{"id":4696,"date":"2020-11-28T10:37:26","date_gmt":"2020-11-28T10:37:26","guid":{"rendered":"https:\/\/zeepedia.com\/?p=4696"},"modified":"2021-08-23T07:42:02","modified_gmt":"2021-08-23T07:42:02","slug":"act-hib","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/act-hib\/","title":{"rendered":"Act-HIB &#8211; Haemophilus influenzae type B polysaccharide uses, dose and side effects"},"content":{"rendered":"\n<p>Powder and solvent for solution for injection<br>vaccine against&nbsp;Haemophilus influenzae&nbsp;type b, conjugated.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Act-HIB is and what it is used for<\/h2>\n\n\n\n<p>Act-HIB&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b, the conjugate vaccine is a bacterial vaccine used to prevent&nbsp;infection&nbsp;caused by&nbsp;Haemophilus influenzae&nbsp;type b (such as&nbsp;meningitis, blood poisoning,&nbsp;cellulite, joint inflammation,&nbsp;laryngitis, pneumonia, bone rot from 2 months of age).<\/p>\n\n\n\n<p>The vaccine activates the body&#8217;s immune system to provide protection (&nbsp;antibodies&nbsp;) against&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Act-HIB<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Act-HIB<\/h2>\n\n\n\n<p><em>If the child to be vaccinated:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>is allergic (hypersensitive) to any of the ingredients of Act-HIB, especially the tetanus protein and formaldehyde.<\/li><li>previously had a severe reaction after vaccination with Act-HIB or any other vaccine containing the same substances.<\/li><li>have a high fever or an&nbsp;acute&nbsp;infection, the vaccination should be postponed.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to a doctor before the child is vaccinated.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if your child has a latex allergy.&nbsp;The syringe tip cap on the prefilled syringes contains latex.&nbsp;May cause severe allergic reactions.<\/li><\/ul>\n\n\n\n<p>Act-HIB does not protect against&nbsp;infection&nbsp;caused by other types of&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;or against&nbsp;meningitis&nbsp;of other origins.<br><\/p>\n\n\n\n<p>The tetanus protein contained in the Act-HIB can under no circumstances be used to replace the standard vaccination against tetanus (&nbsp;tetanus&nbsp;).<\/p>\n\n\n\n<p>Before Act-HIB is given, the recipient&#8217;s parent or guardian or the adult recipient must be asked about personal history, family history, and recent health status, including vaccination history, current health status, and any&nbsp;side effects&nbsp;from previous vaccinations.&nbsp;The vaccination procedure must be well considered for patients who have had a severe reaction within 48 hours after a previous&nbsp;injection&nbsp;containing similar ingredients.<\/p>\n\n\n\n<p>A treatment that lowers the immune system or a condition with a reduced&nbsp;immune response&nbsp;can cause a weakened&nbsp;immune response&nbsp;to the vaccine.&nbsp;The recommendation is therefore to wait with the vaccination until after the end of treatment or to ensure that the patient is well protected.&nbsp;Vaccination of patients with&nbsp;chronic&nbsp;immune suppression in&nbsp;HIV&nbsp;&#8211;&nbsp;infection, asplenia, or sickle cell disease is still recommended even if the antibody response may be limited.<\/p>\n\n\n\n<p>As with all injectable vaccines, the vaccine must be given with caution to patients with&nbsp;thrombocytopenia&nbsp;or bleeding disorders as bleeding may occur after&nbsp;intramuscular injection&nbsp;in these patients.<\/p>\n\n\n\n<p><strong><em>Effect on blood tests<\/em><\/strong><\/p>\n\n\n\n<p>Because&nbsp;antigen&nbsp;in the urine has been detected in some cases within 2 weeks of the patient receiving Act-HIB, false-positive reactions are possible in suspected positive&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b disease.&nbsp;Therefore, in such cases, the detection of&nbsp;antigen&nbsp;in the urine may not have a decisive diagnostic value in suspected&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b disease.