Pneumococcus/ Haemophilus Influenzae Conjugated (PCV/HIB)

Registered South African indications:

• Prevention of pneumococcal disease
• Prevention of acute otitis media caused by Non-Typeable Haemophilus influenzae 

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Acute febrile illness

Cautions

• Renal impairment
• Hepatic impairment
• Children >5 years
• History of respiratory immaturity
• Psychogenic response to needle injection
• Thrombocytopaenia
• Coagulation disorders
• Congenital or acquired immunodeficiency
• Seizure disorders or history thereof
• Previous history of respiratory immaturity
• Children >2 years of age with sickle cell disease
• Children >2 years of age with asplenia
• Children >2 years of age with HIV infection
• Children >2 years of age with chronic illness
• Children >2 years of age with immunocompromising conditions

Not established for use in adults

Forms avail. in SA and covered in this monograph: inj

Prevention of pneumococcal disease 

• IM: 0.5ml, See table below: 

The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children

Under no circumstances should the vaccine be administered intravascularly or intradermally. No data are available on subcutaneous administration

If coadminstered with other monovalent or combination vaccines, different injection sites should be used

Pregnancy

• Not indicated for use in adults

Breastfeeding

• Not indicated for use in adults

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly 

• Not indicated for use in geriatric patients

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in sport

• Permitted - no warnings

Central Nervous System Disorders

• Irritability
• Abnormal crying
• Drowsiness
• Seizures (including febrile seizures)
• Hypotonic-hyporesponsive episode  
• Headache

Cardiovascular Disorders

• Kawasaki disease

Respiratory Disorders

• Apnoea

Gastrointestinal Disorders

• Diarrhoea  
• Nausea and vomiting

Endocrine and Metabolic Disorders

• Loss of appetite

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritus
• Eczema
• Allergic or atopic dermatitis
• Injection site reactions
  - Irritability
  - Redness
  - Pain
  - Haematoma
  - Haemorrhage
  - Nodule
• Diffuse swelling of affected limb and/or adjacent joint

Immune, Blood and Lymphatic System Disorders

• Hypersenstivity  
• Anaphylactic reaction
• Allergic reactions  
• Angioedema  
• Fever

• Immunosuppressants

None routine

Traceability

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

Prophylactic use of antipyretics

• Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions
• The use of prophylactic antipyretic medicinal products is recommended:
  - for all children receiving this vaccine simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions
  - for children with seizure disorders or with a prior history of febrile seizures
• Antipyretic treatment should be initiated according to local treatment guidelines.

The combination vaccine promotes immunization against invasive disease caused by S. pneumoniae capsular subtypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F, all which are individually conjugated to a carrier protein (protein D, tetanus toxoid, or diphtheria toxoid); the aluminum salt, a mineral adjuvant, that enhances the antibody response.

COMBINATION PREPARATIONS 

Polysaccharide for Serotypes: 1; 5; 6B; 9V; 7F; 14; 23F/ Polysaccharide for Serotypes: 4; 18CV; 19F

Injection (per 0.5ml) 1μg/3μg

• Synflorix (GSK) originator