LUTREPULSE POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

GONADORELIN ACETATE

Disponible desde:

FERRING INC

Código ATC:

H01CA01

Designación común internacional (DCI):

GONADORELIN

Dosis:

3.2MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

GONADORELIN ACETATE 3.2MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10ML VIAL

tipo de receta:

Prescription

Área terapéutica:

GONADOTROPINS AND ANTIGONADOTROPINS

Resumen del producto:

Active ingredient group (AIG) number: 0121867001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-08-27

Ficha técnica

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PRODUCT MONOGRAPH
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LUTREPULSE
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Gonadorelin Acetate for Injection
3.2 mg/vial
(0.9% Sodium Chloride for Injection (USP) (diluent)
Subcutaneous (SC) Use Only
Ovulatory Agent
Ferring Inc.
200 Yorkland Blvd.
Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
May 17, 2016
Submission Control No: 187199
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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
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
..........................................................................................................26
TOXICOLOGY
.....................................................................................