{"id":6228,"date":"2021-01-03T15:28:00","date_gmt":"2021-01-03T15:28:00","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6228"},"modified":"2021-06-26T07:45:45","modified_gmt":"2021-06-26T07:45:45","slug":"brinavess","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/brinavess\/","title":{"rendered":"Brinavess &#8211; Vernakalanth Hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n20 mg \/ ml, concentrate for solution for infusion&nbsp;<br>vernakalanth hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What BRINAVESS is and what it is used for<\/h2>\n\n\n\n<p>BRINAVESS contains the active substance vernakalant hydrochloride.&nbsp;BRINAVESS works by changing your irregular or fast heartbeat to normal.<br><\/p>\n\n\n\n<p>In adults, BRINAVESS is used if you have recently, less than or equal to 7 days ago for patients who have not undergone&nbsp;surgery&nbsp;and less than or equal to 3 days for patients who have undergone heart surgery, have had irregular or rapid heart rhythm called&nbsp;atrial fibrillation.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using BRINAVESS<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use BRINAVESS:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you have recently had or experienced worsening chest pain (angina) that has been assessed by your doctor as&nbsp;acute&nbsp;coronary heart disease within the last 30 days or if you have had a heart attack within the last 30 days<\/li><li>if you have a very narrow heart valve, systolic&nbsp;blood pressure&nbsp;lower than 100 mmHg, or if you have advanced&nbsp;heart failure&nbsp;with symptoms of light exertion or rest<\/li><li>if you have an abnormally slow or skipped heartbeat and do not have a pacemaker or if you have conduction disturbances (prolonged&nbsp;QT time&nbsp;) that your doctor can see on your&nbsp;ECG<\/li><li>if you have used certain other intravenous medicines (&nbsp;class I and III&nbsp;antiarrhythmics&nbsp;)&nbsp;during the last four hours before BRINAVESS&nbsp;to normalize an abnormal heart rhythm.<\/li><\/ul>\n\n\n\n<p>You may not use BRINAVESS if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor before using this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using BRINAVESS if you have:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>heart failure<\/li><li>certain heart diseases involving the heart muscle, the membrane surrounding the heart, or a severe narrowing of the heart valves<\/li><li>any disease of the heart valves<\/li><li>liver problem<\/li><li>you are taking other antidote medicines.<\/li><\/ul>\n\n\n\n<p>If you have very low&nbsp;blood pressure&nbsp;or slow heart rate or some changes in your&nbsp;ECGwhile using this medicine, your doctor will stop your treatment.<br><\/p>\n\n\n\n<p>Your doctor will consider whether you need additional rhythm control medication 4 hours after using BRINAVESS.<br><\/p>\n\n\n\n<p>BRINAVESS may not work in the treatment of certain other types of abnormal heart rhythms, but your doctor will know who they are.<\/p>\n\n\n\n<p>Tell your doctor if you have a pacemaker.<br><\/p>\n\n\n\n<p>Talk to your doctor if any of the above apply to you (or if you are unsure).&nbsp;Detailed information on warnings and precautions for&nbsp;side effects&nbsp;that may occur is presented in section 4.<br><\/p>\n\n\n\n<p><strong>Blood tests<\/strong><\/p>\n\n\n\n<p>Before you are treated with this medicine, your doctor will decide if your blood should be tested to check how well it coagulates and to check your potassium levels.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Do not give this medicine to children and adolescents under 18 years of age as there is no experience of using it in this patient group.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and BRINAVESS<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>Do not use BRINAVESS if you are taking certain other intravenous medicines (&nbsp;class I and III&nbsp;antiarrhythmics&nbsp;) that are used to normalize abnormal heart rhythms, 4 hours before BRINAVESS is to be used.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>BRINAVESS should preferably be avoided during pregnancy<\/li><li>It is not known whether BRINAVESS passes into breast milk<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>You should keep in mind that some people may experience dizziness, usually during the first 2 hours, after treatment with BRINAVESS (see section \u201cPossible side effects\u201d).&nbsp;Do not drive or use machines if you become dizzy after treatment with BRINAVESS.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">BRINAVESS contains sodium<\/h2>\n\n\n\n<p>This medicine contains 32 mg&nbsp;sodium&nbsp;(the main ingredient in table salt\/table salt) per 200 mg&nbsp;vial.