{"id":35485,"date":"2022-11-24T10:07:33","date_gmt":"2022-11-24T10:07:33","guid":{"rendered":"https:\/\/zeepedia.com\/?p=35485"},"modified":"2022-11-25T10:26:40","modified_gmt":"2022-11-25T10:26:40","slug":"zinplava","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/zinplava\/","title":{"rendered":"ZINPLAVA &#8211; Bezlotoxumab uses, dose and side effects"},"content":{"rendered":"\n<p>25 mg\/ml&nbsp;concentrate for&nbsp;infusion&nbsp;solution,<br>bezlotoxumab<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What ZINPLAVA is and what it is used for<\/h2>\n\n\n\n<p>ZINPLAVA contains the active substance bezlotoxumab.<\/p>\n\n\n\n<p>ZINPLAVA is given together with an&nbsp;antibiotic&nbsp;to prevent&nbsp;infection&nbsp;with the bacterium&nbsp;<em>Clostridium difficile<\/em>&nbsp;(CDI) from coming back in patients aged 18 and over who are at high risk of CDI coming back.<\/p>\n\n\n\n<p><strong>How ZINPLAVA works<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>When you get CDI, you are usually given\u00a0antibiotics\u00a0to get rid of the\u00a0infection, but in many cases, CDI can come back within weeks or months.<\/li><li>The bacterium that causes CDI produces a harmful substance (\u00a0toxin\u00a0) that can inflame and damage the large intestine, causing stomach pain and severe diarrhea.\u00a0ZINPLAVA works by binding to the\u00a0toxin\u00a0and blocking it.\u00a0This prevents the symptoms of CDI from returning.<\/li><\/ul>\n\n\n\n<p><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you receive ZINPLAVA<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use ZINPLAVA<\/h2>\n\n\n\n<p>Talk to your doctor before receiving ZINPLAVA.<\/p>\n\n\n\n<p><strong>You should not receive ZINPLAVA:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>ZINPLAVA is not a treatment for CDI.&nbsp;ZINPLAVA has no effect on the CDI you have now.<\/p>\n\n\n\n<p>ZINPLAVA is given along with the antibiotic treatment you are taking for CDI.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>ZINPLAVA should not be used in children and adolescents under the age of 18.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and ZINPLAVA<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Tell the doctor if you are pregnant or trying to become pregnant.<\/li><li>It is not known whether ZINPLAVA can harm the fetus during pregnancy.<\/li><li>If you are breastfeeding or plan to breastfeed, consult your doctor first.<\/li><li>It is not known whether ZINPLAVA can pass into breast milk and pass on to the baby.<\/li><li>You and your doctor must decide together whether or not to take ZINPLAVA.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>ZINPLAVA has no or very little effect on the ability to drive and use machines.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ZINPLAVA contains sodium<\/h2>\n\n\n\n<p>This medicine contains 182.8 mg of\u00a0sodium\u00a0(the main ingredient in common\/table salt) per\u00a0vial.\u00a0This corresponds to 9.1% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to get ZINPLAVA<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>You will receive ZINPLAVA as an&nbsp;infusion&nbsp;(drip) into a vein.<\/li><li>You receive ZINPLAVA as a single dose.&nbsp;It takes about 1 hour.&nbsp;The dose&nbsp;is calculated based on your body weight.<\/li><li>You should continue to take your CDI&nbsp;antibiotic&nbsp;as directed by your doctor.<\/li><\/ul>\n\n\n\n<p><strong>If you miss a visit when you should have received ZINPLAVA<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Contact a doctor or healthcare professional immediately to get a new appointment.