50 mg \/ ml solution for infusion
Human normal immunoglobulin (IVIg)<\/p>\n\n\n\n
What Octagam is:<\/strong><\/p>\n\n\n\n Octagam is a solution containing human normal immunoglobulin (IgG) (solution containing human antibodies ) for intravenous administration ( infusion into a vein). Immunoglobulins are normal components in the body and form part of the body’s immune system. Octagam contains all subgroups of IgG that occur in healthy people. Appropriate doses of this medicine can restore abnormally low levels of IgG to normal levels.<\/p>\n\n\n\n Octagam contains many antibodies against various infectious agents.<\/p>\n\n\n\n What Octagam is used for:<\/strong><\/p>\n\n\n\n Octagam is given as a\u00a0substitution treatment\u00a0to children, adolescents (0-18 years), and adults in different patient groups:<\/p>\n\n\n\n Octagam can also be given as a treatment for the following autoimmune diseases (immune modulation):<\/p>\n\n\n\n Human normal immunoglobulin (IVIg) contained in Octagam may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n Talk to your doctor or pharmacist before using Octagam.<\/p>\n\n\n\n When you are given Octagam, it is strongly recommended that the product name and batch number be recorded so that a list of used manufacturing batches is compiled.<\/p>\n\n\n\n Some side effects may occur more often<\/p>\n\n\n\n In case of\u00a0side effects, either the infusion rate must be reduced or the\u00a0infusion\u00a0stopped.\u00a0The treatment that needs to be given depends on the type of side effect and its severity.<\/p>\n\n\n\n Circumstances and conditions that increase the risk of side effects<\/p>\n\n\n\n When can the infusion be slowed down or stopped?<\/p>\n\n\n\n Tell your doctor or healthcare provider immediately if you notice the above\u00a0side effects\u00a0during or after an\u00a0Octagam infusion.\u00a0He or she decides whether the infusion rate should be reduced or whether the\u00a0infusion\u00a0should be stopped completely or if further measures are required.<\/p>\n\n\n\n Virus security<\/p>\n\n\n\n When medicines are made from human blood or\u00a0plasma, special measures are taken to prevent the transmission of\u00a0infection\u00a0to patients.\u00a0This includes<\/p>\n\n\n\n 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 The measures taken are considered effective against enveloped\u00a0viruses\u00a0such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0and\u00a0hepatitis\u00a0C\u00a0virus.<\/p>\n\n\n\n The measures may have a limited effect on non-enveloped\u00a0viruses\u00a0such as\u00a0hepatitis\u00a0A\u00a0virus\u00a0and parvovirus B19.<\/p>\n\n\n\n No association was found between immunoglobulins and hepatitis A and parvovirus B19. This may be because the product contains antibodies against these infections which protect against infection.<\/p>\n\n\n\n No specific or supplementary warning texts or precautions need to be applied to children and adolescents.<\/p>\n\n\n\n The infusion line can be flushed with either normal saline or 5% glucose solution after administering Octagam.<\/p>\n\n\n\n Concomitant use of loop diuretics should be avoided.<\/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, or if you have been vaccinated in the last three months. <\/p>\n\n\n\n Octagam may reduce the effects of vaccinations against live attenuated\u00a0viruses, such as measles, rubella, mumps, and chickenpox.<\/p>\n\n\n\n After administration of this product, it should be 3 months before vaccination with live virus vaccines is given. For measles, the risk of reduced effect can be up to 1 year.<\/em><\/p>\n\n\n\n Effect on blood tests<\/strong><\/p>\n\n\n\n If you have a blood test after taking Octagam, tell your doctor that you have received human normal immunoglobulin as this treatment may affect the results.<\/p>\n\n\n\n Blood glucose tests<\/p>\n\n\n\n Some systems for blood glucose tests (so-called glucometer tests) incorrectly interpret the maltose found in Octagam as\u00a0glucose.\u00a0This can lead to glucose levels during an\u00a0infusion\u00a0and up to 15 hours after the end of the infusion being incorrectly read as elevated and to insulin treatment being given unnecessarily, which can lead to life-threatening\u00a0hypoglycemia\u00a0(decreased blood sugar level).<\/p>\n\n\n\n In addition, true\u00a0hypoglycemia\u00a0can remain untreated if the low blood sugar level is not detected due to an incorrectly elevated glucose reading.<\/p>\n\n\n\n Therefore, when Octagam or other maltose-containing products are used, blood glucose should be measured using a test system that applies glucose-specific methods. Systems based on glucose dehydrogenase pyrroloquinoline quinone (GDH PQQ) or oxidoreductase methods for glucose staining should not be used.<\/strong><\/p>\n\n\n\n Read the product information for the blood glucose test carefully – including the information on the test strips – to determine if the system is suitable for use with parenteral products containing maltose. If you are not sure, ask your treating physician to determine if the system is suitable for use with parenteral products containing maltose.<\/p>\n\n\n\n No effects were noted.\u00a0When using Octagam, adequate fluid supply to the patient before\u00a0infusion\u00a0should be considered.<\/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 or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n 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.