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Nunavut

RSV/Synagis Program 2012-13

Department of Health and Social Services

November 2012

Nunavut RSV/Synagis Program 2012-13

Table of Contents

Section I: RSV Public Health Protocol……………………………………………………. 1

Section II: Synagis Immunization Protocol...…………………………………………….. 4

Appendices

i. Appendix A: Nasopharyngeal Swab Procedure………………………...……..... 8

ii. Appendix B: Communicable Disease Reporting Form……,,……………….….. 9

iii. Appendix C: RSV Fact Sheet………………………………………….……….….10

iv. Appendix D: Synagis Registration and Dispensing Flow Chart………………..14

v. Appendix E: Synagis Annual Registration Form……………………………......15

vi. Appendix F: Synagis Consent……………………………………………………..16

vii. Appendix G: Synagis Refill Request Form……………………………………….17

RSV – Public Health Protocol (Revised November 2012) 1

Respiratory Syncytial Virus (RSV)

Infectious Agent Respiratory syncytial virus (RSV) is an enveloped, non-segmented RNA virus. Thetwo major strains of RSV (groups A and B), each of which have numerousidentified genotypes, often circulate concurrently.

Clinical

ClinicalPresentation

While RSV can cause acute illness at any age, in infants and young children it isthe most important cause of bronchiolitis and pneumonia.

Most RSV begins with nasal congestion, upper respiratory tract infectionand may include a low-grade fever. Classic presentation is bronchiolitiswith diffuse wheezing, cough, difficulty breathing, lung hyperinflation andtrouble feeding.

For newborns and preterm infants respiratory signs can begin with periodsof apnea over a few days, especially under 6 months of age.

For older children and adults illness generally manifests as upperrespiratory illness and exacerbation of underlying lung conditions.

Diagnostics The specimen of choice is the nasopharyngeal (NP) swab (See Appendix A).

If a rapid test (BinexNOW® RSV) is used, a positive result is reportable (use theCommunicable Disease Reporting Form Appendix B) and the test should befollowed with confirmatory laboratory testing.

Note: The same NP swab can be used for both the rapid and confirmatory tests. Itis suggested that the tests be conducted simultaneously.

Treatment As per physician direction.

Pathogen

Occurrence Worldwide: RSV is the most common cause of bronchiolitis and pneumonia inchildren under 1 year worldwide. In the northern hemisphere, epidemics peakFebruary to March and can last up to 5 months, however timing varies by locationand year.

Canada: 10% of respiratory-related hospital admissions in children can beattributed to RSV infection, the highest rate is in infants under 6 months. RSV isnot a nationally notifiable disease thus complete national data is not available.Based on the laboratory network data available RSV activity generally starts latefall, peaking in early winter and tapering into late spring.

Nunavut: There are sporadic cases throughout the year with activity peaking

January to the end of May, from 2008-2012 there were between 93-168 reported

cases per year. There is no consistent regional trend from 2008-2012 except

activity generally appears to begin in Baffin region.

Reservoir Humans

Transmission Contact with infected droplets or indirectly by hands or freshly contaminatedarticles.

Special Precautions/ConsiderationsPrecautions: Droplet

ReportingNotifiable: YesReporting: Routine


Risk factors include: living in crowded conditions, day care attendance and oldersiblings in school.

IncubationPeriod

Ranges from 2 to 8 days; 4 to 6 days is most common.

Communicability Shortly prior to and for the duration of active disease. In infants, RSV sheddingmay very rarely persist up to four weeks after clinical symptoms subside.

Susceptibilityand Resistance

Illness severity is affected by conditions such as: age (under 3 months),prematurity, tobacco smoke exposure, congenital heart disease, underlyingpulmonary disease, immunodeficiency, immunosuppression and lack ofbreastfeeding.

Public Health Management

Case At this time individual cases do not require public health follow up.

Contacts Contact management of community cases is not necessary.

Outbreaks For Nunavut purposes an RSV outbreak is defined as:

A single laboratory confirmed RSV case AND Community clinics report above expected levels of ILI or respiratory illness

in children under two years

PreventionMessaging

Prophylaxis of eligible children is effective in preventing illness and reducing theimpact of disease. Synagis® (Palivizumab) is an antibody available for RSVprevention. See Synagis® protocol.

NOTE: Synagis provides passive immunity, thus missed doses leavepatients unprotected. Evidence suggests Synagis compliance in Nunavuthas been sub-optimal, thus further encouragement should be provided toadhere to the schedule.

Basic personal hygiene is also important in reducing transmission i.e. coveringnose and mouth when coughing or sneezing and regular hand hygiene. Alsoavoiding crowded living and sleeping conditions is important to preventing viraltransmission.

Health Settings Management

Infection ControlMeasures inHealth CareSettings

Place suspect RSV cases in isolation room as soon as possible, if an isolationroom is unavailable separate patient from others by at least two meters.

Instruct suspect RSV cases to don a surgical/procedural mask (with ear loops)while in the clinic, if tolerated. This is not applicable to children.

Perform hand hygiene using liquid soap and water or 60-90% alcohol-basedsanitizer before and after patient contact/assessment and after contact withcontaminated equipment.

Follow standard cleaning and disinfecting procedures for rooms and equipment.

OccupationalHealth

Surgical/procedural mask and eye protection when in close contact with thesecretions of infected patients (within two meters).

Staff providing clinical care to these patients should also wear gloves and a gown.


