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Product Information (PI) is a sheet written for healthcare professionals (HPs, more specifically Australian HPs) that provides a summary of the scientific information that is relevant to the safe and effective use of the information the PI is written for. 

SectionsEdit

It has the following sections:

  • NAME OF THE MEDICINE[note 1]
  • DESCRIPTION[note 2]
  • PHARMACOLOGY
    • Pharmacodynamics
    • Pharmacokinetics
  • CLINICAL TRIALS
  • INDICATIONS[note 3]
  • CONTRAINDICATIONS[note 4]
  • PRECAUTIONS (the sections are not always in the below order)
    • Special populations: Elderly, Pregnancy, Lactation, Children/Adolescents, Preexisting Medical Problems.
    • Carcinogenicity, Mutagenicity, Impairment of Fertility
    • Effects on driving
    • Dietary restrictions (if applicable)
  • INTERACTIONS WITH OTHER MEDICINES
  • ADVERSE EFFECTS[note 5]
  • DOSAGE AND ADMINISTRATION
  • OVERDOSAGE[note 6]
  • PRESENTATION
  • STORAGE[note 7]
  • SPONSOR[note 8]

External linksEdit

  • Product Information sheets that are hosted by the TGA-eBS may be found for here [1]. This picture [1] should help you in searching for the PI.

NotesEdit

  1. Includes the structure of the drug, generic name, molecular formula, molar mass and IUPAC name
  2. Includes the physical and chemical properties of the drug and the appearance of the dosage form (e.g., tablets). Includes excipients (i.e., non-active ingredients in the dosage form).
  3. Medical uses
  4. These are pre-existing conditions or medicines that should be avoided in all circumstances
  5. Side effects, usually listed in their respective frequency; e.g., very common (occurring in ≥10% of patients), common (1%≤frequency<10%), uncommon (0.1%≤frequency<1%), rare (0.01%≤frequency<0.1%) and very rare (frequency<0.01%).
  6. What treatment is required in cases of overdose
  7. The storage conditions required to protect the drug from degradation
  8. The drug company that sponsors the drug's development and sale

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