NUCEIVA POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRABOTULINUMTOXINA

Διαθέσιμο από:

EVOLUS INCORPORATED

Φαρμακολογική κατηγορία (ATC):

M03AX01

INN (Διεθνής Όνομα):

BOTULINUM TOXIN

Δοσολογία:

100UNIT

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

PRABOTULINUMTOXINA 100UNIT

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

2.5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0160590001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-08-16

Αρχείο Π.Χ.Π.

_NUCEIVA (prabotulinumtoxinA) _
_ _
_Page 1 of 22 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NUCEIVA
prabotulinumtoxinA for injection
Sterile vacuum-dried powder for solution for injection
100 Units per vial
Neuromuscular Blocking Agent
Evolus, Inc.
520 Newport Center Drive, Suite 1200
Newport Beach, CA 92660
Date of Initial Approval:
August 16, 2018
Date of Revision:
November 1, 2023
Submission Control No: 274457
_NUCEIVA (prabotulinumtoxinA) _
_ _
_Page 2 of 22 _
RECENT MAJOR LABEL CHANGES
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2022
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
............................................ 4
4
DOSAGE AND ADMINISTRATION
.....................................................................
5
4.1
Dosing Considerations
...............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................... 5
4.3
Reconstitution
............................................................................................
5
4.4
Administration
............................................................................................
5
5
OVERDOSAGE
......................................................