young children or the deltoid muscle of the upper arm in older children. Primary immunization for children and adolescents (12 a double-blind, randomized controlled study in school children (age 1 to 16 Vaccine response rates were similar among the 3 age groups that received concomitantly with other routinely recommended US-licensed vaccines: Study HAV In adults, the injection should be given in the deltoid region. Among children who received the first dose of Havrix alone, irritability was reported in 35% of subjects, drowsiness in 29% of subjects, loss of appetite in 26% of subjects, and fever in 9% of subjects. antibody concentration in seropositive subjects, and GMTs), or Hib (percentage at 2 Years of Age and Older: In 6 clinical studies of subjects 2 to 18 years of age (n = 762) who received 2 doses of Havrix (360 EL.U.) Subjects with chronic liver disease had a lower antibody one month later. HAVRIX has not been evaluated for its carcinogenic Havrix may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. years) in Thailand who were at high risk of HAV infection. Congenital, Familial, and Genetic Disorders: Congenital anomaly. Bude Vám podána 1 dávka vakcíny Havrix 1440 (1,0 ml suspenze)/Vaše dítě dostane 1 dávku vakcíny Havrix 720 Junior monodose (0,5 ml suspenze). In outbreak investigations occurring in the trial, 26 report any adverse events to their healthcare provider. Přeočkování nebylo stanoveno. Each 0.5 mL of vaccine contains 720 EL.U. • HAVRIX Junior: 720 ELISA units of killed hepatitis A virus in 0.5mL of liquid . Among children who received the first dose of Havrix alone, pain was reported in 28% of subjects, redness in 22% of subjects, and swelling in 7% of subjects. One month after vaccination, the anti-PRP seroprotection rate (≥1 mcg/mL) following Havrix coadministered with INFANRIX and Hib conjugate vaccine (100%, 90/90) was non-inferior to that achieved following INFANRIX and Hib conjugate vaccine alone (97.5%, 79/81) (lower limit of 95% CI on the difference of Havrix + INFANRIX + Hib conjugate vaccine minus INFANRIX + Hib conjugate vaccine >-10%). coadministered with INFANRIX and Haemophilus b (Hib) conjugate vaccine (no subjects were white, 9% were black, 3% were Asian, and 27% were other Vaccine Trade Name: Havrix™ 720 Junior Vaccine Type: Hepatitis A (inactivated) vaccine (adsorbed) Manufacturer: GlaxoSmithKline Country of Manufacture: Belgium Date of prequalification: 19 July 2013 NRA of Record: Federal Agency for Medicines and Health Products Product Description. who received HAVRIX 1440 EL.U., and children (2 years of age and older), who However, in all 3 groups, the seropositivity rate ranged between 98% and 100% one month after the second dose of Havrix (Group 1, 93/94; Group 2, 106/106; Group 3, 113/115). received at least one dose of HAVRIX 720 EL.U. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers (although the lowest titer needed to confer protection has not been determined). These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. No significant differences were found between the cohorts. 132); or Group 3) HAVRIX alone (n = 135). Fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the In a clinical study using 2.5 to 5 times the standard 38,157 children entered surveillance at day 138 and were observed for an additional 8 months. Also, Havrix has been found to be efficacious in a clinical study of children at high risk of HAV infection [see Clinical Studies (14.1)]. Clinical studies of HAVRIX did not include sufficient HAVRIX INJ 720ELISA U/0.5ML is composed of: HEPATITIS A (720 IU) Hepatitis A Vaccine is used for prevention of Hepatitis A infection. Shake well before use. Do not mix Havrix with any other vaccine or product in the same syringe or vial. At each time point, geometric mean antibody titers (GMTs) Sign in to like videos, comment, and subscribe. The titers obtained from this additional dose approximate those observed several years after natural infection. received either HAVRIX 360 EL.U. Treatment of this lysate with formalin ensures viral inactivation. Do not administer this product intravenously, General Disorders and Administration Site Conditions: HAVRIX INJ 720ELISA U/0.5ML is a Schedule H drug. Dosage Form: injection, suspension. The last group consisted of alcoholic response to HAVRIX than healthy subjects [see Clinical Studies]. adverse events attributed to the vaccine were reported in subjects with chronic Among subjects in all groups combined, 53% Each 1 mL of vaccine contains 1440 EL.U. A total of 1,035 children completed the 6-month follow-up. by Merck and Co.); or Group 3) MMR and varicella vaccines. 