MIFISO KIT

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MISOPROSTOL; MIFEPRISTONE

Pieejams no:

LINEPHARMA INTERNATIONAL LIMITED

ATĶ kods:

G03XB51

SNN (starptautisko nepatentēto nosaukumu):

MIFEPRISTONE, COMBINATIONS

Deva:

200MCG; 200MG

Zāļu forma:

KIT

Kompozīcija:

MISOPROSTOL 200MCG; MIFEPRISTONE 200MG

Ievadīšanas:

BUCCAL

Vienības iepakojumā:

1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0257170002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-12-16

Produkta apraksts

_Mifiso (mifepristone tablets and misoprostol tablets kit) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MIFISO
Mifepristone tablet
Tablet, mifepristone 200 mg, oral administration
Progesterone receptor modulator
and
Misoprostol tablets
Tablets (4), misoprostol 200 mcg (each),
buccal administration
Prostaglandin
Medical Termination of Pregnancy
Sponsor:
LINEPHARMA INTERNATIONAL LIMITED
16, Upper Woburn Place,
London, WC1H 0BS
United Kingdom
Date of Initial Authorization:
DEC. 15, 2022
Date of Revision:
DEC. 15, 2022
Importer and distributor in Canada:
LINEPHARMA INTERNATIONAL INC.
402-21 St Clair Ave E
Toronto, Ontario
M4T 1L9
Submission Control No: 265940
_Mifiso (mifepristone tablets and misoprostol tablets kit) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjus