible for monitoring your medication supply and ensuring that your laboratory values \u200b\u200bare appropriate.<\/p>\n\n\n\n Do not use it after the expiry date which is stated on the label.<\/p>\n\n\n\n Frozen octaplasLG can be thawed in several ways:<\/strong><\/p>\n\n\n\n Thaw in the outer casing for at least 30 minutes in a circulating water bath at + 30 \u00b0 C to Prevent water from contaminating the connection port.\u00a0The minimdefrostsost time is 30 minutes at 37 \u00b0 C.\u00a0The temperature in the water bath must never exceed + 37 \u00b0 C and should not be lower than + 30 \u00b0 C.<\/p>\n\n\n\n The time for thawing depends on the number of bags in the water bath. If several plasma bags are thawed at the same time, the thawing time can be extended, but should not be longer than 60 minutes.<\/p>\n\n\n\n Place the octaplasLG bags on the agitation plate according to the manufacturer’s instructions and thaw the plasma with the quick defrost function. When the temperature display shows that the blood component has reached +37 \u00b0 C, the thawing process should be terminated and the bags removed. Other thawing methods for frozen octaplasLG may be used provided that these methods are validated for this purpose.<\/p>\n\n\n\n Heat the contents of the bag to approximately + 37 \u00b0 C before infusion one. The temperature of octaplasLG must not exceed + 37 \u00b0 C. Remove the outer casing and check the bag for cracks and leaks.<\/p>\n\n\n\n Avoid shaking the bag.<\/p>\n\n\n\n Once thawed, the solution is clear to slightly opalescent and free of solid or gelatinous particles.<\/p>\n\n\n\n Do not use solutions that are cloudy or contain\u00a0precipitates\u00a0and\/or are discolored.<\/p>\n\n\n\n Thawed octaplasLG must not be re-frozen.\u00a0Unused products must be discarded.<\/p>\n\n\n\n Any unused product or waste material should be disposed of following local requirements.<\/p>\n\n\n\n Like all medicines, octaplasLG can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n In rare cases,\u00a0hypersensitivity reactions\u00a0may be observed.\u00a0These are usually mild allergic reactions and consist of localized or generalized redness, rash, or\u00a0itching\u00a0\u00a0More severe forms can be complicated by a drop in blood pressure or swelling of the face or tongue.\u00a0Severe allergic reactions throughout the body can set in quickly and can become serious.\u00a0Symptoms include a drop in blood pressure, increased heart rate, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhea, abdominal or back pain.\u00a0Severe reactions can lead to\u00a0shock, unconsciousness, respiratory failure, and in very rare cases even to death. For all patients at increased risk of blood clots, special care should be taken and appropriate measures considered.<\/p>\n\n\n\n In rare cases, reactions between\u00a0antibodies\u00a0in octaplasLG and with\u00a0antigens\u00a0in your blood can result in degradation of\u00a0red blood cells\u00a0(hemolytic transfusion reactions) such as chills, fever, dry cough, difficulty breathing, rash, and bleeding in the body.<\/p>\n\n\n\n Infusion of octaplasLG may give rise to specific coagulation factor antibodies.<\/p>\n\n\n\n High\u00a0dose\u00a0or high infusion rate may result in increased blood volume, fluid in the lungs, and\/or\u00a0heart failure.<\/p>\n\n\n\n During\u00a0clinical trials\u00a0with octaplasLG’s precursors and their use after authorization, the following\u00a0adverse reactions\u00a0have been identified: <\/p>\n\n\n\n Your doctor will decide if the infusion rate should be reduced or if the infusion should be stopped depending on the type and severity of the side effect.<\/p>\n\n\n\n If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.<\/p>\n\n\n\n Additional side effects are in children<\/strong><\/p>\n\n\n\n During plasma exchange procedures, low calcium levels may be observed in children, especially in patients with hepatic impairment or at high infusion rates. Monitoring of calcium is recommended during such use of octaplasLG.<\/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 after EXP.<\/p>\n\n\n\n Store and transport in a frozen state (at \u2264 \u201318 \u00b0 C). After thawing, chemical and physical in-use stability has been demonstrated for 5 days at From a microbiological point of view, the product should be used immediately, unless the opening method excludes the risk of microbial contamination. If the product is not used immediately, the user is responsible for storage times during use and conditions before use.<\/p>\n\n\n\n Do not use this medicine if you notice that the solution is cloudy or contains precipitates and\/or is discolored.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n octaplasLG is supplied as\u00a0an infusion solution.<\/p>\n\n\n\n 200 ml in a bag.<\/p>\n\n\n\n Pack sizes of 1 and 10.<\/p>\n\n\n\n The frozen solution is (light) yellow.