Surveillance

Case Definition Clinically compatible illness AND

Isolation of RSV respiratory secretions in cell culture OR Identification of viral antigen in nasopharyngeal cells by polymerase chain

reaction (PCR) or enzyme immunoassay (EIA) OR Significant rise (e.g. ≥ fourfold) in RSV antibody titre between acute and

convalescent sera

ReportingRequirementsand Forms

RSV is reportable in Nunavut. Surveillance includes laboratory-confirmed RSV,hospitalized cases and weekly reporting of respiratory illness in children less thantwo years. Note the required forms:

1. Fax the weekly ILI and Respiratory Infections reporting form eachWednesday by noon to the RCDC as follows: Baffin: 867-975-4833 Kitikmeot: 867-983-4088 Kivalliq: 867-645-8272

2. In the case of a positive rapid RSV test complete the Communicable DiseaseReporting Form (see Appendix B)

3. Report outbreaks to your RCDC who will report the information to HealthProtection

Tools

Guidelines

Materials &Resources

Nasopharyngeal swab procedure

Public Health Agency of Canada. FluWatch. Website: http://www.phac-aspc.gc.ca/fluwatch/index-eng.php

Public Health Agency of Canada. RSV: Pathogen safety data sheet (2011).Source: http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/pneumovirus-eng.php

RSV fact sheet (Appendix C)

Cross Reference Synagis Program (Nunavut)

References

Beers, MH; Porter, RS; Jones, TV; Kaplan, JL & Berkwits, M. (Eds). The Merck Manual ofDiagnosis and Therapy, 18th Edition. 2006, Merck Research Laboratories, Whitehouse StationNJ.

Hay, WW; Levin, MJ; Sondheimer, JM; & Deterding, RR (Eds). Current Diagnosis & TreatmentPediatrics 19th Ed. 2009, McGraw Hill Medical, New York

Heymann D., editor. Control of communicable diseases manual. 18th ed. Washington: AmericanPublic Health Association; 2004.

McPhee, SJ & Papadakis (Eds) 2009 Current Medical diagnosis & Treatment. 2009, McGraw Hill/Lang, San Francisco.

Public Health Agency of Canada. Canadian Immunization Guide – Seventh Edition (2006).Available online at: http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php

Synagis protocol (revised November 2012) 4

Synagis (Palivizumab) Protocol

Objective Reduce RSV-related morbidity and mortality

Note: This protocol does not replace professional judgment, NACI statements orthe product monograph.

Product

Manufacturer Boehringer Ingelheim (BI) Pharma KG and distributed by Abbott Laboratories, Ltd.

Vaccine Type Synagis® is a humanized monoclonal antibody that provides passive immunity.

Vaccinecomposition

Clinically relevant: Glycine, Histidine and Mannitol. Synagis does not containThimerosal or trace antibiotics.

Formats available Synagis® is supplied in 50 or 100 mg vials of sterile lyophilized powder forreconstitution with sterile water (specifically for reconstitution). Nunavut uses only50mg vials.

Storage Store between 2-8oC (NOTE: Consult pharmacist in the case of productfreezing)

Interchangeability Not Applicable

Administration

Indications Infants at high risk for serious morbidity and mortality secondary to RSV infection.

Eligibility Premature infants born at ≤ 35 weeks and 6 days gestation AND ≤ 6 months of

age at the start or during of the RSV season (season: January 1 to May 31)

Children < 24 months of age at the beginning of the RSV season with:

Bronchopulmonary dysplasia/Chronic lung disease of prematurity requiring

oxygen and/or ongoing medical therapy for that illness in the previous 6

months OR

Hemodynamically significant congenital heart disease OR

Other pulmonary disorders requiring oxygen therapy e.g. recurrent

aspiration OR

Other medical conditions as identified by a specialist and approved by

reviewing Synagis pediatrician

Consent Consent forms must be reviewed and signed by the parent/guardian prior to product

administration.

Dose Series Administer 15 mg/kg (if >1 mL give as divided dose).

Administer first dose beginning of January. Note: The Nunavut season is Januaryto May.

Given monthly during anticipated periods of community RSV risk to a maximum of 5doses.

Infants starting Synagis® outside of Nunavut will be reviewed on a case by casebasis upon return.


Booster Dose Not Applicable

Route ofadministration

Intramuscular (IM) injection (typically in the anterolateral thigh)

Precautions andadditional notes

Defer drug administration with moderate to severe illness, with or without fever.

Use with caution in infants with bleeding disorders.

Contraindications Do NOT administer if there is a known hypersensitivity to any component ofSynagis® or to other humanized monoclonal antibodies.

Side effects Commonly: fever, redness or swelling at the injection site Less commonly: colds, coughs, runny nose, wheeze, vomiting, rash, diarrhea,

pain, viral infections and increase in liver function tests Rare: pause in breathing or other breathing difficulties Very rare: severe allergic reactions

Anaphylaxis Please review the principles of the emergency management of anaphylaxis, asfound in Anaphylaxis: Initial Management in the Non-Hospital Setting, found in theCanadian Immunization Guide.

For emergency management of anaphylaxis refer to Anaphylaxis ManagementPolicy in the Formulary

SpecialInstruction

Ensure children referred out of territory or their communities for healthcare areaccompanied with information on their Synagis schedule and the date of their lastdose.

It is recommended that 2 nurses review the dose calculations and the reconstitutionprocess, as an additional safeguard to prevent medication errors.

If there is a significant change in weight between doses inform the CMOH office(Synagis Coordinator).

Minor illnesses (e.g. common cold) proceed to administer Synagis® if meetsremaining criteria and consent has been obtained from caregiver.

It does not interfere with the immune response to vaccines and can be administeredat the same time in a separate site i.e. normal childhood immunization schedule canbe maintained.

It does not interfere with the immune response to a TST and can be administered atthe same time in a separate site.

Synagis Registration Process (Appendix D)

1. Practitioners (in and outside the territory) identify Synagis® programcandidates throughout the year based on eligibility criteria

2. Complete Annual Synagis Registration Form (Appendix E)

3. Send registration form to the CMOH office throughout the year forapproval (approval in collaboration with pediatrician as required)

NOTE: Synagis provides passive immunity, thus missed doses

leave patients unprotected. Ensure all doses are administered

on time for maximum protection.


4. CMOH office (Synagis Coordinator) will send approved registrations toCommunity Health Center (CHC)

5. CHC will obtain consent and weight on Synagis Consent Form(Appendix F)

6. Send signed consent form to CMOH office (Synagis Coordinator)

7. CMOH office (Synagis Coordinator) to forward consent to pharmacy

8. Pharmacy to send Synagis to CHC

9. CHC to administer dose and complete Synagis Refill Request FormAppendix G) send to pharmacy

10. Pharmacy to inform CMOH office (Synagis Coordinator) of given doses

Synagis Reconstitution:

1. Synagis® is expensive, the preparation and reconstitution should bedone only when the child is in the clinic, has been weighed and is foundto be fit to receive the immunization.

