Appendix I Template - Schedule D Drugs

Contact: Policy Bureau Enquiries

[Product Monograph Template - Schedule D]

[Title Page]

PRODUCT MONOGRAPH

• <Scheduling Symbol> <BRAND NAME>
• <Proper name>
• < Dosage Form(s) and Strength(s)>
• <Pharmaceutical standard (if applicable)>
• <Therapeutic Classification>
• <Sponsor Name>
• <Sponsor Address>
• Date of Preparation:
  • <MON DD, YYYY> or
• Date of Revision:
  • <MON DD, YYYY>

Submission Control No: <control number> [optional]

Table of Contents

[To create the table of contents, select from the toolbar: Tools - Reference - Table of Contents - Generate]

• PART I: HEALTH PROFESSIONAL INFORMATION
  • SUMMARY PRODUCT INFORMATION
  • DESCRIPTION
  • INDICATIONS AND CLINICAL USE
  • CONTRAINDICATIONS
  • WARNINGS AND PRECAUTIONS
  • ADVERSE REACTIONS
  • DRUG INTERACTIONS
  • DOSAGE AND ADMINISTRATION
  • OVERDOSAGE
  • ACTION AND CLINICAL PHARMACOLOGY
  • STORAGE AND STABILITY
  • SPECIAL HANDLING INSTRUCTIONS
  • DOSAGE FORMS, COMPOSITION AND PACKAGING
• PART II: SCIENTIFIC INFORMATION
  • PHARMACEUTICAL INFORMATION
  • CLINICAL TRIALS
  • DETAILED PHARMACOLOGY
  • MICROBIOLOGY
  • TOXICOLOGY
  • REFERENCES
• PART III: CONSUMER INFORMATION

<PROPRIETARY OR BRAND NAME>

< proper name >

PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION

Route of Administration	Dosage Form / Strength	Clinically Relevant Nonmedicinal Ingredients
< oral>	<tablet 5 mg, 10 mg>	<ethanol, gluten, etc> For a complete listing see Dosage Forms, Composition and Packaging section.

DESCRIPTION

• <narrative>

INDICATIONS AND CLINICAL USE

• <Brand Name (proper name)> is indicated for:
  • treatment of <text>
  • prevention of <text>
  • diagnosis of <text>
• [Brief discussion of any relevant clinical information - if applicable]
• [Distribution restrictions - if applicable]
• [When the product is not recommended - if applicable]
• Geriatrics (> x years of age):
  • <text>
• Pediatrics (x - y years of age) or (< years of age):
  • <text>

CONTRAINDICATIONS

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or
  component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. [if applicable]
• <text>
• <text>

WARNINGS AND PRECAUTIONS

• Serious Warnings and Precautions
  [Clinically significant or serious life-threatening warnings should be placed in the warning box. Generally not to exceed 20 lines]

  • <text>
  • <text>
• [headings to be included as applicable]
• General
  • <text>
• Carcinogenesis and Mutagenesis
  • <text>
• Cardiovascular
  • <text>
• Dependence/Tolerance
  • <text>
• Ear/Nose/Throat
  • <text>
• Endocrine and Metabolism
  • <text>
• Gastrointestinal
  • <text>
• Genitourinary
  • <text>
• Hematologic
  • <text>
• Hepatic/Biliary/Pancreas
  • <text>
• Immune
  • <text>
• Neurologic
  • <text>
• Ophthalmologic
  • <text>
• Peri-Operative Considerations
  • <text>
• Psychiatric
  • <text>
• Renal
  • <text>
• Respiratory
  • <text>
• Sensitivity/Resistance
  • <text>
• Sexual Function/Reproduction
  • <text>
• Skin
  • <text>
• Special Populations
  • Pregnant Women: <text>
    • [The extent of exposure in pregnancy during clinical trials should be included:
    • Wide: > 1000 pregnancies
    • Limited: < 1000 pregnancies
    • Very Limited: individual cases only
    • No experience ]
  • Nursing Women: <text>
  • Pediatrics (x - y years of age) or (< years of age):<text>
  • Geriatrics (> x years of age):<text>
• Monitoring and Laboratory Tests
  • <text>

