{"id":35100,"date":"2022-11-22T07:29:01","date_gmt":"2022-11-22T07:29:01","guid":{"rendered":"https:\/\/zeepedia.com\/?p=35100"},"modified":"2022-11-24T08:07:48","modified_gmt":"2022-11-24T08:07:48","slug":"zevtera","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/zevtera\/","title":{"rendered":"Zevtera &#8211; Ceftobiprole uses, dose and side effects"},"content":{"rendered":"\n<p>500 mg&nbsp;powder for concentrate for&nbsp;infusion&nbsp;solution<br>ceftobiprole<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Zevtera is and what it is used for<\/h2>\n\n\n\n<p>Zevtera is an antibiotic medicine that contains the active substance ceftobiprole medical sodium.\u00a0It belongs to a group of medicines called &#8220;cephalosporin antibiotics&#8221;.<\/p>\n\n\n\n<p>Zevtera is used to treat newborn babies (not born prematurely), infants, children, adolescents, and adults with an\u00a0infection\u00a0in the lungs, i.e.\u00a0pneumonia<\/p>\n\n\n\n<p>Zevtera works by killing certain bacteria, which can cause serious lung infections.<br><br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before you use Zevtera<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Zevtera<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to ceftobiprole medical sodium or any of the other ingredients of this medicine (listed in section 6),<\/li><li>if you are allergic to other\u00a0cephalosporins\u00a0or beta-lactam antibiotics,<\/li><li>if you have previously had severe allergic reactions to other\u00a0antibiotics\u00a0such as\u00a0penicillin\u00a0or carbapenems,<\/li><\/ul>\n\n\n\n<p>Do not use Zevtera if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor before receiving Zevtera.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor or nurse before using Zevtera<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have kidney problems (your doctor may need to lower your\u00a0dose\u00a0of this medicine),<\/li><li>if you have ever had an\u00a0allergic reaction\u00a0to other\u00a0antibiotics\u00a0such as\u00a0penicillin\u00a0or carbapenems,<\/li><li>if you have ever had seizures,<\/li><li>if you have diarrhea before, during, or after your treatment with this medicine (you may have a bowel inflammation called &#8220;colitis&#8221;).\u00a0Do not take any other medicine to treat diarrhea without first consulting your doctor,<\/li><li>if you are\u00a0HIV\u00a0positive,<\/li><li>if your immune system is severely weakened,<\/li><li>if you have a low\u00a0white blood cell count\u00a0or inhibited bone marrow function,<\/li><li>if your lung infection occurred more than 48 hours after starting artificial ventilation (breathing), Zevtera is not suitable for you (your doctor will prescribe the appropriate\u00a0antibiotic\u00a0for you),<\/li><li>if you need (or are expected to need) simultaneous solutions containing\u00a0calcium, except lactated Ringer&#8217;s solution for\u00a0injection, in the same intravenous\u00a0catheter\u00a0due to the risk of precipitation.<\/li><\/ul>\n\n\n\n<p>If your doctor thinks you need more fluids, you will be told to drink plenty of fluids, or you may need to receive fluids as a drip into a vein, while you are receiving Zevtera.<\/p>\n\n\n\n<p>If you start using Zevtera and then need ventilation, your doctor will assess whether Zevtera is still suitable for you.<\/p>\n\n\n\n<p><em>Lab tests<\/em><\/p>\n\n\n\n<p>You may develop an abnormal lab test (called the Coombs test), which looks for certain\u00a0antibodies\u00a0that can act against\u00a0red blood cells.\u00a0Zevtera may also affect tests to measure\u00a0serum creatinine\u00a0(Jaff\u00e9&#8217;s reaction) or some tests to determine the glucose content of urine.\u00a0These tests can give you wrong results.<\/p>\n\n\n\n<p>If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you start using Zevtera.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Zevtera is not recommended for use in premature babies (premature babies) as safety and efficacy in this age group have not been established.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Zevtera<\/h2>\n\n\n\n<p>Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.<br><\/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, consult your doctor before using this medicine.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Zevtera can cause&nbsp;side effects&nbsp;such as dizziness.