{"id":21312,"date":"2022-05-19T07:20:17","date_gmt":"2022-05-19T07:20:17","guid":{"rendered":"https:\/\/zeepedia.com\/?p=21312"},"modified":"2022-05-19T16:04:26","modified_gmt":"2022-05-19T16:04:26","slug":"prolastina","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/prolastina\/","title":{"rendered":"Prolastina &#8211; Alpha 1 -proteinase inhibitor uses, dose and side effects"},"content":{"rendered":"\n<p>1000 mg&nbsp;powder and solvent for solution for&nbsp;infusion&nbsp;alpha<br>1&nbsp;<sub>-proteinase<\/sub>&nbsp;inhibitor,&nbsp;human<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Prolastina is and what it is used for<\/h2>\n\n\n\n<p>Prolastina belongs to a class of drugs called proteinase inhibitors.<\/p>\n\n\n\n<p>Alpha\u00a0<sub>1<\/sub>\u00a0-proteinase inhibitor is a substance that is formed in the body to\u00a0inhibit\u00a0the effect of substances called elastases and which damage the lungs.\u00a0In the case of hereditary deficiency of alpha\u00a0<sub>1<\/sub>\u00a0-proteinase inhibitors, there is an imbalance between alpha\u00a0<sub>1<\/sub>\u00a0-proteinase inhibitors and elastase.\u00a0This can lead to gradual degradation of lung tissue and the development of\u00a0pulmonary emphysema.\u00a0Pulmonary emphysema\u00a0is an abnormal enlargement of the lungs, with degradation of the lung tissue.\u00a0Prolactin is used to restore the balance between alpha\u00a01\u00a0-proteinase inhibitors and elastase in the lungs, which prevents further deterioration of the\u00a0pulmonary emphysema.<\/p>\n\n\n\n<p>Prolactin is used for the long-term treatment of patients with certain forms of alpha\u00a0<sub>1<\/sub>\u00a0-proteinase inhibitor deficiency, as determined by your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Prolastina<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Prolastina<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic (hypersensitive) to the active substance alpha&nbsp;<sub>1<\/sub>&nbsp;-proteinase inhibitor or any of the other ingredients of Prolastina (listed in section 6).<\/li><li>if you have a known deficiency of certain&nbsp;immunoglobulins&nbsp;(&nbsp;IgA&nbsp;) because severe allergic reactions and even anaphylactic&nbsp;shock&nbsp;then may occur.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Talk to your doctor, pharmacist, or nurse before using Prolastina.<\/li><li>Talk to your doctor if you have a very weak heart (\u00a0heart failure\u00a0).\u00a0Particular care should be taken as Prolastina may lead to a temporary increase in blood volume.<\/li><\/ul>\n\n\n\n<p><strong>Allergic reactions (\u00a0hypersensitivity reactions)<\/strong><\/p>\n\n\n\n<p>In rare cases, your\u00a0hypersensitivity reaction\u00a0to Prolastina may occur even if you have tolerated alpha\u00a0<sub>1<\/sub>\u00a0proteinase inhibitors well with prior\u00a0administration.<\/p>\n\n\n\n<p>Your doctor will inform you about the signs of allergic reactions and what to do if they occur (see also section 4).<\/p>\n\n\n\n<p>Tell your doctor or nurse immediately if you experience an&nbsp;allergic reaction&nbsp;during the&nbsp;infusion&nbsp;of this medicine.<\/p>\n\n\n\n<p><strong>Safety information regarding the risk of infections<\/strong><\/p>\n\n\n\n<p>When medicines are made from&nbsp;human&nbsp;plasma&nbsp;or blood, special measures are taken to prevent the transmission of&nbsp;infection&nbsp;to patients.&nbsp;This includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>careful selection of blood and plasma donors to ensure that people at risk of becoming carriers are excluded, <\/li><li>testing of individual donations and plasma pools for signs of virus\/infection,<\/li><li>the inclusion of steps in the processing of blood and\u00a0plasma\u00a0that can inactivate and secrete\u00a0viruses.<\/li><\/ul>\n\n\n\n<p>Nevertheless, the risk of transmission of\u00a0infection\u00a0can not be completely ruled out when drugs made from human blood or\u00a0plasma\u00a0are given.