ADVERSE REACTIONS

• [For vaccines, break down by age of patient; focus on Canadian data]
• Adverse Drug Reaction Overview
  • [An overview of the ADR information that may affect prescribing decisions. It should contain: serious and important ADRs; the most frequent ADRs; and ADRs that most commonly result in clinical intervention.]
• Clinical Trial Adverse Drug Reactions
  • Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
• [Include description of data sources]
• Table <#> - <Title of Table>
  • Digestive [use MedDRA terms for headings, as applicable]
    • <text>
    • <text>
  • Gastrointestinal
    • <text>
  • <drug name> n= <#> (%)
  • <placebo> n= <#> (%)
• [Narrative to follow table to explain or supplement the information provided in the table]
• Less Common Clinical Trial Adverse Drug Reactions (<1%)
  • [Presented as a list and categorized by body system]
  • Cardiovascular: <text>
  • Digestive: <text>
  • Gastrointestinal: <text>
• Abnormal Hematologic and Clinical Chemistry Findings
  • <table>
• Post-Market Adverse Drug Reactions
  • <narrative>

DRUG INTERACTIONS

Overview

<narrative>

[should include the following information: interactions suspected based on the pharmacokinetic or pharmacologic profile of the drug (e.g., cytochrome P450 interactions); drug class statements if the interaction has not yet been documented, but would be clinically significant; potential interaction with alcohol].

Drug-Drug Interactions

Table <# >- Established or Potential Drug-Drug Interactions

<Proper name>	Ref	Effect	Clinical comment
< drug A>	<level of evidence, see legend>	↓ <drug A> conc	<Caution is warranted and therapeutic concentration monitoring is recommended>
Legend: C = Case Study; CT = Clinical Trial; T = Theoretical

• Drug-Food Interactions
  • <narrative>
• Drug-Herb Interactions
  • <narrative>
• Drug-Laboratory Interactions
  • <narrative>
• Drug-Lifestyle Interactions
  • <narrative>

DOSAGE AND ADMINISTRATION

• Dosing Considerations
  [include all situations that may affect dosing of the drug]
  • <text>
  • <text>
• Recommended Dose and Dosage Adjustment
  
• [Include for each indication, route of administration or dosage form]
  [For vaccines, describe number and frequency of booster doses]
  • <narrative>
• Missed Dose
  • <narrative>
• Administration
  • <narrative>
• Reconstitution:
  • Oral Solutions : <text>
  • Parenteral Products:
    • Vial Size
    • Volume of Diluent to be Added to Vial
    • Approximate Available Volume
    • Nominal Concentration per mL
    • <any specific precautions, storage periods and incompatibilities>

OVERDOSAGE

• <narrative>

ACTION AND CLINICAL PHARMACOLOGY

• Mechanism of Action
  • <narrative>
  • [For anti-infective products: a brief description of action against micro-organisms]
• Pharmacodynamics
  • <narrative>
• Pharmacokinetics
  • Table <#> Summary of <proper name>’s Pharmacokinetic Parameters in a <specific patient population>
    • Cmax
    • t½ (h)
    • AUC_0-∞
    • Clearance Volume of distribution
    • Single dose mean
  • Absorption: <text>
  • Distribution: <text>
  • Metabolism: <text>
  • Excretion: <text>
• Special Populations and Conditions
  • Pediatrics: <text>
  • Geriatrics: <text>
  • Gender: <text>
  • Race: <text>
  • Hepatic Insufficiency: <text>
  • Renal Insufficiency: <text>
  • Genetic Polymorphism: <text>
  • Duration of Effect
    • <text>
    • [For vaccines, duration of immune status]

STORAGE AND STABILITY

• <narrative>

SPECIAL HANDLING INSTRUCTIONS

• <narrative>

DOSAGE FORMS, COMPOSITION AND PACKAGING

• <narrative>

PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION

• Drug Substance
  • Proper name: <text>
  • Chemical name: <text>
  • Molecular formula and molecular mass: <text>
  • Structural formula: <image>
  • Physicochemical properties: <text>
• Product Characteristics
  • <narrative>
• Viral Inactivation
  • <narrative>
  • [For products derived from plasma, detail the steps]
    [Include information on selection criteria for donors - if applicable]

CLINICAL TRIALS

Study demographics and trial design

• Table <#>- Summary of patient demographics for clinical trials in specific indication
  • Study #
  • Trial design
  • Dosage, route of administration and duration
  • Study subjects (n=number)
  • Mean age (Range)
  • Gender
  • [Provide a brief narrative describing the demographic characteristics of the study population].

