1,000 mg, 4,000 mg and 5,000 mg powder and liquid for infusion , solution
human alpha-1-proteinase inhibitor<\/p>\n\n\n\n
What Respreeza is<\/strong><\/p>\n\n\n\n This medicine contains the active substance\u00a0human\u00a0alpha-1-proteinase inhibitor, which is a normal component of the blood and is found in the lungs.\u00a0There, its main function is to protect the lung tissue by limiting the action of a certain\u00a0enzyme, called\u00a0neutrophil\u00a0elastase.\u00a0Neutrophil\u00a0elastase can cause harm if its effect is not controlled (for example, if you are deficient in alpha-1 proteinase inhibitors).<\/p>\n\n\n\n What Respreeza is used for<\/strong><\/p>\n\n\n\n This medicine is used in adults with known, severe alpha-1-proteinase inhibitor deficiency (a hereditary disease also known as the alpha-1-antitrypsin deficiency) who have developed a lung disease called\u00a0emphysema.<\/p>\n\n\n\n Emphysema develops when the lack of alpha-1-proteinase inhibitors leads to a condition where neutrophil elastase is not sufficiently controlled, which damages the small air bubbles in the lung through which oxygen passes into the body. Due to this injury, the lungs do not function normally.<\/p>\n\n\n\n Regular use of this drug increases blood and lung levels of alpha-1-proteinase inhibitors and thus slows the development of\u00a0emphysema.<\/p>\n\n\n\n Information on allergic reactions: when to infuse one must be reduced or discontinued?<\/p>\n\n\n\n You may be allergic to\u00a0human\u00a0alpha-1-proteinase inhibitors even if you have previously received\u00a0human\u00a0alpha-1-proteinase inhibitors and tolerated them well.\u00a0In some cases, severe allergic reactions may occur.\u00a0Your doctor will tell you about signs of allergic reactions (eg chills,\u00a0redness,\u00a0faster heartbeat, drop in blood pressure, dizziness, rash,\u00a0urticaria,\u00a0itching,\u00a0difficulty breathing or swallowing as well as swelling of the hands, face or mouth) (see also section 4).<\/p>\n\n\n\n Safety information regarding your infection<\/p>\n\n\n\n Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed).<\/p>\n\n\n\n Because blood can contain\u00a0the infection, special measures are taken when drugs are made from human blood or\u00a0plasma, to prevent them from being present in the drug and transferred to patients.\u00a0These measures include:<\/p>\n\n\n\n The measures taken are considered effective against\u00a0viruses\u00a0such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0A\u00a0virus,\u00a0hepatitis\u00a0B\u00a0virus,\u00a0hepatitis\u00a0C\u00a0virus,\u00a0and parvovirus B19.<\/p>\n\n\n\n Despite these measures, however, 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\u00a0or other types of\u00a0infection.<\/p>\n\n\n\n Your doctor may suggest hepatitis A and B vaccination if you are regularly \/ repeatedly treated with human plasma-derived protein inhibitors.<\/p>\n\n\n\n Smoking<\/p>\n\n\n\n As smoking is an important risk factor for the development and progression of\u00a0emphysema, it is strongly recommended that you stop smoking and avoid passive smoking.<\/p>\n\n\n\n This medicine should not be used by children or adolescents under 18 years of age.<\/p>\n\n\n\n Because alpha-1 proteinase inhibitors are normally present in human blood, the recommended dose of this medicine is not expected to cause harm to the growing fetus. However, as there is no safety information available when using Respreeza during pregnancy, this medicine should only be given to you with caution if you are pregnant.<\/p>\n\n\n\n It is unknown whether Respreeza passes into human breast milk.\u00a0If you are breastfeeding, your doctor will discuss the risks and benefits of taking this medicine.<\/p>\n\n\n\n There are no data on the effect on\u00a0fertility, but as alpha-1-proteinase inhibitors are a normal component of human blood, no adverse effects on\u00a0fertility\u00a0are expected when using Respreeza at the recommended\u00a0dose.<\/p>\n\n\n\n Dizziness may occur after\u00a0the administration\u00a0of this medicine.\u00a0If you become dizzy, do not drive or use machines until the dizziness has passed (see section 4).<\/p>\n\n\n\n This medicine contains approximately 37 mg\u00a0sodium\u00a0per\u00a0vial\u00a0of Respreeza 1,000 mg, 149 mg\u00a0sodium\u00a0per\u00a0vial\u00a0of Respreeza 4,000 mg, and 186 mg of\u00a0sodium\u00a0per\u00a0vial\u00a0of Respreeza 5,000 mg.\u00a0This corresponds to 1.9%, 7.4%, and 9.3% respectively of the WHO maximum recommended daily intake of 2 g\u00a0sodium\u00a0for adults.\u00a0Your doctor or healthcare professional will take this into account if you have been prescribed a low-salt diet.<\/p>\n\n\n\n After reconstitution,\u00a0Respreeza\u00a0is given as\u00a0an infusion\u00a0into a friend.\u00a0Healthcare professionals experienced in the treatment of alpha-1-proteinase inhibitor deficiency will monitor the first\u00a0infusions.<\/p>\n\n\n\n Treatment at home \/ self-administration<\/p>\n\n\n\n After the first\u00a0infusions, you or your healthcare provider can also\u00a0administer\u00a0Respreeza, but only after receiving\u00a0adequate\u00a0training.\u00a0If your doctor decides that you are suitable for such treatment at home \/ self-administration, he or she will instruct you on:<\/p>\n\n\n\n Your doctor or healthcare professional will regularly review your or your healthcare provider’s infusion technology to ensure that continued handling is appropriate.<\/p>\n\n\n\n Dosage<\/p>\n\n\n\n The amount of Respreeza you receive is based on your body weight.\u00a0The recommended\u00a0dose\u00a0is 60 mg per kg body weight and should be administered once a week.