{"id":20406,"date":"2022-04-04T07:56:27","date_gmt":"2022-04-04T07:56:27","guid":{"rendered":"https:\/\/zeepedia.com\/?p=20406"},"modified":"2022-04-04T11:52:18","modified_gmt":"2022-04-04T11:52:18","slug":"panzyga","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/panzyga\/","title":{"rendered":"Panzyga &#8211; Human normal immunoglobulin (IVIg) uses, dose and side effects"},"content":{"rendered":"\n<p>100 mg \/ ml solution for infusion<br>Human normal immunoglobulin (IVIg)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Panzyga is and what it is used for<\/h2>\n\n\n\n<p><strong>What Panzyga is<\/strong><br>Panzyga is a solution of human normal immunoglobulin (IgG) (solution containing human&nbsp;antibodies&nbsp;) for&nbsp;intravenous&nbsp;use (&nbsp;infusion&nbsp;into a vein).&nbsp;Immunoglobulins are normal constituents of human blood and help the body&#8217;s immune system.&nbsp;Panzyga contains all IgG&nbsp;antibodies&nbsp;found in the blood of healthy people.&nbsp;Appropriate&nbsp;doses&nbsp;of Panzyga can restore abnormally low IgG levels to normal levels.<br>Panzyga contains a wide range of&nbsp;antibodies&nbsp;against various infectious agents.<\/p>\n\n\n\n<p><strong>What Panzyga is used for<\/strong><\/p>\n\n\n\n<p>Panzyga is used as replacement therapy in children and adolescents (0-18 years) and adults in different groups of patients:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Patients with congenital\u00a0antibody\u00a0deficiency (primary immunodeficiency syndrome, such as congenital agammaglobulinemia and\u00a0hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiency)<\/li><li>Patients with an acquired (non-congenital) deficiency of\u00a0antibodies\u00a0(secondary immunodeficiency) caused by specific diseases and\/or treatments and who suffer from severe or recurrent\u00a0infections.<\/li><\/ul>\n\n\n\n<p>Panzyga can also be used to treat (immune modulation) the following autoimmune diseases (ie when the patient&#8217;s antibody\u00a0damages the body&#8217;s cells):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Patients with immunological\u00a0thrombocytopenia\u00a0(ITP), a condition in which\u00a0platelets\u00a0break down and therefore decrease in number, as well as patients with an increased risk of bleeding or who need to correct the number of\u00a0platelets\u00a0before\u00a0surgery<\/li><li>Patients with Kawasaki disease, a condition that causes\u00a0inflammation\u00a0in various organs<\/li><li>Patients with\u00a0Guillain-Barr\u00e9 syndrome, a condition that causes\u00a0inflammation\u00a0in certain parts of the nervous system<\/li><li>Patients with\u00a0chronic\u00a0demyelinating\u00a0polyneuropathy\u00a0(CIDP), a disease that leads to chronic\u00a0inflammation\u00a0in peripheral parts of the nervous system (which does not belong to the brain and spinal cord) which causes muscle weakness and\/or numbness, especially in the legs and arms<\/li><li>Patients with\u00a0multifocal\u00a0motor\u00a0neuropathy\u00a0(MMN), a condition characterized by slowly progressing asymmetric (unevenly distributed) weakness in the legs and arms without loss of sensation.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Panzyga<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Panzyga<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to human normal immunoglobulin or any of the other ingredients of Panzyga (listed in section 6).<\/li><li>if you have immunoglobulin A (\u00a0IgA\u00a0) deficiency and if you have developed\u00a0antibodies to\u00a0IgA\u00a0immunoglobulin.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before using Panzyga.<\/p>\n\n\n\n<p><em>When you are given Panzyga, it is recommended that the product name and batch number be registered to enable the tracking of the product used.<\/em><\/p>\n\n\n\n<p>Some&nbsp;side effects&nbsp;may occur more often:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>at a high infusion rate<\/li><li>when you receive Panzyga for the first time or, in rare cases, when it has been a long time since the last\u00a0infusion.<\/li><li>when you have an untreated\u00a0infection\u00a0or an underlying\u00a0chronic\u00a0inflammation<\/li><\/ul>\n\n\n\n<p>If you get a\u00a0side effect, your doctor will either reduce the infusion rate or stop the\u00a0infusion.\u00a0How a\u00a0side effect\u00a0is treated depends on the type and severity of the side effect.<\/p>\n\n\n\n<p><em>Circumstances and conditions that increase the risk of&nbsp;side&nbsp;effects<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have a history of kidney problems or if you have certain risk factors such as\u00a0diabetes, obesity, or are over 65 years of age, Panzyga should be given as slowly as possible, as cases of\u00a0acute\u00a0kidney failure\u00a0have been reported in patients with these risk factors.