haemophiliacs), this vaccine may be administered by deep subcutaneous injection as per local guidance. HAVRIX is a formaldehyde-inactivated hepatitis A virus vaccine. Havrix Junior Monodose. This vaccine confers protection against hepatitis A within two to four weeks. The use of this vaccine may be considered during pregnancy, if necessary. 2. Havrix is a brand name drug used as a vaccine to prevent Hepatitis A. Distributed In New Zealand by: GlaxoSmithKline NZ Ltd. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart. Popis HAVRIX 720 Junior monodose sus inj 720 E.U. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Data available after 17 years allow prediction that at least 95% and 90% of subjects will remain seropositive (>15 mIU/ml) 30 and 40 years after vaccination, respectively. Havrix™ 720 Junior. Vaccin inactivé de l'hépatite A adsorbé Vaccin inactivé de l'hépatite A adsorbé Havrix 1440u/1ml adulte susp inj ser 1 P Prix … Havrix has been linked to reports of severe side effects like … • In Panama, a retrospective database study showed a 90% reduction in reported hepatitis A incidence in the vaccinated population, and 87% in the general population, 3 years after implementation of the vaccination programme. HAVRIX JUNIOR, 720UI, VACCIN Description. By continuing to browse the site you are agreeing to our policy on the use of cookies. 980 Great West Road, Brentford, Middlesex TW8 9GS, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK. Virusul este cultivat pe celule diploide umane MRC5. Hepatitis A virus causes an infection of the liver. 720 JuniorHavrix™ according to the age of the vaccinee). Same active ingredients; Same company; Bookmark; Email; SmPC; Patient Leaflet; Live Chat; Last updated on emc: 20 Nov 2020. The 2021–22 ISU Junior Grand Prix will be the 25th season of a series of junior international competitions organized by the International Skating Union.It will be the junior-level complement to the 2021–22 ISU Grand Prix of Figure Skating.Skaters will compete for medals in the disciplines of men's singles, ladies' singles, pair skating, and ice dance, as well as for qualifying points. Immunization guideline: Children and adolescents from 1 year up to and including 18 years of age should receive a single dose of HAVRIX 720 Junior (0.5 mL suspension) for ... Read more Havrix 720 Junior In order to obtain more persistent immunity, for at least 10 years, a booster dose is recommended between 6 and 12 months after primary immunisation. Havrix Junior Monodose vaccine may contain traces of neomycin B sulfate, which is used during the manufacturing process (see section 4.3). By continuing to browse the site you are agreeing to our policy on the use of cookies. monovalent and combination vaccines … GlaxoSmithKline UK contact details. Présentation: Boîte de 1 seringue préremplie: Distributeur ou fabriquant: GSK MAROC ... Vaccin: Statut: Commercialisé: Code ATC: J07A3: PPV: 186.90 dhs: Prix … NDC 58160-826-01 Vial in Package of 10: NDC 58160-826-11 NDC 58160-826-05 … It stimulates the body to … total of 3193 doses of HAVRIX Junior 720 and 7131 doses of HAVRIX 1440 was administered in clinical studies. POM: Prescription only medicine. 3. 2. Start typing to retrieve search suggestions. Distributor . A vaccine coverage of 80% led to termination of the outbreaks. The vaccine should never be administered intravascularly. 5. Ce produit est un vaccin permettant de développer une immunité contre l'hépatite A. Il produit son plein effet après quelques semaines, mais on ne sent normalement pas son action. Havrix Junior Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine. For the full list of excipients, see section 6.1. Havrix (GSK); 3. Continue. This provides anti-HAV antibodies for at least one year. Persistence of the immune response. In the event of a subject being exposed to a high risk of contracting hepatitis A within two weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites. Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to neomycin (present at traces). Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX is available in single-dose vials and prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation): 720 EL.U./0.5 mL. This information is intended for use by health professionals, suspension for injection in a pre-filled syringe, Hepatitis A (inactivated) vaccine (adsorbed), 1 Produced on human diploid (MRC-5) cells, 2Adsorbed on aluminium hydroxide, hydrated. Immunosuppressed patients or those with chronic liver disease planning to depart in less than 2 weeks should receive an initial dose of the vaccine plus immune globulin 0.02 mL/kg at a different injection site. Le vaccin ne protège pas contre l'infection … 1 Produced on human diploid (MRC-5) cells . Continue typing to refine. The New York Times Archives. Havrix® is indicated for active immunization against disease caused by hepatitis A virus (HAV) for persons equal to or older than 12 months of age. Do not administer if it appears otherwise. To email a medicine you must sign up and log in. Our coupons never expire