LAPELGA SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

PEGFILGRASTIM

Inapatikana kutoka:

APOTEX INC

ATC kanuni:

L03AA13

INN (Jina la Kimataifa):

PEGFILGRASTIM

Kipimo:

6MG

Dawa fomu:

SOLUTION

Tungo:

PEGFILGRASTIM 6MG

Njia ya uendeshaji:

SUBCUTANEOUS

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-07-22

Tabia za bidhaa

_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
.......................................................