Study results

• Table <#>- Results of study <#> in specific indication
  • Primary Endpoints
  • Associated value and statistical significance for Drug at specific dosages
  • Associated value and statistical significance for Placebo or active control

Comparative Bioavailability Studies [if required]

[narrative outlining the design of the bioequivalence study. The values in the table should be based on the measured data from the study; no potency correction should be applied.]
[Table for single dose studies:]

• Analyte Name (x mg)
• From measured data
• Geometric Mean
• Arithmetic Mean (CV %)

• Parameter
  • AUC_T (units)
    For drugs with a half-life greater than 24 hours AUCT should be replaced with AUC0-72.
  • AUC_I (units)
  • C_MAX
    (units)
  • T_MAX (h)
    Expressed as either the arithmetic mean (CV%) or the median (range) only.
  • T_½ (h)
    Expressed as the arithmetic mean (CV%) only.
• Test
  Identity of the test product.
• Reference
  Identity of the reference product, including the manufacturer, and origin (country of purchase).
• % Ratio of Geometric Means
• Confidence Interval
  Indicate % Confidence Interval (i.e., 90% or 95%) in the column heading and list for the AUCT, AUCI and CMAX (if required).

[Table for multiple dose studies:]

• Analyte Name ( x mg)
• From measured data
• Geometric Mean
• Arithmetic Mean (CV %)

• Parameter
  • AUC_tau (units)
  • C_MAX (units)
  • C_MIN (units)
  • T_MAX (h)
    For drugs with a half-life greater than 24 hours AUC_T should be replaced with AUC0-72.
• Test
  Identity of the test product.
• Reference
  Identity of the reference product, including the manufacturer, and origin (country of purchase),where applicable.
• % Ratio of Geometric Means
• Confidence Interval
  Indicate % Confidence Interval (i.e., 90% or 95%) in the column heading and list for the AUC_T, AUC_I and C_MAX (if required).

DETAILED PHARMACOLOGY

• <narrative>

MICROBIOLOGY

• <narrative>

TOXICOLOGY

• [table format wherever possible]

REFERENCES

• [numbered list]

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION

• <Brand name>
• <Proper Name>

This leaflet is part III of a three-part "Product Monograph" published when <brand name> was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about <brand name>. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

<narrative> and/or

• <text>
• <text>

What it does:

<text>

When it should not be used:

<text>

What the medicinal ingredient is:

<proper name>

What the important nonmedicinal ingredients are:

<alphabetical listing>

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

<dosage form(s) and strength(s)>

WARNINGS AND PRECAUTIONS

BEFORE you use <brand name> talk to your doctor or pharmacist if:

• <Activities (Warnings and Precautions, e,g, under Occupational Hazards)>
• <Current conditions (Contraindications, Warnings and Precautions)>
• <Past diseases (Contraindications, Warnings and Precautions)>
• <Reproductive issues (Contraindications, Warnings and Precautions)>
• <Anticipated medical procedures (Warnings and Precautions)>
• <Any allergies to this drug or its ingredients or components of the container (Contraindications)>

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with <brand name> include: <text> .

PROPER USE OF THIS MEDICATION

• Usual dose: <text>
• Overdose: <text>
• Missed Dose: <text>

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

<text>

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
		Only if severe	In all cases
Common	<symptom / effect> <symptom / effect>	X	X
Uncommon	<symptom / effect> <symptom / effect>		X	X

This is not a complete list of side effects. For any unexpected effects while taking <Brand Name>, contact your doctor or pharmacist.

HOW TO STORE IT

<text>

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you
may notify Health Canada by:

toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca

By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.website.document
or by contacting the sponsor, <Sponsor Name>,
at: 1-800-XXX-XXXX

This leaflet was prepared by <Sponsor Name>

Last revised: <MON DD, YYYY>.