2. Very slowly inject (drip along inside of vial) sterile water using aseptictechnique

3. Gently swirl vial for 30 seconds to dissolve powder. Do NOT shake orinvert vial as this may cause separation of the solute and solvent.

4. Let prepared solution stand at room temperature for at least 20 minutesuntil the solution clarifies or becomes opalescent. Use within 3 hours ofreconstitution as there is no preservative

5. Invert vial for about 30 seconds prior to drawing up solution

Vaccine Supplyand Distribution

Pharmacy will send the first dose to communities.

Each Synagis® vial is accompanied by the Synagis® Refill Request Form. Uponadministering a dose complete this form and immediately fax it to QGH pharmacy toensure timely arrival of the next dose.

Report the child’s weight at each dosing to ensure that the appropriate dose is sent.

Report changes to a patient’s home community as it affects product shipping.

Reporting

Coverage Schedule compliance is based on returned refill forms.

A final compliance report is created annually.

AEFI Report all significant adverse events using the Public Health Agency of Canada(PHAC) Adverse Events Following Immunization (AEFI) Form. Fax the form to theRCDC.

Materials andResources

A parent’s guide to prevention of RSV infection in babies. Abbott booklet. (4languages)

Annual Synagis Registration form

Synagis Consent Form

Synagis Dispensing Flow

Synagis Refill Request Form

Cross Reference RSV Public Health Protocol

References Canada Communicable Disease Report (2003). National Advisory CommitteeStatement on the Recommended Use of Monoclonal Anti-RSV Antibody


(Palivizumab); 29(ACS-7, 8).

Synagis® Product Monograph. Boehringer Ingelheim (BI) Pharma KG. December16, 2009

Prescription forprogramadministration

Administer Synagis® according to the criteria above and in accordance with theNunavut RSV season.

Name of prescriber: Dr. Maureen Baikie, Acting Chief Medical Health Officer ofHealth November 2012. This protocol is in effect for all eligible Nunavut childrenuntil rescinded or modified by CMOH.

8

Appendix A

Nasopharyngeal Swab Procedure

1. Use the swab supplied with the viral (pink universal transport media) transport media (Ensure media isrefrigerated).

2. Explain the procedure to the patient.3. When you collect specimens, wear gloves and a mask. Change gloves and wash your hands between

each patient.4. If the patient has a lot of mucous in the nose, this can interfere with the collection of cells. Either ask the

patient to use a tissue to gently clean out visible nasal mucous or clean the nostril yourself with a cottonswab (not the same swab you will be using to collect the specimen).

5. Estimate the distance to the nasopharynx; prior to insertion, measure the distance from the corner ofthe nose to the front of the ear; the swab should be inserted approximately half the length of thisdistance.

6. Seat the patient comfortably. Tilt the patient’s head back slightly to straighten the passage from thefront of the nose to the nasopharynx. This will make insertion of the swab easier.

7. Insert the swab along the medial part of the septum, along the floor of the nose, until it reaches theposterior nares; gentle rotation of the swab may be helpful (if resistance is encountered, try the othernostril, as the patient may have a deviated septum).

8. Cut the shaft of the swab with scissors, recap and place in a specimen bag with the requisition to be sentto the laboratory.

Revised November 2012 9

Appendix B

Communicable DiseaseReporting Form

Note: Only use this form if: (1) case report form is required (2) there is no specific casereport form is available or (3) reporting a rapid test result.

Fill in OR affix addressograph here

Last Name: _____________________________

First Name: ____________________________

Sex: □ Male □ Female

Date of Birth: ___(DD) ______(month) ____(YYYY)

Chart#: ________________________________

Health Card #: __________________________

Community of Residence: __________________

1. Reportable disease:________________________________________

2. Has laboratory confirmation been sought? Yes No

Result if available: _________________________________________

3. Illness onset: ______(dd)__________(month)_______(yyyy)

4. Diagnosis date: ______(dd)__________(month)_______(yyyy)

Notes (for healthcare worker use)___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

Reported by (print):________________________________________

Signature: _______________________________________________

Reporting community: ______________________________________

Report date: ______ (dd) __________ (month) _______ (yyyy)

Send to RCDC

Baffin: 867-975-4833

Kitikmeot: 867-983-4088

Kivalliq: 867-645-8272

What is respiratory syncytial virus (RSV)?

RSV is a major cause of respiratory illnessear infections and pneumonia in infants and young children

What are the symptoms of RSV?

Begins with fever, runny nose, cough and sometimes wheezin Chronic lung conditions and asthma may be aggravated Infants and children with heart or respiratory problems are at increased risk of pneumonia and

other complications from RSV

What is the treatment for RSV?

There is no specific treatment for RSV.(Synagis) to infants who are at high risk

How is RSV spread?

Contact with the discharge from the nose or mouth of an infected person The virus can be spread on a person’s hands after RSV can persist on environmental surfaces for many hours.

For how long is an infected person able to spread RSV?

Infected individuals spread RSV for as long as they are ill

How can RSV infection be prevented?

Thorough handwashing with soap and warm water. Clean surfaces with hot water and soap and disinfect

teaspoon chlorine beach in 2 cups of water) Avoid taking infants and children to public gatherings when

your community RSV prophylaxis (Synagis) is

Contact your community health centre to find out

For More InformationContact your local Community Health Center.

Fact Sheet


hat is respiratory syncytial virus (RSV)?

RSV is a major cause of respiratory illness in people. It is the most common cause of bronchiinfants and young children.

What are the symptoms of RSV?

egins with fever, runny nose, cough and sometimes wheezingChronic lung conditions and asthma may be aggravated by RSVInfants and children with heart or respiratory problems are at increased risk of pneumonia andother complications from RSV

no specific treatment for RSV. Health care providers may prescribe preventive medications(Synagis) to infants who are at high risk of becoming very ill from RSV including

Contact with the discharge from the nose or mouth of an infected personvirus can be spread on a person’s hands after he or she touches things

RSV can persist on environmental surfaces for many hours.

