Ingovax ACWY SC Injection

Ingovax ACWY is 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.

After reconstitution, 1 dose (0.5 ml) contains:

• Neisseria meningitidis group A polysaccharide: 5 micrograms
• Neisseria meningitidis group C polysaccharide: 5 micrograms
• Neisseria meningitidis group W-135 polysaccharide: 5 micrograms
• Neisseria meningitidis group Y polysaccharide: 5 micrograms
• Conjugated to tetanus toxoid carrier protein: 44 micrograms

Meningococcal Polysaccharide Vaccine is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.

The immunizing dose is a single injection of 0.5 ml administered subcutaneously. Primary Immunization For both adults and 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.

Hypersensitivity to the active substances or to any of the excipients.

Ingovax ACWY 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.

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.

As with other vaccines, the administration of Ingovax ACWY 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. Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.

Vaccines, Anti-sera & Immunoglobulin

Store in a refrigerator (2-8°C). Do not freeze. Store in the original package in order to protect from light.