Product Monograph Template - Schedule C

[Title Page]

Product Monograph

Including Patient Medication Information

<Scheduling Symbol> <Brand Name>

<Proper name>

<Dosage Form(s), Strength(s) and Route(s) of Administration>

<Pharmaceutical Standard (if applicable)>

<Therapeutic Classification>

<Sponsor Name>

<Sponsor Address>

Date of Initial Approval:
<MON DD, YYYY>

Date of Revision:
<MON DD, YYYY>

Submission Control No: <control number>

Recent Major Label Changes

<Section Heading>, <Subsection heading> <(Section or Subsection number)> <MON, YYYY>

<Section Heading>, <Subsection heading> <(Section or Subsection number)> <MON, YYYY>

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

1 Indications

<Brand name (proper name)> is indicated for:

  • <text>
  • <text>

<text>

1.1 Pediatrics

[One of the following or similar statements should be used:]

Pediatrics <(age range)> : Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use. <(cross-reference to relevant sections)>

[or]

Pediatrics <(age range)> :No data are available to Health Canada; therefore,Health Canada has not authorized an indication for pediatric use.

[or]

Pediatrics <(age range)> : Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections)>

1.2 Geriatrics

[One of the following or similar statements may be used:]

Geriatrics <(> x years of age)>: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.

[or]

Geriatrics <(> x years of age)>: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.

2 Contraindications

<Proper name> is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.

  • <text>
  • <text>

3 Serious Warnings and Precautions Box

[Delete this section if there is no Serious Warnings and Precautions box.]

Serious Warnings and Precautions

[Clinically significant or serious (e.g., life-threatening) safety hazards should be placed in this box, with a cross reference to the relevant section(s) for more detailed information. 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>

4 Dosage and Administration

4.1 Dosing Considerations

[Briefly list all situations that may affect dosing of the drug:]

  • <text>
  • <text>

[In the absence of a Health Canada authorized pediatric indication, the following or similar statement should be used:]

Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections, if applicable)>

4.2 Dosage

<text>

4.3 Administration

[Include the following or similar statement, if applicable:]

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

<text and/or table>

4.4 Image Acquisition and Interpretation

<text>

4.5 Instructions for Preparation and Use

<text>

[The following or similar statement should be included:]

The components of the reagent vial are sterile and nonpyrogenic. It is essential that the user follows the directions carefully and adheres to strict aseptic technique.

[or]

Use aseptic technique and wear waterproof gloves throughout the entire preparation procedure.

[or]

Make all transfers of radioactive solutions with an adequately shielded syringe and maintain adequate shielding around the vial during the useful life of the radioactive product.

4.6 Directions for Quality Control

[Include the following or similar statement:]

The appearance, pH and radiochemical purity of the radiopharmaceutical product should be determined prior to administration to the patient.

<text>

5 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)

6 Overdosage

<text>

For management of a suspected drug overdose, contact your regional poison control centre.

7 Dosage Forms, Strengths, Composition and Packaging

Table - Dosage Forms, Strengths, Composition and Packaging
Route of Administration Dosage Form / Strength /Composition Non-medicinal Ingredients
<oral> <tablet 5 mg, 10 mg> [List all non-medicinal ingredients in alphabetical order.]

<text>

8 Description

Physical Characteristics
<table>

External Radiation
<table>

9 Warnings and precautions

[If applicable, include the following statement:]

Please see the Serious Warnings and Precautions Box at the beginning of Part I: Health Professional Information.

[Subheadings to be included as applicable, in alphabetical order:]

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>

Carcinogenesis and Mutagenesis
<text>

Cardiovascular
<text>

Contamination
<text>

Dependence/Tolerance
<text>

Ear/Nose/Throat
<text>

Endocrine and Metabolism
<text>

Gastrointestinal
<text>

Genitourinary
<text>

Hematologic
<text>

Hepatic/Biliary/Pancreatic
<text>

Immune
<text>

Monitoring and Laboratory Tests
<text>

Neurologic
<text>

Ophthalmologic
<text>

Peri-Operative Considerations
<text>

Psychiatric
<text>

Renal
<text>

Respiratory
<text>

Sensitivity/Resistance
<text>

Sexual Health

Reproduction
<text>

Function
<text>

Fertility
<text>

Skin
<text>

9.1 Special Populations

9.1.1 Pregnant Women

[The following or similar statement should be included:]

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, or after ensuring the woman is not pregnant. The benefit of using a diagnostic radiopharmaceutical should be weighed against the possible risk to an embryo or a fetus.

<text>

[The extent of exposure in pregnancy during clinical trials should be included:

  • Wide: > 1,000 pregnancies
  • Limited: < 1,000 pregnancies
  • Very Limited: individual cases only
  • No experience]
9.1.2 Breast-feeding

[Unless studies have shown that the product is not excreted in human breast milk, the following or similar statement should be included:]

Where an assessment of the risk to benefit ratio suggests the use of this product in nursing mothers, formula feeding should be substituted for breast feeding.