and are … Žiadna zo zložiek očkovacej látky nie je infekčná. This site uses cookies. Back to top. NDC 58160-825-01 Vial in Package of 10: NDC 58160-825-11 NDC 58160-825-43 Syringe in Package of 10: NDC 58160-825-52. Hepatitis A Vaccine (inactivated, adsorbed) Havrix Junior Monodose summary of product characteristics. By intramuscular injection. Data from the National Surveillance also showed a 95% reduction in hepatitis A incidence as compared to the pre-vaccination era. Grand Prix New York Racing (GPNY) is the only large indoor racing, social entertainment, and corporate event venue in the New York City-metro area. Long term persistence of hepatitis A antibody titres has been evaluated following 2 doses of Havrix given 6 to 12 months apart to healthy immunocompetent subjects aged 17 to 40 years . HAVRIX is approved for use in persons 12 months of age and older. This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way. Is there anything wrong with this page? Continue, 2. • HAVRIX Junior: 720 ELISA units of killed hepatitis A virus in 0.5mL of liquid . Booster vaccination delayed up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval. How to use this medication. When suggestions are available use up and down arrows to review and ENTER to select. Patient information: Important information for patients. What side effects are possible with this medication? We would like to show you a description here but the site won’t allow us. The vaccine is available in packs of 1 or 10 pre-filled syringes. HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus . Des vaccins combinés HAHB ainsi que HA-Typh-Isont dispo… To email a medicine you must sign up and log in. Section 5.1 Updated to add data on the Havrix UMV experience in Israel and Panama. Date of Preparation: 13 December 2007, Version 1.0 . Last updated: 4 June 2018. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Havrix confers immunisation against HAV by stimulating specific immune responses evidenced by the induction of antibodies against HAV. When concomitant administration is considered necessary the vaccines must be given at different injection sites. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Havrix Junior is indicated in subjects aged 2 to 15 years … To view the changes to a medicine you must sign up and log in. View changes; Print PDF; What is a Patient … 4. Who should NOT take this medication? How Havrix Junior Monodose works • The virus is not alive so this vaccine cannot cause hepatitis A infection. You can catch the virus by eating or drinking contaminated food or water. Inactive ingredients in the vaccine are: aluminium hydroxide, polysorbate 20, amino acids for injection, phosphate … 2. Havrix Junior Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine. General information on hepatitis A. Players 18 and under, of any skill level, are welcome to play. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Havrix is indicated for active immunisation against hepatitis A virus (HAV) infection in susceptible subjects at risk of exposure to HAV. HAVRIX JUNIOR: 720 EU/0.5 mL inactivated hepatitis A virus (HM 175 hepatitis A virus strain) vaccine, suspension for injection. Avaxim (Sanofi Pasteur); 2. You … The most common side effect is soreness and pain where the shot was given. 7. HAVRIX JUNIOR is indicated in subjects aged … Prix de HAVRIX 1440 U/1 ml ADULTES, suspension injectable en seringue pré-remplie. It is important that procedures are in place to avoid injury from faints. A reduction in the incidence of hepatitis A was observed in countries where a two-dose Havrix immunization programme was implemented for children in their second year of life: • In Israel, a retrospective database study showed up to 95 % reduction in hepatitis A incidence in the general population 8 years after the implementation of the vaccination program. 2 2 DOSAGE AND ADMINISTRATION 2.1 Preparation for Administration Shake well before use. IM Havrix 1440 Adult Adult ≥19 yr Primary immunization: 1 mL single dose.Havrix 720 Junior Childn & adolescent 1-18 yr Primary immunization: 0.5 mL single dose. If either of these conditions exists, the vaccine should not be administered. Initially 1 mL for 1 dose, then 1 mL after 6–12 months, dose given as booster; booster dose may be delayed by up to 3 years if not given after recommended interval following primary dose, the deltoid region is the preferred site of injection; not to be injected into the gluteal region. Twitter; Facebook; Email; Who's responsible for the Handbook. Lyfjaform: Stungulyf í vöðva. Neutral glass vials (type 1, PhEur) with grey butyl rubber stoppers and aluminium overcaps fitted with flip-off tops. Il doit être administré par un professionnel de la santé. To bookmark a medicine you must sign up and log in. 92% of tested recipients developed measurable anti-HAV responses. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. Centrally located in … 1x0,5 ml: Očkovacia látka sa používa na ochranu pred hepatitídou A. Očkovacia látka účinkuje tým, že jej pôsobením si telo vytvára vlastnú ochranu (protilátky) pred týmto ochorením. For Child 16–17 years. In areas of low prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in the following subjects: Travellers : Persons travelling to areas of intermediate or high endemicity for hepatitis A. HAVRIX Junior - monodose vials in packs of 1 and 10 and prefilled syringes in packs of 1 . Havrix Junior Monodose Vaccine - Patient Information Leaflet (PIL) by GlaxoSmithKline UK Trouver un équivalent. HAVRIX 720 JUNIOR, Vaccin. The observed reduction in hepatitis A incidence in the general population (vaccinated and non-vaccinated) in both countries are consistent with herd immunity. It is used to boost the body’s immune system to help protect against hepatitis A infection in children and adolescents from 1 year up to and including 15 years of age. HAVRIX JUNIOR is indicated in subjects aged 2 to 15 years and HAVRIX 1440 is indicated in subjects aged older than 15 years. Havrix (720) (Hepatitis A Vaccine) Drug Price and Information Havrix (720) is a vaccine given to individuals over 2 years of age to prevent hepatitis A infection. A total of 3971 doses of HAVRIX was administered concomitantly with ENGERIX B to 2064 adult subjects. In clinical trials, virtually all vaccinees were seropositive one month after the booster dose. IM Primary immunisation Adult ≥19 yr Havrix 1440 Adult 1 mL single dose in deltoid area.Childn & adolescent 1-18 yr Havrix 720 Junior 0.5 mL single dose in deltoid area (in the antero-lateral part of the thigh in young childn).Booster vaccination After primary vaccination w/ Havrix 1440 Adult or Havrix 720 Junior… Primary … It is written for patients and gives information about taking or using a medicine. chaque dose de , ml contient unités elisa de virus de l'hépatite a inactivés par havrix junior: le vaccin de l'hépatite a appartient à la … Immunisation should be postponed in subjects suffering from an acute severe febrile illness. receiving HAVRIX 720 Junior (N=324) or HAVRIX 720 Junior plus measles-mumps-rubella (MMR) plus varicella vaccines (N=462) or MMR plus varicella plus HAVRIX 720 Junior (N=455), the primary analysis of safety (N=1,241) demonstrated that all the three vaccines, HAVRIX… Very small amounts of neomycin sulfate and formaldehyde may also be present. HAVRIX should be administered by intramuscular injectio… Patient Information leaflet (PIL) 18-12-2020. hepatitis a vaccine; Legal Category. Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course (see section 5.1). 0.5 ml of suspension in prefilled syringe or vial (type I glass) with a plunger stopper (rubber butyl) with or without needles - pack size of 1 or 10. Havrix Junior. Havrix Junior Monodose is a vaccine containing the hepatitis A virus. What will it do for me? Summary of Product characteristics (SPC) 30-06-2018. What other drugs could interact with this medication? 4. Who should NOT take this medication? Allergic reactions including anaphylactoid reactions and mimicking serum sickness, Headache (common with Havrix Junior Monodose formulation), Gastrointestinal symptoms* (rare with Havrix Junior Monodose formulation#), Diarrhoea (uncommon with Havrix Junior Monodose formulation), Transient increase in liver function tests, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Fatigue* (rare with Havrix Junior Monodose formulation#), Injection site reaction, such as swelling or induration (uncommon with Havrix Junior Monodose formulation). Immunization guideline: Children and adolescents from 1 year up to and including 18 years of age should receive a single dose of HAVRIX 720 Junior (0.5 mL suspension) for ... Read more Havrix 720 Junior Share this. Dostanete 1 dávku očkovacej látky HAVRIX 1440 Dosis adulta (1,0 ml suspenzia) alebo vaše dieťa dostane 1 dávku očkovacej látky HAVRIX 720 Junior monodose (0,5 ml suspenzia). The vaccine should not be administered subcutaneously/intradermally since administration by these routes may result in a less than optimal anti-HAV antibody response. Hepatitis A Vaccine (inactivated, adsorbed) Havrix Junior Monodose summary of product characteristics. To bookmark a medicine you must sign up and log in. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Buy It Now. Active ingredient. Havrix Junior Monodose patient information leaflet. Adverse events reported following overdosage were similar to those reported with normal vaccine administration. Store in the original package in order to protect from light. 1x0,5 ml: Očkovacia látka sa používa na ochranu pred hepatitídou A. Očkovacia látka účinkuje tým, že jej pôsobením si telo … Notkun á lyfi. There are no or limited amount of data from the use of this vaccine in pregnant women. Even though you may not feel its effects, this medication takes effect after a few weeks. Venjulegar skammtastærðir: 1 skammtur gefinn 2svar sinnum, sá seinni 6-12 mánuðum eftir fyrri skammtinn til þess að tryggja langtímavörn. Current data do not support the need for further booster vaccination among immunocompetent subjects after a 2 dose vaccination course. Active immunisation against HAV infection from 1 year up to and including 15 years of age. Pharmaco-therapeutic group: Hepatitis A vaccine, ATC code J07BC02. 