&nbsp;This may impair your ability to drive or use machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with a doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>Zevtera contains approximately 1.3 mmol (29 mg) of\u00a0sodium\u00a0per\u00a0dose.\u00a0<\/strong>If you are on a diet with controlled salt intake, your doctor may need to adjust this.<br><br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Zevtera<\/h2>\n\n\n\n<p>You will be given Zevtera by a doctor or nurse.<\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0for adults is 500 mg of ceftobiprole every 8 hours as a drip into a vein over 2 hours.<\/p>\n\n\n\n<p>The recommended\u00a0dose\u00a0for newborns, infants, children, and adolescents depends on the child&#8217;s age and weight and is given every 8 hours (infants from 3 months and older, children and adolescents), or every 12 hours (newborns and infants younger than 3 months) as a drip into a vein over 2 hours.<\/p>\n\n\n\n<p>An infusion solution with a ceftobiprole concentration of 2 mg\/ml is used for adults and adolescents.\u00a0For infants and newborns, an infusion solution with a ceftobiprole concentration of 4 mg\/ml should be used.<\/p>\n\n\n\n<p><strong>Patients with kidney problems<\/strong><\/p>\n\n\n\n<p>If you have kidney problems, you may need to take a lower&nbsp;dose&nbsp;of Zevtera.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use too much Zevtera&nbsp;<\/h2>\n\n\n\n<p>If you think you have been given too much Zevtera, talk to your doctor or nurse straight away.<br><a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Zevtera<\/h2>\n\n\n\n<p>If you think you have missed a\u00a0dose, talk to your doctor or nurse immediately.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor or nurse.<br><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.\u00a0The following\u00a0side effects\u00a0may occur with this medicine:<\/p>\n\n\n\n<p><strong>Tell your doctor immediately if you get these symptoms, as you may need&nbsp;urgent&nbsp;treatment:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Sudden swelling of the lips, face, throat, or tongue, severe rash, and swallowing or breathing problems.\u00a0This can be a sign of a serious\u00a0allergic reaction\u00a0(anaphylaxis) and can be life-threatening.<\/li><li>Diarrhea that becomes severe or does not go away, or stools that contain blood or mucus during or after treatment with Zevtera.\u00a0In this situation, you should not take medicines that stop or delay bowel movements.<\/li><\/ul>\n\n\n\n<p><strong>Common: may affect up to 1 in 10 people<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nausea<\/li><li>Headache, sleepiness<\/li><li>Dizziness<\/li><li>Rash,\u00a0itching,\u00a0or hives<\/li><li>Diarrhea.\u00a0If you develop diarrhea, tell your doctor immediately<\/li><li>vomiting<\/li><li>Stomach pain (\u00a0abdominal pain\u00a0), indigestion, or heartburn (\u00a0dyspepsia\u00a0)<\/li><li>Unusual taste (\u00a0dysgeusia\u00a0)<\/li><li>Fungal infections in various parts of the body<\/li><li>Redness, pain, or swelling where the\u00a0injection\u00a0was given<\/li><li>Low levels of the mineral\u00a0sodium\u00a0in the blood<\/li><li>Increase in the level of certain liver enzymes in the blood<\/li><li>Hypersensitivity, including skin redness<\/li><\/ul>\n\n\n\n<p><strong>Uncommon: may affect up to 1 in 100 people<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Seizures<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Temporarily decreased or increased number of certain types of\u00a0blood\u00a0cells<\/li><li>Blood tests showing decreased levels of\u00a0potassium<\/li><li>Insomnia and sleep disturbances, possibly including anxiety, panic attacks, and nightmares<\/li><li>Shortness of breath or difficulty breathing,\u00a0asthma<\/li><li>Muscle cramps<\/li><li>Kidney problems<\/li><li>Swelling, especially in the ankles and legs<\/li><li>Blood tests that show temporarily increased levels of\u00a0triglycerides, blood sugar, or\u00a0creatinine<\/li><\/ul>\n\n\n\n<p><strong>Not known frequency: cannot be estimated from the available data<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A more severe decrease in a specific type of&nbsp;white blood cell&nbsp;(&nbsp;<em>agranulocytosis<\/em>&nbsp;)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Zevtera<\/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 &#8220;EXP&#8221;.&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).