<\/p>\n\n\n\n<p><strong>Children<\/strong><\/p>\n\n\n\n<p>The possible risk of respiratory arrest (&nbsp;apnea&nbsp;) and the need for respiratory monitoring during the first 48-72 hours after&nbsp;administration&nbsp;of the basic vaccination schedule to very premature infants (born at gestational week \u226428) should be considered and especially for children who have had a&nbsp;respiratory&nbsp;immaturity.<\/p>\n\n\n\n<p>As the benefit of vaccination is great within this group of children, one should not refrain from or postpone vaccination.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Act-HIB<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if the child to be vaccinated is taking, has recently taken, or might take other medicines.<\/p>\n\n\n\n<p>Tell your doctor if your child is taking so-called immunosuppressive drugs as the effect of the vaccination may be worse.<\/p>\n\n\n\n<p>Act-HIB can be injected at the same time as other recommended vaccines against&nbsp;diphtheria,&nbsp;tetanus&nbsp;(tetanus), pertussis (pertussis), and polio, at the same injection site if combined or at two different injection sites if given simultaneously but as two different&nbsp;injections.<\/p>\n\n\n\n<p>Act-HIB can be given concomitantly with the&nbsp;hepatitis&nbsp;B or MPR (measles-mumps-rubella) vaccine at two different injection sites.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>Vaccination of adults against&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b is uncommon.&nbsp;Data on the use of this vaccine in pregnant women are limited.&nbsp;Therefore,&nbsp;administration&nbsp;of the vaccine during pregnancy&nbsp;is not recommended.&nbsp;Act-HIB should be given to pregnant women only if there is a clear need and after an assessment of the risks and benefits.<br><\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>Vaccination of adults against&nbsp;<em>Haemophilus influenzae<\/em>&nbsp;type b is uncommon.&nbsp;It is not known if this vaccine is excreted in human milk.&nbsp;Therefore, caution should be exercised when administering Act-HIB to a nursing mother.<br><\/p>\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 or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>No studies on the effects on the ability to drive and use machines have been performed<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Act-HIB contains sodium<\/h2>\n\n\n\n<p>Act-HIB contains less than 1 mmol (23 mg) per&nbsp;dose of&nbsp;sodium, ie is essential &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Act-HIB<\/h2>\n\n\n\n<p>The vaccine is given by a doctor or healthcare professional.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is:<\/p>\n\n\n\n<p><em>Children 2-3 months:<\/em><\/p>\n\n\n\n<p>Basic protection (basic immunization) is achieved by giving 3 doses at intervals of:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>1 to 2 months, starting at 2-3 months of age or<\/li><li>2 doses at intervals of 2 months, starting at 3 months of age, and the third&nbsp;dose&nbsp;at 12 months of age.<\/li><\/ul>\n\n\n\n<p>A fourth&nbsp;dose&nbsp;(booster vaccination) should be given within the second year of life in children who have received a three-dose&nbsp;basic immunization at the age of 2-6 months.<\/p>\n\n\n\n<p><em>Children between 6 and 12 months of age:<\/em><\/p>\n\n\n\n<p>2 doses are given at one-month intervals and a 3rd dose (booster dose) at 18 months of age.<\/p>\n\n\n\n<p><em>Children between 1 to 5 years of age:<\/em><\/p>\n\n\n\n<p>1&nbsp;dose.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/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.<\/p>\n\n\n\n<p>The most common&nbsp;adverse reactions&nbsp;that occurred shortly after Act-HIB administration (within 6-24 hours) were local reactions at the injection site, fever, and irritability.&nbsp;They are transient and mild or moderate.<\/p>\n\n\n\n<p>No increase in incidence or severity has been noted for these&nbsp;adverse reactions&nbsp;at subsequent&nbsp;doses&nbsp;in the basic immunization.