PDF Expectations for Registered Nurses - CRNNL Part I: Health Professional Information Whether comparator data would be included or not in this subsection of the product monograph, should be based on consultation with Health Canada. Products authorized under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. If blood or urine gets onto clothing such clothing should be washed separately or stored for 1 to 2 weeks to allow for decay. Tests and resources are available in libraries and online to ensure the readability of text such as the Flesch-Kincaid, Fry Graph Readability Formula and SMOG (Simple Measure of Gobbledygook) health literacy readability tools. Generally, the pharmacokinetic data from a healthy population should be presented. Words or phrases that lack a commonly understood meaning (e.g., imprecise quantitative terms), are not easily defined, are vague, misleading, or promotional in tone should be avoided (e.g., unique, novel, convenient, potent). Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. This guidance document supersedes the Guidance Document: Product Monograph (2014) and the Guidance Document: Product Monograph (2016) for all drug product submissions identified under section 1.2 Scope and application. It is also intended to serve as a guide for healthcare professionals to easily identify the information needed for counselling patients. General inquiries may be directed to hc.rpmd-dgpr.sc@canada.ca or hc.brdd.ora.sc@canada.ca. An electronic template in Microsoft Wordformat is provided on the Health Canada website. Include the specific gamma ray constant for the radioisotope, and the radiation attenuation by lead shielding (in tabular format). [Brand name] comes in the following dosage forms: From 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, provide the available marketed dosage forms and strengths. Services. Use the shortest, most common words possible (e.g.. Avoid acronyms, abbreviations, foreign terms and technical jargon. Introduction. Pharmacokinetic studies presenting information regarding the kinetics of specific drug combinations should be presented here. Documentation in Health Care - American Speech-Language-Hearing The product monograph, as a document, will be included by Health Canada as part of the NOC respecting an NDS or, when appropriate, an SNDS, an ANDS or a Supplement to an ANDS. The description of adverse reactions in this section is based on clinical experience with the reference biologic drug. Inclusion of events that are infrequent and minor, typically observed in the absence of drug therapy, or not plausibly related to the drug should be avoided. Details regarding interpretive criteria, standards for susceptibility testing, and standards for reference pathogens, should be included (as per current acceptable standards). Flexibility will be exercised in those situations where a smaller font may be necessary due to packaging constraints or printing limitations. Criteria for determining the levels or types of changes are described in both the Guidance Document: Post Notice of Compliance (NOC) Changes: Safety and Efficacy Document and the Guidance Document: Post Notice of Compliance (NOC) Changes: Quality Document. Revisions should be initiated by the sponsor any time updating of the product monograph is required to incorporate additions or other changes related to safety (particularly with respect to warnings, precautions, adverse reactions, and mode of administration) that may be necessary as a result of newly available information. Where applicable, there should be one table for hematologic changes, one for chemistry changes, and one for quantitative data (e.g., electrocardiograms). The type of data should be briefly stated (human or animal) and the recommendation (e.g., avoid in a particular trimester) for prescribing the drug safely should be provided. The Patient Medication Information section should be simple, clear and easy to understand so that patients are able to find, understand and act upon the information. Footnotes should not be added to the serious side effects table. This leaflet is a summary and will not tell you everything about this drug. It should also contain a description of the microbiological data that supports the pathogen(s) for the authorized indication, and that supports the microbiological information summarized under section 10 CLINICAL PHARMACOLOGY. Cross-reference to other relevant sections (e.g., 2 CONTRAINDICATIONS, 7.1.1 Pregnant Women); include information on contraception for both females and males. Cross-reference to renal and hepatic subheadings where appropriate. A single table is preferable. PDF Guidelines for the Nurse-Client Relationship January 2020 4 For more information, refer to the College's Therapeutic Nurse-Client Relationship, Revised 2006 practice standard at Interactions caused by different formulations of the drug should also be indicated. Degree of protein binding, sites of distribution, rate and extent of uptake by target organs if clinically relevant, and whether the drug crosses the blood-brain barrier. The text in the box should generally not exceed 20 lines. February 17, 2005. If research supports a particular approach, citations are provided. The frequency cut-off should be noted in the table header and the text accompanying the table. For products that have received an NOC and are marketed, the product monograph must be available in both official languages. (Ref: C.01.001. Multiple tables are appropriate when the drug's adverse reaction profile differs substantially from one setting to another. Photosensitivity: an abnormal cutaneous response involving the interaction between photosensitizing substances and sunlight or filtered or artificial light at wave lengths of 280-400 nm. Separate tables may be required for different indications (e.g., oncology and a non-oncology indication) or different formulations (e.g., oral, intravenous) or different drug combinations. For biosimilars only, otherwise delete this subheading. Where there is no proper name, use the common name in final dosage form. Our file number: 05-104120-52. These adverse reactions should be listed even if there are only one or two reported events, unless it is clear that a causal relationship can be excluded. Disease-associated maternal and/or fetal risk. The section numbers should be included as well. Interactions with herbal products have not been established. For Parts I and II, the first use of the brand name should be followed by the proper name (or common name, where there is no proper name) in final dosage form, in parentheses. 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. In the case of normal immunoglobulins, the IgG subclass distribution should be stated in terms of percent of total IgG present Footnote 2. addressograph machine For radiopharmaceutical use during pregnancy, 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. assigned to the drug in section C.01.002. Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New For drugs with multiple indications, dosage information should be clearly provided for each indication, route of administration and dosage form. Refrain from any involvement, direct or indirect, in fraudulent billing activities. Parallel Study: control subjects are administered a placebo or active standard therapy at the same time as other subjects are administered experimental treatment. When the genotype of the patient or that of an infectious agent will affect the treatment outcome, relevant information should also be included in this section. Examples include: The most frequent adverse reactions (e.g., those occurring at a rate of 10% or greater); Adverse reactions that most commonly result in clinical intervention such as: concomitant medication to treat an adverse reaction symptom; Factors that may affect the rate or severity of a reaction: duration of therapy (e.g., adverse reactions that appear in the beginning of treatment but usually resolve with continuous treatment, or adverse reactions that may only appear with longer term treatment); In some cases it may be appropriate to list the serious adverse reactions that are typical for the drug class, but have not been specifically observed in the clinical trials with this particular drug. Where a pediatric indication has not been authorized by Health Canada, it may still be useful to include the results of pharmacokinetic studies in children that have been submitted to Health Canada, if these results provide useful information for the prescriber. Tabulated results should include footnotes describing any statistical method used and any applied acceptance criteria (i.e., the "equivalence margin"). Toilet should be flushed several times after use. Find out how to get help. The safety and efficacy of Drug X in pediatric patients < 12 years of age have not been established. The method of calculation (including parameters and models) should be specified. increase in severity and/or frequency over adverse reactions observed in clinical trials; The principal pharmacodynamic effects related to the therapeutic action. NOTICE. List the section headings in the product monograph where any major label changes related to safety and efficacy have been made within the past 24 months, under the following sections only: Major label changes include Level I changes filed with an SNDS or SANDS for either a prescription or non-prescription drug. organ toxicity, current recommended management of overdosage (e.g., monitoring, use of agonist/antagonist/antidotes, method to increase elimination and/or other clinical interventions), and. In the absence of a serious drug interaction at the time of authorization, this box is omitted, along with the heading 9.1 Serious Drug Interactions, Presentation: bullet form within a box (see template). In cases where this may not be easily understood or predictable, a statement may be added to help the patient understand what course of action they should take. [Include cross-reference to relevant sections.]. The product monograph should also be revised whenever substantial information is available to support new indications or when other changes or deletions in 1 INDICATIONS are required as a result of additional available information. Subsection C.08.002(2) of the. This addendum covers the period following the conclusion of the evaluation phase including contract award and debriefings. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents. For a particular subheading, if there are no effects that may pose a hazard to the patient or precautions to be exercised by the health professional, care provider or patient to promote safe and effective use of the drug, then the subheading should be omitted. This section is required for all antimicrobial drugs. Addendum to the fairness monitor final report dated August 22, 2022 for the competitive procurement process of the Defence Resource Management Information System In Service Support. The colour, contrast, the position, and the spacing of the information are all to be taken into consideration in complying with these requirements. The following information should be provided to the patient when applicable: The following measures should be taken for up to 12 hours after receiving the radiopharmaceutical product: Toilet should be used instead of urinal. For biosimilars, include toxicology information that appears in the reference biologic drug product monograph. pH 1.2-6.8), should also be provided to determine the Dose/Solubility volume ratio where applicable (e.g. The numbering for remaining subsection headings does not change. Illustrations that help demonstrate the proper use of a self-administered product (e.g., inhaler, injectable product) are encouraged. Provide information to the patient, or care provider, on how to prepare, reconstitute or administer the drug or operate a device (e.g., metered dose inhaler). If the product is intended for use as an authorized adjunct to other measures (for example, diagnosis, treatment/therapy), this should be included. Dose estimates from any radiocontaminant should be provided either as a separate dose or expressed as a percentage of total dose estimates. Include information that does not fall under the subheadings listed below. Health Canada recognizes that this guidance document may not address the information requirements for all drugs and individual judgement remains critical in assessing how or whether to present the information. a basis for decisions regarding patient care, an efficient and effective way information can be authorized and serves as a legal document what is the meaning of the acronym HIPPA? Program Evaluation of Therapeutic Services at the Prison for Women that is used to distinguish the drug (Ref: C.01.001. the words "Product Monograph, Including Patient Medication Information". For example, adhesive bandages and manual toothbrushes are . The time of day for optimal drug effect should be indicated (e.g., evening, morning) where applicable. Subheadings should be used to group the information in this section. For products derived from plasma, the viral reduction steps should be detailed. The demographic and baseline characteristics data should be presented in one table (see template) with the aggregate results provided in a separate table. The following factors may be considered for the inclusion of adverse reactions: In addition, the adverse reactions for vaccines should be broken down by age of patient and should draw out relevant Canadian clinical experience. Important differences may result from: Data in the primary adverse reactions table should be derived from clinical trials submitted in support of the proposed indication. If no dosage adjustments are required a statement to that effect should be included, e.g.. No dosage adjustment required in hepatic or renal impairment.
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