MORPHINE SULFATE INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

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Prenos Lastnosti izdelka (SPC)
17-06-2020

Aktivna sestavina:

MORPHINE SULFATE

Dostopno od:

JAMP PHARMA CORPORATION

Koda artikla:

N02AA01

INN (mednarodno ime):

MORPHINE

Odmerek:

10MG

Farmacevtska oblika:

SOLUTION

Sestava:

MORPHINE SULFATE 10MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

15G/50G

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

OPIATE AGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0104545001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-06-18

Lastnosti izdelka

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MORPHINE SULFATE INJECTION
Sterile Solution
2 mg/mL
,
10 mg/mL and 15 mg/mL
USP
Intravenous, Intramuscular, and Subcutaneous
Narcotic Analgesic
JAMP Pharma Corporation
Date of Preparation: June 17, 2020
1310 rue Nobel
Boucherville, Quebec,
Canada
J4B 5H3
Submission Control Number: 233783
_Morphine Sulfate Injection _
_Page 2 of 32_
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 20
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION 23
PHARMACEUTICAL INFORMATION
.........................................................................
23
REFERENCES
..................................................................................................................
24
PATIEN
                                
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