LAPELGA SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PEGFILGRASTIM

Prieinama:

APOTEX INC

ATC kodas:

L03AA13

INN (Tarptautinis Pavadinimas):

PEGFILGRASTIM

Dozė:

6MG

Vaisto forma:

SOLUTION

Sudėtis:

PEGFILGRASTIM 6MG

Vartojimo būdas:

SUBCUTANEOUS

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Produkto santrauka:

Active ingredient group (AIG) number: 0149962001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2022-07-22

Prekės savybės

_Lapelga_
_®_
_ Product Monograph _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LAPELGA
®
pegfilgrastim Injection
Solution, 10 mg/mL,
Subcutaneous Injection Only
Professed Standard
Hematopoietic Agent,
Granulocyte Colony-Stimulating Factor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF INITIAL APPROVAL:
April 5, 2018
DATE OF REVISION:
July 22, 2022
Submission Control No: 259222
_ _
_Lapelga_
_®_
_ Product Monograph _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis
5/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
5/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1 Pediatrics (< 18 years of age):
...........................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 4
4
DOSAGE AND ADMINISTRATION
..............................................................................
4
4.1 Dosing Considerations
.......................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
................................................... 4
4.3
Reconstitution....................................................................................................
5
4.4
Administration....................................................................................................
5
4.5 Missed Dose
.....................................................................................................
5
5
OVERDOSAGE
.......................................................