{"id":13731,"date":"2021-09-20T07:54:13","date_gmt":"2021-09-20T07:54:13","guid":{"rendered":"https:\/\/zeepedia.com\/?p=13731"},"modified":"2021-11-02T09:53:43","modified_gmt":"2021-11-02T09:53:43","slug":"hbvaxpro-5-micrograms","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/hbvaxpro-5-micrograms\/","title":{"rendered":"HBVAXPRO 5 micrograms &#8211; Hepatitis B vaccine uses, dose and side effects"},"content":{"rendered":"\n<p>injection,&nbsp;suspension.<br>Hepatitis&nbsp;B vaccine (&nbsp;recombinant DNA&nbsp;)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What HBVAXPRO 5 micrograms is and what it is used for<\/h2>\n\n\n\n<p>This vaccine is used for active immunization against&nbsp;hepatitis&nbsp;B virus infection caused by all known&nbsp;subtypes&nbsp;of individuals from birth to 15 years of age who are at risk of being exposed to the&nbsp;hepatitis&nbsp;B&nbsp;virus.<\/p>\n\n\n\n<p>The protection with HBVAXBRO probably also includes&nbsp;hepatitis&nbsp;D because&nbsp;hepatitis&nbsp;D does not occur in the absence of&nbsp;hepatitis&nbsp;B&nbsp;infection.<\/p>\n\n\n\n<p>The vaccine does not protect against&nbsp;infection&nbsp;caused by other&nbsp;agents&nbsp;such as&nbsp;hepatitis&nbsp;A,&nbsp;hepatitis&nbsp;C, and&nbsp;hepatitis&nbsp;E, and other&nbsp;pathogens&nbsp;known to infect the liver.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before you or your child receive HBVAXPRO 5 micrograms<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use HBVAXPRO 5 micrograms<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you or your child are allergic to&nbsp;hepatitis&nbsp;B surface antigen or any of the other ingredients of HBVAXPRO (see section 6.).<\/li><li>if you or your child have a serious illness with fever<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>The container for this vaccine contains latex rubber.&nbsp;Latex rubber can cause severe allergic reactions.<\/p>\n\n\n\n<p>Talk to a doctor, pharmacist, or nurse before you or your child receive HBVAXPRO 5 micrograms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and HBVAXPRO 5 micrograms<\/h2>\n\n\n\n<p>HBVAXPRO can be given concomitantly with&nbsp;hepatitis&nbsp;B immunoglobulin, at separate injection sites.<\/p>\n\n\n\n<p>HBVAXPRO can be used to complete a primary immunization or as a booster dose to people who have previously received another&nbsp;hepatitis&nbsp;B vaccine.<\/p>\n\n\n\n<p>HBVAXPRO can be administered concomitantly with certain other vaccines using separate injection sites and syringes.<\/p>\n\n\n\n<p><strong>Tell your doctor, pharmacist, or nurse if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Prescribing of the vaccine to pregnant or lactating women should be done with caution.<\/p>\n\n\n\n<p>Consult a doctor, pharmacist, or nurse before taking any medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>HBVAXPRO is expected to have no or negligible impact on the ability to drive and use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">HBVAXPRO 5 micrograms contains sodium<\/h2>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)&nbsp;sodium&nbsp;per&nbsp;dose, ie essentially &#8216;sodium-free.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use HBVAXPRO 5 micrograms<\/h2>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;for each&nbsp;injection&nbsp;(0.5 ml) is 5 micrograms for individuals (from birth to 15 years of age).<\/p>\n\n\n\n<p>A vaccination round must include at least three&nbsp;injections.<\/p>\n\n\n\n<p>Two immunization schedules can be used: &#8211;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>two&nbsp;injections&nbsp;at an interval of one month followed by a third&nbsp;injection&nbsp;6 months after the first&nbsp;administration&nbsp;one (0,1,6 months).