Example: Infanrix Hexa - DRAFT
- Heiner Oberkampf
- Elisa Kendall
- Konrad Krebs
Disclaimer
This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.
Introduction
Infanrix Hexa is a multi-component vaccine that is prepared for administration as illustrated in the next diagram:
Related Competency Questions:
- What is the basis of strength for 'Tetanus Toxoid adsorbed on aluminium' in the product 'Infanrix hexa'? → 'Tetanus Toxoid adsorbed on aluminium' → Activity based (linked to corresponding Pharmacopeia)
- What is the basis of strength for 'Hib-TT' in the product 'Infanrix hexa'? → 'Hib' and 'TT' (Tetanus Toxoid) → Mass based
Model Pattern Instantiation
Infanrix Hexa Ingredients
The following table shows the different ingredients of the Powder and Suspension DTPa-HBV-IPV in the pharmaceutical product, i.e. without considering the overfill of the MI but before reconstitution.
Ingredients in Powder Hib
Substance | Role | Strength (Concentration) | Reference Substance | Role | Reference Strength (Concentration) |
Haemophilus influenzae type b polysaccharide, adsorbed on aluminium phosphate, conjugated to tetanus toxoid as carrier protein | ACTI | Not applicable | Haemophilus influenzae type b polysaccharide Tetanus toxoid (carrier protein) | ACTIM ACTIM | 10 µg/0.5 ml 25 µg/0.5 ml |
Lactose anhydrous | IACT | 20mg (dummy value) |
Ingredients in Suspension DTPa-HBV-IPV
Substance | Role | Strength (Concentration) | Reference Substance | Role | Reference Strength (Concentration) |
Diphtheria toxoid, adsorbed on aluminium hydroxide, hydrated | ACTIB | ≥ 30 IU/0.5 ml | Not applicable | ||
Tetanus toxoid, adsorbed on aluminium hydroxide hydrated | ACTIB | ≥ 40 IU/0.5 ml | Not applicable | ||
Bordetella pertussis Pertussis toxoid (PT), adsorbed on aluminium hydroxide hydrated | ACTI | Not applicable | Pertussis toxoid (PT) | ACTIR | 25 µg/0.5 ml |
Bordetella pertussis Filamentous Haemagglutinin (FHA), adsorbed on aluminium hydroxide hydrated | ACTI | Not applicable | Filamentous Haemagglutinin (FHA) | ACTIR | 25 µg/0.5 ml |
Bordetella pertussis Pertactin (PRN), adsorbed on aluminium hydroxide hydrated | ACTI | Not applicable | Pertactin (PRN) | ACTIR | 8 µg/0.5 ml |
Hepatitis B surface antigen (HBs), adsorbed on aluminium phosphate | ACTI | Not applicable | Hepatitis B surface antigen (HBs) | ACTIR | 10 µg/0.5 ml |
Poliovirus (inactivated) (IPV) type 1 (Mahoney strain) | ACTIB | 40 D-antigen unit | Not applicable | ||
Poliovirus (inactivated) (IPV) type 2 (MEF-1 strain) | ACTIB | 8 D-antigen unit | Not applicable | ||
Poliovirus (inactivated) (IPV) type 3 (Saukett strain) | ACTIB | 32 D-antigen unit | Not applicable | ||
Aluminium hydroxide | ADJV | Not applicable | Aluminium (ion) | ADJV | 0.5 mg/0.5 ml |
Aluminium phosphate | ADJV | Not applicable | Aluminium (ion) | ADJV | 0.32 mg/0.5 ml |