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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
ShingrixNovember 22, 2021 Shingrix, Herpes Zoster vaccinePage 1 of 36 PRODUCT MONOGRAPHINCLUDING PATIENT MEDICATION INFORMATIONSHINGRIXH erpes Zoster vaccine (non-live recombinant, AS01 Badjuvanted)Suspension for injection, 50 mcg Varicella Zoster Virus (VZV) glycoprotein E (gE), Intramuscular InjectionActive Immunizing AgentGlaxoSmithKline RoadMississauga, OntarioL5N 6L4 Date of Initial Authorization:October13, 2017 Date of Revision:November 24, 2021 Submission Control Number: 246933 2021 GSK group of companies or its licensorTrademarks are owned by or licensed to theGSK group of companiesShingrixNovember 22, 2021 Shingrix, Herpes Zoster vaccinePage 2 of 36 RECENTMAJOR LABEL CHANGESS ectionDate1 INDICATIONS11/20214 DOSAGE AND ADMINISTRATION, Recommended Dose andDose Adjustment11/20217 WARNINGSAND PRECAUTIONS11/2021 TABLE OF CONTENTSS ections orsubsections that are not applicable at the time of authorization are MAJOR LABEL OF 44 DOSAGE AND Dose and Dosage FORMS, STRENGTHS, COMPOSITION AND 57 WARNINGS AND Reaction 22, 2021 Shingrix, Herpes Zoster vaccinePage 3 of Trial Advers
4.5 Missed Dose If you miss a scheduled injection, it is important that you make another appointment. 5 OVERDOSAGE No cases of overdosage have been reported. For management of a suspected drugoverdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
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