&nbsp;<\/li><li>if rapid immunity is desired: three&nbsp;injections&nbsp;at an interval of one month and a fourth&nbsp;dose&nbsp;1 year later (0, 1, 2.12 months).<\/li><\/ul>\n\n\n\n<p>In the event of&nbsp;recent&nbsp;exposure to&nbsp;the hepatitis&nbsp;B&nbsp;virus, the first&nbsp;dose&nbsp;of HBVAXPRO may be co-administered with the appropriate&nbsp;dose&nbsp;of&nbsp;immunoglobulin.&nbsp;<\/p>\n\n\n\n<p>Some local vaccination schedules today include recommendations for a booster dose.&nbsp;Your doctor, pharmacist, or nurse will inform you if a booster dose should be given.&nbsp;<\/p>\n\n\n\n<p><strong>Method of administration<\/strong><\/p>\n\n\n\n<p>The vial should be shaken well until a slightly opaque white&nbsp;suspension&nbsp;is obtained.<\/p>\n\n\n\n<p>Once the vial has penetrated, the vaccine drawn into the syringe should be used immediately and the vial must then be discarded.<\/p>\n\n\n\n<p>A doctor or nurse will give the vaccine as an&nbsp;injection&nbsp;into the muscle.&nbsp;The upper thigh is the best injection site for newborns and infants.&nbsp;The upper arm muscle is the best injection site for children and teens.<\/p>\n\n\n\n<p>This vaccine should never be given to a blood vessel.&nbsp;<\/p>\n\n\n\n<p>In exceptional cases, this vaccine may be given under the skin to patients with&nbsp;thrombocytopenia&nbsp;(reduction in&nbsp;platelet count&nbsp;) or persons at risk of bleeding.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you or your child miss a dose of HBVAXPRO 5 micrograms<\/h2>\n\n\n\n<p>If you or your child misses a scheduled&nbsp;injection, contact your doctor, pharmacist, or nurse.&nbsp;Your doctor or nurse will decide when the missed&nbsp;dose&nbsp;should be given.&nbsp;<\/p>\n\n\n\n<p>If you or your child have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this vaccine can cause&nbsp;side effects,&nbsp;although not everybody gets them.<\/p>\n\n\n\n<p>As with other&nbsp;hepatitis&nbsp;B vaccines, in many cases, the causal relationship between&nbsp;side effects&nbsp;and the vaccine has not been established.&nbsp;<\/p>\n\n\n\n<p>The most common&nbsp;side effects&nbsp;are injection site reactions: tenderness,&nbsp;redness,&nbsp;and hardening.<\/p>\n\n\n\n<p>Other&nbsp;side effects&nbsp;have been reported very rarely:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low&nbsp;platelet count&nbsp;,&nbsp;lymph node&nbsp;disease<\/li><li>allergic reactions<\/li><li>Nervous system disorders such as numbness and tingling, facial numbness, neuritis including&nbsp;Guillain-Barr\u00e9 syndrome&nbsp;,&nbsp;inflammation&nbsp;of the eye nerve leading to impaired vision, encephalitis, exacerbation of&nbsp;multiple sclerosis&nbsp;,&nbsp;multiple sclerosis&nbsp;, seizures, headache, dizziness and fainting<\/li><li>low&nbsp;blood pressure&nbsp;,&nbsp;inflammation&nbsp;of the blood vessels<\/li><li>asthma-like symptoms<\/li><li>vomiting, nausea, diarrhea, abdominal pain<\/li><li>skin reactions such as&nbsp;eczema&nbsp;, rash, hair loss,&nbsp;itching&nbsp;, hives and blisters on the skin<\/li><li>joint pain, arthritis, muscle pain, pain in&nbsp;extremities&nbsp;are<\/li><li>fatigue, fever, vague feeling of illness, flu-like symptoms<\/li><li>increase in liver enzymes.<\/li><li>eye inflammation with pain and&nbsp;redness<\/li><\/ul>\n\n\n\n<p>In very premature infants (born \u2264 28 weeks of gestation), prolonged stays than normal between breaths may occur for 2-3 days after vaccination.<\/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 also applies to any side effects not mentioned in this information.&nbsp;You can also report side effects directly to the Medical Products Agency.