1 mg \/ ml concentrate for solution for infusion
Galsulfase<\/p>\n\n\n\n
Naglazyme is used to treat patients with MPS VI (mucopolysaccharidosis VI).<\/p>\n\n\n\n
People with MPS VI have either very little or nothing at all of an enzyme called N-acetylgalactosamine-4-sulfatase, which is needed to break down certain special substances (glycosaminoglycans) in the body. The result is that these substances are not broken down and processed by the body as they should. They accumulate in many of the body’s tissues and give rise to the symptoms of MPS VI.<\/p>\n\n\n\n
How this medicine works<\/strong><\/p>\n\n\n\n This medicine contains a\u00a0recombinant\u00a0enzyme\u00a0called galsulfase.\u00a0It can replace the natural\u00a0enzyme\u00a0that is missing in patients who have MPS VI.\u00a0The treatment has been shown to improve the ability to walk and walk upstairs and reduce the levels of glycosaminoglycans in the body.\u00a0This medicine may improve the symptoms of MPS VI.<\/p>\n\n\n\n Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n Naglazyme should not be given during pregnancy unless necessary.\u00a0Ask your doctor or pharmacist for advice before taking any medicine.\u00a0It is not known whether bile sulfate passes into breast milk.\u00a0Therefore, you should not breastfeed while you are being treated with Naglazyme.\u00a0Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n No studies on the effects of Naglazymes on the ability to drive and use machines have been performed.<\/p>\n\n\n\n Each vial contains 0.8 mmol (18.4 mg) sodium . This should be considered by patients on a low-salt diet.<\/p>\n\n\n\n Your doctor or nurse will give you Naglazyme.<\/p>\n\n\n\n The\u00a0dose\u00a0you receive is based on your body weight.\u00a0The recommended\u00a0dose\u00a0is 1 mg\/kg body weight given weekly by a drip into a blood vessel (an\u00a0intravenous\u00a0infusion\u00a0).\u00a0Each\u00a0infusion\u00a0takes approximately 4 hours.\u00a0During the first hour, the\u00a0infusion\u00a0will be slow (about 2.5% of the total solution) and the remaining volume (about 97.5%) will be given over the next three hours.<\/p>\n\n\n\n Naglazyme is given under the supervision of a nurse or doctor, and he or she will check that you have received the correct dose and, if necessary, take appropriate action.<\/p>\n\n\n\n Contact your doctor if you have missed a Naglazyme\u00a0infusion.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Side effects were mainly seen during or shortly after the patients received the medicine (“infusion-related reactions”). The most serious side effects were swollen face and fever (very common); longer than normal intervals between breathing, difficulty breathing, asthma and hives (common); swollen tongue and throat, and severe allergic reaction to this drug (no known frequency).<\/p>\n\n\n\n Should you experience such a reaction,\u00a0tell your doctor immediately<\/strong>.\u00a0You may need to take additional medicines to prevent an\u00a0allergic reaction\u00a0(eg\u00a0antihistamines\u00a0and\/or\u00a0corticosteroids\u00a0) or to lower your fever (antipyretics).<\/p>\n\n\n\n The most common symptoms of infusion-related reactions include fever, chills, rash,\u00a0hives,\u00a0and shortness of breath.<\/p>\n\n\n\n Very common\u00a0side effects\u00a0(they may affect more than 1 in 10 people):<\/p>\n\n\n\n Common\u00a0side effects\u00a0(these may affect up to 1 in 10 people):<\/p>\n\n\n\n Other\u00a0side effects\u00a0with unknown frequency:<\/p>\n\n\n\n Keep out of sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Unopened vials: Do not freeze.<\/p>\n\n\n\n Diluted solutions: For the product to be safe from a\u00a0microbiological\u00a0point of view, it must be used immediately.\u00a0If the solution is not used immediately, the user is responsible for the storage time and conditions of use.\u00a0The storage time should not normally exceed 24 hours at 2 \u00b0 C – 8 \u00baC followed by a maximum of 24 hours at room temperature (23 \u00b0 C – 27 \u00b0 C) during\u00a0infusion.<\/p>\n\n\n\n Naglazyme should not be used if it contains any visible particles.<\/p>\n\n\n\n The medicine 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 Naglazyme is supplied as a concentrate for infusion solutions (“drip”).\u00a0The concentrate should be completely clear or slightly opalescent.\u00a0It should also be colorless to pale yellow and there must be no visible particles in it.\u00a0The solution must be diluted before it can be used for\u00a0infusion.<\/p>\n\n\n\n Pack sizes:<\/strong> 1 and 6 vials. Not all pack sizes may be marketed.<\/p>\n\n\n\n Naglazyme is used to treat patients with MPS VI (mucopolysaccharidosis VI).<\/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":[2200,15581],"tags":[18378,18383,18374,18377,18379,18382,18375,18376,18381],"class_list":["post-18575","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-galsulfase","tag-benefits-of-naglazyme","tag-galsulfase","tag-galsulfase-side-effects","tag-naglazyme","tag-naglazyme-side-effects","tag-wat-is-galsulfase","tag-what-galsulfase-is-used-for","tag-what-naglazyme-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18575","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=18575"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18575\/revisions"}],"predecessor-version":[{"id":18634,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18575\/revisions\/18634"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before you are given this medicine<\/h2>\n\n\n\n
You must not be given this medicine<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Naglazyme<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
This medicine contains sodium<\/h2>\n\n\n\n
How to get this medicine<\/h2>\n\n\n\n
If you take more Naglazyme than you should<\/h2>\n\n\n\n
If you forget to take this medicine<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Sore throatGastrointestinal inflammation bad reflexesHeadacheEye inflammationBlurred eyePoor hearingHigh\u00a0blood pressure<\/td> Nasal congestionBulging navelVomitingNauseaItchingPain (including ear, abdomen, joint, chest pain)Feeling sick<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n ShakingLow\u00a0blood pressure cough<\/td> WheezingReddening of the skin<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n ShockKnittingDecreased heart rate increased heart rate<\/td> Bluish skinPale skinLow oxygen content in the blood paid to breathe<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n How to store this medicine<\/h2>\n\n\n\n
Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n
Chemical and physical in-use stability has been demonstrated when used for up to 4 days at room temperature (23 \u00b0 C – 27 \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 Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/strong>BioMarin International Limited Shanbally, RingaskiddyCounty Cork, P43 R298Ireland<\/td> Manufacturer<\/strong>BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298Ireland<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"