For how long is an infected person able to spread RSV?

spread RSV for as long as they are ill (usually 3-8 days).

How can RSV infection be prevented?

Thorough handwashing with soap and warm water.urfaces with hot water and soap and disinfect with a simple bleach and water solution (1/4

teaspoon chlorine beach in 2 cups of water)Avoid taking infants and children to public gatherings when there is a lot of respiratory illness in

RSV prophylaxis (Synagis) is recommended for prevention of RSV infection in some children.Contact your community health centre to find out if your child is eligible.

Contact your local Community Health Center.


Appendix C

February 2012 nnn

10

t is the most common cause of bronchiolitis, croup,

Infants and children with heart or respiratory problems are at increased risk of pneumonia and

Health care providers may prescribe preventive medicationsincluding premature babies.

Contact with the discharge from the nose or mouth of an infected personthings

8 days).

with a simple bleach and water solution (1/4

there is a lot of respiratory illness in

recommended for prevention of RSV infection in some children.


ᓄᕙᓗᐊᕐᓂᖅ ᐱᔾᔪᑕᐅᓪᓗᐊᑕᖅᐸᒃᐳᖅ ᐊᓂᖅᑎᕆᕙᖕᓂᒃᑯᑦ ᐋᓐᓂᐊᕆᔭᐅᕙᒃᑐᓂᒃ ᐃᓄᖕᓂᑦ

ᐱᔾᔪᑕᐅᒐᔪᖕᓂᖅᐹᖑᕗᖅ ᒪᑯᓄᖓ, bronchiolitis, croup,

ᓄᕙᖕᒥᒃ ᓄᑕᕋᓛᓂ ᓄᑕᕋᑯᓗᖕᓂᓗ.

ᑭᓲᕙᑦ ᓄᕙᓗᐊᓕᕐᓂᕐᒥᒃ ᖃᐅᔨᔾᔪᑕᐅᔪᓐᓇᖅᑐᑦ

ᐱᒋᐊᖅᐸᒃᑐᖅ ᐆᑎᕐᓇᖅᑐᖃᖅᖢᓂ

ᐊᓂᖅᑎᕆᒡᒐᓕᕐᓂᕐᒥᒃ.

ᐳᕙᒃᑯᑦ ᐋᓐᓂᐊᖃᐃᓐᓇᕐᓂᐅᕙᒃᑐᑦ ᐃᔾᔭᙳᓂᐅᕙᒃᑐᓪᓗ ᑲᔪᓯᑎᑕᐅᒃᑲᓐᓂᑐᐃᓐᓇᕆᐊᖃᖅᐳᑦ

ᓄᕙᓗᐊᕐᓂᕐᒧᑦ.

ᓄᑕᕋᓛᑦ ᓄᑕᕋᑯᓗᓄᐃᓪᓗ ᐆᒻᒪᑎᒥᒍᑦ ᐊᓂᖅᑎᕆᓂᕐᒥᒍᓪᓘᓐᓃᑦ ᐊᑲᐅᙱᓕᐅᕈᑎᖃᖅᐸᒃᑐᑦ ᐊᖏᓂᖅᓴᒥᒃ

ᖁᐊᖅᓵᕐᓇᖅᑐᒦᑉᐸᒃᐳᑦ ᐳᕙᒃᑯᓪᓗ ᐃᒻᒪᒃᓯᒪᕙᖕᓂᖅ ᓄᕙᖕᒥᒃ ᐊᓯᖏᓐᓄᓪᓗ

ᐱᔾᔪᑎᖃᕐᓗᑎᒃ.

ᖃᓄᐃᓕᐅᖅᑐᖃᖅᖢᓂ ᓄᕙᓗᐊᕐᓂᖃᖅᑐᒥᒃ ᐃᓗᐊᖅᓴᐃᔪᖃᖅᐸᒃᐸ

ᓄᕙᓗᐊᕐᓇᖅᑐᒧᑦ ᑐᕌᖓᓪᓚᑦᑖᖅᑐᒥᒃ ᐃᓗᐊᖅᓴᐅᑎᑕᖃᙳᓚᖅ

ᐱᑎᑦᑎᑐᐃᓐᓇᕆᐊᓖᑦ ᑕᐃᒪᐃᑦᑐᖅᑖᖅᑎᑦᑎᑦᑕᐃᓕᒪᓂᕐᒧᑦ ᐃ

ᖁᐊᖅᓵᕐᓇᖅᑐᒦᓪᓚᕆᒃᑐᓄᑦ ᐋᓐᓂᐊᕐᔪᐊᓕᑐᐃᓐᓇᕆᐊᖃᕐᓂᖏᓐᓄᑦ

ᐃᓄᖅᖢᑎᒃ ᐃᓅᓂᑯᑦ ᓄᑕᕋᓛᑦ.