&nbsp;By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store HBVAXPRO 5 micrograms<\/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 label and carton after EXP.<\/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>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required. These measures are intended 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<p>The active substance is:<\/p>\n\n\n\n<p>Hepatitis&nbsp;B&nbsp;virus&nbsp;surface antigen,&nbsp;recombinant&nbsp;(HBsAg) * &#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;. 5 micrograms&nbsp;<\/p>\n\n\n\n<p>Adsorbed&nbsp;on&nbsp;amorphous&nbsp;aluminum&nbsp;hydroxyphosphate&nbsp;sulfate (0.25 milligrams Al&nbsp;<sup>+<\/sup>&nbsp;)&nbsp;<sup>#<\/sup><\/p>\n\n\n\n<p>* produced in&nbsp;<em>Saccharomyces cerevisiae<\/em>&nbsp;(strain 2150-2-3) yeast cells by&nbsp;recombinant DNA&nbsp;technology.<\/p>\n\n\n\n<p><sup>#&nbsp;<\/sup>Amorphous&nbsp;aluminum&nbsp;hydroxyphosphate&nbsp;sulphate is included as an&nbsp;adjuvant&nbsp;in this vaccine.&nbsp;Adjuvants&nbsp;are substances that are included in certain vaccines to accelerate, improve and\/or prolong the protective effects of the vaccine.<\/p>\n\n\n\n<p>The other ingredients are sodium chloride, sodium borate, and water for injections.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p><strong>HVBAXPRO&nbsp;<\/strong>&nbsp;<strong>5&nbsp;<\/strong>&nbsp;<strong>micrograms is a&nbsp;<\/strong>suspension&nbsp;in a&nbsp;vial.<\/p>\n\n\n\n<p>Pack sizes of 1 and 10 vials without syringe\/needle.<\/p>\n\n\n\n<p>Pack size of 1&nbsp;vial&nbsp;with&nbsp;syringe&nbsp;and needle.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Marketing Authorisation Holder:&nbsp;<\/p>\n\n\n\n<p>MSD VACCINS<\/p>\n\n\n\n<p>162 avenue Jean Jaur\u00e8s<\/p>\n\n\n\n<p>69007 Lyon<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p>Manufacturer:<\/p>\n\n\n\n<p>Merck Sharp and 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>Further information on this vaccine can be obtained from the national representative of the marketing authorization holder.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Belgi\u00eb \/ Belgique \/<\/strong><br>Belgien MSD Belgium BVBA \/ SPRL<br>T\u00e9l \/ Tel: +32 (0) 27766211<br>dpoc_belux@merck.com<\/td><td><strong>Lietuva<\/strong><br>UAB Merck Sharp &amp; Dohme<br>Tel .: +370.5.2780.247<br>msd_lietuva@merck.com<\/td><\/tr><tr><td><strong>\u0411\u044a\u043b\u0433\u0430\u0440\u0438\u044f<br><\/strong>\u041c\u0435\u0440\u043a \u0428\u0430\u0440\u043f \u0438 \u0414\u043e\u0443\u043c \u0411\u044a\u043b\u0433\u0430\u0440\u0438\u044f \u0415\u041e\u041e\u0414,<br>tel .: + 359 2 819 3737<br>info-msdbg@merck.com<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong><br>MSD Belgium BVBA \/ SPRL<br>Tel: +32 (0) 27766211<br>dpoc_belux@merck.com<\/td><\/tr><tr><td><strong>Czech Republic<\/strong><br>Merck Sharp &amp; Dohme sro<br>Tel .: +420 233 010 111<br>dpoc_czechslovak@merck.com<\/td><td><strong>Magyarorsz\u00e1g<br><\/strong>MSD Pharma Hungary Kft.<br>Tel .: + 36.1.888.5300<br>hungary_msd@merck.com<\/td><\/tr><tr><td><strong>Denmark<\/strong><br>MSD Danmark ApS<br>Tel: + 45 4482 4000<br>dkmail@merck.com<\/td><td><strong>Malta<br><\/strong>Merck Sharp &amp; Dohme Cyprus Limited.<br>Tel: 8007 4433 (+356 99917558)<br>malta_info@merck.com<\/td><\/tr><tr><td><strong>Deutschland<\/strong><br>MSD SHARP &amp; DOHME GMBH<br>Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)<br>e-mail@msd.de<\/td><td><strong>Netherlands<\/strong><br>Merck Sharp &amp; Dohme BV<br>Tel: 0800 9999000 (+31 23 5153153)<br>medicalinfo.nl@merck.com&nbsp;<\/td><\/tr><tr><td><strong>Eesti<br><\/strong>Merck Sharp &amp; Dohme O\u00dc,<br>Tel: +372.614.4200<br>msdeesti@merck.com<\/td><td><strong>Norway<\/strong><br>MSD (Norway) AS<br>Tel: +47 32 20 73 00<br>msdnorge@msd.no<\/td><\/tr><tr><td><strong>D\u03bb\u03bb\u03ac\u03b4\u03b1<\/strong><br>MSD \u0391.