&nbsp;This corresponds to 1.6% of the maximum recommended daily&nbsp;sodium intake&nbsp;for adults.<\/p>\n\n\n\n<p>This medicine contains 80 mg of&nbsp;sodium&nbsp;(the main ingredient in table salt\/table salt) per 500 mg&nbsp;vial.&nbsp;This corresponds to 4% of the maximum recommended daily intake of&nbsp;sodium&nbsp;for adults.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use BRINAVESS<\/h2>\n\n\n\n<p>The amount of BRINAVESS you receive depends on your weight.&nbsp;The recommended starting dose is 3 mg\/kg body weight, where the maximum calculated&nbsp;dose&nbsp;is based on 113 kg.&nbsp;If you weigh more than 113 kg, you will receive a fixed&nbsp;dose&nbsp;of 339 mg.&nbsp;During the time you receive BRINAVESS, your breathing, your heart rate, your&nbsp;blood pressure,&nbsp;and your heart&#8217;s electrical activity are monitored.<br><\/p>\n\n\n\n<p>If your heart rate has not returned to normal 15 minutes after your first&nbsp;dose&nbsp;has been completed, you may receive a second&nbsp;dose.&nbsp;This will be a slightly lower&nbsp;dose, 2 mg\/kg body weight, where the maximum calculated&nbsp;dose&nbsp;is based on 113 kg.&nbsp;If you weigh more than 113 kg, you will receive a fixed&nbsp;dose&nbsp;of 226 mg.&nbsp;A higher&nbsp;dose&nbsp;than a total of 5 mg\/kg body weight should not be over 24 hours.<br><\/p>\n\n\n\n<p>BRINAVESS will be given to you by healthcare professionals.&nbsp;BRINAVESS should be diluted before it is given to you.&nbsp;Information on how to dilute the solution can be found at the end of this leaflet.<\/p>\n\n\n\n<p>It will be given into your veins for 10 minutes.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more BRINAVESS than you should<\/h2>\n\n\n\n<p>Tell your doctor immediately if you think you have been treated with too much BRINAVESS.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p>Your doctor may decide to discontinue the&nbsp;infusion&nbsp;if he\/she observes any of the following abnormal changes:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>your heart rhythm (eg a very fast (uncommon) or very slow heartbeat (common), a missed stroke (uncommon), or a short pause in the normal activity of your heart (uncommon))<\/li><li>your&nbsp;blood pressure&nbsp;(eg very low&nbsp;blood pressure&nbsp;which can cause serious heart problems) (uncommon)<\/li><li>your heart&#8217;s electrical activity (less common)<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;are<\/strong><\/p>\n\n\n\n<p>Very common (may affect more than 1 user in 10)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>taste changes<\/li><li>sneezing<\/li><\/ul>\n\n\n\n<p>Common (may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fast heartbeat<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>pain or numbness at the infusion site, numbness, decreased sensation in the skin, or tingling sensation<\/li><li>nausea and vomiting<\/li><li>feeling of warmth<\/li><li>low&nbsp;blood pressure, slow heartbeat, dizziness<\/li><li>cough, sore nose<\/li><li>excessive sweating,&nbsp;itching<\/li><li>numbness or tingling that occurs in the oral&nbsp;mucosa&nbsp;or&nbsp;tissue&nbsp;s<\/li><\/ul>\n\n\n\n<p>Uncommon (may affect up to 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>certain types of heart rhythm problems (eg an awareness of your heartbeat (palpitations) or an extra heartbeat)<\/li><li>reduced sensitivity<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>eye irritation, watery eyes, or vision changes<\/li><li>changes in the sense of smell<\/li><li>pain in fingers and toes, a burning sensation<\/li><li>cold sweats, hot flashes<\/li><li>increased need for bowel movements, diarrhea<\/li><li>shortness of breath or tightness in the chest<\/li><li>feeling of suffocation<\/li><li>pain in the mouth or throat<\/li><li>irritation,&nbsp;itching&nbsp;at the infusion site<\/li><li>high&nbsp;blood pressure<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>fainting or fainting, general malaise, drowsiness or drowsiness<\/li><li>runny nose, sore throat<\/li><li>nasal congestion<\/li><li>dry mouth<\/li><li>pale skin color<\/li><li>general&nbsp;itching<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>fatigue<\/li><li>decreased sensation or sensitivity in the mouth<\/li><\/ul>\n\n\n\n<p>These effects, which occur within 24 hours after using BRINAVESS, should be transient.&nbsp;If this does not happen, talk to your doctor.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store BRINAVESS<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and label on the vial after EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>No special storage instructions.<br><\/p>\n\n\n\n<p>BRINAVESS must be diluted before use.&nbsp;The diluted sterile concentrate is chemically and physically stable for 12 hours when stored at 25 \u00b0 C or lower.