<\/p>\n\n\n\n<p>Store the vial in the outer carton.&nbsp;Light sensitive.<\/p>\n\n\n\n<p>For storage of prepared and diluted Zevtera&nbsp;<strong>infusion<\/strong>&nbsp;solutions, see the attached information for healthcare professionals.<\/p>\n\n\n\n<p>Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<br><\/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 ceftobiprole.\u00a0Each\u00a0vial\u00a0contains 500 mg of ceftobiprole (666.6 mg of ceftobiprole medical sodium).\u00a0After\u00a0reconstitution, each ml of concentrate will contain 50 mg of ceftobiprole, corresponding to 66.7 mg of ceftobiprole medical sodium.<\/li><li>Other ingredients are citric acid monohydrate (E330) and sodium hydroxide (E524), see also section 2.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Zevtera is a white, yellowish to slightly brownish, cake to broken cake or powder to concentrate to solution for\u00a0infusion\u00a0in a 20 ml\u00a0vial.\u00a0It is available in packs containing 10 vials.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing authorization holder and manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Basilea Pharmaceutica Deutschland GmbH<\/p>\n\n\n\n<p>Marie-Curie-Strasse 8<\/p>\n\n\n\n<p>79539 L\u00f6rrach<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>ACS Dobfar SpA<\/p>\n\n\n\n<p>Via A. Fleming, 2<\/p>\n\n\n\n<p>37135 Verona (VR)<\/p>\n\n\n\n<p>Italy<\/p>\n\n\n\n<p><strong>This medicine is authorized in the Member States of the EEA under the following names:<\/strong><\/p>\n\n\n\n<p>Austria: Zevtera&nbsp;<em>500 mg Pulver f\u00fcr ein Konzentrat zur Herstellung einer Infusionsl\u00f6sung<\/em><\/p>\n\n\n\n<p>Denmark: Zevtera<\/p>\n\n\n\n<p>Finland: Zevtera&nbsp;<em>500 mg, kuiva-aine v\u00e4likonsentratiksi inf\u00fczionesest\u00e4tt\u00e4 v\u00e4rten, liuos<\/em><\/p>\n\n\n\n<p>France: Mabelio&nbsp;<em>500 mg, poudre pour solution \u00e0 diluter pour solution pour&nbsp;<\/em><em>perfusion<\/em><em><\/em><\/p>\n\n\n\n<p>Germany: Zevtera&nbsp;<em>500 mg Pulver f\u00fcr ein Konzentrat zur Herstellung einer&nbsp;<\/em><em>Infusionsl\u00f6sung<\/em><\/p>\n\n\n\n<p>Italy: Mabelio&nbsp;<em>500 mg, polvere per concentrato per&nbsp;<\/em><em>soluzione per infusione<\/em><\/p>\n\n\n\n<p>Ireland: Adaluzis&nbsp;<em>500 mg powder for concentrate for solution for&nbsp;infusion<\/em><\/p>\n\n\n\n<p>Luxembourg: Mabelio&nbsp;<em>500 mg, poudre pour solution \u00e0 diluter&nbsp;<\/em><em>pour solution pour&nbsp;perfusion<\/em><\/p>\n\n\n\n<p>Norway: Zevtera&nbsp;<em>500 mg, powder for concentrate for&nbsp;<\/em><em>infusion, solution<\/em><\/p>\n\n\n\n<p>Poland: Zevtera,&nbsp;<em>500 mg, proszek do sporz\u0105dzania koncentratu s\u0142ottu do infusji<\/em><\/p>\n\n\n\n<p>Portugal: Zevtera&nbsp;<em>500 mg p\u00f3 para concentrado para solu\u00e7\u00e3o para perfus\u00e3o<\/em><\/p>\n\n\n\n<p>Spain: Zevtera\u00a0<em>500 mg, polvo para concentrado\u00a0para soluci\u00f3n para perfusi\u00f3n<\/em><\/p>\n\n\n\n<p>United Kingdom (Northern Ireland): Zevtera&nbsp;<em>500 mg powder for concentrate for solution for&nbsp;infusion&nbsp;.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Zevtera is an antibiotic medicine that contains the active substance ceftobiprole medocaryl sodium.\u00a0It belongs to a group of medicines called &#8220;cephalosporin antibiotics&#8221;.<\/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":[28390,28395,28386,28389,28388,28387,28392,28393,28391,28394],"class_list":["post-35100","post","type-post","status-publish","format-standard","hentry","category-medicines","category-z","tag-benefits-of-ceftobiprole","tag-benefits-of-zevtera","tag-ceftobiprole","tag-ceftobiprole-side-effects","tag-what-ceftobiprole-is-used-for","tag-what-is-ceftobiprole","tag-what-is-zevtera","tag-what-zevtera-is-used-for","tag-zevtera","tag-zevtera-side-effects"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35100","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=35100"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35100\/revisions"}],"predecessor-version":[{"id":35405,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/35100\/revisions\/35405"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=35100"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=35100"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=35100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}