ACH-OSELTAMIVIR PHOSPHATE CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
31-03-2023

Viambatanisho vya kazi:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Inapatikana kutoka:

ACCORD HEALTHCARE INC

ATC kanuni:

J05AH02

INN (Jina la Kimataifa):

OSELTAMIVIR

Kipimo:

75MG

Dawa fomu:

CAPSULE

Tungo:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 75MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0139501001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2023-04-03

Tabia za bidhaa

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-OSELTAMIVIR PHOSPHATE
Oseltamivir Phosphate Capsules
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
USP
Antiviral Agent
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
March 31, 2023
Submission Control Number: 247245
ACH-OSELTAMIVIR PHOSPHATE (oseltamivir phosphate)
Page 2 of 41
RECENT MAJOR LABEL CHANGES
Not applicable
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
...................................................................................................................................
5
1.2
Geriatrics
...................................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................................
5
4
DOSAGE AND ADMINISTRATION
................................................................................................
5
4.1
Dosing Considerations
...............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................................................................
6
4.3
Reconstitution
..........................................................................
                                
                                Soma hati kamili
                                
                            

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