<br><\/p>\n\n\n\n<p>From a microbiological perspective, the drug should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 \u00b0 C to 8 \u00b0 C, unless reconstitution and dilution have been performed under controlled and validated aseptic conditions.<br><\/p>\n\n\n\n<p>Do not use this medicine if you notice that the contents are cloudy or discolored.<br><\/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\">6. 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 vernakalant hydrochloride.&nbsp;One ml of concentrate contains 20 mg of vernakalant hydrochloride equivalent to 18.1 mg of vernakalant.&nbsp;One&nbsp;vial&nbsp;of 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant. One&nbsp;vial&nbsp;of 500 mg vernakalant hydrochloride is equivalent to 452.5 mg vernakalant.<\/li><li>The other ingredients are citric acid, sodium chloride, sodium hydroxide (E524), and water for injections (see section 2 \u201cBrinavess contains sodium\u201d).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>BRINAVESS is a concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;(sterile concentrate) that is clear and colorless to pale yellow.<br><\/p>\n\n\n\n<p>BRINAVESS is available in packs containing 1&nbsp;vial&nbsp;of 200 mg or 500 mg of vernakalant hydrochloride.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Marketing Authorisation Holder<\/strong>&nbsp;Correvio15 rue du Bicentenaire92800 PuteauxFrance<\/td><td><strong>Manufacturer<\/strong>Geodis Logistics Netherlands BVColumbusweg 165928 LC VenloNetherlands<\/td><\/tr><\/tbody><\/table><\/figure>\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 \/ Belgique \/ Belgien<\/strong>CorrevioTel: +32 28 08 86 20<\/td><td><strong>Lithuania<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>\u0411\u044a\u043b\u0433\u0430\u0440\u0438\u044f<\/strong>&nbsp;<br>CorrevioTel .: +41 848 00 79 70<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>CorrevioTel: +41 848 00 79 70<\/td><td><strong>Hungary<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Denmark<\/strong>CorrevioTel: +45 8082 6022<\/td><td><strong>Malta<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Germany<\/strong>CorrevioTel: +49 69 33 29 62 76<\/td><td><strong>The Netherlands<\/strong>CorrevioTel: +31 20 808 32 06<\/td><\/tr><tr><td><strong>Eesti<\/strong>CorrevioTel: +41 848 00 79 70<\/td><td><strong>Norway<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Greece<\/strong>Correvio:\u0397\u03bb: +41 848 00 79 70<\/td><td><strong>Austria<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Spain<\/strong>CorrevioTel: +34 93 179 05 36<\/td><td><strong>Poland<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>France<\/strong>CorrevioTel: +33 1 77 68 89 17<\/td><td><strong>Portugal<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Croatia<\/strong>CorrevioTel: +41 848 00 79 70<\/td><td><strong>Romania<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Ireland<\/strong>CorrevioTel: +41 848 00 79 70<\/td><td><strong>Slovenia<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Iceland<\/strong>CorrevioPhone: +41 848 00 79 70<\/td><td><strong>Slovak Republic<\/strong>CorrevioTel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>Italy<\/strong>CorrevioTel: +39 02 600 63037<\/td><td><strong>Finland \/ Finland<\/strong>CorrevioPuh \/ Tel: +41 848 00 79 70<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Correvio:\u0397\u03bb: +41 848 00 79 70<\/td><td><\/td><\/tr><tr><td><strong>Latvia<\/strong>CorrevioTel: +41 848 00 79 70<\/td><td><strong>United Kingdom<\/strong>CorrevioTel: +44 203 002 8114<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>BRINAVESS contains the active substance vernakalant hydrochloride. BRINAVESS works by changing your irregular or fast heartbeat to normal.<\/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":[2202,2200],"tags":[8421,8423,8425,8420,8416,8418,8424,8422,8417,8419],"class_list":["post-6228","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-brinavess","tag-brinavess-side-effects","tag-side-effects-of-brinavess","tag-side-effects-of-vernakalanth-hydrochloride","tag-vernakalanth-hydrochloride","tag-vernakalanth-hydrochloride-side-effects","tag-what-brinavess-is-used-for","tag-what-is-brinavess","tag-what-is-vernakalanth-hydrochloride","tag-what-vernakalanth-hydrochloride-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6228","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=6228"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6228\/revisions"}],"predecessor-version":[{"id":11833,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6228\/revisions\/11833"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6228"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6228"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6228"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}