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Interim guidance for emerge.

Interim Guidance for emergency use of oseltamivir (Tamiflu®) In children.
Home > H1N1 flu virus > Information For Health Professionals > Interim Guidance for emergency use of Interim Guidance for emergency use of oseltamivir (Tamiflu® ) In childrenunder one year of age in the context of 2009 (H1N1) pandemic The following guidance should be read in conjunction with relevant provincial and territorial guidancedocuments. The Public Health Agency of Canada will be posting regular updates and related documents
This guidance document has been prepared by the Public Health Agency of Canada to assist clinicians in themanagement of children under one year of age presenting with Influenza-like-illness (ILI) in the context ofthe (H1N1) 2009 pandemic. It is based on current scientific evidence, expert opinion and Health Canada’sInterim Order regarding the expanded use of oseltamivir for the novel influenza A H1N1 virus in children under 1 year of age. [7] Although there are limited data supporting the use of Tamiflu® in children underone, there now exists an urgent need for recommendations to treat this population, given this group’sincreased risk for morbidity and mortality from influenza. Similar actions have also been taken internationally by the US FDA [3] and the EMEA [4] . This guidance is subject to review and change as newinformation becomes available. These guidelines should be used in conjunction with guidance contained inthe H1N1 PHAC Guidelines for health professionals , Annex E and Annex G of the Canadian PandemicInfluenza Plan. Healthy children under 24 months and children with certain chronic health conditions are at increased risk of influenza-related complications and hospitalization from influenza.[1] Recent Canadian epidemiologicaldata shows higher rates of hospitalization, ICU admissions and deaths in children under 1 compared withall H1N1 cases in Canada. Young children usually have higher temperatures and may have febrile seizures.
Unexplained fever may be the only manifestation of the disease in infants. In infants less than 2 monthsold, the condition can progress rapidly to severe illness. Children 3 years and younger may experiencenausea, vomiting, diarrhea and abdominal pain. Up to 20% of infants and may also present with neurologic symptoms suggestive of meningitis or encephalitis.[2] CLINICAL MANAGEMENT of children under 1 year of age Antivirals can reduce complications and mortality from influenza. Currently, the novel H1N1 virus is susceptible to oseltamivir (Tamiflu® ) and zanamivir (Relenza® ), but resistant to amantadine. Relenza® isindicated only in children 7 years or older. Health Canada’s Interim Order permits the expanded use ofoseltamivir as a treatment or prophylaxis for children under 1 year of age, for infection caused by thepandemic (H1N1) 2009 virus due to recent clinical data suggesting its comparable safety profile identified in children over 1. [5] Adverse event data regarding use in children over 1 year of age is available in the Product Monograph. [6] After a careful assessment, antivirals may be prescribed with clinical discretionproviding the potential benefits to the health of the infant outweigh the risks. The parents or guardianshould be informed that this is exceptional use. This may apply to suspect cases where rapid test ispositive, febrile children without another clear cause and a positive contact history, and febrile infants withrespiratory compromise. If oseltamivir is prescribed, the following dosing is recommended: Interim Guidance for emergency use of oseltamivir (Tamiflu®) In children.
Paediatric suspension should be given if available; if not, refer to “Emergency Compounding of an oral suspension from Tamiflu® capsules” on page 16 of the product monograph. [6] Children under 1 year ofage with influenza should be treated in hospital. If during the H1N1 pandemic demands on hospitalresources become too great, hospitalization is still indicated in children less than 3 months, due to theirincreased risk of progressing rapidly to severe disease. Treatment should be started as soon as possible;benefit wanes if treatment is initiated after 48 hours of the onset of symptoms. Prophylactic use of antivirals other than for outbreak control in closed settings are NOT an approved use ofthe National Antiviral Stockpile. If, after a careful risk/benefit assessment this is thought to be clinicallyindicated for a particular patient, antivirals would need to be prescribed through the usual means (i.e.,obtained through a pharmacy). *Note that based on the available data, prevention of influenza in infants under 3 months of age is notrecommended at this time unless there has been significant exposure and/or the risk of severe illness isconsidered to be high. In children, viral shedding may continue for up to 14 days after the onset of influenza illness. Therefore, if the index case is a child, prophylaxis with TAMIFLU® may continue for up to14 days.
Reports of adverse reactions to antiviral medications are important as this information will be used to guidetheir safe and effective use, particularly in certain populations where there may only be limited safety dataavailable, for example pregnant women and children <1. Please promptly report any suspected seriousadverse reactions involving an antiviral medication to Health Canada at: Adverse reaction reporting, Marketed Health Products or call: 1-866-234-2345. [8] The Interim Order regarding the expanded use of Tamiflu® for children under one year of age applies to allstrengths and formulations: DIN#02304848, 30mg capsuleDIN#02304856, 45mg capsuleDIN#02241472, 75mg capsuleDIN#02245549, 12mg/ml (reconstituted) oral suspension 1. National Advisory Committee on Immunization. Statement on influenza vaccination for the 2007-2008 season. Canadian Communicable Disease report 2008; 34:10-14.
2. Public Health Agency of Canada. Canadian Pandemic Influenza Plan for the Health Sector: Annex G Clinical Care Guidelines and Tools. 2008; 16.
3. US FDA. Tamiflu Emergency Use letter April 2009. Available at: /DrugSafety/InformationbyDrugClass/UCM143872.pdf 4. European Medical Agency. Follow-up Recommendations from CHMP on Novel Influenza (H1N1) outbreak .May 2009. Available at: Interim Guidance for emergency use of oseltamivir (Tamiflu®) In children.
5. Okamato S , Kamiya I , Kishida K et al. Experience with Oseltamivir for Infants Younger than 1 year old in Japan. Pediatric Infectious Disease Journal;24:931-932.
6. Roche Canada. Tamiflu product monograph. July 2009.Available at: /portal/eipf/ca/portal/roche/consumer_information;jsessionid=KlX2hJpc6hXp8gQ1mb6RSpV5WLWf2LVhpZsDN2CrZGvC1JC2Q64M!792815078?paf_gear_id=17700009&paf_pageId=re7191019&glossary_id=static/glossary/re7300002/re77300002/re77300003/re753001/Definition_01049.content 7. Interim Order Respecting the Sale of Oseltamivir Phosphate – Expanded Use for Children Under 1 8. Reporting Adverse Reactions to Antiviral Drugs During an Influenza Pandemic - Guidelines for Health Professionals and Consumers. Located at:


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