Appendix I - Product Monograph Template - Schedule D

[Title Page]

Product Monograph Including Patient Medication Information

<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>

Date of Revision:
<MON DD, YYYY>

Submission Control No: <control number>

Table of Contents

[To update, right-click anywhere in the Table of Contents and select "Update Field", "Update entire table", click OK.]

• 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: Patient Medication Information

<Proprietary or Brand Name>
<proper name>

Part I: Health Professional Information

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/Pancreatic
<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]

[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

Serious Drug Interactions

[Serious, life-threatening drug interactions should be highlighted in this box. Not to exceed 20 lines].

• <text>
• <text>

Overview

<narrative>
[should include the following information: interactions suspected based on the pharmacokinetic or pharmacologic profile of the drug [for example (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

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:

<any specific precautions, storage periods and incompatibilities>

Overdosage
<narrative>

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Action and Clinical Pharmacology

Mechanism of Action
<narrative>
[For anti-infective products: a brief description of action against micro-organisms]

Pharmacodynamics
<narrative>

Pharmacokinetics

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

[Provide a brief narrative describing the demographic characteristics of the study population].

Study Results

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:]

[Table for multiple dose studies:]

Detailed pharmacology

<narrative>

Microbiology

<Narrative>

Toxicology

[table format wherever possible]

References

[numbered list]

Read this for safe and effective use of your medicine

Patient Medication Information

<Brand Name>
<Proper Name in final dosage form>

Read this carefully before you start taking <Brand name> and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about <Brand name>.

Serious Warnings and Precautions

• <text>
• <text>

What is <Brand name> used for?

• <text>
• <text>

How does <Brand name> work?
<text>

What are the ingredients in <Brand name>?
Medicinal ingredients: [List all medicinal ingredients from Part I.]
Non-medicinal ingredients: [List all non-medicinal ingredients in alphabetical order from Part I.]

<Brand name> comes in the following dosage forms:
<dosage form(s) and strength(s)>

Do not use <Brand name> if:
[Enter one point for each contraindication from Part I.]

• <text>
• <text>

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take <Brand name>. Talk about any health conditions or problems you may have, including if you:
[Enter one point for each warning and precaution from Part I.]

• <text>
• <text>

Other warnings you should know about:
[Enter general information that would not appear in the serious warnings and precautions box or other existing headings. Otherwise this heading is not required.]
<text>

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with <Brand name>:

• <list>

How to take <Brand name>:
<text>

Usual dose:
<text>

Overdose:
<text>

If you think you have taken too much <Brand name>, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

[The boxed message may be modified to provide the most appropriate advice according to current standards of care for this drug product.]

Missed Dose:
<text>

What are possible side effects from using <Brand name>:

These are not all the possible side effects you may feel when taking <Brand name>. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

<text>

[Self-limiting side effects should be described in the text section only. Serious side effects must be listed in the serious side effects table. Each side effect should appear only once, in text or in the table, as duplication generally is not wanted in Part III.]

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);
• By completing a Consumer Side Effect Reporting Form and sending it by:
  • Fax to 1-866-678-6789 (toll-free), or
  • Mail to: Canada Vigilance Program
    Health Canada, Postal Locator 0701E
    Ottawa, ON
    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

Reporting Suspected Vaccine Adverse Events

For the general public:
If you suspect you have had a serious or unexpected event following receipt of a vaccine, please ask your healthcare professional to complete the Adverse Events Following Immunization (AEFI) Form and send it to your local health unit in  your province/territory.

For healthcare professionals:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to your local health unit in  your province/territory.

If you have any questions or have difficulty contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada:
Toll-free telephone: 1-866-844-0018
Toll-free fax: 1-866-844-5931
By email:  caefi@phac-aspc.gc.ca

[Include the text box that is appropriate, according to the biologic drug product.]

Storage:
<text>

Keep out of reach and sight of children.

If you want more information about <Brand name>:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer's website <website>, or by calling 1-800-<phone number>.

This leaflet was prepared by <Sponsor Name>

Last Revised <MON-DD-YYYY>