Sii Pneumosil Special Precautions

Risk of Sensitization in Relation to Thiomersal and Other Preservatives.
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE. For the treatment of severe anaphylaxis, the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 ml of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children, the recommended dose of adrenaline is 0.01 mg/kg (0.01 ml/kg of 1:1000 injection). Single paediatric dose should not exceed 0.5 mg (0.5 ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis.
As with the use of all vaccines, the vaccines should remain under observation for not less than 30 minutes for possibility of occurrence of immediate or early allergic reactions. Hydrocortisone and antihistaminics should also be available in addition to supportive measures such as oxygen inhalation and IV fluids.
Special care should be taken to ensure that the injection does not enter a blood vessel. IT IS EXTREMELY IMPORTANT WHEN THE PARENT, GUARDIAN RETURNS FOR THE NEXT DOSE IN THE SERIES. THE PARENT AND GUARDIAN SHOULD BE QUESTIONED CONCERNING OCCURANCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE.
This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder, or to those receiving anticoagulant therapy.
This vaccine is not intended to be used for treatment of active infection. As with any vaccine, SII PNEUMOSIL (10-valent) may not protect all individuals receiving the vaccine from pneumococcal disease.
Minor illnesses, such as mild respiratory infection, with or without low grade fever, are not generally contraindications to vaccination. The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. The administration of SII PNEUMOSIL (10-valent) should be postponed in subjects suffering from acute severe febrile illness.
Based on experience with use of other pneumococcal conjugate vaccines, for vaccine serotypes protection against otitis media is expected to be lower than protection against invasive disease. As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low.
Special Populations: Safety and immunogenicity data on SII PNEUMOSIL (10-valent) are not available for children in specific groups at higher risk for invasive pneumococcal disease (e.g. children with congenital or acquired splenic dysfunction, HIV infection, malignancy, nephrotic syndrome). Children in these groups may have reduced antibody response to active immunization due to impaired immune responsiveness. Limited data have demonstrated that other pneumococcal conjugate vaccines induce an immune response in children with HIV, sickle cell disease, and children born prematurely with a safety profile similar to that observed in non-high-risk groups. The use of SII PNEUMOSIL (10-valent) in high-risk groups should be considered on an individual basis.
Apnoea in Premature Infants: Based on experience with use of other pneumococcal conjugate vaccines, the potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination with SII PNEUMOSIL (10-valent) should not be withheld or delayed.
Effects on ability to drive and use machine: Not relevant.
Use in Children: SII PNEUMOSIL (10-valent) is not intended for use in children below the age of 6 weeks. The safety and effectiveness in children below the age of 6 weeks has not been established.