Vaksin Havrix

Vaksin Havrix. Havrix 1 mL IM followed by a 1 mL booster dose 6 to 12 months following primary immunization Primary immunization is recommended at least 2 weeks before expected exposure to hepatitis A virus Immune globulin may be administered with the vaccine (at a different injection site) to patients requiring immediate prophylaxis or postexposure prophylaxis Occupation Pharmd BCPS.

HAVRIX 42 days later A second dose of HAVRIX was administered to all subjects 6 to 9 months after the first dose of HAVRIX Solicited local adverse reactions and general events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination File Size 108KBPage Count 14.

Havrix Junior Monodose Vaccine Summary of Product

Hepatitis A vaccine is administered by injection into the muscle of the upper arm Two separate shots of 05 ml for children and 1 ml for adults are required and should be given 6 to 12 months apart (Havrix) or 6 to 18 months apart (Vaqta) Hepatitis A vaccine may be given at the same time as other vaccines Children should be vaccinated at 12.

Havrix Monodose Vaccine Summary of Product Characteristics

Havrix Monodose can be given concomitantly with monovalent and combination vaccines comprised of measles mumps rubella and varicella When concomitant administration is considered necessary the vaccines must be given at different injection sites Havrix Monodose must not be mixed with other vaccines in the same syringe.

Hepatitis A Vaccine (Havrix, Vaqta): Side Effects & Dosage

Berlaku untuk Anak (di atas 1 tahun) Brand Havrix Anak Metode pemberian Injeksi Perhatian Demam dan pusing ringan dan akan hilang dengan sendirinya Detil Vaksin Havrix 720 Injeksi SMP / Junior Injection in Indonesian mengandung komposisi aktif Hepatitis A Immunoglobulin Human yang diindikasikan untuk perawatan Hepatitis A dan kondisi lainnya.

Fosamax 70 Mg 2 Tablet Beta Fouda Pharmacy

Indications and Usage For Havrix VaccineHavrix Vaccine Dosage and AdministrationDosage Forms and StrengthsContraindicationsWarnings and PrecautionsAdverse ReactionsDrug InteractionsUse in Specific PopulationsHavrix Vaccine DescriptionHavrix Vaccine Clinical PharmacologyHAVRIX is indicated for active immunization against disease caused by hepatitis A virus (HAV) HAVRIX is approved for use in persons 12 months of age and older Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV Preparation for Administration Shake well before use With thorough agitation HAVRIX is a homogeneous turbid white suspension Do not administer if it appears otherwise Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit If either of these conditions exists the vaccine should not be administered For the prefilled syringes attach a sterile needle and administer intramuscularly For the vials use a sterile need Administration HAVRIX should be administered by intramuscular injection only HAVRIX should not be administered in the gluteal region such injections may result in suboptimal response Do not administer this product intravenously intradermally or subcutaneously Recommended Dose and Schedule Children and Adolescents (aged 12 months through 18 years) Primary immunization for children and adolescents consists of a single 05mL dose and a 05mL booster dose administered anytime between 6 and 12 months later 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 Adults (aged 19 years and older) Primary immunization for adults consists of a single 1mL dose and a 1mL boo Suspension for injection available in the following presentations • 1 05mL singledose vials and prefilled TIPLOK syringes • 1 1mL singledose vials and prefilled TIPLOK syringes [See How Supplied/Storage and Handling (16)] Severe allergic reaction (eg anaphylaxis) after a previous dose of any hepatitis Acontaining vaccine or to any component of HAVRIX including neomycin is a contraindication to administration of HAVRIX [see Description (11)] Latex The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions Syncope Syncope (fainting) can occur in association with administration of injectable vaccines including HAVRIX Syncope can be accompanied by transient neurological signs such as visual disturbance paresthesia and tonicclonic limb movements Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope Preventing and Managing Allergic Vaccine Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see Contraindications (4)] Clinical Trials Experience 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 The safety of HAVRIX has been evaluated in 61 clinical trials involving approximately 37000 individuals receiving doses of 360 ELU (n = 21928 in 3 or 4dose schedule) 720 ELU (n = 12274 in 2 or 3dose schedule) or Postmarketing Experience The following adverse reactions have been identified during postapproval use of HAVRIX Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine Infections and Infestations Rhinitis Blood and Lymphatic System Disorders Thrombocytopenia Immune System Disorders Anaphylactic reaction anaphylactoid reaction serum sickness–like syndrome Nervous System Concomitant Administration with Vaccines and Immune Globulin In clinical studies HAVRIX was administered concomitantly with the following vaccines [see Adverse Reactions (61) Clinical Studies (145)] • 1 INFANRIX (DTaP) • 1 Hib conjugate vaccine • 1 pneumococcal 7valent conjugate vaccine • 1 MMR vaccine • 1 varicella vaccine HAVRIX may be administered concomitantly with immune globulin When concomitant administration of other vaccines or immune globulin is required they should be given with different syringes and at different injection Immunosuppressive Therapies Immunosuppressive therapies including irradiation antimetabolites alkylating agents cytotoxic drugs and corticosteroids (used in greaterthanphysiologic doses) may reduce the immune response to HAVRIX Pregnancy Risk Summary All pregnancies have a risk of birth defect loss or other adverse outcomes In the US general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively There are no adequate and wellcontrolled studies of HAVRIX in pregnant women in the US Available data do not suggest an increased risk of major birth defects and miscarriage in women who received HAVRIX during pregnancy (se Lactation Risk Summary There is no information regarding the presence of HAVRIX in human milk the effects on the breastfed child or the effects on milk production 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 For preventive vaccines the underlying maternal condition is susceptibility to disease prevented by the Pediatric Use The safety and effectiveness of HAVRIX doses of 360 ELU or 720 ELU have been evaluated in more than 22000 subjects aged 1 to 18 years The safety and effectiveness of HAVRIX have not been established in subjects younger than 12 months HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration The virus (strain HM175) is propagated in MRC5 human diploid cells After removal of the cell culture medium the cells are lysed to form a suspension This suspension is purified through ultrafiltration and gel permeation chromatography procedures Treatment of this lysate with formalin ensures viral inactivation Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA) and is therefore expressed in terms of ELISA Units (ELU) Each 1mL adult dose of vaccine contains 1440 ELU of viral antigen adsorbed on 05 mg of aluminum as aluminum hydroxide Each 05mL pediatric dose of vaccine contains 720 ELU of viral antigen adsorbed onto 025 mg of aluminum as aluminum hydroxide HAVRIX contains the following excipients Amino acid supplement (03% w/v) in a phosphatebuffered saline solution and polysorbate 20 (005 mg/mL) From Mechanism of Action The hepatitis A virus belongs to the picornavirus family It is 1 of several hepatitis viruses that cause systemic disease with pathology in the liver The incubation period for hepatitis A averages 28 days (range 15 to 50 days)1The course of hepatitis A infection is extremely variable ranging from asymptomatic infection to icteric hepatitis and death The presence of antibodies to HAV confers protection against hepatitis A infection However the lowest titer needed to confer protection h.