LAPELGA SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PEGFILGRASTIM

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

L03AA13

INN (Διεθνής Όνομα):

PEGFILGRASTIM

Δοσολογία:

6MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

PEGFILGRASTIM 6MG

Οδός χορήγησης:

SUBCUTANEOUS

Μονάδες σε πακέτο:

0.6ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HEMATOPOIETIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-04-05

Αρχείο Π.Χ.Π.

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