ᖃᓄᖅ ᓄᕙᓗᐊᕐᓂᖅ ᐊᐃᑦᑐᕐᓘᑕᐅᕙᓪᓕᐊᕙᒃᐸ

ᐊᒃᑐᖅᓯᓂᒃᑯᑦ ᑲᒃᑭᒋᔭᐅᔪᓂᒃ ᖃᓂᕐᓂᙶᖅᑐᒥᒡᓘᓐᓃᑦ

ᑕᒪᓐᓇ ᐋᓐᓂᐊᕆᔭᐅᔭᒃᑐᖅ ᐊᐃᑦᑐᕐᓘᑕᐅᔪᓐᓇᖅᐳᖅ

ᓄᕙᓗᐊᕐᓇᖅᑐᖅ ᐆᒪᔪᓐᓇᖅᑐᖅ

ᖃᓄᖅ ᐊᑯᓂᐅᑎᒋᔪᖅ ᑕᐃᒪᐃᑦᑐᓕᒃ

ᑕᐃᒪᐃᑦᑐᓖᑦ ᐃᓄᐃᑦ ᐊᐃᑦᑐᕐᓗᐃᔪᓐᓇᖅᐳᑦ

ᖃᓄᖅ ᓄᕙᓗᐊᕐᓂᕐᒥᒃ ᐊᐃᑦᑐᕐᓗᒃᑕᐅᑕᐃᓕᒪᔪᖃᕈᓐᓇᖅᐸ

ᐊᒡᒐᐃᑦ ᐅᐊᓴᑦᑎᐊᖅᐸᒡᓗᒋᑦ ᐅᐊᓴᐅᒻᒧᑦ

ᖄᕆᔭᐅᔪᑦ ᓴᓗᒻᒪᖅᓴᖅᐸᒡᓗᒋᑦ ᐃᒪᕐᒧᑦ

ᑲᑎᓯᒪᔪᒧᑦ (1/4 ᐊᓗᑎᕋᓛᖅ ᔮᕕᒃᓯ

ᓄᑕᕋᓛᑦ ᓄᑕᕋᑯᓗᐃᓪᓗ ᐃᓄᒋᐊᒃᑐᓄᐊᖅᑎᑦᑕᐃᓕᕙᒡᓗᒋᑦ

ᓄᕙᓗᐊᕐᓇᖅᑐᒧᑦ prophylaxis (Synagis)

ᖃᐅᔨᒋᐊᕐᕕᒋᓗᒍ ᓄᓇᔅᓯᓐᓂ ᐋᓐᓂᐊᕕᓕᐊᕐᕕᒥ

ᑐᓴᖅᑕᖃᒃᑲᓐᓂᕈᒪᒍᕕᑦ

ᖃᐅᔨᒋᐊᕐᕕᒋᓗᒍ ᓄᓇᔅᓯᓐᓂ ᐋᓐᓂᐊᕕᓕᐊᕐᕕᓯ

ᓱᓕᔪᑦ ᑎᑎᕋᖅᓯᒪᔪᑦ

ᓄᕙᓗᐊᕐᓂᕐᒧᑦ (RSV

ᑭᓲᕙ ᓄᕙᓗᐊᕐᓂᖅ (RSV

ᓄᕙᓗᐊᕐᓂᖅ ᐱᔾᔪᑕᐅᓪᓗᐊᑕᖅᐸᒃᐳᖅ ᐊᓂᖅᑎᕆᕙᖕᓂᒃᑯᑦ ᐋᓐᓂᐊᕆᔭᐅᕙᒃᑐᓂᒃ ᐃᓄᖕᓂᑦ

bronchiolitis, croup, ᓯᐅᑎᒃᑯᑦ ᒪᕿᓂᐅᕙᒃᑐᓂ

ᓄᕙᓗᐊᓕᕐᓂᕐᒥᒃ ᖃᐅᔨᔾᔪᑕᐅᔪᓐᓇᖅᑐᑦ?

ᐱᒋᐊᖅᐸᒃᑐᖅ ᐆᑎᕐᓇᖅᑐᖃᖅᖢᓂ, ᑲᒃᑭᓕᑲᑕᒃᖢᓂ, ᖁᐃᖅᑐᖅᐸᒃᖢᓂ ᐃᓛᓐᓂᒃᑯᓪᓗ


ᓄᑕᕋᑯᓗᓄᐃᓪᓗ ᐆᒻᒪᑎᒥᒍᑦ ᐊᓂᖅᑎᕆᓂᕐᒥᒍᓪᓘᓐᓃᑦ ᐊᑲᐅᙱᓕᐅᕈᑎᖃᖅᐸᒃᑐᑦ ᐊᖏᓂᖅᓴᒥᒃ

ᐳᕙᒃᑯᓪᓗ ᐃᒻᒪᒃᓯᒪᕙᖕᓂᖅ ᓄᕙᖕᒥᒃ ᐊᓯᖏᓐᓄᓪᓗ ᓄᕙᓗᐊᕐᓂᕐᒥᒃ

ᓄᕙᓗᐊᕐᓂᖃᖅᑐᒥᒃ ᐃᓗᐊᖅᓴᐃᔪᖃᖅᐸᒃᐸ?

ᓄᕙᓗᐊᕐᓇᖅᑐᒧᑦ ᑐᕌᖓᓪᓚᑦᑖᖅᑐᒥᒃ ᐃᓗᐊᖅᓴᐅᑎᑕᖃᙳᓚᖅ. ᐋᓐᓂᐊᕕᖕᓂ ᐱᓕᕆᔨᒋᔭᐅᕙᒃᑐᑦ

ᐱᑎᑦᑎᑐᐃᓐᓇᕆᐊᓖᑦ ᑕᐃᒪᐃᑦᑐᖅᑖᖅᑎᑦᑎᑦᑕᐃᓕᒪᓂᕐᒧᑦ ᐃᓗᐊᖅᓴᐅᑎᓂᒃ (Synagis)

ᖁᐊᖅᓵᕐᓇᖅᑐᒦᓪᓚᕆᒃᑐᓄᑦ ᐋᓐᓂᐊᕐᔪᐊᓕᑐᐃᓐᓇᕆᐊᖃᕐᓂᖏᓐᓄᑦ ᓄᕙᓗᐊᕐᓇᖅᑐᒥᒃ, ᐃᓚᒋᔭᐅᓪᓗᑎᒃ

ᐊᐃᑦᑐᕐᓘᑕᐅᕙᓪᓕᐊᕙᒃᐸ?

ᖃᓂᕐᓂᙶᖅᑐᒥᒡᓘᓐᓃᑦ ᑕᐃᒪᐃᑦᑐᒥᒃ ᐋᓐᓂᐊᓕᖕᒥᑦ.

ᐊᐃᑦᑐᕐᓘᑕᐅᔪᓐᓇᖅᐳᖅ ᐃᓅᑉ ᐊᒡᒐᖏᓐᓂᑦ ᐱᖁᑎᓂᒃ ᐊᒃᑐᖅᓯᐊᓪᓚᓚᐅᕐᓗᑎᒃ

ᐊᕙᑎᑦᑕ ᖄᖏᓐᓂ ᐃᑲᕐᕋᒐᓴᖕᓄᑦ.