<\/p>\n\n\n\n Octapharma AB<\/p>\n\n\n\n SE-112 75 Stockholm<\/p>\n\n\n\n Manufacturer<\/strong> SE-112 75 Stockholm<\/p>\n","protected":false},"excerpt":{"rendered":" octaplasLG is human plasma , which has been pooled and treated for virus inactivation. Human plasma is the liquid part of human blood that transports cells. It contains human plasma protein , which is important for maintaining normal coagulation properties. octaplasLG is used in the same way as normal, fresh frozen plasma (FFP).<\/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":[19634,19627,19630,19635,19633,19636,19629,19628,19631,19632],"class_list":["post-19480","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-octaplaslg","tag-human-plasma-protein","tag-octaplaslg","tag-octaplaslg-dosage","tag-octaplaslg-side-effects","tag-octaplaslg-usage","tag-what-human-plasma-protein-is-used-for","tag-what-is-human-plasma-protein","tag-what-is-octaplaslg","tag-what-octaplaslg-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19480","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=19480"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19480\/revisions"}],"predecessor-version":[{"id":19526,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19480\/revisions\/19526"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Children<\/h2>\n\n\n\n
Other medicines and octaplasLG<\/h2>\n\n\n\n
When\u00a0administering\u00a0octaplasLG, you may also receive substances (eg pregnancy hormones) that may lead to false-positive test results (eg positive pregnancy test even though you are not pregnant).<\/p>\n\n\n\noctaplasLG with food and drink<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Important information about some of the ingredients of octaplasLG<\/h2>\n\n\n\n
This medicine contains a maximum of 920 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per bag.\u00a0This corresponds to a maximum of 46% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\nHow to use octaplasLG<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you use more octaplasLG than you should<\/h2>\n\n\n\n
If you forget to use octaplasLG<\/h2>\n\n\n\n
If you stop using octaplasLG<\/h2>\n\n\n\n
+ 37 \u00b0 C. If appropriate, a cover bag can be used to further protect the contents.<\/p>\n\n\n\n
During defrosting of octaplasLG with a dry heating system, it is recommended that the printer function be used to document the temperature course and error messages in the event of deviations.<\/p>\n\n\n\nPossible side effects<\/h2>\n\n\n\n
Side effects can be caused by the citrate contained in octaplasLG and by the low calcium levels associated with it, especially if the infusion rate is high, if you have impaired liver function or if you are undergoing plasma exchange procedures.\u00a0You may experience symptoms such as fatigue, tingling (\u00a0paresthesia\u00a0), tremors, and low calcium levels.<\/p>\n\n\n\n
octaplasLG may increase the risk of blood clots in the veins in:<\/p>\n\n\n\nClassification
of organ systems<\/th>Common
(\u2265 <\/strong>1\/100 to <\/strong><1\/10 <\/strong>)<\/strong><\/th>Uncommon
(\u2265 <\/strong>1\/1,000 to <\/strong><1\/100 <\/strong>)<\/strong><\/th>Rare
(\u2265 <\/strong>1 \/ 10,000 to <\/strong><1 \/ 1,000 <\/strong>)<\/strong><\/th>Very rare
(<1 \/ 10,000)<\/strong><\/th><\/tr>Blood disorders<\/td> <\/td> <\/td> <\/td> lack of red blood cells
bleeding tendency<\/td><\/tr>Disorders of the immune system<\/td> <\/td> <\/td> hypersensitivity<\/td> severe allergic reaction and shock<\/td><\/tr> Mental disorders<\/td> <\/td> <\/td> <\/td> anxiety
agitation
restlessness<\/td><\/tr>Disorders of the nervous system<\/td> <\/td> reduced sensation of touch and
feeling<\/td><\/td> dizziness
stinging sensation<\/td><\/tr>Disorders of the heart rhythm<\/td> <\/td> <\/td> <\/td> heart failure
irregular heartbeat
increased heart rate<\/td><\/tr>Blood vessel and circulatory disorders<\/td> <\/td> <\/td> <\/td> blood vessel clots drop-in
blood
the pressure increase in blood pressure
disorders in the blood circulation<\/td><\/tr>Respiratory disorders<\/td> <\/td> acid deficiency<\/td> <\/td> respiratory failure
bleeding in the lungs
-contraction of the trachea
fluid in the lungs
shortness of breath
breathing difficulties<\/td><\/tr>Gastrointestinal disorders<\/td> <\/td> vomiting
nausea<\/td><\/td> abdominal pain<\/td><\/tr> Skin disorders<\/td> hives
itching<\/td><\/td> <\/td> rash
increased sweating<\/td><\/tr>Musculoskeletal disorders<\/td> <\/td> <\/td> <\/td> back pain<\/td><\/tr> General disorders and administration site conditions<\/td> <\/td> fever<\/td> <\/td> chest pain
discomfort
in the chest
chills
localized swelling
general malaise
local reaction at the infusion site<\/td><\/tr>Surveys<\/td> <\/td> <\/td> <\/td> positive antibody test
reduced oxygen content in the blood<\/td><\/tr>Injuries, poisonings
and treatment complications<\/td><\/td> <\/td> <\/td> increased blood volume
citrate poisoning
degradation of red blood cells<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\nHow to store octaplasLG<\/h2>\n\n\n\n
Store in the original package. Sensitive to light.<\/p>\n\n\n\n
2-8 \u00b0 C or 8 hours at room temperature (20-25 \u00b0 C).<\/p>\n\n\n\nContents of the pack 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
Marketing Authorisation Holder<\/h2>\n\n\n\n
Octapharma AB<\/p>\n\n\n\n