<\/p>\n\n\n\n<p>Contact a doctor immediately if your child develops any of the following symptoms:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling of the face, tongue, or throat<\/li><li>difficulty swallowing<\/li><li>hives&nbsp;and difficulty breathing.<\/li><\/ul>\n\n\n\n<p>Other&nbsp;side effects&nbsp;are:<\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(affects 1 to 10 users in 100):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>crying (uncontrolled or abnormal)<\/li><li>vomiting<\/li><\/ul>\n\n\n\n<p><strong>Less&nbsp;<\/strong><strong>common<\/strong>&nbsp;(affects 1 to 10 users in 1000):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fever above 39 \u00b0 C<\/li><\/ul>\n\n\n\n<p><strong>Unknown frequency<\/strong>&nbsp;(as these are voluntarily reported and very rare, the frequency cannot be calculated from the available data):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>hypersensitivity&nbsp;s<\/li><li>cramps with or without fever<\/li><li>hives, rash,&nbsp;itching, widespread rash<\/li><li>facial swelling, swelling in the throat (hint of a possible&nbsp;hypersensitivity reaction&nbsp;)<\/li><li>swelling in legs and feet<\/li><li>the strong reaction at the injection site (&gt; 50 mm)<\/li><li>swelling in the lower part of the legs: with bluish discoloration of the skin (cyanosis) or small transient red rashes (transient purpura) that appear during the first hours after vaccination and which disappear quickly and spontaneously without any suites.&nbsp;These reactions are not associated with signs of heart-lung problems.<\/li><\/ul>\n\n\n\n<p>Respiratory arrest (&nbsp;apnea&nbsp;) in premature babies (born in or before the 28th week of pregnancy).<br><\/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.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Act-HIB<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.<\/p>\n\n\n\n<p>The vaccine must be used immediately after&nbsp;reconstitution.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton after \u201cEXP\u201d or \u201cEXP\u201d<\/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<p><strong>1 reconstituted&nbsp;dose&nbsp;(0.5 ml) contains:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is<em>&nbsp;Haemophilus influenzae&nbsp;type b polysaccharide (polyribosyl ribitol phosphate) 10 micrograms conjugated to tetanus protein, 24 micrograms.<\/em><\/li><li><em>The other ingredients are<\/em> tromethanol, sucrose, concentrated&nbsp;hydrochloric acid(for&nbsp;pH&nbsp;adjustment), sodium chloride solution, water for injections.<\/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>Powder and solvent for solution for&nbsp;injection.<\/p>\n\n\n\n<p>White powder in a&nbsp;vial&nbsp;and a clear and colorless&nbsp;diluent&nbsp;in a&nbsp;syringe.<\/p>\n\n\n\n<p>Powder for&nbsp;vial&nbsp;(type \u2011 1 glass) with stopper (chlorobutyl) and 0.5 ml suspension solution in a pre-filled disposable syringe (type \u2011 1 glass) with a plunger stopper (halobutyl) with or without the needle in pack sizes of 1 or 10 doses.<\/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><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Sanofi Pasteur Europe<\/p>\n\n\n\n<p>14 Henry Vall\u00e9e Space<\/p>\n\n\n\n<p>69007 Lyon<\/p>\n\n\n\n<p>France<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Sanofi Pasteur<\/p>\n\n\n\n<p>1541 Avenue Marcel M\u00e9rieux<\/p>\n\n\n\n<p>69280 Marcy l&#8217;Etoile, Lyon<\/p>\n\n\n\n<p>France<br><\/p>\n\n\n\n<p><strong>Local representative:<\/strong><\/p>\n\n\n\n<p>Sanofi AB<\/p>\n\n\n\n<p>Box 30052<\/p>\n\n\n\n<p>104 25 Stockholm<\/p>\n\n\n\n<p>Tel: +46 8-634 50 00<br><\/p>\n\n\n\n<p>This leaflet was last modified on 11\/16\/2020.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The following information is intended for healthcare professionals only:<\/h2>\n\n\n\n<p>In accordance with the immunization programs for children, the recommendations of the WHO (World Health Organization) and ACIP (Advisory Committee on Immunization Practices) administered Act-HIB is rarely alone but is often given at the same time as, or combined with other vaccines, such as vaccines against&nbsp;diphtheria-tetanus&nbsp;(lockjaw ) -pertussis).