Country: Канада
Језик: Енглески
Извор: Health Canada
PERMETHRIN
INSIGHT PHARMACEUTICALS, LLC
P03AC04
PERMETHRIN
1%
CREAM
PERMETHRIN 1%
TOPICAL
56 GM
OTC
SCABICIDES AND PEDICULICIDES
Active ingredient group (AIG) number: 0120085001; AHFS:
APPROVED
2001-02-01
_Product Monograph _ _Прочитајте комплетан документ _ _Page 1 of 16_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NIX® CRÈME RINSE PERMETHRIN CREAM 1% Topical Pediculicide and Ovicide ATC Code: P03AC04 Insight Pharmaceuticals LLC 660 White Plains Road, Suite 250 Tarrytown, NY 10591, USA Date of Initial Authorization: Apr 29, 2003 Date of Revision: Dec 6, 2022 Submission Control Number: 263926 ®Trademark _ _ _Product Monograph _ _ _ _ _ _Page 2 of 16_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 4 DOSAGE AND ADMINISTRATION 01/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 4 4.1 Dosing Considerations ....................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.3 Reconstitution ................................................................................................... 5 4.4 Administration