<\/li><li>You mustn&#8217;t miss your\u00a0dose\u00a0of this medicine.<\/li><\/ul>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor.<a><\/a><\/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>The following&nbsp;side effects&nbsp;have been reported in clinical studies:<\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 users)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>diarrhea<\/li><li>dizziness<\/li><li>nausea<\/li><li>fever<\/li><li>headache<\/li><li>high&nbsp;blood pressure<\/li><li>shortness of breath<\/li><li>fatigue<\/li><\/ul>\n\n\n\n<p>Tell your doctor or healthcare professional if you get any of the&nbsp;side effects&nbsp;above.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store ZINPLAVA<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date which is stated on the carton and vial after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2\u00b0C\u20138\u00b0C).&nbsp;Do not freeze.&nbsp;Store the vial in the outer carton.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>The reconstituted ZINPLAVA solution can be stored either at room temperature for up to 16 hours or in a refrigerator at 2\u00b0C\u20138\u00b0C for up to 24 hours.&nbsp;If stored in a refrigerator, the infusion bag should be allowed to reach room temperature before use.<\/p>\n\n\n\n<p>Do not save any remaining&nbsp;infusion fluid&nbsp;for later use.&nbsp;Unused medicines and waste must be disposed of according to current instructions.<a><\/a><\/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\">Contents declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is bezlotoxumab.&nbsp;Each ml of the concentrate contains 25 mg of bezlotoxumab.<\/li><li>The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for&nbsp;pH&nbsp;adjustment).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>The concentrate for the infusion solution is clear to moderately opalescent (pearlescent), colorless to pale yellow liquid.<\/p>\n\n\n\n<p>It is packaged in cartons containing a\u00a0glass\u00a0vial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Merck Sharp &amp; Dohme BV<\/p>\n\n\n\n<p>Waarderweg 39<\/p>\n\n\n\n<p>2031 BN Haarlem<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>SP Labo NV<\/p>\n\n\n\n<p>Industriepark 30<\/p>\n\n\n\n<p>B-2220 Heist-op-den-Berg<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgi\u00eb\/Belgique\/Belgien<\/strong>MSD BelgiumTel\/Tel: +32(0)27766211dpoc_belux@merck.com<\/td><td><strong>Lithuania<\/strong>UAB Merck Sharp &amp; DohmeTel.&nbsp;+ 370 5 278 02 47msd_lietuva@merck.com<\/td><\/tr><tr><td><strong>Bulgaria<\/strong>\u041c\u0435\u0440\u043a \u0428\u0430\u0440\u043f \u0438 \u0414\u043e\u043c \u0411\u0443\u043b\u0433\u0430\u0440\u0438\u044f \u0415\u041e\u041e\u0414Tel.: +359 2 819 3737info-msdbg@merck.com<\/td><td><strong>Luxembourg\/Luxembourg<\/strong>MSD BelgiumTel\/Tel: +32(0)27766211dpoc_belux@merck.com<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Merck Sharp &amp; Dohme s.r.oPhone: +420 233 010 111dpoc_czechslovak@merck.com<\/td><td><strong>Magyarorsz\u00e1g<\/strong>MSD Pharma Hungary Kft.Phone: +36 1 888 5300hungary_msd@merck.com<\/td><\/tr><tr><td><br><strong>Denmark<\/strong>MSD Danmark ApSPhone: + 45 4482 4000dkmail@merck.com<\/td><td><strong>Malta<\/strong>Merck Sharp &amp; Dohme Cyprus LimitedPhone: 8007 4433 (+356 99917558)malta_info@merck.com<\/td><\/tr><tr><td><br><strong>Deutschland<\/strong>MSD Sharp &amp; Dohme GmbHPhone: 0800 673 673 673 (+49 (0) 89 4561 0)e-mail@msd.de<\/td><td><strong>The Netherlands<\/strong>Merck Sharp &amp; Dohme BVPhone: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com<\/td><\/tr><tr><td><br><strong>Estonia<\/strong>Merck Sharp &amp; Dohme O\u00dcTel.: +372 6144 200msdeesti@merck.com<\/td><td><strong>Norway<\/strong>MSD (Norway) iPhone: +47 32 20 73 00msdnorge@msd.no<\/td><\/tr><tr><td><strong>Greece<\/strong>MSD \u0391.