HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP POWDER FOR SOLUTION
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
24-03-2022
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)
Inapatikana kutoka:
HIKMA CANADA LIMITED
ATC kanuni:
H02AB09
INN (Jina la Kimataifa):
HYDROCORTISONE
Kipimo:
250MG
Dawa fomu:
POWDER FOR SOLUTION
Tungo:
HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 250MG
Njia ya uendeshaji:
INTRAMUSCULAR
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
ADRENALS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0106344004; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2022-05-04
Tabia za bidhaa
Page 1 of 38
PRODUCT MONOGRAPH
Pr
HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP
Sterile Powder for Solution,
100 mg and 250 mg hydrocortisone per vial
For Intramuscular and Intravenous use
Glucocorticoid
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Preparation:
March 24, 2022
Control number: 263057
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................
3
CONTRAINDICATIONS
...................................................................................................
6
WARNINGS AND PRECAUTIONS
..................................................................................
6
ADVERSE REACTIONS
..................................................................................................14
DRUG
INTERACTIONS...................................................................................................18
DOSAGE AND
ADMINISTRATION................................................................................22
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
...............................................................25
STORAGE AND
STABILITY...........................................................................................27
DOSAGE FORMS, COMPOSTION AND PACKAGING
..................................................27
PART II: SCIENTIFIC
INFORMATION.........................................................................
28
TOXICOLOGY
.................................................................................................................28
REFERENCES
...........................................................................................................
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