\u00a0Tell your doctor if any of the above applies to you, or if you have had it before.<\/li><li>Thromboembolic events such as heart attack,\u00a0stroke,\u00a0and a blood clot in a vein (deep\u00a0vein thrombosis\u00a0) in, for example, the calves or a blood vessel in the lungs, can occur in very rare cases after using Panzyga.\u00a0These types of events are more common in patients with risk factors such as obesity, old age, high\u00a0blood pressure,\u00a0diabetes, previous thrombotic disease, long periods of immobility, and intake of certain\u00a0hormones\u00a0(eg\u00a0pills\u00a0).\u00a0Be sure to drink enough fluids during the day to avoid signs of low fluid intake (eg, feeling thirsty) before\u00a0infusing\u00a0one.\u00a0Panzyga should also be given as slowly as possible.<\/li><li>Allergic reactions are rare but can cause anaphylactic\u00a0shock\u00a0even in patients who have tolerated previous treatments.<\/li><li>Rare cases of severe headache and stiff neck may occur from several hours to two days after treatment with Panzyga.<\/li><li>The risk of\u00a0red blood cells\u00a0being broken down by the administered immunoglobulins (so-called\u00a0hemolysis\u00a0) is higher in patients with blood groups A, B, or AB as well as patients with certain inflammatory conditions.<\/li><\/ul>\n\n\n\n<p><em>When may you need to slow down or stop the\u00a0infusion?<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe headaches and stiff neck may occur from several hours to two days after treatment with Panzyga.<\/li><li>Allergic reactions are rare but can cause an allergic\u00a0shock\u00a0even in patients who have tolerated previous treatments.\u00a0A sudden drop in blood pressure or\u00a0shock\u00a0can be the result of an\u00a0acute\u00a0and severe\u00a0allergic reaction.<\/li><li>In very rare cases, transfusion-related\u00a0acute\u00a0lung injury (TRALI) may occur after treatment with immunoglobulins such as Panzyga.\u00a0This leads to an accumulation of fluid in the lungs that is not due to heart problems (non-cardiogenic\u00a0pulmonary edema\u00a0).\u00a0TRALI is characterized by severe breathing difficulties, normal heart function, and elevated body temperature (fever).\u00a0Symptoms usually appear within 1 to 6 hours after treatment.<\/li><\/ul>\n\n\n\n<p><br>Tell your doctor or healthcare professional immediately if you notice any of the above symptoms in the meantime, or after&nbsp;infusion&nbsp;of Panzyga.&nbsp;He or she will decide if the infusion rate should be reduced or if the infusion should be&nbsp;stopped&nbsp;altogether or if other measures are required.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Occasionally, immunoglobulin solutions such as Panzyga may cause a decrease in the number of\u00a0white blood cells.\u00a0This condition resolves spontaneously on its own within 1-2 weeks.<\/li><\/ul>\n\n\n\n<p><em>Effects on blood tests<\/em><\/p>\n\n\n\n<p>Panzyga contains a variety of&nbsp;antibodies&nbsp;and some of these may affect blood test results.&nbsp;If you take a blood sample after receiving Panzyga, tell the person taking the sample or your doctor that you have received human normal immunoglobulin.<\/p>\n\n\n\n<p><em>Virus security<\/em><\/p>\n\n\n\n<p>When medicines are made from human blood or human\u00a0plasma, special measures are taken to prevent the transmission of\u00a0infection\u00a0to patients.\u00a0These include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a 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>introduction of steps in\u00a0the preparation\u00a0one of blood or\u00a0plasma\u00a0that can inactivate or remove\u00a0viruses<\/li><\/ul>\n\n\n\n<p>Despite these measures, 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 effective against enveloped\u00a0viruses\u00a0such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0and\u00a0hepatitis\u00a0C\u00a0virus\u00a0as well as against non-enveloped\u00a0viruses\u00a0such as\u00a0hepatitis\u00a0A\u00a0virus\u00a0and parvovirus B19.<\/p>\n\n\n\n<p>Immunoglobulins have not been associated with\u00a0hepatitis\u00a0A or parvovirus B19\u00a0infections.\u00a0This may be because the medicine contains\u00a0antibodies\u00a0against these infectious agents, which have a protective effect.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>There are no special or additional warnings or precautions for children and adolescents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Panzyga<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, or if you have been vaccinated in the last three months.