ᑕᐃᒪᐃᑦᑐᓕᒃ ᐃᓄᒃ ᐊᐃᑦᑐᕐᓗᐃᔪᓐᓇᖅᐸ ᓄᕙᓗᐊᕐᓂᕐᒥᒃ?

ᐊᐃᑦᑐᕐᓗᐃᔪᓐᓇᖅᐳᑦ ᓄᕙᓗᐊᕐᓂᕐᒥᒃ ᖃᓂᒪᓂᓕᒫᒥᓂ (3-ᓂᑦ-8

ᖃᓄᖅ ᓄᕙᓗᐊᕐᓂᕐᒥᒃ ᐊᐃᑦᑐᕐᓗᒃᑕᐅᑕᐃᓕᒪᔪᖃᕈᓐᓇᖅᐸ?

ᐅᐊᓴᐅᒻᒧᑦ ᐃᒪᕐᒧᓪᓗ ᐆᓇᖅᑐᒧᑦ.

ᐃᒪᕐᒧᑦ ᐆᓇᖅᑐᒧᑦ ᐅᐊᓴᐅᒻᒧᓪᓗ ᖁᐱᕐᕈᐃᓪᓗ ᑐᖁᕋᖅᐊᒡᓗᒋᑦ

ᔮᕕᒃᓯ ᐃᒪᕐᒧᑦ ᒪᕐᕉᖕᓄᑦ ᐃᕐᙳᓰᖕᓄᒃ ᐃᒪᖃᖅᑎᒋᔪᒧᑦ).

ᐃᓄᒋᐊᒃᑐᓄᐊᖅᑎᑦᑕᐃᓕᕙᒡᓗᒋᑦ ᐊᓂᖅᑎᕆᓂᒃᑯᑦ ᐋᓐᓂᐊᖅᑐᖃᐅᖅᐸᒃ

prophylaxis (Synagis) ᐊᑐᖁᔭᐅᕙᒃᐳᖅ RSV-ᑖᖅᑎᑦᑎᑦᑕᐃᓕᒪᓂᕐᒧᑦ

ᐋᓐᓂᐊᕕᓕᐊᕐᕕᒥ ᖃᐅᔨᔪᒪᒍᕕᑦ ᓄᑕᕋᐃᑦ ᑕᐃᒪᐃᑦᑐᒥᒃ

ᖃᐅᔨᒋᐊᕐᕕᒋᓗᒍ ᓄᓇᔅᓯᓐᓂ ᐋᓐᓂᐊᕕᓕᐊᕐᕕᓯ.

ᑎᑎᕋᖅᓯᒪᔪᑦ ᑕᒪᑐᒧᖓ

(RSV-ᒧᑦ)

Appendix C

ᕕᕗᐊᕆ 2012

(RSV-ᖑᓂᕋᖅᑕᐅᕙᒃᑭᓪᓗᓂ)?

ᓄᕙᓗᐊᕐᓂᖅ ᐱᔾᔪᑕᐅᓪᓗᐊᑕᖅᐸᒃᐳᖅ ᐊᓂᖅᑎᕆᕙᖕᓂᒃᑯᑦ ᐋᓐᓂᐊᕆᔭᐅᕙᒃᑐᓂᒃ ᐃᓄᖕᓂᑦ. ᑕᒪᓐᓇ

ᐳᕙᒃᑯᓪᓗ ᐃᒻᒪᒃᓯᒪᕙᖕᓂᖅ

ᖁᐃᖅᑐᖅᐸᒃᖢᓂ ᐃᓛᓐᓂᒃᑯᓪᓗ


ᓄᑕᕋᑯᓗᓄᐃᓪᓗ ᐆᒻᒪᑎᒥᒍᑦ ᐊᓂᖅᑎᕆᓂᕐᒥᒍᓪᓘᓐᓃᑦ ᐊᑲᐅᙱᓕᐅᕈᑎᖃᖅᐸᒃᑐᑦ ᐊᖏᓂᖅᓴᒥᒃ

ᓄᕙᓗᐊᕐᓂᕐᒥᒃ

ᐋᓐᓂᐊᕕᖕᓂ ᐱᓕᕆᔨᒋᔭᐅᕙᒃᑐᑦ

(Synagis) ᓄᑕᕋᓛᓄᑦ

ᓄᕙᓗᐊᕐᓇᖅᑐᒥᒃ, ᐃᓚᒋᔭᐅᓪᓗᑎᒃ

ᐊᒃᑐᖅᓯᐊᓪᓚᓚᐅᕐᓗᑎᒃ.

?

8-ᓄᑦ ᐅᓪᓗᓅᒐᔪᒃᑐᖅ).

ᑐᖁᕋᖅᐊᒡᓗᒋᑦ ᔮᕕᒃᓯᒧᑦ ᐃᒪᕐᒧᓪᓗ

).

ᐋᓐᓂᐊᖅᑐᖃᐅᖅᐸᒃ ᓄᓇᔅᓯᓐᓂ.

ᑖᖅᑎᑦᑎᑦᑕᐃᓕᒪᓂᕐᒧᑦ ᐃᓚᖏᓐᓂ ᓄᑕᖅᑲᓂ.

ᐱᑎᑕᐅᔪᓐᓇᕋᔭᕐᒪᖔᑦ.

10

Hunaukmat puvakliurniq (RSV)?

RSV puvaklipkaitjutauyuq inuknut. Bronchiolitisnamuunaqtitauyuqlu biibinnuanut nutaqqannuanutlu.

Qanuq naunaitkutauva RSV-qaliqqat?

Pilihaarutivaktuq aanialiqluni

Puvaklukhimainnaqtut anirlipkailunilu

Biibinnuat nutaqqatlu uumallukhimayut puvaklukhimayutluuniit namuuniaqtaaqtut atlatluuniit

ayurhautigiyauyut RSV-mit

Hunaukmata havautikhat RSV-mut?

Ihuarhaitjutaittuq RSV. Munarhitkut tunittaaqtut aaniarnairutimik havautinikbiibinnuanut aaniaqtaalaqihimayut RSVbiibinnuat.

Qanuqtauq RSV hiamitiqpakpa?

