Ingovax ACWY

Indicated for the active immunization of children from 2 years of age, adolescents and adults against meningococcal disease caused by meningococci of serogroups A, C, W135 and Y. The vaccine may also be used for: Subjects who are living in closed communities and close contacts of patients with disease caused by meningococci of serogroups A, C, W135 and Y. Travellers to countries where the disease is epidemic or highly endemic.

Administer IM only; do not administer IV, SC, or ID Give IM injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in toddlers, adolescents, and adults

The recommended dose for vaccines in all age groups is 0.5mL, administered as a single dose. Vaccine is administered subcutaneously as a single 0.5 ml dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination.

The recommended dose for vaccines is 0.5mL, administered as a single dose. Children from 2 years of age, vaccine is administered subcutaneously as a single 0.5 ml dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination. Revaccination of a single 0.5 ml dose administered subcutaneously may be indicated for individuals at high-risk of infection, particularly children who were first vaccinated when they were less than 4 years of age; such children should be considered for revaccination after 2 or 3 years if they remain at high-risk.

Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine, or to any component.

Meningococcal serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein carrier. These products convey active immunity via stimulation of production of endogenously produced antibodies.

As with other vaccines, the administration of Meningococcal polysaccharide vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunization. This vaccine gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response. As with all injectable vaccines, appropriate medication (e.g. adrenaline) should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.

Meningococcal polysaccharide vaccine is generally well tolerated. Adverse reactions usually occur within 48 hours following vaccination.Metabolism and nutrition disorders: Common: appetite lost. Psychiatric disorders: Very common: irritability. Nervous system disorders: Very common: drowsiness, headache. Uncommon: dizziness. Gastrointestinal disorders: Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhea. Musculoskeletal and connective tissue disorders: Common: myalgia. General disorders and administration site conditions: Very common: pain and redness at the injection site, fatigue. Common: swelling at the injection site, fever.

Pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. This vaccine should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus.

This can be administered at the same time as other vaccines. Different injectable vaccines should always be administered at a different injection site. Incompatibilities: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.