\u00a0This also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n<p>The measures taken are considered to be effective against enveloped\u00a0viruses\u00a0such as\u00a0HIV,\u00a0hepatitis\u00a0B, and\u00a0hepatitis\u00a0C\u00a0virus.\u00a0They may be of limited value against non-enveloped\u00a0viruses\u00a0such as\u00a0hepatitis\u00a0A and parvovirus B19.\u00a0Parvovirus B19\u00a0infection can be serious in pregnant women (fetal\u00a0infection\u00a0) and immunocompromised individuals or patients with certain types of\u00a0anemia\u00a0(eg\u00a0hemolytic anemia\u00a0).<\/p>\n\n\n\n<p>Your doctor may suggest&nbsp;hepatitis&nbsp;A and B vaccination if you are regularly \/ repeatedly treated with plasma-derived human proteinase inhibitors.<\/p>\n\n\n\n<p>the product name and batch number must be registered each time you are given Prolastina, to maintain a register of the batch numbers of Prolastina you have received.<\/p>\n\n\n\n<p><strong>Smoking<\/strong><\/p>\n\n\n\n<p>As the effect of Prolastina is negatively affected by tobacco smoke in the lungs, smoking cessation is recommended.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>There is no experience in the use of Prolastina in children and adolescents up to 18 years of age.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Prolastina<\/h2>\n\n\n\n<p>There are no known&nbsp;interactions&nbsp;between Prolastina and other medicines.<\/p>\n\n\n\n<p>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<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n<p>There is no experience with the use of Prolastina during pregnancy.&nbsp;Tell your doctor if you are pregnant or planning to become pregnant.<\/p>\n\n\n\n<p>It is not known if Prolastina passes into breast milk.\u00a0Ask your doctor if you are breastfeeding.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>There is no evidence that Prolastina affects your ability to drive or use machines.<\/p>\n\n\n\n<p>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<h2 class=\"wp-block-heading\">Prolastina contains sodium<\/h2>\n\n\n\n<p>Prolastina contains approximately 110.4 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0If the patient weighs 75 kg, this corresponds to 24.84% of the highest recommended daily intake of\u00a0sodium\u00a0for adults.\u00a0Talk to your doctor or pharmacist if you have been prescribed a low-salt diet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Prolastina<\/h2>\n\n\n\n<p>After\u00a0reconstitution\u00a0with the supplied bottle of solvent, Prolastina is given as\u00a0an infusion\u00a0into a vein.\u00a0A physician experienced in the treatment of patients with\u00a0chronic\u00a0obstructive pulmonary disease will monitor the first\u00a0infusions.\u00a0with Prolastina.<\/p>\n\n\n\n<p><strong>Treatment at home<\/strong><\/p>\n\n\n\n<p>After the first\u00a0infusions, other healthcare professionals can also give Prolastina, but only after receiving adequate training.\u00a0Your treating physician will determine if you are suitable for treatment at home and will ensure that your healthcare professional receives instructions on:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>how to prepare and give the finished infusion solution (see the illustrated instructions at the end of this leaflet).<\/li><li>how to keep the medicine sterile (aseptic infusion techniques).<\/li><li>how to keep a treatment diary.<\/li><li>how to identify\u00a0side effects, including signs of allergic reactions, and measures to be taken if such\u00a0side effects\u00a0occur (see also section 4)<\/li><\/ul>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>The amount of Prolastina you receive is based on your body weight.\u00a0A weekly\u00a0dose\u00a0of 60 mg of active\u00a0substance per\u00a0kg body weight (equivalent to, if the patient weighs 75 kg, 180 ml of reconstituted solution for\u00a0infusion\u00a0containing 25 mg\/ml\u00a0human\u00a0alpha\u00a01\u00a0proteinase inhibitor) is usually sufficient to maintain protective levels of\u00a0human\u00a0serum\u00a0alpha\u00a01\u00a0proteinase inhibitor, which prevents further worsening of\u00a0pulmonary emphysema.