Cihexa ≥ 30 IU/40 IU/4 IU/15 mcg/10 mcg Suspension

CIHEXA is indicated for active immunisation of infants, at or above the age of 6 weeks against diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b for 3 dose regimen (6, 10 and 14 weeks) for primary vaccination, and a booster dose at the age of 12 to 24 months.

Posology
Primary vaccination: For active immunisation of infants, it is recommended that 3 doses of 0,5 mL to be administered with an interval of at least four weeks between doses starting at six weeks of age. In countries, where peri-natal transmission of hepatitis B virus (HBV) is common, the first dose of hepatitis B should be given as soon as possible after birth. In this case, CIHEXA can be used to complete the primary series from 6 weeks of age.
Booster vaccination: A booster dose of diphtheria, tetanus, pertussis, Haemophilus influenza type b and inactivated polio vaccine should be given preferably during the second year of life (u2265 6 months after last primary dose). Booster doses should be given in accordance with the official recommendations. Booster dose may be provided to children having received primary vaccinations of CIHEXA or any other diphtheria, tetanus and pertussis containing vaccines and poliomyelitis vaccine (OPV and/or IPV).
Method of administration
CIHEXA liquid vaccine vial should be shaken before use to homogenise the suspension. CIHEXA should be administered intramuscularly. The recommended injection sites are generally the antero-lateral aspect of the upper thigh in infants and toddlers. Do not administer by intravascular, intradermal or subcutaneous injection. A sterile syringe and sterile needle must be used for the injection. Any other injection if co-administered with CIHEXA should be given at a different site.

CIHEXA is contraindicated in:
u2022 Patients with known hypersensitivity to administration of diphtheria, tetanus, Bordetella pertussis, hepatitis B, polio or Haemophilus influenza type b vaccines or to any of the excipients in CIHEXA (see section 6.1).
u2022 Infants who have experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine (whole cell or acellular pertussis vaccines). Pertussis vaccination should be discontinued, and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Haemophilus influenza type b vaccines.
u2022 Uncontrolled neurologic disorder or uncontrolled epilepsy. Pertussis vaccine should not be administered to individuals with these conditions until the treatment regimen has been established, the condition has stabilised, and the benefit clearly outweighs the risk. Generally, vaccination must be postponed in cases of acute moderate or severe febrile illness. The presence of a minor infection and/or low-grade fever does not constitute a contraindication.

As with any vaccine, a protective immune response may not be elicited in all vaccines. CIHEXA will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. It does not prevent hepatitis caused by other agents different from HBV (such as virus A, C and E) but it is considered effective in preventing hepatitis caused by the delta agent. Haemophilus influenza type b vaccine does not protect against disease due to other types of Haemophilus influenzae nor against meningitis caused by other organisms. Due to the long incubation period of hepatitis B (up to 6 months or more), cases where prior exposure to hepatitis B virus has taken place, vaccination may not be effective. Vaccination should be preceded by a review of medical history (previous vaccinations and possible adverse events). In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of CIHEXA must be carefully considered.
If any of the following events occur in temporal relation to receipt of CIHEXA, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
u2022 Temperature 40,5 u00b0C or more within 48 hours of a dose unexplained by another cause.
u2022 Collapse or shock-like state (hypnotic- hypo responsive episode) within 48 hours.
u2022 Persistent, inconsolable crying lasting 3 hours or more occurring within 48 hours.
u2022 Convulsions with or without fever occurring within three days. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks. CIHEXA should not be given to children with any coagulation disorder, including thrombocytopenia that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. Infants and children with a history of convulsions in first-degree family members (i.e., siblings and parents) when administered diphtheria, tetanus and pertussis containing vaccines have an increased risk for neurologic events and permanent neurologic damage when compared with infants without such history. Infants and children with recognised possible or potential underlying neurologic conditions seem to be at enhanced risk for the appearance of manifestation of the underlying neurologic disorder within two or three days following vaccination. The administration of CIHEXA vaccine to children with proven or suspected underlying neurologic disorders that are not actively evolving must be decided on an individual basis.
As with the use of all vaccines, the vaccinated individual should remain under observation for not less than 30 minutes for possibility of occurrence of immediate or early allergic reactions. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of CIHEXA.
Immune deficiency: Individuals infected with the human immune-deficiency virus (HIV), both asymptomatic and symptomatic, should be immunised with combined vaccine according to standard schedules. Immunosuppressed children may not obtain expected immunological response.

Concomitant use with other vaccines
CIHEXA can be administered concomitantly with a pneumococcal polysaccharide conjugate vaccine, measles, mumps, rubella (MMR) containing vaccines, oral polio vaccine, rotavirus vaccines, a meningococcal conjugate vaccine, as it is unlikely to result in an interference with the immune responses. CIHEXA can be given safely and effectively at the same time as BCG, yellow fever vaccines and vitamin A supplementation. If co-administration with another vaccine is considered, immunisation should be carried out on separate injection sites. CIHEXA must not be mixed with any other vaccines or other parenterally administered medicinal products.
As with other intramuscular injections, use with caution in patients on anticoagulant therapy, immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic medicines and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines. Short-term (u02c2 2 weeks) corticosteroid therapy or intra-articular, bursal or tendon injections with corticosteroids should not be immunosuppressive.

CIHEXA is not intended for administration to women of child-bearing age, thus human data on use during pregnancy or lactation are not available.

Not applicable.

Summary of the safety profile
The safety profile presented below is based on data from pivotal clinical trial (SII-wHEXA/IN-02) conducted in India where CIHEXA was administered to 110 toddlers and 88 infants. The majority of the reactions observed following vaccination were of mild to moderate severity and were of short duration.
Tabulated summary of adverse reactions
Adverse events are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse events are defined as: very common (u2265 1/10); common (u2265 1/100 to u02c2 1/10); uncommon (u2265 1/1000 to u02c2 1/100); rare (u2265 1/10000 to u02c2 1/1000) and very rare (u02c2 1/10000).

MedDRA system organ class Frequency Side effects
Metabolism and nutrition disorders Very common Decreased appetite
Nervous system disorders Very common Somnolence
Gastrointestinal disorders Very common Vomiting
Skin and subcutaneous tissue disorders Uncommon Rash
General disorders and administration site conditions Very common Injection site erythema
Very common Injection site pain
Very common Injection site swelling
Uncommon Nodule
Very common Crying
Very common Irritability
Very common Pyrexia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free).

No cases of overdose were reported.