Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
HYOSCINE BUTYLBROMIDE
OMEGA LABORATORIES LIMITED
A03BB01
BUTYLSCOPOLAMINE
20MG
SOLUTION
HYOSCINE BUTYLBROMIDE 20MG
INTRAMUSCULAR
100
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0104703002; AHFS:
APPROVED
2020-11-23
PRESCRIBING INFORMATION AND PATIENT MEDICATION INFORMATION PR HYOSCINE BUTYLBROMIDE INJECTION BP 20 mg/mL Sterile Solution Antispasmodic Omega Laboratories Ltd. Date of Preparation: November 20, 2020 11177 Hamon Montreal, Quebec, H3M 3E4 Submission Control No.: 235093 _Hyoscine Butylbromide Injection BP _ _Page 2 of 18 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................. 3 INDICATIONS AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS ............................................................................................................ 3 WARNINGS AND PRECAUTIONS .......................................................................................... 4 ADVERSE REACTIONS ............................................................................................................ 6 DRUG INTERACTIONS ............................................................................................................. 7 DOSAGE AND ADMINISTRATION ......................................................................................... 8 OVERDOSAGE ........................................................................................................................... 9 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 10 STORAGE AND STABILITY .................................................................................................. 11 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 11 PART II: SCIENTIFIC INFORMATION ................................................................................ 12 PHARMACEUTICAL INFORMATION .................................................................................. 12 REFERENCES .............................................. Aqra d-dokument sħiħ