\u00a0The infusion solution is normally given for about 15 minutes (about 0.08 ml solution per kg body weight every minute).\u00a0Your doctor will determine the appropriate infusion rate for you by taking into account your weight and how you tolerate the\u00a0infusion.<\/p>\n\n\n\n The consequences of an overdose are not known.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Such\u00a0side effects\u00a0may occur even if you have previously received human alpha-1 proteinase inhibitors and have tolerated them well.<\/p>\n\n\n\n Some side effects can be serious:<\/strong><\/p>\n\n\n\n In less common cases (which may affect up to 1 in 100 people) allergic reactions have been observed.\u00a0In some very rare cases (which may affect up to 1 in 10,000 people) they may develop into severe allergic reactions even if you have not shown any signs of\u00a0allergy\u00a0during previous\u00a0infusions.<\/p>\n\n\n\n Other side effects can<\/strong> be:<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Dizziness, headache, shortness of breath ( dyspnoea ), nausea.<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Altered sensations such as burning sensation, tingling or numbness in the hands, arms, legs, or feet (\u00a0paresthesia\u00a0),\u00a0redness,\u00a0hives\u00a0(\u00a0urticaria\u00a0), scaly rash and rash all over the body, physical weakness (\u00a0asthenia\u00a0), reactions to the infusion site (such as burning, tingling, pain, swelling or\u00a0redness\u00a0at the infusion site (hematoma)).<\/p>\n\n\n\n Very rare<\/strong> (may affect up to 1 in 10,000 people)<\/p>\n\n\n\n Decreased sensations such as burning sensation, tingling, or feeling of numbness in hands, arms, legs, or feet (\u00a0hypoesthesia\u00a0), excessive sweating (\u00a0hyperhidrosis\u00a0),\u00a0itching, chest pain, chills, fever (\u00a0pyrexia\u00a0).<\/p>\n\n\n\n No known frequency<\/strong> (frequency can not be calculated from available data)<\/p>\n\n\n\n Pain in the lymph nodes (oval tissue nodules that are distributed over the body and may be palpated (feel with light pressure) in, for example, armpits, groin, or neck), swelling of the face, swelling of the eyes and lips.<\/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 carton and bottle label after EXP. 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.<\/p>\n\n\n\n After\u00a0reconstitution, the solution should be used immediately.\u00a0If this is not possible, the solution can be stored for up to 3 hours at room temperature (up to 25 \u00b0 C).\u00a0The prepared solution must not be frozen.<\/p>\n\n\n\n The\u00a0active substance<\/strong>\u00a0is\u00a0a human\u00a0alpha-1 proteinase inhibitor.\u00a0One\u00a0vial\u00a0contains approximately 1,000 mg, 4,000 mg, or 5,000 mg of\u00a0human\u00a0alpha-1 proteinase inhibitors.<\/p>\n\n\n\n The other ingredients<\/strong>\u00a0are sodium chloride, sodium dihydrogen phosphate monohydrate, and mannitol (see section 2).<\/p>\n\n\n\n Liquid: Water for injections.<\/p>\n\n\n\n This medicine is a white to off-white powder.<\/p>\n\n\n\n After\u00a0reconstitution\u00a0with water for injections, the solution should be clear, colorless to pale yellow, and free from visible particles.<\/p>\n\n\n\n Packaging<\/strong><\/p>\n\n\n\n A package contains:<\/p>\n\n\n\n Respreeza 1,000 mg powder and solvent for solution for infusion :<\/p>\n\n\n\n Respreeza 4,000 mg powder and solvent for solution for infusion :<\/p>\n\n\n\n Administration set (inner packaging):<\/p>\n\n\n\n Respreeza 5 000 mg powder and solvent for solution for infusion :<\/p>\n\n\n\n Administration set (inner packaging):<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n CSL Behring GmbH<\/strong><\/p>\n\n\n\n Emil-von-Behring-Strasse 76<\/p>\n\n\n\n D-35041 Marburg<\/p>\n\n\n\n Germany<\/p>\n","protected":false},"excerpt":{"rendered":" This medicine contains the active substance human alpha-1-proteinase inhibitor, which is a normal component of the blood and is found in the lungs. There, its main function is to protect the lung tissue by limiting the action of a certain enzyme , called neutrophil elastase. Neutrophil elastase can cause harm if its effect is not controlled (for example, if you are deficient in alpha-1 proteinase inhibitors).<\/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":[2200,18529],"tags":[22879,22882,22883,22888,22884,22887,22881,22880,22885,22886],"class_list":["post-22010","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-alpha-1-proteinase-inhibitor-2","tag-alpha-1-proteinase-inhibitor-side-effects-2","tag-benefits-of-alpha-1-proteinase-inhibitor-2","tag-benefits-of-respreeza","tag-respreeza","tag-respreeza-sdie-effects","tag-what-alpha-1-proteinase-inhibitor-is-used-for-2","tag-what-is-alpha-1-proteinase-inhibitor-2","tag-what-is-respreeza","tag-what-respreeza-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22010","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=22010"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22010\/revisions"}],"predecessor-version":[{"id":22054,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22010\/revisions\/22054"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Respreeza<\/h2>\n\n\n\n
Ta NOT Respreeza<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Respreeza<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Respreeza contains sodium<\/h2>\n\n\n\n
How to use Respreeza<\/h2>\n\n\n\n
If you use more Respreeza than you should <\/h2>\n\n\n\n
If you forget to use Respreeza<\/h2>\n\n\n\n
If you stop using Respreeza<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Respreeza<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n