{"id":22465,"date":"2022-06-29T07:03:44","date_gmt":"2022-06-29T07:03:44","guid":{"rendered":"https:\/\/zeepedia.com\/?p=22465"},"modified":"2022-06-29T11:36:15","modified_gmt":"2022-06-29T11:36:15","slug":"rotarix","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/rotarix\/","title":{"rendered":"Rotarix &#8211; Rotavirus vaccine uses, dose and side effects"},"content":{"rendered":"\n<p>oral&nbsp;suspension&nbsp;in a squeeze tube<br>rotavirus vaccine, live<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Rotarix is \u200b\u200band what it is used for<\/h2>\n\n\n\n<p>Rotarix is \u200b\u200ba viral vaccine, containing live attenuated human rotavirus, that helps protect your baby, from 6 weeks of age, against&nbsp;gastroenteritis&nbsp;(diarrhea and vomiting) caused by rotavirus infection.<\/p>\n\n\n\n<p><strong>How Rotarix works<\/strong><\/p>\n\n\n\n<p>Rotavirus infection is the most common cause of severe diarrhea in infants and young children.\u00a0Rotavirus is easily spread from hand to mouth through contact with feces from an infected child.\u00a0Most children with rotavirus-induced diarrhea recover without treatment.\u00a0However, some children can become very ill with severe vomiting, diarrhea, and life-threatening fluid loss that requires hospitalization.<\/p>\n\n\n\n<p>When a person receives the vaccine, the immune system (the body&#8217;s natural defense) will make\u00a0antibodies\u00a0against the most common types of rotavirus.\u00a0The antibodies\u00a0protect against diseases caused by these types of rotavirus.<\/p>\n\n\n\n<p>Like all vaccines, Rotarix may not completely protect all vaccinated people against the rotavirus infections that are intended to be prevented.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before your child receives Rotarix<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Rotarix should not be given<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if your child has previously had an\u00a0allergic reaction\u00a0to the rotavirus vaccine or any of the other ingredients of this vaccine (listed in section 6).\u00a0Signs of an\u00a0allergic reaction\u00a0may include itchy skin rash, shortness of breath, and swelling of the face or tongue.<\/li><li>if your child has previously had invagination (blockage of the intestinal passage that occurs when one segment of the intestine is folded into another segment)<\/li><li>if your baby is born with a malformation of the gut that can lead to invagination<\/li><li>if your child has an unusual hereditary disease that affects the child&#8217;s immune system called Severe Combined Immunodeficiency (SCID)<\/li><li>if your child has a serious\u00a0infection\u00a0with a high fever.\u00a0It may be necessary to postpone vaccination until the child has recovered.\u00a0A minor\u00a0infection\u00a0such as a cold should not be a problem but talk to your doctor first<\/li><li>if your child has diarrhea or vomiting.\u00a0It may be necessary to postpone vaccination until the child has recovered.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor\/healthcare professional before giving your child Rotarix<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>he\/she has close contact with a person, for example, a family member, who has weakened the immune system, for example, due to cancer, or who is taking drugs that weaken the immune system<\/li><li>he\/she has a gastrointestinal disease<\/li><li>he\/she has not gained weight or grown as expected<\/li><li>he\/she has an illness or is taking any medication that reduces his \/ her resistance to\u00a0infection, or if his \/ her\u00a0mother\u00a0took any medication during pregnancy that may have weakened the immune system.<\/li><\/ul>\n\n\n\n<p>If your child develops severe abdominal pain, persistent vomiting, blood in the stool, bloated stomach, and\/or fever after taking Rotarix, contact a doctor\/healthcare professional immediately (see also section 4 \u201cPossible side effects\u201d).<\/p>\n\n\n\n<p>As always, be sure to wash your hands thoroughly after changing diapers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Rotarix<\/h2>\n\n\n\n<p>Tell your doctor if your child is taking, has recently taken, or might take other medicines, or if the child has recently been vaccinated with another vaccine.<\/p>\n\n\n\n<p>Rotarix can be given at the same time as your child receives other commonly recommended vaccines such as vaccines against\u00a0diphtheria, tetanus, pertussis (pertussis),\u00a0<em>Haemophilus influenzae\u00a0<\/em>type b, polio (oral or inactivated),\u00a0hepatitis\u00a0B as well as conjugated\u00a0pneumococcal\u00a0and\u00a0meningococcal\u00a0serogroup C vaccines<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Rotarix with food and drink<\/h2>\n\n\n\n<p>There are no restrictions on your child&#8217;s intake of food and drink, either before or after vaccination.