\u03a6.\u0392.\u0395.\u0395.<br>:\u0397\u03bb: +30 210 98 97 300<br>dpoc_greece@merck.com<\/td><td><strong>Austria<\/strong><br>Merck Sharp &amp; Dohme Ges.mbH<br>Tel: +43 (0) 1 26 044<br>msd-medizin@merck.com<\/td><\/tr><tr><td><strong>Spain<br><\/strong>Merck Sharp &amp; Dohme de Espa\u00f1a, SA<br>Tel: +34 91 321 06 00<br>msd_info@merck.com<\/td><td><strong>Polska<br><\/strong>MSD Polska Sp.&nbsp;z oo<br>Tel .: +48.22.549.51.00<br>msdpolska@merck.com<\/td><\/tr><tr><td><strong>France<br><\/strong>MSD VACCINS<br>Tel: +33 (0) 1 80 46 40 40information.medicale@msd.com<\/td><td><strong>Portugal<\/strong><br>Merck Sharp &amp; Dohme, Lda<br>Tel: +351 21 4465700<br>inform_pt@merck.com<\/td><\/tr><tr><td><strong>Hrvatska<br><\/strong>Merck Sharp &amp; Dohme doo<br>Tel: +385 1 66 11 333<br>croatia_info@merck.com<\/td><td><strong>Rom\u00e2nia<br><\/strong>Merck Sharp &amp; Dohme Romania SRL<br>Tel: + 4021 529 29 00<br>msdromania@merck.com<\/td><\/tr><tr><td><strong>Ireland<\/strong><br>Merck Sharp &amp; Dohme Ireland (&nbsp;Human&nbsp;Health) Limited<br>Tel: +353 (0) 1 2998700<br>medinfo_ireland@merck.com<\/td><td><strong>Slovenia<\/strong><br>Merck Sharp &amp; Dohme, innovative zdravila doo<br>Tel: +386.1.520.4201<br>msd.slovenia@merck.com<\/td><\/tr><tr><td><strong>Iceland<br><\/strong>Vistor hf.<br>Phone: + 354 535 7000<\/td><td><strong>Slovak Republic<br><\/strong>Merck Sharp &amp; Dohme, sr o<br>Tel: +421 2 58282010<br>dpoc_czechslovak@merck.com<\/td><\/tr><tr><td><strong>Italy<\/strong><br>MSD Italia Srl<br>Tel: +39 06 361911<br>medicalinformation.it@merck.com<\/td><td><strong>Suomi \/ Finland<\/strong><br>MSD Finland Oy<br>Puh \/ Tel: +358 (0) 9 804 650<br>info@msd.fi<\/td><\/tr><tr><td><strong>Mer\u03c0\u03c1\u03bf\u03c2<br><\/strong>Merck Sharp &amp; Dohme Cyprus Limited<br>:\u03b7\u03bb: 800 00 673 (+357 22866700)<br>cyprus_info@merck.com<\/td><td><strong>Sweden<br><\/strong>Merck Sharp &amp; Dohme (Sweden) AB<br>Tel: +46 77 5700488<br>medicinskinfo@merck.com<\/td><\/tr><tr><td><strong>Latvia<br><\/strong>SIA Merck Sharp &amp; Dohme Latvia<br>Tel: +371.67364.224<br>msd_lv@merck.com<\/td><td><strong>United Kingdom<br><\/strong>Merck Sharp &amp; Dohme Limited<br>Tel: +44 (0) 1992 467272<br>medicalinformationuk@merck.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>This vaccine is used for active immunization against hepatitis B virus infection caused by all known subtypes of individuals from birth to 15 years of age who are at risk of being exposed to the hepatitis B virus.<\/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":[2200,2208],"tags":[13916,13910,13911,13905,13908,13909,13913,13907,13912,13906],"class_list":["post-13731","post","type-post","status-publish","format-standard","hentry","category-medicines","category-h","tag-benefits-of-hbvaxpro-5-micrograms","tag-benefits-of-hepatitis-b-vaccine","tag-hbvaxpro-5-micrograms","tag-hepatitis-b-vaccine","tag-hepatitis-b-vaccine-injection","tag-hepatitis-b-vaccine-side-effects","tag-what-hbvaxpro-5-micrograms-is-used-for","tag-what-hepatitis-b-vaccine-is-used-for","tag-what-is-hbvaxpro-5-micrograms","tag-what-is-hepatitis-b-vaccine"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13731","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=13731"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13731\/revisions"}],"predecessor-version":[{"id":15322,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13731\/revisions\/15322"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=13731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=13731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=13731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}