<\/p>\n\n\n\n<p><em>Panzyga may impair the effectiveness of certain vaccines (live attenuated viral vaccines) such as\u00a0<\/em>\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>measles<\/li><li>rubella<\/li><li>mumps<\/li><li>chicken-pox<\/li><\/ul>\n\n\n\n<p><strong>After administration of this drug, it should be 3 months before vaccination with live attenuated virus vaccines is given.&nbsp;For measles, the risk of reduced effect can persist for up to 1 year.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Panzyga with food, drink, and alcohol<\/h2>\n\n\n\n<p>No effects were noted.\u00a0When using Panzyga 100 mg\/ml, adequate fluid supply to the patient before\u00a0infusion\u00a0should be considered.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist if you can or should continue to use Panzyga.<\/p>\n\n\n\n<p>The safety of the drug during use in human pregnancy has not been established in controlled\u00a0clinical trials.\u00a0It should therefore be given with caution to pregnant and lactating women.\u00a0Drugs with immunoglobulins have been shown to pass through the placenta, increasing in size during the last third of pregnancy.\u00a0Experience with the use of immunoglobulins does not indicate harmful effects<\/p>\n\n\n\n<p>expected during pregnancy or on the fetus and the newborn.<\/p>\n\n\n\n<p>Immunoglobulins are excreted in breast milk.\u00a0No adverse effects are expected on the breast-fed infant\/infant.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Panzyga has no or negligible effect on the ability to drive and use machines.&nbsp;However, patients who experience&nbsp;side effects&nbsp;during treatment should not drive or use machines until they have passed.<\/p>\n\n\n\n<p><br><strong>Panzyga contains\u00a0sodium<\/strong><br>This medicine contains 69 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 100 ml.\u00a0This corresponds to 3.45% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n<p>This should be considered by patients on a low-salt diet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Panzyga<\/h2>\n\n\n\n<p>Your doctor will decide if you need Panzyga and what&nbsp;dose&nbsp;you should be given.&nbsp;Panzyga is given as an&nbsp;intravenous&nbsp;infusion&nbsp;(&nbsp;infusion&nbsp;into a vein) by healthcare professionals.&nbsp;Dosage&nbsp;one and&nbsp;dosage&nbsp;one depend on the indication and may need to be individually adjusted for each patient.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Use for children and adolescents<\/h2>\n\n\n\n<p>Panzyga (&nbsp;intravenously&nbsp;) is given in the same way to children and adolescents (0-18 years) as to adults.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>Contact a doctor as soon as possible if you experience any of the following serious\u00a0side effects\u00a0(\u00a0<strong>all of which are very rare<\/strong>\u00a0and may occur in up to 1 in<br>10,000\u00a0infusions\u00a0).\u00a0In some cases, the doctor may need to discontinue the\u00a0infusion\u00a0one and lower the\u00a0dose\u00a0or stop the treatment.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Swelling of the face, tongue,<\/strong> and trachea\u00a0can cause severe breathing problems<\/li><li>Sudden\u00a0allergic reaction\u00a0with shortness of breath, rash, wheezing, and drop in blood pressure<\/li><li>Stroke\u00a0that can cause weakness and\/or loss of sensation along one side of the body<\/li><li>A myocardial infarction\u00a0that causes chest pain<\/li><li>Blood clots\u00a0that cause pain and swelling in the arms and legs<\/li><li>Blood clot in the lung\u00a0that causes chest pain and shortness of breath<\/li><li>Anemia\u00a0that causes shortness of breath or pallor<\/li><li>Severe kidney disease\u00a0that can make you unable to urinate<\/li><li>A\u00a0lung disease\u00a0called transfusion-related\u00a0acute\u00a0lung injury (TRALI) causes difficulty breathing, blue skin, fever, drop in blood pressure<\/li><\/ul>\n\n\n\n<p>If you experience any of the above symptoms, contact your doctor as soon as possible.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have also been reported:<\/p>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 10&nbsp;people&nbsp;):<\/p>\n\n\n\n<p>Headache, nausea, fever<\/p>\n\n\n\n<p><strong>Uncommon&nbsp;side effects&nbsp;(<\/strong>&nbsp;may affect up to 1 in 100&nbsp;people&nbsp;):<\/p>\n\n\n\n<p>Skin rash, back pain, chest pain, chills, dizziness, fatigue, cough, vomiting, abdominal pain, diarrhea, joint pain, muscle pain,\u00a0itching\u00a0at the infusion site, skin rash, neck pain, pain in arms or legs, decreased sensation of touch or sensation, decreased number of\u00a0red blood cells, decreased\u00a0white blood cell count, aseptic\u00a0meningitis\u00a0(non-infectious\u00a0meningitis, a syndrome characterized by headache, neck stiffness and mild fever) (see also section Warnings and precautions), itchy eyes, palpitations, high\u00a0blood pressure, earache, stiffness, coldness, malaise, malaise, chills, numbness, altered liver function values \u200b\u200b(measured by blood tests).