Appendix H - Product Monograph Template - Schedule C

[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.]

<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

Physical Characteristics
<text>

External Radiation
<text>

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]

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]

  • Radiopharmaceuticals should be used only by those health professionals who are appropriately qualified in the use of radioactive prescribed substances in or on humans.
  • <text>

[headings to be included as applicable]

General

The product should be administered under the supervision of a health professional who is experienced in the use of radiopharmaceuticals. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.

The radiopharmaceutical product may be received, used and administered only by authorized persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organizations.

As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers.

<text>
<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:  [Ideally examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability should be performed during the first ten days following the onset of menses.]

[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

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>
  <drug name>
n = <#>
(%)
<placebo>
n = <#>
(%)

Digestive [use MedDRA terms for headings, as applicable]

<text>

<text>

Gastrointestinal

<text>

[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

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
<text>

Dosage
<text>

Administration
The patient dose should be measured by a suitable radioactivity calibration system prior to administration.
<narrative>

Image Acquisition and Interpretation
<text>

Instructions for Preparation and Use
<text>

Directions for Quality Control
<text>

Radiation Dosimetry

Example of Acceptable Presentation of Dose Estimate Data:

Final Dose Estimates: (The model and method of calculation should be specified)
Organ mGy/MBq rad/mCi

Adrenals

Brain

Breasts

Gallbladder Wall

LLI Wall

Small Intestine

Stomach

ULI Wall

Heart Wall

Kidneys

Liver

Lungs

Muscle

Ovaries

Pancreas

Red Marrow

Bone Surfaces

Skin

Spleen

Testes

Thymus

Thyroid

Urinary Bladder

Uterus

Effective Dose Equivalent (mSv/MBq) (rem/mCi)
Effective Dose (mSv/MBq) (rem/mCi)

Overdosage
<narrative>

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

Action and Clinical Pharmacology

Mechanism of Action
<narrative>

Pharmacodynamics
<narrative>

Pharmacokinetics

Table <#> - Summary of <proper name>'s Pharmacokinetic Parameters in a <specific patient population>
  Cmax t½(h) AUC0-∞ 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>

Storage and Stability

<narrative>

Special Handling Instructions

As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers.
<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>

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

Primary Endpoints Associated value and statistical significance for Drug at specific dosages Associated value and statistical significance for Placebo or active control
     

Detailed pharmacology

<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; e.g., a general statement regarding the specialized nature of radiopharmaceuticals should be included>

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>:
<Brand name> will be given to you by a healthcare professional who is experienced in the use of radiopharmaceuticals.

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.]

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Stop taking drug and get immediate medical help
Only if severe In all cases

Very common
< Condition: symptom / effect>

   

< Condition: symptom / effect>

     

Common
< Condition: symptom / effect>

     
< Condition: symptom / effect>      

Rare
< Condition: symptom / effect>

     

< Condition: symptom / effect>

     

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.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

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>

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