&nbsp;The side effects&nbsp;of Act-HIB reflect this concomitant use<\/p>\n\n\n\n<p><em>To think about before and during vaccination<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Vaccination should be postponed in case of fever or&nbsp;acute&nbsp;febrile illness.<\/li><li>Do not give as an intravascular injection: make sure that the needle does not penetrate any blood vessels.<\/li><li>As with all injectable vaccines, the vaccine must be administered with caution to patients with&nbsp;thrombocytopenia&nbsp;or hemorrhagic disease, as bleeding may occur during&nbsp;intramuscular&nbsp;administration&nbsp;to these patients.<\/li><li>Before any biological product is injected, the person in charge of&nbsp;administration must&nbsp;take all known precautions to prevent an&nbsp;allergic reaction&nbsp;or a reaction of any other type.&nbsp;As with all injectable vaccines, appropriate medical treatment and monitoring should always be readily available in the event of a rare&nbsp;anaphylactic reaction&nbsp;following vaccination.<\/li><li>Any unused product or waste material should be disposed of in accordance with local requirements.<\/li><\/ul>\n\n\n\n<p><em>Reconstitution<\/em><\/p>\n\n\n\n<p>Reconstitute the vaccine by injecting the contents of the supplied disposable syringe with&nbsp;diluent&nbsp;(0.5 ml) into the powder vial and shaking vigorously until the powder is completely dissolved.&nbsp;The vaccine is then drawn into the disposable syringe and injected.&nbsp;Shake again just before&nbsp;injecting&nbsp;one.<br><\/p>\n\n\n\n<p>Use the product immediately after reconstitution.<br><\/p>\n\n\n\n<p>After reconstitution, the vaccine is clear and colorless.<\/p>\n\n\n\n<p>Act-HIB can be given in the same&nbsp;syringe&nbsp;as the inactivated polio vaccine.&nbsp;Act-HIB can be given at the same time as other vaccines.&nbsp;In such cases, separate syringes and injection sites must be used.<\/p>\n\n\n\n<p><em>Administration<\/em><\/p>\n\n\n\n<p>The reconstituted vaccine should preferably be administered&nbsp;intramuscularly, although it may also be given&nbsp;subcutaneously.<\/p>\n\n\n\n<p>The recommended site of administration in infants is the anterolateral part of the thigh and in children the deltoid region.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Act-HIB Haemophilus influenzae type b, the conjugate vaccine is a bacterial vaccine used to prevent infection caused by Haemophilus influenzae type b (such as meningitis, blood poisoning, cellulite, joint inflammation, laryngitis, pneumonia, bone rot from 2 months of age).<\/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":[2201,2200],"tags":[11777,11780,11781,11775,11771,11774,11776,11782,11779,11773,11778,11772],"class_list":["post-4696","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-act-hib","tag-act-hib-injection","tag-benefits-of-act-hib","tag-benefits-of-haemophilus-influenzae-type-b-polysaccharide","tag-haemophilus-influenzae-type-b-polysaccharide","tag-haemophilus-influenzae-type-b-polysaccharide-injection","tag-haemophilus-influenzae-type-b-polysaccharide-side-effects","tag-side-effects-of-act-hib","tag-what-act-hib-is-used-for","tag-what-haemophilus-influenzae-type-b-polysaccharide-is-used-for","tag-what-is-act-hib","tag-what-is-haemophilus-influenzae-type-b-polysaccharide"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4696","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=4696"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4696\/revisions"}],"predecessor-version":[{"id":13149,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4696\/revisions\/13149"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=4696"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=4696"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=4696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}