Kahakkumi kakkinganit qingarminit qanirminitluuniit aaniaqtumit

Tamna aaniarut hiamitiqpaktuq

RSV ittaaqtuq avatingani hunavaluit amihunik ikaarnimik

Qanuraaluk aaniarutiqaqtuq inuk hiamitiqtaaqtuq RSV

Aaniarutiqaqtut hiamitiqpaktaat RSV

CQanuqtut RSV-mik aaniarutailigiami piniaqqa?

Uaqpaklugit algaktit irmiunmik ihaqumut imarmut.

Halummaqpaklugit hunavaluit uunaqtumut imaqmut irmiutmutlu halumaiyaqlugu jaavaksiliqlugu

imaqaqtumik (1/4-mik aluutinnuamut jaavaksimik malruknut imaqmut)

Aggitihuiqlugit biibinnuat nutaqqatlu inugiaktunut puvakliuliraangata inuit nunagiyarni

RSV havaut (taiyauyuq Synagis

Uqaqatigilugu munarhitkut naunaiyariaqni nutarat havautituqtaarumi

NaunairyuumirumaguvitUqaqatigilugu Nunakni Munarhit.

Itquumayunut Titiraq

Naunaitkutaq Puvakliurniq (RSV)

Hunaukmat puvakliurniq (RSV)?

RSV puvaklipkaitjutauyuq inuknut. Bronchiolitis-lirutigivaktuq, anirliqtipkaivlunilu, hiulliuqtirutivaktuqnamuunaqtitauyuqlu biibinnuanut nutaqqannuanutlu.

qaliqqat?

Pilihaarutivaktuq aanialiqluni, kakkiktulaqiluni, qalakhuqluni anirliqlunilu

Puvaklukhimainnaqtut anirlipkailunilu pipkaitjutigivaktuq RSV-mit


mut?

Ihuarhaitjutaittuq RSV. Munarhitkut tunittaaqtut aaniarnairutimik havautinik (taiyauyuq Synagisbiibinnuanut aaniaqtaalaqihimayut RSV-mit ukuatlu Inuunarikhimayut annivikhat tikihimaittumik

Qanuqtauq RSV hiamitiqpakpa?

Kahakkumi kakkinganit qingarminit qanirminitluuniit aaniaqtumit

Tamna aaniarut hiamitiqpaktuq inuup algaminit kahagaangamik hunavaluknik

ittaaqtuq avatingani hunavaluit amihunik ikaarnimik.

Qanuraaluk aaniarutiqaqtuq inuk hiamitiqtaaqtuq RSV-mik?

Aaniarutiqaqtut hiamitiqpaktaat RSV-mik qanuraaluktut aaniarumi (3mit-

mik aaniarutailigiami piniaqqa?

Uaqpaklugit algaktit irmiunmik ihaqumut imarmut.


mik aluutinnuamut jaavaksimik malruknut imaqmut)


RSV havaut (taiyauyuq Synagis-mik) atuquyauyuq RSV-qnaittumik ilanganut nutaqqanut.

Uqaqatigilugu munarhitkut naunaiyariaqni nutarat havautituqtaarumi.

Naunaitkutaq Puvakliurniq (RSV)

Appendix C

Fipyuali 2012

10

anirliqtipkaivlunilu, hiulliuqtirutivaktuq


(taiyauyuq Synagis-mik)mit ukuatlu Inuunarikhimayut annivikhat tikihimaittumik

inuup algaminit kahagaangamik hunavaluknik

-8mut ublunik).



qnaittumik ilanganut nutaqqanut.

Qu’est-ce que le virus respiratoire syncytial (

Le VRS est une cause principale de maladies respiratoires chez les personnes.plus fréquente de bronchiolite, de croup,et les jeunes enfants.

Quels sont les symptômes du

Le VRS commence par de la fièvre, le nez qui coule,sifflante.

Le VRS peut aggraver les affection Le VRS augmente le risque de pneumonie et d’autres complications chez les nourrissons et

enfants qui ont des problèmes cardiaques ou respiratoires.

Y a-t-il un traitement pour le VRS

Il n’y a pas de traitement particulier pour lemédicaments préventifs (Synagis) aux nourrissons quimalades à cause du VRS, notamment les bébés

Comment le VRS se propage-t Par contact avec les écoulements du nez et de la bouche d’une personne infe Le virus peut se propager aux mains après Le virus peut demeurer sur

plusieurs heures.

Pendant combien de temps une personne infectée peut Une personne infectée peut propager le VRS aussi longtemps qu’elle est malade

à 8 jours).

Comment peut-on prévenir l’infection à

En se lavant bien les mains avec du savon et En nettoyant les surfaces avec de l’eau chaude et du savon et en d

javellisant et une solution aqueused’eau).

En évitant d’amener les nourrissons etplusieurs cas de maladies respiratoires dans votre collectivité.

On recommande de prendre de laVRS chez certains enfants. Communiquez avec vsi votre enfant est admissible.

Pour de plus amples renseignementsCommuniquez avec votre Centre local de santé communautaire

Fiche de renseignements

Le virus respiratoire syncytial (VRS)

virus respiratoire syncytial (VRS)?

cause principale de maladies respiratoires chez les personnes.croup, d’infections aux oreilles et de pneumoni

VRS?

ommence par de la fièvre, le nez qui coule, la toux et quelquefois une respiration

affections pulmonaires et l’asthme chroniques.augmente le risque de pneumonie et d’autres complications chez les nourrissons et

enfants qui ont des problèmes cardiaques ou respiratoires.

VRS?

pas de traitement particulier pour le VRS. Les professionnels de la santé peuventdicaments préventifs (Synagis) aux nourrissons qui présentent des risques élevés de devenir

à cause du VRS, notamment les bébés prématurés.

t-il?ontact avec les écoulements du nez et de la bouche d’une personne infe

Le virus peut se propager aux mains après qu’une personne ait touché des objets.peut demeurer sur des surfaces présentes dans l’environnement contaminé pendant

de temps une personne infectée peut-elle propager leUne personne infectée peut propager le VRS aussi longtemps qu’elle est malade

on prévenir l’infection à VRS?

