b MMR = Measles, mumps, and rubella vaccine; V = Varicella vaccine. After the second dose of HAVRIX, there was no evidence for interference with the anti-HAV response in the children who received concomitantly administered vaccines compared with those who received HAVRIX alone. Grade 3: Drowsiness defined as prevented normal daily activities; irritability/fussiness defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as no eating at all. Cargo Insurance. L'efficacité d'HAVRIX a été évaluée au cours de diverses épidémies communautaires (Alaska, Slovaquie, États-Unis, Royaume-Uni, Israël et Italie) durant lesquelles il a été montré que la vaccination avec HAVRIX pouvait contribuer à interrompre ces épidémies. Drug Name : Hepatitis A Vaccine Hepatitis A Vaccine (Havrix) generic Havrix (720) is a vaccine given to individuals over 2 years of age to prevent hepatitis A infection. The GMTs obtained following a single dose of HAVRIX are at least several times higher than that expected following receipt of immune globulin. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. No cases occurred in vaccinees who received HAVRIX. Portail des communes de France : nos coups de coeur sur les routes de France. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received HAVRIX during pregnancy (see Data). Total vaccinated cohort (TVC) = all subjects who received at least 1 dose of vaccine. The safety and effectiveness of HAVRIX, doses of 360 EL.U. HAVRIX may be administered concomitantly with immune globulin. Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, U.S. License No. Si HAVRIX® 720 Junior n’est pas disponible, on peut retirer une dose pédiatrique de 0,5 Ml d’une fiole de HAVRIX® 1440. In 2 clinical trials in which a booster dose of 1440 EL.U. Ce médicament contient du potassium. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Syncope (fainting) can occur in association with administration of injectable vaccines, including HAVRIX. a Within 4 days of vaccination defined as day of vaccination and the next 3 days. CPT Code Description NDCs* ICD-10-CM Code **; Pediatric/ adolescent dose (persons 12 months through 18 years of age): 720 EL.U./0.5 mL Recommended dosing: A single 0.5-mL dose and a 0.5-mL booster dose administered between 6 and 12 months later 90633: HAVRIX is available in single-dose vials and prefilled disposable Tip-Lok ® syringes (packaged without needles) (Preservative Free … Havrix 720 Junior Monodose Vaccine protects against Hepatitis A which is a serious liver disease caused by hepatitis A virus (HAV). Ce vaccin est indiqué pour l'immunisation active contre l'infection provoquée par le virus de l'hépatite A chez les enfants à partir de l'âge de 1 an. Hepatitis A vaccine is a vaccine that prevents hepatitis A. Concomitant Administration with MMR and Varicella Vaccines (Study HAV 231), In a U.S. multicenter study, there was no evidence for interference in the immune response to MMR and varicella vaccines (the percentage of subjects with pre-specified seroconversion/seroresponse levels) administered to subjects aged 15 months concomitantly with HAVRIX relative to the response when MMR and varicella vaccines are administered without HAVRIX. Each 1-mL adult dose of vaccine contains 1440 EL.U. Trademarks are owned by or licensed to the GSK group of companies. Among subjects who received HAVRIX concomitantly with other childhood vaccines, 0.9% (8/909) reported a serious adverse event. Using available testing, these illnesses could neither be proven nor disproven to have been caused by HAV. Among subjects in all groups combined, 53% were male; 69% of subjects were white, 16% were Hispanic, 9% were black, and 6% were other racial/ethnic groups. The titers obtained from this additional dose approximate those observed several years after natural infection. In this U.S. multicenter study, 468 subjects, children aged 15 months were randomized to receive: Group 1) HAVRIX coadministered with INFANRIX and Hib conjugate vaccine (n = 127); Group 2) INFANRIX and Hib conjugate vaccine alone followed by a first dose of HAVRIX 1 month later (n = 132); or Group 3) HAVRIX alone (n = 135). 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. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children. One month later, all subjects were seropositive, with a GMT of 2,657 mIU/mL. HAVRIX is approved for use in persons 12 months of age and older. Remboursement en fonction de l'indication (JO du 15/11/2011) : Les seules indications thérapeutiques ouvrant droit à la prise en charge ou au remboursement par l’assurance maladie estl'immunisation active contre l'infection provoquée par le virus de l'hépatite A. dans les populations suivantes :- patients atteints de mucoviscidose (la prévention des hépatites est essentielle chez ces patients à risque de complications hépatiques) ;- patients atteints d’hépatopathies chroniques actives notamment dues au virus de l’hépatite B et C. Code Identifiant de Spécialité (CIS) : 60152436, Service médical rendu (SMR) : In 6 clinical studies, 762 subjects aged 2 to 18 years received 2 doses of HAVRIX (360 EL.U.) This vaccine is administered for active immunization against contagious liver disease, caused by a virus called Hepatovirus (HAV). Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Select one or more newsletters to continue. HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. HAVRIX720 Junior : 720 unités ELISA par 0,5 mL du virus de l’hépatite A (souche HM175) inactivé par le formaldéhyde. At Month 7, the GMTs ranged from 478 mIU/mL (chronic hepatitis C) to 1,245 mIU/mL (healthy). Cargo insurance covers physical damage to or loss of your goods while being transported by any means of transport, during loading and unloading operations and while in storage. One month following the booster dose at Month 6, all subjects were seropositive, with GMTs ranging from 2,495 mIU/mL to 3,644 mIU/mL. There was no evidence for reduced antibody response to diphtheria and tetanus toxoids (percentage of subjects with antibody levels ≥0.1 mIU/mL to each antigen), pertussis antigens (percentage of subjects with seroresponse, antibody concentrations ≥5 EL.U./mL in seronegative subjects or post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration in seropositive subjects, and GMTs), or Hib (percentage of subjects with antibody levels ≥1 mcg/mL to polyribosyl-ribitol phosphate, PRP) when HAVRIX was administered concomitantly with INFANRIX and Hib conjugate vaccine (Group 1) relative to INFANRIX and Hib conjugate vaccine administered together (Group 2). At each time point, GMTs were lower for subjects with chronic liver disease than for healthy subjects. If either of these conditions exists, the vaccine should not be administered. Human Data: In pre- and post-licensure clinical studies of HAVRIX, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered HAVRIX following their last menstrual period. Specific humoral antibodies against HAV were elicited in more than 96% of subjects when measured 1 month after vaccination. Pharmaceutical form: liquid, ready to use Presentation: 1 dose vial Route of administration: intramuscular 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. Headache was reported by 14% of adults and less than 9% of children. Ce médicament contient du sodium. Of solicited adverse reactions in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (aged 2 years and older), who received either HAVRIX 360 EL.U. Investigations: Creatine phosphokinase increased. For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. In studies in which sera were obtained 2 weeks following the initial dose, seroconversion ranged from 91.6% to 96.1%. Le vaccin contient des virus inactivés de l'hépatite A; ils ne peuvent provoquer la maladie, mais ils stimulent la production d'éléments producteurs (anticorps) de l'organisme contre la maladie. In 3 additional clinical studies (HAV 232, HAV 220, and HAV 231), children received either 2 doses of HAVRIX alone or the first dose of HAVRIX concomitantly administered with other routinely recommended U.S.-licensed vaccines followed by a second dose of HAVRIX. Conditions de prescription et de délivrance : In subjects with chronic liver disease, local injection site reactions with HAVRIX were similar among all 4 groups, and no serious adverse reactions attributed to the vaccine were reported in subjects with chronic liver disease. Poils du bébé : Qu’est-ce que le lanugo ? [See Adverse Reactions (6.1). Up to 3 additional cases of mild clinical illness may have occurred in vaccinees. In a clinical study using 2.5 to 5 times the standard dose of immune globulin (standard dose = 0.02 to 0.06 mL/kg), the GMT in recipients was 146 mIU/mL at 5 days post-administration, 77 mIU/mL at Month 1, and 63 mIU/mL at Month 2. Clinical data reveal Havrix induced an immune response in 97% of those immunized after a single dose of 720 EL.U. The studies included HAV 210 (N = 1,084), HAV 232 (N = 394), Concomitant Administration with Pneumococcal 7-Valent Conjugate Vaccine (Study HAV 220). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. Treatment of this lysate with formalin ensures viral inactivation. La protection contre l'hépatite A est habituellement obtenue au cours du mois qui suit l'injection. [See Adverse Reactions (6.1).]. a Calculated on vaccine responders 1 month post-dose 2. (n = 2,782 in 2- or 3-dose schedule). Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. Inactive ingredients in the vaccine are: aluminium hydroxide, polysorbate 20, amino acids for injection, phosphate salts, sodium chloride, and water. on a 0- and 6-month schedule. 111 talking about this. HAVRIX may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater-than-physiologic doses), may reduce the immune response to HAVRIX. One hundred eighty-nine healthy adults and 220 adults with either chronic hepatitis B (n = 46), chronic hepatitis C (n = 104), or moderate chronic liver disease of other etiology (n = 70) were vaccinated with HAVRIX 1440 EL.U. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. , Sc, Classe pharmacothérapeutique : Hépatite a, virus entier inactivé. Le taux de potassium est inférieur à 1 mmol par dose administrée, c'est-à-dire « sans potassium ». A total of 1,035 children completed the 6-month follow-up. Each 0.5 mL monodose vial or pre-filled syringe contains: 720 ELISA units of inactivated hepatitis A virus (HM175 … When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. among Individuals Aged 2 to 18 Years. Découvrez toute l’actualité sur le Coronavirus heure après heure. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HAVRIX and any potential adverse effects on the breastfed child from HAVRIX or from the underlying maternal condition. Do not administer if it appears otherwise. By Day 15, 80% to 98% of vaccinees had already seroconverted (anti-HAV ≥20 mIU/mL [lower limit of antibody measurement by assay]). The solicited adverse reactions from the 3 additional coadministration studies conducted with HAVRIX were comparable to those from Study HAV 231. Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. Telephone follow-up was conducted 6 months after the last vaccination to inquire about serious adverse events, new onset chronic illnesses, and medically significant events. The safety of HAVRIX has been evaluated in 61 clinical trials involving approximately 37,000 individuals receiving doses of 360 EL.U. A second dose of HAVRIX was administered to all subjects 6 to 9 months after the first dose of HAVRIX. Percentages of subjects with solicited local adverse reactions and general adverse reactions following HAVRIX administered alone (Group 1) or concomitantly with MMR and varicella vaccines (Group 2) are presented in Table 1. The following adverse reactions have been identified during post-approval use of HAVRIX. General Disorders and Administration Site Conditions: Fatigue; fever >99.5°F (37.5°C); induration, redness, and swelling of the injection site; malaise. Infections and Infestations: Pharyngitis, upper respiratory tract infections. Suspension for injection available in the following presentations: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see Description (11)]. ], Immune Response to HAVRIX 360 EL.U. Our vaccines business develops, produces and distributes around 2 million vaccines every day to people across over 160 countries One month after the first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults. administered alone or concomitantly with other routine childhood vaccinations [see Clinical Studies (14.2, 14.5)]. A total of 40,119 children were randomized to be vaccinated with either HAVRIX 360 EL.U. Do not mix HAVRIX with any other vaccine or product in the same syringe or vial. In 1 subject who received INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and Hib conjugate vaccine followed by HAVRIX 6 weeks later, bronchial hyperreactivity and respiratory distress were reported on the day of administration of HAVRIX alone. Patient information: Important information for patients. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Vaccine response = Seroconversion (anti-HAV ≥15 mIU/mL [lower limit of antibody measurement by assay]) in children initially seronegative or at least the maintenance of the pre-vaccination anti-HAV concentration in initially seropositive children. Primary immunization for children and adolescents consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. ], Concomitant Administration with DTaP and Hib Conjugate Vaccine (Study HAV 232). In this prospective, open-label, multicenter study, 1,084 children were administered study vaccine in 1 of 5 groups: (1) Children aged 11 to 13 months who received HAVRIX on a 0- and 6-month schedule; (2) Children aged 15 to 18 months who received HAVRIX on a 0- and 6-month schedule; (3) Children aged 15 to 18 months who received HAVRIX coadministered with INFANRIX and Haemophilus b (Hib) conjugate vaccine (no longer U.S.-licensed) at Month 0 and HAVRIX at Month 6; (4) Children aged 15 to 18 months who received INFANRIX coadministered with Hib conjugate vaccine at Month 0 and HAVRIX at Months 1 and 7; (5) Children aged 23 to 25 months who received HAVRIX on a 0- and 6-month schedule. Serious Adverse Events in Children Aged 11 to 25 Months: hepatitis a vaccine injection, suspension, We comply with the HONcode standard for trustworthy health information -, HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED). The virus (strain HM175) is propagated in MRC-5 human diploid cells. HAVRIX should be administered by intramuscular injection only. General Disorders and Administration Site Conditions: Musculoskeletal and Connective Tissue Disorders: a in Children Aged 15 to 24 Months with HAVRIX Administered Alone or Concomitantly with MMR and Varicella Vaccines (TVC). HAVRIX is available in vials and prefilled syringes. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. Solicited local adverse reactions and general events were recorded by parents/guardians on diary cards for 4 days (Days 0 to 3) after vaccination. It is effective in around 95% of cases and lasts for at least fifteen years and possibly a person's entire life. However, the lowest titer needed to confer protection has not been determined. Of these, 19,037 children received 2 doses of HAVRIX (0 and 1 months) and 19,120 children received 2 doses of control vaccine, ENGERIX-B (0 and 1 months). In these 4 studies, there were 4 reports of seizure within 31 days post-vaccination: these occurred 2, 9, and 27 days following the first dose of HAVRIX administered alone and 12 days following the second dose of HAVRIX. Respiratory, Thoracic, and Mediastinal Disorders. or ENGERIX-B [Hepatitis B Vaccine (Recombinant)] 10 mcg at 0, 1, and 12 months. Available for Android and iOS devices. On l'utilise pour prévenir l'infection causée le virus de l'hépatite A. Hepatitis A virus has a relatively long incubation period (15 to 50 days).

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