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Breast-feeding<\/h2>\n\n\n\n<p>Based on the results of\u00a0clinical trials, breastfeeding does not reduce the protection that Rotarix provides against\u00a0gastroenteritis\u00a0caused by rotavirus.\u00a0Breast-feeding can therefore continue independently of the vaccination.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Rotarix contains sucrose, glucose, phenylalanine, and sodium<\/h2>\n\n\n\n<p>If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving your child this vaccine.<br><br>This vaccine contains 0.15 micrograms of phenylalanine per\u00a0dose.\u00a0Phenylalanine can be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.<\/p>\n\n\n\n<p>This vaccine contains 34 mg of\u00a0sodium\u00a0(the main component of cooking\/table salt) per\u00a0dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How Rotarix is \u200b\u200bgiven<\/h2>\n\n\n\n<p>Your doctor or nurse will give the recommended&nbsp;dose&nbsp;of Rotarix to your child.&nbsp;The vaccine (1.5 ml liquid) should be given&nbsp;<strong>orally<\/strong>&nbsp;(orally).&nbsp;Under no circumstances may the vaccine be injected.<\/p>\n\n\n\n<p>Your child will receive two\u00a0doses\u00a0of the vaccine.\u00a0The doses\u00a0are given at different times with an interval of at least 4 weeks between the two\u00a0doses.\u00a0The first\u00a0dose\u00a0can be given from 6 weeks of age.\u00a0Both vaccine doses must be given before 24 weeks of age, and should preferably be given before 16 weeks of age.<\/p>\n\n\n\n<p>Rotarix can be given according to the same vaccination schedule to infants born prematurely, provided the pregnancy lasts for at least 27 weeks.<\/p>\n\n\n\n<p>If your child spits out or vomits most of the vaccine dose, a new vaccine dose can be given on the same vaccination occasion.<\/p>\n\n\n\n<p>When Rotarix is \u200b\u200bgiven to your child as the first\u00a0dose, it is recommended that your child also receive Rotarix (and not another rotavirus vaccine) as the second\u00a0dose.<\/p>\n\n\n\n<p>You must follow the instructions from your doctor and nurse regarding return visits.\u00a0If you miss an appointment, ask your doctor for advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this vaccine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;may occur with this vaccine:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Common (these may occur in up to 1 in 10 vaccine doses):<ul><li>diarrhea<\/li><li>irritability<br><\/li><\/ul><\/li><li>Uncommon (these may occur in up to 1 in 100 vaccine doses):<ul><li>abdominal pain (see also below for signs of intestinal invagination, which is a very rare&nbsp;side effect&nbsp;)<\/li><li>gases<\/li><li>dermatitis<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>Side effects&nbsp;reported after the launch of Rotarix:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Very rare: hives (\u00a0urticaria\u00a0)<\/li><li>Very rare: intestinal invasion (part of the intestine is twisted and thus blocked).\u00a0Signs of this can be severe abdominal pain, repeated and persistent vomiting, blood in the stool, swollen stomach, and\/or high fever.\u00a0Contact your doctor\/healthcare professional immediately if your child experiences any of these symptoms<\/li><li>blood in the stool<\/li><li>in children born prematurely (born week 28 or earlier in pregnancy), there may be longer than usual respiratory arrest for 2-3 days after vaccination<\/li><li>Children with an unusual hereditary disease called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or intestine (\u00a0gastroenteritis\u00a0), which causes the vaccine virus to pass out with the feces.\u00a0Signs of\u00a0gastroenteritis\u00a0may include nausea, vomiting, stomach cramps, or diarrhea.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Rotarix<\/h2>\n\n\n\n<p>Keep this vaccine out of the reach and sight of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the 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).<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>The vaccine should be used immediately after opening the package.<\/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 packaging 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:<br><br>Human rotavirus strain RIX4414 (live attenuated) * not less than\u00a0<sup>6.0<\/sup>\u00a0CCID\u00a0<sub>50<\/sub><br><br>* produced on Vero cells<\/li><li>The other ingredients in Rotarix are sucrose, disodium Adipate, and Dulbecco&#8217;s Modified Eagle Medium (DMEM) (which contains phenylalanine,\u00a0sodium,\u00a0glucose,\u00a0and other substances), sterile water, (see also section 2, &#8220;Rotarix contains sucrose,\u00a0glucose, phenylalanine, and sodium&#8221; ).