En se lavant bien les mains avec du savon et de l’eau chaude.En nettoyant les surfaces avec de l’eau chaude et du savon et en désinfectant avec

aqueuse (1/4 cuil. à thé de produit à blanchir au chlore dans

En évitant d’amener les nourrissons et les enfants à des rencontres publiques quand il y aplusieurs cas de maladies respiratoires dans votre collectivité.

de prendre de la prophylaxie anti-VRS (Synagis) pour prévenir les infections àins enfants. Communiquez avec votre centre de santé communautaire pour savoir

si votre enfant est admissible.

Pour de plus amples renseignementsCommuniquez avec votre Centre local de santé communautaire.

Fiche de renseignements


Appendix C

Février 2012 nnn

10

cause principale de maladies respiratoires chez les personnes. Le VRS est la cause lapneumonie chez les nourrissons

la toux et quelquefois une respiration

s.augmente le risque de pneumonie et d’autres complications chez les nourrissons et les

Les professionnels de la santé peuvent prescrire dessentent des risques élevés de devenir

ontact avec les écoulements du nez et de la bouche d’une personne infectée.qu’une personne ait touché des objets.

présentes dans l’environnement contaminé pendant

elle propager le VRS?Une personne infectée peut propager le VRS aussi longtemps qu’elle est malade (en général de 3

sinfectant avec un simplecuil. à thé de produit à blanchir au chlore dans 2 tasses

les enfants à des rencontres publiques quand il y a

(Synagis) pour prévenir les infections àotre centre de santé communautaire pour savoir


Synagis®

Practitioners identify Synagis®program candidates throughout

the year based on eligibility criteria

Practitioners completeSynagis Registration Form

Send registration form to OCMOHthroughout the year for approval

Approved registrations sent to CHC

CHC to:

1. Obtain consent and weight

2. Send signed consent to OCMOH

OCMOH to send consent topharmacy

Pharmacy to send Synagis to CHC

CHC to:

1. Administer dose

2. Complete Synagis refill request formand sent to pharmacy

Appendix D

Synagis® Registration and Dispensing Flow

Practitioners identify Synagis®program candidates throughout

the year based on eligibility criteria

Practitioners complete AnnualSynagis Registration Form

Send registration form to OCMOHthroughout the year for approval

Consult with designatedpediatrician as required

Approved registrations sent to CHC

1. Obtain consent and weight

2. Send signed consent to OCMOH

OCMOH to send consent topharmacy

Pharmacy to send Synagis to CHC

Synagis refill request form

Pharmacy to inform OCMOH of givendoses

Abbreviations:CHC = Community Health CenterOCMOH = Office of the Chief Medical Officer of Health

14

Consult with designatedpediatrician as required

Pharmacy to inform OCMOH of givendoses

Abbreviations:CHC = Community Health CenterOCMOH = Office of the Chief Medical Officer of Health

Synagis Registration Form (revised November 2012) 15

Appendix E

Annual Synagis Registration Form


Last Name: _____________________

First Name: _____________________



Chart#: ________________________

Health Card #: ________________________


Eligibility criteria (check all applicable):

Fax to CMOH Office 1-867-979-3190

CMOH /DCMOH or Designated Pediatrician

Signature: ________________

Date: ___ (DD) ______ (month) ____ (YYYY)

□ Premature infants ≤ 35 weeks + 6 days gestation AND ≤ 6 months of age at or during the RSV season (season: January 1 to May 31). Gestational age at birth:______________

□ Children < 24 months of age at the beginning of the RSV season with:

□ Bronchopulmonary dysplasia/Chronic lung disease of prematurity requiring oxygenand/or ongoing medical therapy for that illness in the previous 6 months

□ Hemodynamically significant congenital heart disease

□ Other pulmonary disorders requiring oxygen therapy e.g. recurrent aspiration

□ Children < 24 months of age at the beginning of the RSV season with other medical conditionas identified by a specialist/healthcare provider (Specify condition or attach letter):

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Practitioner Name____________________________________________Signature___________________________________________________Contact information __________________________________________

Comments______________________________________________________________________________________________________________________________________________________________________________________________________________________________

Submission date: ___ (DD) ______ (month) ____ (YYYY)

Synagis Consent Form (revised November 2012) 16

Appendix F

Synagis Consent Form

Information:

Fax to CMOH Office 1-867-979-3190


Last Name: _____________________

First Name: _____________________



Chart#: ________________________

Health Card #: ________________________


Parent/Guardian Name: ____________________________

Signature: ____________________________Date: ____ (DD) ______ (month) _____ (YYYY)

Synagis (palivizumab) provides protection against Respiratory Syncytial Virus (RSV), the cause ofpotentially serious respiratory illnesses

The protection that each dose of Synagis provides against RSV wears off in 3-4 weeks

To decrease the chance of your child from getting sick from RSV it is important that they get allSynagis doses on schedule

Be aware your child may not get Synagis if they have:

Known hypersensitivity to Synagis® components or other humanized monoclonalantibodies

Moderate to severe illness, with or without fever (call the health center to inform them and

schedule next dose for as soon as possible)

Adverse Events:

Commonly: fever, redness or swelling at the injection site

Rare: pause in breathing or other breathing difficulties

Very rare: severe allergic reactions

I have read the above information or had it read it to me and understand it. I understand to best protect my child from RSV I must bring them on time for all doses. I have asked questions and had them answered to my satisfaction.

Child’s current weight (kg) ____________________

Synagis Refill Request Form (revised November 2012) 17

Appendix G

Synagis Refill Request

Form

Complete this form as soon as a dose of Synagis is given

Drug administration information:

Refill request:


Last Name: _____________________

First Name: _____________________



Chart#: ________________________

Health Card #: ________________________


Current weight (kg)___________

Dose given (mg) ____________

Date given _____ (dd) _______(month) _____(yyyy)

Fax to QGH Pharmacy

1-867-979-7338

Administrator Name: ________________

Signature: ______________________

Date: ___ (DD) ______ (month) ____ (YYYY)

Send next dose

Synagis discontinued

Last dose – do not send next dose

Next Dose Due

Comments:___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

___________________________________________________________________

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