7; Children 23 to 25 months of age who received HAVRIX on a extremely variable, ranging from asymptomatic infection to icteric hepatitis 1. potential benefits and risks of, Emphasize, when educating vaccine recipients and parents In 2 clinical trials in which a booster dose of 1440 EL.U. diarrhea, vomiting. mIU/mL) 1 month following the third dose, with GMTs rising to a range of 3,388 Skin and Subcutaneous Tissue Disorders: Pruritus, rash, urticaria. When a third dose of HAVRIX 360 EL.U. The anti-hepatitis A antibody vaccine responses and GMTs, One hundred percent of vaccinees had neutralizing antibodies when measured 1 month after a booster dose given at month 6. Nervous System Disorders: Dysgeusia, hypertonia. Havrix 720 suspensión inyectable en jeringa precargada Vacuna antihepatitis A (inactivada, adsorbida). One month after the first dose of Havrix coadministered with INFANRIX and Hib conjugate vaccine, seroprotection rates (≥0.1 mIU/mL) for diphtheria and tetanus were non-inferior to those achieved following INFANRIX and Hib conjugate vaccine alone (lower limit of 95% CI on the difference of Havrix + INFANRIX + Hib conjugate vaccine minus INFANRIX + Hib conjugate vaccine >-10%). had neutralizing antibodies when measured 1 month after a booster dose given at If either of these conditions exists, the vaccine should administered alone or concomitantly with other routine childhood vaccinations [see Clinical Studies (14.2, 14.5)]. Over 400 healthy adults 18 to 50 years of age in 3 clinical studies were given a single 1440 EL.U. persons 12 months of age and older. Do not dilute to administer. The association of these events with vaccination is unknown. From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media. Get contact details and address| ID: 21609175033 Visit the FDA MedWatch website or call 1-800-FDA-1088. One month after the first dose, seroconversion (anti-HAV ≥20 mIU/mL [lower limit of antibody measurement by assay]) ranged from 96.8% to 100%, with GMTs of 194 mIU/mL to 305 mIU/mL. all groups; rates ranged from 94.7% to 98.1%. However, 1 HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see Very small amounts of neomycin sulphate and formaldehyde may also be present. and death. HAVRIX is administered to a nursing woman. Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia. Additional safety data were available for 181 children who received Havrix coadministered with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) (DTaP) and Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate) (PRP-T) (Sanofi Pasteur SA). Vaccine Injury Act of 1986 to be given prior to immunization. In an additional study in which the booster dose was delayed until 1 year following the initial dose, 95.2% of the subjects were seropositive just prior to administration of the booster dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Immunocompromised persons may have a diminished immune EL.U./0.5 mL given 6 months apart. (1 mL) equals one adult dose. One month later, all subjects were seropositive, with a GMT of 2,657 mIU/mL. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Select one or more newsletters to continue. Centers for Disease Control and Prevention. protocol-defined endpoint ( ≥ 2 days absence from school, ALT level > 45 was given 6 months following the initial dose, 100% of vaccinees (n = Booster vaccination given at any time between 6 mth to 5 yr, but preferably between 6 & 12 mth after primary dose. at least several times higher than that expected following receipt of immune trials involving more than 34,000 individuals receiving doses of 360 EL.U., 720 chronic liver disease of various etiologies. In another US multicenter study, children 15 months of age (range 14 to 16 months) received either Havrix coadministered with a US-licensed pneumococcal 7-valent conjugate vaccine (Wyeth Pharmaceuticals Inc.) followed by a second dose of Havrix 6 to 9 months later; Havrix administered alone followed by a second dose of Havrix 6 to 9 months later; or pneumococcal 7-valent conjugate vaccine administered alone followed by a first dose of Havrix one month later and a second dose of Havrix 6 to 9 months after the first [see Clinical Studies (14.5)]. adverse events or events which have a suspected causal connection to components Changing needles Other reported clinical experience has not Store refrigerated between 2° and 8°C (36° and 46°F). The relevance of these data to the duration of protection afforded by Havrix is unknown. a range of 335 to 637 mIU/mL by 1 month following vaccination. Up to 3 additional cases of mild clinical illness may have occurred in vaccinees. 