Product Monograph

Product Monograph

Product Monograph should have the information which can communicate with the sections described below:

Health Professional Information: This particular area  covers essential prescribing information, including dosage and strength, indications and clinical uses, warnings and precautions, adverse reactions and drug interactions.

Scientific Information:The Scientific Information section contains more detailed scientific information including toxicology and data from animal studies, clinical trials, pharmaceutical information and pharmacology.

Patient Information: Such a section may or may not be included. It is informative about how to use the medicine safely and most effectively.

Contents of a product monograph:

1. Pharmacology of the drug
2. Clinical Trials
3. Indications and Clinical Uses
4. Contraindications
5. Warnings and Precautions
6. Adverse Reactions
7. Toxicology and Drug Interactions
8. Dosage and Administration
9. Special Handling Instructions
10. Glossary

Source: http://www.chillibreeze.com/articles/Product-Monograph.asp
Product Monograph Sample: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/monograph/pmappe_mpanne-eng.php
http://www.janssen-ortho.com/JOI/pdf_files/Elmiron_E.pdf