<\/p>\n\n\n\n<p>The doctor responsible for treatment determines the length of the treatment period.&nbsp;Today, there are no signs that the length of treatment needs to be limited.<\/p>\n\n\n\n<p>If you have the impression that the effect of Prolastina is too strong or too weak, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Prolastina than you should<\/h2>\n\n\n\n<p>To date, there are no known consequences of overdose.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Talk to your doctor or healthcare professional if you think you have been given more Prolastina than you should.&nbsp;He or she will take appropriate action.<\/li><\/ul>\n\n\n\n<p>If you have ingested too much medicine or if e.g.\u00a0a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Prolastina<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Talk to your doctor, who will decide if you should be given the\u00a0missed\u00a0dose.<\/li><li>Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0infusion.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Prolastina<\/h2>\n\n\n\n<p>If treatment with Prolastina is stopped, your condition may worsen.&nbsp;Talk to the doctor in charge of your treatment if you want treatment with Prolastina to be stopped prematurely.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, Prolastina can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>If&nbsp;side effects&nbsp;occur during&nbsp;infusion&nbsp;with Prolastina, the infusion should&nbsp;be&nbsp;stopped temporarily or stopped completely depending on the type of side effect and its severity.<\/p>\n\n\n\n<p><strong>Any serious&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p>In rare cases (may affect up to 1 in 1,000 people)\u00a0<strong>hypersensitivity reactions\u00a0may<\/strong>\u00a0occur, in some very rare cases (may affect up to 1 in 10,000 users) these reactions may occur as allergic reactions of some kind, although You have not experienced any signs of\u00a0allergy\u00a0with previous\u00a0infusions.<\/p>\n\n\n\n<p>If&nbsp;you notice any of the following signs, tell your doctor or nurse&nbsp;<strong>immediately :<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>rash,\u00a0hives,\u00a0itching,<\/li><li>difficulty swallowing,<\/li><li>swelling of the face or mouth,<\/li><li>redness,<\/li><li>difficulty breathing (\u00a0dyspnoea\u00a0),<\/li><li>drop in blood pressure,<\/li><li>change in heart rate,<\/li><li>overindulge.<\/li><\/ul>\n\n\n\n<p>Your doctor or healthcare professional may decide to slow down or discontinue the&nbsp;infusion&nbsp;completely and initiate appropriate necessary treatment.<\/p>\n\n\n\n<p>During treatment at home, the\u00a0infusion\u00a0should be stopped <strong>immediately<\/strong>\u00a0and a doctor or healthcare professional should be contacted.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been observed with Prolastina.<\/p>\n\n\n\n<p>Uncommon (may affect 1 in 100 people):<\/p>\n\n\n\n<p>chills, fever, flu-like symptoms, chest pain<\/p>\n\n\n\n<p>&#8211;&nbsp;hives&nbsp;(&nbsp;urticaria&nbsp;)<\/p>\n\n\n\n<p>&#8211; dizziness, fainting, headache<\/p>\n\n\n\n<p>&#8211; difficulty breathing (&nbsp;dyspnoea&nbsp;)<\/p>\n\n\n\n<p>rash<\/p>\n\n\n\n<p>&#8211; nausea<\/p>\n\n\n\n<p>&#8211; joint pain (arthralgia)<\/p>\n\n\n\n<p>Rare (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<p>&#8211;&nbsp;hypersensitivity reaction&nbsp;er<\/p>\n\n\n\n<p>&#8211; fast&nbsp;pulse&nbsp;(&nbsp;tachycardia&nbsp;)<\/p>\n\n\n\n<p>&#8211; low&nbsp;blood pressure&nbsp;(&nbsp;hypotension&nbsp;)<\/p>\n\n\n\n<p>&#8211; high&nbsp;blood pressure&nbsp;(&nbsp;hypertension&nbsp;)<\/p>\n\n\n\n<p>&#8211; back pain<\/p>\n\n\n\n<p>Very rare (may affect up to 1 in 10,000 people):<\/p>\n\n\n\n<p>&#8211; allergic&nbsp;shock<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Prolastina<\/h2>\n\n\n\n<p>Do not store above 25 \u00b0 C.