1. 2. •HAVRIX Junior: 720 ELISA units of killed hepatitis A virus in 0.5mL of liquid Inactive ingredients in the vaccine are: aluminium hydroxide, polysorbate 20, amino acids for injection, phosphate salts, sodium chloride, and water. monovalent and combination vaccines comprised of measles, mumps, rubella and varicella). In one study, vaccine coverage in excess of 80% was followed by termination of the outbreak within 4 to 8 weeks. When suggestions are available use up and down arrows to review and ENTER to select. What will it do for me? Animal studies are insufficient with respect to reproductive toxicity. HAVRIX is a formaldehyde-inactivated hepatitis A virus vaccine. Médicament Havrix nourrissons et enfants 720 u/0,5 ml : action et effets thérapeutiques, prix, taux de remboursement Sécu, condition de prescription, contre-indications, posologie, … In the event of a subject being exposed to a high risk of contracting hepatitis A within two weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites. With thorough agitation, HAVRIX … Section 4.8: Simplification with no changes to the clinical information. Ce vaccin est indiqué pour l'immunisation active contre l'infection provoquée par le virus de l'hépatite A chez les adultes de plus de 15 ans. It is not known whether Havrix Junior Monodose will prevent hepatitis A in such cases. You are now leaving GSK’s website. Trois vaccins inactivés contre l’hépatite Asont distribués au Canada : 1. This vaccine is administered for active immunization against contagious liver disease, caused by a virus called Hepatovirus (HAV). To view the changes to a medicine you must sign up and log in. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart. Havrix Junior - - - Havrix Is Indicated For Active Immunisation Against Hav Infection In Subjects At Risk Of Exposure To Hav. or . Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. Go back. Havrix Will Not Prevent Hepatitis Infection Caused By Other Agents Such As Hepatitis B Virus, Hepatitis C Virus, Hepatitis E Virus Or Other Booster vaccination After primary vaccination w/ Havrix 1440 Adult or Havrix 720 Junior, a booster dose should be given between 6 mth & 5 yr, but preferably between 6 & 12 mth after primary dose. 1440 EL.U./mL. The safety profile presented below is based on data from more than 5300 subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance. Havrix ® 1440 is approved for use for adolescents from 16 years of age and adults. Swelling at the site of injection was the next most frequently reported reactions. The vaccine should not be administered in the gluteal region. This vaccine is administered for active immunization against contagious liver disease, caused by a virus called Hepatovirus (HAV). Section 4.5: Updated to clarify the list of vaccines that can be co-administered with Havrix Monodose and Havrix Junior Monodose vaccines (i.e. These data are intended to guide healthcare professionals in case of temporary temperature excursion only. 3. The most frequently reported reactions are pain and redness at site of injection (Havrix Monodose has reports in over 50% of doses, Havrix Junior Monodose has reports in 18.2% of doses overall). How does this medication work? Last reviewed: 4 June 2018. 6. No studies of the effects of Havrix Junior Monodose on the ability to drive and use machines have been performed. Before use, the vaccine should be well shaken to obtain a slightly opaque white suspension. The vaccine is particularly indicated for those at increased risk of infection or transmission. HAVRIX is approved for use in persons 12 months of age and older. Date of first authorisation/renewal of the authorisation. Vaqta (Merck). In areas of low prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in the following subjects: Travellers : Persons travelling to areas of intermediate or high endemicity for hepatitis A. To prolong the protective effect, a single booster dose of HAVRIX JUNIOR is recommended at any time … Il s’agit de vaccins préparés à partir du VHAcultivé sur cellules diploïdes humaines et inactivé par le formaldéhyde. Discard the vaccine if the content appears otherwise. The vaccine should be injected intramuscularly in the deltoid region or into the antero-lateral part of the thigh in young children. In subjects with a bleeding disorder who are at risk of haemorrhage following intramuscular injection (e.g. This product is a vaccine that will help you develop an immunity to hepatitis A. HAVRIX JUNIOR is indicated in subjects aged 2 to 15 years and HAVRIX 1440 is indicated in subjects aged older than 15 years. This link will take you to a non-GSK website. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. It is unknown whether this vaccine is excreted in human milk. How does this medication work? Preliminary data on the concomitant administration of Havrix, at a dose of 720 ELISA units/ml, with recombinant hepatitis B virus vaccine suggests that there is no interference in the immune response to either antigen. Ph: (09) 367 2900 . Page history. What form(s) does this medication come in? This site uses cookies. Adults at least 40 years, immunosuppressed patients, or those with chronic liver disease planning to … Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Il est important de noter que les unités utilisées pour quantifier la teneur en antigène viral de chaque vaccin sont différentes et ne peuvent être comparées entre elles. Havrix Junior Monodose Vaccine Malta - English - Medicines Authority. Fax (09) 367 2910 . GSK does not recommend, endorse or accept liability for sites controlled by third-parties. receiving HAVRIX 720 Junior (N=324) or HAVRIX 720 Junior plus measles-mumps-rubella (MMR) plus varicella vaccines (N=462) or MMR plus varicella plus HAVRIX 720 Junior (N=455), the primary analysis of safety (N=1,241) demonstrated that all the three vaccines, HAVRIX, MMR and varicella, whether co-administered or administered alone, were well tolerated. Continue. (striek.) ATAGI; NHMRC; Chief Medical Officer; Department of Health ; Useful links and tools. This medication must be administered by a health professional. 6. How should I use this medication? What form(s) does this medication come in? The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines. # this adverse reaction was identified through post-marketing surveillance but was not observed in randomised controlled clinical trials. Havrix Junior Monodose can be given concomitantly with monovalent and combination vaccines comprised of measles, mumps, rubella and varicella. Mode d'emploi. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. HAVRIX JUNIOR, 720IU, VACCINE Common uses. Children and Adolescents . Havrix inniheldur dauðar lifrarbólgu A veirur sem eiga að örva líkamann til þess að mynda vörn gegn veirunni án þess að fólk veikist. HAVRIX Vaccines HAVRIX Product information: HAVRIX product monograph. Havrix 720 Junior vaccin hepatic A inactivat si adsorbit, Gsk [5054626300032] Havrix, vaccin hepatitic A, este o suspensie sterila ce contine virusul hepatitic A inactivat cu formaldehida (tulpina de virus hepatitic AHM175), absorbit pe hidroxid de aluminiu. (striek.) Childn & adolescent 1-18 yr Havrix 720 Junior 0.5 mL single dose in deltoid area (in the antero-lateral part of the thigh in young childn). This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. Havrix is an immunization against Hepatitis A. A single 0.5 mL dose of HAVRIX JUNIOR is recommended for primary immunisation. Continue typing to refine. HAVRIX is indicated for active immunisation against hepatitis A virus (HAV) infection in susceptible subjects at risk of exposure to HAV. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK. Cases of overdose have been reported during post-marketing surveillance. What side effects are possible with this medication? The frequency category of rare was estimated from a statistical calculation based on the total number of paediatric patients exposed to Havrix in randomised controlled clinical trials (n=4574). (For division information, see … Tout sur havrix junior 720 u.el ser/0.5ml action et effets thérapeutiques, prix, condition de prescription, contre-indications havrix est indique pour l'immunisation active des personnes qui … Popis HAVRIX 720 Junior monodose sus inj 720 E.U. Primary immunisation consists of a single dose given intramuscularly. Havrix Junior Monodose Vaccine. 7. Downtown Auckland . Method of administration. Havrix 720 Junior vaccin hepatic A inactivat si adsorbit, Gsk [5054626300032] Havrix, vaccin hepatitic A, este o suspensie sterila ce contine virusul hepatitic A inactivat cu formaldehida … You can save on Havrix prices and Havrix alternatives, the Havrix generic being the hepatitis A vaccine, with our Havrix coupon card or Havrix pharmacy coupon. Simultaneous administration of Havrix with normal immunoglobulin does not influence the seroconversion rate to Havrix, however, it may result in a lower antibody titre. Healthcare Professional Information: May 1, 2018 - Important Safety Information for several GlaxoSmithKline Inc. vaccines: Potential Risk of Underdosing Trademarks are owned by or licensed to the GSK group of companies. 1. Tradename: HAVRIX Manufacturer: GlaxoSmithKline Biologicals Indication: For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age … These studies indicated that administration of a single dose of Havrix contributed to termination of the outbreaks. Havrix Junior Monodose. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1.0 mL) of HAVRIX 1440 contains: Hepatitis A virus (inactivated) 1,2 1440 ELISA Units. It allows continued monitoring of the benefit/risk balance of the medicinal product. Private Bag 106600 . Frequencies per dose are defined as follows: Cannot be estimated from the data available, Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness, * refers to adverse reaction reported only for Havrix Monodose (1ml adult dose), ** refers to adverse reactions reported only for Havrix Junior Monodose (0.5ml children's dose).