\u00a0)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What Rotarix looks like and the contents of the pack<\/h2>\n\n\n\n<p><strong>Oral&nbsp;<\/strong>suspension<\/p>\n\n\n\n<p>Rotarix is \u200b\u200bsupplied as a clear colorless liquid in a single-dose tube (1.5 ml).<\/p>\n\n\n\n<p>Rotarix is \u200b\u200bsupplied in packs of 1, 10, or 50.<\/p>\n\n\n\n<p>Not all packaging may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>GlaxoSmithKline Biologicals SA<\/p>\n\n\n\n<p>Rue de l&#8217;Institut 89<\/p>\n\n\n\n<p>B-1330 Rixensart<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgium \/&nbsp;<\/strong><strong>Belgique&nbsp;<\/strong><strong>\/ Belgien<\/strong>GlaxoSmithKline Pharmaceuticals SA \/ NVTel: + 32 10 85 52 00<\/td><td><strong>Lithuania<\/strong>GlaxoSmithKline Biologicals SATel: +370 80000334<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>GlaxoSmithKline Biologicals SATel.&nbsp;+359 80018205<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>GlaxoSmithKline Pharmaceuticals SA \/ NVTel \/ + .: + 32 10 85 52 00<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>GlaxoSmithKline sroTel: + 420 2 22 00 11 11cz.info@gsk.com<\/td><td><strong>Hungary<\/strong>GlaxoSmithKline Biologicals SATel .: +36 80088309<\/td><\/tr><tr><td><strong>Denmark<\/strong>GlaxoSmithKline Pharma A \/ STel: + 45 36 35 91 00dk-info@gsk.com<\/td><td><strong>Malta<\/strong>GlaxoSmithKline Biologicals SATel: +356 80065004<\/td><\/tr><tr><td><strong>Germany<\/strong>GlaxoSmithKline GmbH &amp; Co.&nbsp;KGTel: + 49 (0) 89 360448701produkt.info@gsk.com<\/td><td><strong>The Netherlands<\/strong>GlaxoSmithKline BVTel: + 31 (0) 33 2081100nlinfo@gsk.com<\/td><\/tr><tr><td><strong>Eesti<\/strong>GlaxoSmithKline Biologicals SATel: +372 8002640<\/td><td><strong>Norway<\/strong>GlaxoSmithKline ASTel: + 437 22 70 20 00<\/td><\/tr><tr><td><strong>Greece<\/strong>GlaxoSmithKlineAEBE ActingT\u03b7\u03bb: + 30 210 68 82 100<\/td><td><strong>Austria<\/strong>GlaxoSmithKline Pharma GmbH.Tel .: + 43 (0) 1 97075 0at.info@gsk.com<\/td><\/tr><tr><td><strong>Spain<\/strong>GlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com<\/td><td><strong>Poland<\/strong>GSK Services Sp.&nbsp;z ooTel: + 48 (22) 576 9000<\/td><\/tr><tr><td><strong>France<\/strong>GlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com<\/td><td><strong>Portugal<\/strong>Smith Kline &amp; French Portuguesa &#8211; ProductsTel: + 351 21 412 95 00<br>FI.PT@gsk.com<\/td><\/tr><tr><td><strong>Croatia<\/strong>GlaxoSmithKline Biologicals SATel .: +385 800787089<\/td><td><strong>Romania<\/strong><br>GlaxoSmithKline Biologicals SATel: +40 800672524<\/td><\/tr><tr><td><strong>Ireland<\/strong>GlaxoSmithKline (Ireland) LtdTel: + 353 (0) 1 4955000<\/td><td><strong>Slovenia<\/strong>GlaxoSmithKline Biologicals SATel: +386 80688869<\/td><\/tr><tr><td><strong>Iceland<\/strong>Vistor hf.Phone: +354 530 3700<\/td><td><strong>Slovak Republic<\/strong>GlaxoSmithKline Slovakia SATel: +421 800500589recepcia.sk@gsk.com<\/td><\/tr><tr><td><strong>Italy<\/strong>GlaxoSmithKline SpATel: + 39 (0) 45 7741 111<\/td><td><strong>Finland \/ Finland<\/strong>GlaxoSmithKline OyPuh \/ Tel: + 358 10 30 30 30<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>GlaxoSmithKline Biologicals SA:\u0397\u03bb: +357 80070017<\/td><td><strong>Sweden<\/strong>GlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com<\/td><\/tr><tr><td><strong>Latvia<\/strong>GlaxoSmithKline Biologicals SATel: +371 80205045<\/td><td><strong>United Kingdom (Northern Ireland)<\/strong>GlaxoSmithKline Biologicals SATel: + 44 (0) 800 221 441customercontactuk@gsk.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Rotarix is \u200b\u200ba viral vaccine, containing live attenuated human rotavirus, that helps protect your baby, from 6 weeks of age, against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection.<\/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":[23397,23392,23393,23396,23382,23385,23394,23383,23395,23384],"class_list":["post-22465","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-rotarix","tag-benefits-of-rotavirus-vaccine","tag-rotarix","tag-rotarix-side-effects","tag-rotavirus-vaccine","tag-rotavirus-vaccine-side-effects","tag-what-is-rotarix","tag-what-is-rotavirus-vaccine","tag-what-rotarix-is-used-for","tag-what-rotavirus-vaccine-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22465","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=22465"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22465\/revisions"}],"predecessor-version":[{"id":22492,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22465\/revisions\/22492"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22465"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22465"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22465"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}