\u03a6.\u0392.\u0395.\u0395.Tel: +30 210 98 97 300dpoc_greece@merck.com<\/td><td><strong>Austria<\/strong>Merck Sharp &amp; Dohme Ges.mbHPhone: +43 (0) 1 26 044msd-medizin@merck.com<\/td><\/tr><tr><td><strong>Spain<\/strong>Merck Sharp &amp; Dohme de Espa\u00f1a, SAPhone: +34 91 321 06 00msd_info@merck.com<\/td><td><strong>Polish<\/strong>MSD Polska Sp.\u00a0z o. iPhone: +48 22 549 51 00msdpolska@merck.com<\/td><\/tr><tr><td><strong>France<\/strong>MSD FranceTel: + 33 (0) 1 80 46 40 40<\/td><td><strong>Portugal<\/strong>Merck Sharp &amp; Dohme, LdaPhone: +351 21 4465700inform_pt@merck.com<\/td><\/tr><tr><td><strong>Hrvatska<\/strong>Merck Sharp &amp; Dohme dooPhone: + 385 1 6611 333croatia_info@merck.com<\/td><td><strong>Romania<\/strong>Merck Sharp &amp; Dohme Romania SRLPhone: +40 21 529 29 00msdromania@merck.com<\/td><\/tr><tr><td><strong>Ireland<\/strong>Merck Sharp &amp; Dohme Ireland (&nbsp;Human&nbsp;Health) LimitedPhone: +353 (0)1 2998700medinfo_ireland@merck.com<\/td><td><strong>Slovenija<\/strong>Merck Sharp &amp; Dohme, inovativna svlad\u00edva dooPhone: +386 1 5204 201msd.slovenia@merck.com<\/td><\/tr><tr><td><strong>Iceland<\/strong>Vistor hf.Telephone: + 354 535 7000<\/td><td><strong>Slovenian Republic<\/strong>Merck Sharp &amp; Dohme, s.r.oPhone: +421 2 58282010dpoc_czechslovak@merck.com<\/td><\/tr><tr><td><strong>Italy<\/strong>MSD Italia SrlPhone: +39 06 361911medicalinformation.it@merck.com<\/td><td><strong>Finland\/Finland<\/strong>MSD Finland OyPhone\/Tel: +358 (0)9 804 650info@msd.fi<\/td><\/tr><tr><td><strong>Cyprus<\/strong>Merck Sharp &amp; Dohme Cyprus LimitedTel.: 800 00 673 (+357 22866700)cyprus_info@merck.com<\/td><td><strong>Sweden<\/strong>Merck Sharp &amp; Dohme (Sweden) ABPhone: +46 77 5700488medicalinfo@merck.com<\/td><\/tr><tr><td><strong>Latvia<\/strong>SIA Merck Sharp &amp; Dohme LatvijaPhone: + 371 67364224msd_lv@merck.com<\/td><td><strong>United Kingdom (Northern Ireland)<\/strong>Merck Sharp &amp; Dohme Ireland (&nbsp;Human&nbsp;Health) LimitedPhone: 353 (0)1 2998700medinfoNI@msd.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>ZINPLAVA is given together with an\u00a0antibiotic\u00a0to prevent\u00a0infection\u00a0with the bacterium\u00a0Clostridium difficile\u00a0(CDI) from coming back in patients aged 18 and over who are at high risk of CDI coming back.<\/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":[2200,22506],"tags":[28462,28453,28458,28456,28455,28454,28459,28460,28457,28461],"class_list":["post-35485","post","type-post","status-publish","format-standard","hentry","category-medicines","category-z","tag-benefits-of-zinplava","tag-bezlotoxumab","tag-bezlotoxumab-benefits","tag-bezlotoxumab-side-effects","tag-what-bezlotoxumab-is-used-for","tag-what-is-bezlotoxumab","tag-what-is-zinplava","tag-what-zinplava-is-used-for","tag-zinplava","tag-zinplava-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35485","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=35485"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35485\/revisions"}],"predecessor-version":[{"id":36024,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35485\/revisions\/36024"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=35485"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=35485"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=35485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}