<text>

9.1.3 Pediatrics

[In the absence of a Health Canada authorized pediatric indication, one of the following or similar statements should be used:]

Pediatrics <( age range)> :No data are available to Health Canada; therefore,Health Canada has not authorized an indication for pediatric use.

[or]

Pediatrics <(age range)>: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of <Brand name> in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. <(cross-reference to relevant sections)>

<text>

9.1.4 Geriatrics

<text>

10 Adverse Reactions

10.1 Adverse Reaction Overview

<text>

10.2 Clinical Trial Adverse 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 reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

[Include a brief description of data sources.]
<text>

>Table <#> <Title of Table>
<drug name>
n = <#>
(%)
<placebo>
n = <#>
(%)
[use MedDRA terms for headings, as applicable]

Cardiovascular

<text>

[A brief narrative should follow the table to explain or supplement the information provided in the table:]
<text>

10.3 Less Common Clinical Trial Adverse Reactions

[Present as a list, categorized by System Organ Class, alphabetically:]

Cardiovascular: <text>

Gastrointestinal: <text>

10.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data

<table>

10.5 Clinical Trial Adverse Reactions (Pediatrics)

<text>

10.6 Post-Market Adverse Reactions

<text and/or table>

11 Drug Interactions

11.1 Serious Drug Interactions Box

[Delete this section if there is no Serious Drug Interactions box.]

Serious Drug Interactions

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

  • <text>
  • <text>

11.2 Overview

<text>

11.3 Drug-Drug Interactions

The drugs listed in this table are based on either drug interaction case reports or studies, or potential interactions due to the expected magnitude and seriousness of the interaction (i.e., those identified as contraindicated).

[or]

Interactions with other drugs have not been established.

Table <#> - Established or Potential Drug-Drug Interactions
<Proper/Common name> Source of Evidence Effect Clinical comment
Legend: C = Case Study; CT = Clinical Trial; T = Theoretical
<drug A> <level of evidence, see legend> <drug A> conc <Caution is warranted and therapeutic concentration monitoring is recommended>

11.4 Drug-Food Interactions

<text>

11.5 Drug-Herb Interactions

<text>

11.6 Drug-Laboratory Test Interactions

<text>

11.7 Drug-Lifestyle Interactions

<text>

12 Action and Clinical Pharmacology

12.1 Mechanism of Action

<text>

12.2 Pharmacodynamics

<text>

12.3 Pharmacokinetics

Table <#> - Summary of <proper name> Pharmacokinetic Parameters in <specific patient population>
Cmax Tmax t½ (h) AUC0-∞ CL Vd
Single dose mean

Absorption: <text>

Distribution: <text>

Metabolism: <text>

Elimination : <text>

Special Populations and Conditions

Pediatrics: <text>

Geriatrics: <text>

Sex : <text>

Pregnancy and Breast-feeding: <text>

Genetic Polymorphism: <text>

Ethnic origin : <text>

Hepatic Insufficiency: <text>

Renal Insufficiency: <text>

Obesity: <text>

13 Storage , Stability and Disposal

[For kits, include the following or similar statement:]

Do not use the kit beyond the expiration date stamped on the box. After preparation the <product> should be stored at room temperature until administration, within <x> hours of radiolabelling.

<text>

14 Special Handling Instructions

[Include the following or similar statement:]

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>

Part II: Scientific Information

15 Pharmaceutical Information

Drug Substance

Proper name: <text>

Chemical name: <text>

Molecular formula and molecular mass: <text>

Structural formula: <image>

Physicochemical properties: <text>

Product Characteristics
<text>

16 Clinical Trials

16.1 Trial Design and Study Demographics

Table <#> - Summary of patient demographics for clinical trials in < specific indication >
Study # Trial design Dosage, route of administration and duration Study subjects (n) Mean age (Range) Sex
 

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

<text>

16.2 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
 

17 Non-clinical Toxicology

[Narrative where possible. Include a table only where presentation is made more concise.]
<text>

[The following or similar statements should be included, where applicable:]

No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether <product name> affects fertility in males or females.

As with other radiopharmaceuticals which distribute intracellularly, there may be increased risk of chromosome damage from Auger electrons if nuclear uptake occurs.

18 Supporting Product Monographs

[Where there are no supporting product monographs, this section should be omitted.]
[numbered list:]

<Brand name> <(dosage form, strength)>, submission control <number>, Product Monograph, <sponsor>. <(MON, DD, YYYY)>

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?
[At the grade 6-8 reading level, explain the mechanism of action, in one or two sentences. Indicate how long it takes to work and how to know if it is working.]
<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:
[To maintain brevity, this is the only information required in this section.]
< 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.

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.

<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 report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.
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.

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>

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