Meningococcal Quadrivalent Polysaccharide Vaccine (MPSV-4)

Registered South African indications:

• Immunisation against meningococcal meningitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe acute febrile illness
• Meningococcal infections
• Severely immunocompromised patients
• Thrombocytopenia
• Coagulation disorders
• May impair ability to drive and operate machinery

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

Active immunisation against meningococcal meningitis
- Caused by serogroup A, C, W135 and Y meningococci
- People living in closed communities and close contacts of patients with this disease
- Individuals with terminal complement component deficiency, properdin deficiency and functional or actual splenectomy

• SC: 0.5ml, as a single dose

Reconstituted with the diluent supplied by adding the entire contents of the diluent vial to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent

Paed. forms avail. in SA and covered in this monograph: inj

Active immunisation against meningococcal meningitis
- Caused by serogroup A, C, W135 and Y meningococci
- People living in closed communities and close contacts of patients with this disease
- Individuals with terminal complement component deficiency, properdin deficiency and functional or actual splenectomy

Younger than 2 years

• Not established for use

Older than 2 years

• See adult dosage

Reconstituted with the diluent supplied by adding the entire contents of the diluent vial to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent

Pregnancy

• Caution
• There is limited experience with use of meningococcal quadrivalent polysaccharide vaccine in pregnant women
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development
• Meningococcal quadrivalent polysaccharide vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus

Breastfeeding

• Caution
• It is unknown whether meningococcal quadrivalent polysaccharide vaccine is excreted in human milk
• Meningococcal quadrivalent polysaccharide vaccine should only be used during breastfeeding when the possible advantages outweigh the potential risks

Fertility

• Animal studies do not indicate direct or indirect harmful effects with respect to fertility

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Irritability
• Drowsiness
• Headache
• Dizziness
• Fatigue
• Insomnia

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea

Endocrine and Metabolic Disorders

• Loss of appetite

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Stiffness
• Pain in extremity

Skin and Subcutaneous Tissue Disorders

• Injection site reactions
  - Pain
  - Swelling
  - Redness
  - Haematoma
  - Induration
  - Pruritis
  - Warmth
  - Anaesthesia
• Urticaria
• Pruritis
• Rash
• Angioneurotic oedema
• Limb swelling
• Erythema
• Swelling of adjacent joint

Immune, Blood and Lymphatic System Disorders

• Fever
• Allergic reactions
• Anaphylactic reactions
• Chills
• Influenza-like symptoms

Sensory Disorders

• Hypoaesthesia

Others

• Crying

• Siponimod
• Fingolimod
• Immunosuppressants
• Vaccines

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

Meningococcal quadrivalent polysaccharide vaccine induces bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis groups A, C, W-135 and Y.

Injection (per 0.5ml) 50μg

• Mencevax (GSK) originator