<\/p>\n\n\n\n<p><strong>Reporting of&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p>If you get\u00a0any side effects, talk to your doctor or pharmacist.\u00a0This also applies to any\u00a0side effects\u00a0not mentioned in this information.\u00a0You can also report\u00a0side effects\u00a0directly (see details below).\u00a0By reporting\u00a0side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Panzyga<\/h2>\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 label and carton.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Store the glass bottle in the outer carton.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>The medicine can be stored outside the refrigerator for 12 months (without exceeding the expiry date) and stored between 8 \u00b0 C and 25 \u00b0 C.&nbsp;After this period, the medicine should not be put back in the refrigerator but should be thrown away.&nbsp;The date when the medicine was taken out of the refrigerator must be noted on the outer carton.<\/p>\n\n\n\n<p>Do not use this medicine if you notice that the solution is cloudy, has precipitated, or has a strong color.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack and 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 human normal immunoglobulin (human\u00a0antibody\u00a0).\u00a0Panzyga contains 100 mg\/ml of human\u00a0protein\u00a0of which at least 95% is immunoglobulin G (IgG).<\/li><li>The other ingredients are\u00a0glycine\u00a0and water for injections.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Panzyga is a solution for&nbsp;infusion&nbsp;and is available in vials<\/p>\n\n\n\n<p>(1 g \/ 10 ml, 2.5 g \/ 25 ml) or bottles (5 g \/ 50 ml, 6 g \/ 60 ml, 10 g \/ 100 ml, 20 g \/ 200 ml and 30 g \/ 300 ml).<\/p>\n\n\n\n<p>Pack sizes:<\/p>\n\n\n\n<p>1&nbsp;vial&nbsp;(1 g \/ 10 ml, 2.5 g \/ 25 ml)<\/p>\n\n\n\n<p>1 bottle (5 g \/ 50 ml, 6 g \/ 60 ml, 10 g \/ 100 ml, 20 g \/ 200 ml, 30 g \/ 300 ml)<\/p>\n\n\n\n<p>3 bottles (10 g \/ 100 ml, 20 g \/ 200 ml)<\/p>\n\n\n\n<p>The solution is clear or slightly opalescent, colorless, or pale yellow.<\/p>\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>Marketing Authorisation Holder:<\/p>\n\n\n\n<p>Octapharma AB<\/p>\n\n\n\n<p>112 75 Stockholm<\/p>\n\n\n\n<p>Manufacturer:<br>Octapharma<\/p>\n\n\n\n<p>72 rue du Mar\u00e9chal Foch, 67380 Lingolsheim, France<\/p>\n\n\n\n<p>Octapharma Pharmazeutika Produktionsges.mbH<\/p>\n\n\n\n<p>Oberlaaer Strasse 235, 1100 Vienna, Austria<\/p>\n\n\n\n<p>This medicinal product is authorized under the European Economic Area under the names:<br>Belgium, Bulgaria, Denmark, Estonia, Finland, France, Ireland, Iceland, Croatia, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, UK, Sweden, Czech Republic, Germany, Hungary: Panzyga<br>Italy: Global<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Panzyga is a solution of human normal immunoglobulin (IgG) (solution containing human antibodies ) for intravenous use ( infusion into a vein). Immunoglobulins are normal constituents of human blood and help the body&#8217;s immune system. Panzyga contains all IgG antibodies found in the blood of healthy people. Appropriate doses of Panzyga can restore abnormally low IgG levels to normal levels.<\/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":[13449,20861,2828,2831,20857,20860,9070,9069,20858,20859],"class_list":["post-20406","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-human-normal-immunoglobulin","tag-benefits-of-panzyga","tag-human-normal-immunoglobulin","tag-human-normal-immunoglobulin-side-effects","tag-panzyga","tag-panzyga-side-effects","tag-what-human-normal-immunoglobulin-is-used-for","tag-what-is-human-normal-immunoglobulin","tag-what-is-panzyga","tag-what-panzyga-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20406","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=20406"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20406\/revisions"}],"predecessor-version":[{"id":20456,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/20406\/revisions\/20456"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=20406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=20406"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=20406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}