Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
LANREOTIDE (LANREOTIDE ACETATE)
IPSEN BIOPHARMACEUTICALS CANADA INC
H01CB03
LANREOTIDE
60MG
SOLUTION (EXTENDED RELEASE)
LANREOTIDE (LANREOTIDE ACETATE) 60MG
SUBCUTANEOUS
60MG/SYRINGE
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0151653006; AHFS:
APPROVED
2010-09-13
_SOMATULINE_ _®_ _ AUTOGEL_ _®_ _ _(lanreotide injection)_ _ _Page 1 of 57_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SOMATULINE ® AUTOGEL ® lanreotide injection Extended release solution 60 mg, 90 mg, 120 mg lanreotide (as lanreotide acetate)/unit (syringe), subcutaneous Antigrowth hormone Ipsen Biopharmaceuticals Canada Inc. 5050 Satellite Drive, Suite 500 Mississauga, Ontario L4W 0G1 www.ipsen.ca Date of Initial Authorization: JUL 17, 2006 Date of Revision: AUG 08, 2023 Submission Control Number: 268030 _ _ _SOMATULINE_ _®_ _ AUTOGEL_ _®_ _ (lanreotide injection) _ _Page 2 of 57_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential, Fertility 12/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential, Teratogenic Risk 12/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 12/2022 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 06/2023 11 STORAGE, STABILITY AND DISPOSAL 08/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ............................................................................................................. 4 1.2 Geriatrics ............................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 5 4.1 Dosing Considerations ......................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ..................................................... 6 4.3 Reconsti Belgenin tamamını okuyun