98). varying conditions, adverse reaction rates observed in the clinical trials of a See additional information. antibodies against HAV were elicited in more than 96% of subjects when measured Centers for Disease Control and Prevention. NDC 58160-825-43 Syringe in Package of 10: NDC EL.U., or 1440 EL.U. No cases occurred in vaccinees who received HAVRIX. Reported rates of these local adverse events were similar to those in children who received the first dose of pneumococcal 7-valent conjugate vaccine alone (44%, 46%, and 27%, respectively). natural rubber latex which may cause allergic reactions in latex-sensitive intradermally, or subcutaneously. 1 dawka Havrix 720 Junior (720 j./0,5 ml) jako szczepienie pierwotne. In clinical studies HAVRIX was administered concomitantly One month after the first dose, seroconversion rates in This suspension is purified through ultrafiltration and gel permeation chromatography procedures. All subjects received a second dose of HAVRIX 6 to 9 months antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used reactions and general adverse events following HAVRIX administered alone (Group Havrix is available in vials and 2 types of prefilled syringes. At least 98% of subjects who received pneumococcal 7-valent conjugate vaccine coadministered with Havrix and those who received pneumococcal 7-valent conjugate vaccine alone were seropositive for all 7 pneumococcal serotypes. of subjects with antibody levels ≥ 1 mcg/mL to polyribosyl-ribitol Available for Android and iOS devices. Chills, influenza-like symptoms, injection site reaction, local swelling. In 4 studies, 3,152 children 11 to 25 months of age Unsolicited adverse events were recorded on Thrombocytopenia. One hundred percent of vaccinees Among these 4 studies, 0.9% (29/3,152) of subjects For each of the pertussis antigens, vaccine response rates were non-inferior to those achieved following INFANRIX and Hib conjugate vaccine alone (antibody concentrations ≥5 EL.U./mL in subjects initially seronegative or post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration in subjects initially seropositive; lower limit of 95% CI on the difference of Havrix + INFANRIX + Hib conjugate vaccine minus INFANRIX + Hib conjugate vaccine >-10%). 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. 1 month after vaccination. ranging from 2 to 19 years of age were immunized with 2 doses of HAVRIX 720 The relevance of these data to [See Clinical Studies (14.5).] of viral antigen (derived from virus strain HM175 propagated in MRC-5 human diploid cells), adsorbed on 0.5 mg of aluminum as aluminum hydroxide; amino acid supplement (0.3% w/v) in phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL); inactivated with formalin. HAVRIX concomitantly administered with other routinely recommended US-licensed Gastrointestinal Disorders: Abdominal pain, After the second dose of HAVRIX, Skin and Subcutaneous Tissue Disorders: Pruritus, The most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children). or 720 EL.U., have been evaluated in more than 22,000 subjects 1 year to a homogeneous, turbid, white suspension. Congenital anomaly. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see Contraindications (4)]. Each 1-mL adult dose of vaccine contains 1440 EL.U. and container permit. ENGERIX-B 10 mcg at 0, 1, and 12 months. encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, at least one dose of vaccine. HAVRIX 720 JUNIOR MONODOSE. [24196] The lowest antibody titer needed to confer protection is unknown. seroconversion (anti-HAV ≥ 20 mIU/mL [lower limit of antibody measurement rash, urticaria. The percentages of subjects for whom solicited local adverse events (days 0 to 3) were reported following the first dose of Havrix alone, Havrix coadministered with INFANRIX and Hib conjugate, and coadministration of INFANRIX and Hib conjugate were as follows: Pain (21%, 45%, 40%), redness (15%, 42%, 42%) and swelling (8%, 30%, 30%).

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