ZALTRAP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

AFLIBERCEPT

Διαθέσιμο από:

SANOFI-AVENTIS CANADA INC

Φαρμακολογική κατηγορία (ATC):

L01XX44

INN (Διεθνής Όνομα):

AFLIBERCEPT

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

AFLIBERCEPT 100MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

4ML/3X4ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0154950002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2020-07-13

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
Pr
ZALTRAP
™
Aflibercept
Concentrate for solution for infusion, 25 mg/mL
100 mg and 200 mg vials
Antineoplastic agent
ATC code: L01XX44
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Québec H7V 0A3
Date of Preparation:
August 3, 2016
Submission Control No.: 196179
Date of Approval: August 5, 2016
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
..........................................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
..........................................................................................................28
TOXICOLOGY
............