JAMP MIDODRINE TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

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Download Vara einkenni (SPC)
30-06-2021

Virkt innihaldsefni:

MIDODRINE HYDROCHLORIDE

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

C01CA17

INN (Alþjóðlegt nafn):

MIDODRINE

Skammtar:

5MG

Lyfjaform:

TABLET

Samsetning:

MIDODRINE HYDROCHLORIDE 5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ALPHA-ADRENERGIC AGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0123066002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-07-08

Vara einkenni

                                Page 1 of 22
PRODUCT MONOGRAPH
Pr
JAMP MIDODRINE
Midodrine Hydrochloride Tablets USP
2.5 mg and 5 mg of midodrine hydrochloride
Vasopressor
JAMP PHARMA CORPORATION
1310 rue Nobel
Boucherville, Qu
é
bec
J4B 5H3
DATE OF PREPARATION:
June 30, 2021
CONTROL NO.: 235448
Page 2 of 22
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 4
SUMMARY PRODUCT INFORMATION
.........................................................................
4
INDICATIONS AND CLINICAL USE
..............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE
REACTIONS...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
...............................................................................10
OVERDOSAGE
...............................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
...............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................13
PART II: SCIENTIFIC
INFORMATION.........................................................................
14
PHARMACEUTICAL INFORMATION
...........................................................................14
CLINICAL TRIALS
.........................................................................................................16
DETAILED PHARMACOLOGY
............................................................................
                                
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