Država: Kanada
Jezik: engleski
Izvor: Health Canada
GABAPENTIN
BGP PHARMA ULC
N02BF01
GABAPENTIN
100MG
CAPSULE
GABAPENTIN 100MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125929001; AHFS:
APPROVED
2001-01-05
_NEURONTIN (gabapentin) _ _Page 1 of 38_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NEURONTIN® Gabapentin Capsules Capsules, 100 mg, 300 mg and 400 mg, oral Gabapentin Tablets Tablets, 600 mg and 800 mg, oral Antiepileptic Agent BGP Pharma ULC 85 Advance Road Etobicoke (Ontario) Canada M8Z 2S6 Date of Initial Approval: MAY 05, 2023 Date of Revision: OCTOBER 16, 2023 Submission Control No: 275525 ® Viatris Specialty LLC BGP Pharma ULC, a Viatris company, Licensee © BGP Pharma ULC, 2023 _ _ _NEURONTIN (gabapentin) _ _Page 2 of 38_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 10-2023 7.1 Special Populations, 7.1.1 Pregnant Women, Neonatal withdrawal syndrome 02-2023 7.1 Special Populations, 7.1.1 Pregnant Women, Women of childbearing potential/Contraception 10-2023 7.1 Special Populations, 7.1.1 Pregnant Women, Teratogenic Potential 10-2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ...................... Pročitajte cijeli dokument