\u00a0Clinical experience with immunoglobulins does not indicate that adverse effects can be expected during pregnancy or in the fetus and newborn.<\/p>\n\n\n\n Immunoglobulins are excreted in breast milk.\u00a0No adverse effects on breastfed newborns\/infants are expected.<\/p>\n\n\n\n Clinical experience with immunoglobulins does not suggest that adverse effects can be expected on the ability to conceive.<\/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 Octagam has no or negligible effect on the ability to drive and use machines. However, patients who experience side effects during treatment should wait until they stop before using vehicles or machines.<\/p>\n\n\n\n This medicine contains 35 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 100 ml.\u00a0This corresponds to 1.75% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n This should be considered if you have been prescribed a low-salt (sodium-poor) diet.<\/p>\n\n\n\n Your doctor will decide if you need Octagam and in what\u00a0dose.\u00a0Octagam is given as an\u00a0intravenous\u00a0infusion\u00a0(\u00a0infusion\u00a0into a vein) by healthcare professionals.\u00a0Dosage\u00a0and dosage regimen depends on why you are receiving the medicine and may need to be adjusted individually for each patient.<\/p>\n\n\n\n Administration ( intravenous ) of Octagam in children and adolescents (0-18 years) does not differ from administration in adults.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Contact your doctor as soon as possible if you suffer from any of the following serious side effects ( all of which are very rare<\/strong> and may occur in up to 1 in 10,000 infusions ).<\/p>\n\n\n\n In some cases, your doctor may need to stop treatment and reduce the dose or stop treatment:<\/p>\n\n\n\n If you get any of these symptoms, contact your doctor as soon as possible.<\/p>\n\n\n\n The following side effects have also been reported:<\/p>\n\n\n\n Common side effects (<\/strong> may affect up to 1 in 10 people ):<\/p>\n\n\n\n Uncommon side effects (<\/strong> may affect up to 1 in 100 people ):<\/p>\n\n\n\n Additional adverse reactions that did not occur in clinical trials but that have also been reported:<\/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 and carton.<\/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 Do not use Octagam if the solution is cloudy, contains\u00a0precipitates,\u00a0or has a strong color.<\/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 Octagam 50 mg \/ ml is a solution for infusion and is available in vials (20 ml = 1 g) and infusion vials (50 ml = 2.5 g, 100 ml = 5 g, 200 ml = 10 g and 500 ml = 25 g).<\/p>\n\n\n\n Pack sizes:<\/p>\n\n\n\n 1 gi 20 ml<\/p>\n\n\n\n 2.5 g in 50 ml<\/p>\n\n\n\n 5 in 100 ml<\/p>\n\n\n\n 10 in 200 ml<\/p>\n\n\n\n 25 g 500 ml<\/p>\n\n\n\n 2 x 10 g 2 x 200 ml<\/p>\n\n\n\n 3 x 10 gi 3 x 200 ml<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n The solution is clear or slightly opalescent, colorless, or yellowish.<\/p>\n\n\n\n Octapharma AB<\/p>\n\n\n\n Lars Forssells gata 23<\/p>\n\n\n\n 112 75 Stockholm<\/p>\n\n\n\n Other manufacturers<\/strong><\/p>\n\n\n\n OCTAPHARMA Pharmazeutika Produktionsges.mbH OCTAPHARMA SAS This medicinal product is authorized under the European Economic Area under the names:<\/strong> <\/p>\n\n\n\n Octagam is a solution containing human normal immunoglobulin (IgG) (solution containing human antibodies ) for intravenous administration ( infusion into a vein). Immunoglobulins are normal components in the body and form part of the body’s immune system. Octagam contains all subgroups of IgG that occur in healthy people. Appropriate doses of this medicine can restore abnormally low levels of IgG 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":[2200,18526],"tags":[12577,19655,19650,19651,19654,9070,12575,19652,19653],"class_list":["post-19474","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-human-normal-immunoglobulin-ivig","tag-benefits-of-octagam","tag-human-normal-immunoglobulin-ivig-side-effects","tag-octagam","tag-octagam-side-effects","tag-what-human-normal-immunoglobulin-is-used-for","tag-what-is-human-normal-immunoglobulin-ivig","tag-what-is-octagam","tag-what-octagam-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19474","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=19474"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19474\/revisions"}],"predecessor-version":[{"id":19529,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19474\/revisions\/19529"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Octagam<\/h2>\n\n\n\n
Do not use Octagam<\/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 Octagam<\/h2>\n\n\n\n
Octagam with food, drink and alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Octagam contains sodium<\/h2>\n\n\n\n
How to use Octagam<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Octagam<\/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 contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Oberlaaer Strasse 235
AT-1100 Vienna
AUSTRIA<\/p>\n\n\n\n
70-72, rue du Mar\u00e9chal Foch
BP 33
F-67381 Lingolsheim
FRANCE<\/p>\n\n\n\nAustria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Great Britain<\/td> Octagam<\/td><\/tr> Spain<\/td> Octagamocta<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"