&nbsp;Do not freeze.<\/p>\n\n\n\n<p>The reconstituted solution should not be stored in the refrigerator and should always be used within three hours after\u00a0reconstitution.\u00a0Any unused product should be discarded.\u00a0The medicine should not be disposed of via wastewater or household waste.\u00a0Ask your pharmacist how to dispose of medicines no longer required.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the bottle label and carton.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not use Prolastina if you notice that the reconstituted solution is not ready.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Package contents and other information other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is alpha\u00a0<sub>1<\/sub>\u00a0-proteinase inhibitor,\u00a0human\u00a0(extracted from human blood or\u00a0plasma\u00a0).<\/li><li>The other ingredients are sodium chloride, sodium dihydrogen phosphate, and water for injections (solvent).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Alpha&nbsp;<sub>1<\/sub>&nbsp;proteinase inhibitor is a white to beige powder.<\/p>\n\n\n\n<p>The finished solution is ready.<\/p>\n\n\n\n<p>1 ml of reconstituted solution contains 25 mg alpha&nbsp;<sub>1<\/sub>&nbsp;proteinase inhibitors.<\/p>\n\n\n\n<p>The 1000mg prolactin carton contains:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>1\u00a0vial\u00a0of powder containing 1000 mg alpha\u00a0<sub>1<\/sub>\u00a0&#8211; proteinase inhibitor,\u00a0human.<\/li><li>1\u00a0vial\u00a0with 40 ml liquid (water for injections).<\/li><li>1 Mix2Vial transfer cartridge for\u00a0reconstitution.<\/li><\/ul>\n\n\n\n<p>Prolastina multi-pack contains:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>4 simple Prolastina cartons with 1000 mg<\/li><\/ul>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Grifols Deutschland GmbH<\/p>\n\n\n\n<p>Colmar Stra\u00dfe 22<\/p>\n\n\n\n<p>60528 Frankfurt<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>Tel.&nbsp;+49\/69\/660 593 100<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Instituto Grifols, SA<\/p>\n\n\n\n<p>Can Guasc, 2 &#8211; Parets del Vall\u00e8s<\/p>\n\n\n\n<p>08150 Barcelona<\/p>\n\n\n\n<p>Spain<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alpha 1 -proteinase inhibitor is a substance that is formed in the body to inhibit the effect of substances called elastases and which damage the lungs. In the case of hereditary deficiency of alpha 1 -proteinase inhibitors, there is an imbalance between alpha 1 -proteinase inhibitors and elastase. This can lead to gradual degradation of lung tissue and development of pulmonary emphysema . Pulmonary emphysema is an abnormal enlargement of the lungs, with degradation of the lung tissue. Prolastina is used to restore the balance between alpha 1 -proteinase inhibitors and elastase in the lungs, which prevents further deterioration of the pulmonary emphysema .<\/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":[2200,18527],"tags":[21991,21994,21995,22000,21996,21999,21993,21992,21997,21998],"class_list":["post-21312","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-alpha-1-proteinase-inhibitor","tag-alpha-1-proteinase-inhibitor-side-effects","tag-benefits-of-alpha-1-proteinase-inhibitor","tag-benefits-of-prolastina","tag-prolastina","tag-prolastina-side-effects","tag-what-alpha-1-proteinase-inhibitor-is-used-for","tag-what-is-alpha-1-proteinase-inhibitor","tag-what-is-prolastina","tag-what-prolastina-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21312","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=21312"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21312\/revisions"}],"predecessor-version":[{"id":21364,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21312\/revisions\/21364"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}