CYSTORELIN Solution

Nazione: Canada

Lingua: francese

Fonte: Health Canada

Principio attivo:

Diacétate de gonadoréline tétrahydrique

Commercializzato da:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosaggio:

50MCG

Forma farmaceutica:

Solution

Composizione:

Diacétate de gonadoréline tétrahydrique 50MCG

Via di somministrazione:

Intramusculaire

Confezione:

10/30/50ML

Tipo di ricetta:

Prescription

Gruppo terapeutico:

Bétails

Dettagli prodotto:

Numéro de groupe d'ingrédients actifs (GIA) :0114053001

Stato dell'autorizzazione:

ANNULÉ APRÈS COMMERCIALISATION

Data dell'autorizzazione:

2021-07-05

Foglio illustrativo

LOT
EXP
abcd
ACTIVE INGREDIENT PER ML:
50 µg of gonadorelin
diacetate tetrahydrate
Administer I.M.
100 µg (2 mL) / cow
SEE PACKAGE INSERT
Store at or below 25°C
DO NOT FREEZE
Boehringer Ingelheim
Animal Health Canada Inc.
5180 South Service Road
Burlington ON L7L 5H4
INGRÉDIENT ACTIF PAR ML :
50 µg de diacétate de
gonadoréline tétrahydrique
Administrer par voie i.-m.
100 µg (2 mL) / vache
VOIR LE DÉPLIANT
Entreposer à une température
égale ou inférieure à 25 °C
NE PAS CONGELER
Boehringer Ingelheim
Santé Animale Canada Inc.
5180 South Service Road
Burlington ON L7L 5H4
DIN
02172704
10 ML
Veterinary use only
Usage vétérinaire seulement
Gonadorelin Sterile Solution
Solution stérile de gonadoréline
WARNINGS / MISES EN GARDE :
See package insert for more information
Voir le dépliant pour plus d'information
2020-1865-03
Please provide the regulatory required implementation
date for each country or country group providing approvals.
MARKETING approval:
COMPLETE NAME + DATE + SIGNATURE:
COMPLETE NAME + DATE + SIGNATURE:
REGULATORY approval:
LOCAL REGULATORY AUTH. IMPLEMENTATION REQUIREMENTS
COUNTRY
RA IMPLEMENTATION DEADLINE
COMMENTS/DIRECTIONS
P XXX
BLACK
P XXX
P XXX
P XXX
P 072
P XXX
P XXX
PACKAGING GRAPHIC ARTWORK APPROVAL
CODE: 2020-1865-03
OLD CODE: 2020-1865-01 (02 not produced)
DIMENSIONS:
Please use the official PANTONE® (P) matching
system for an accurate color representation.
SPEC#: TBD
VERSION
PRODUCT: CYSTORELIN
10mL Label
FOR SUBMISSION ONLY
BAR CODE(S): N/A
VERSION - DATE:
A - 03/APR/2020
B - 12/MAY/2020
COUNTRY: CANADA (CA)
NOTES
SITE/SUPPLIER: HOSPIRA
SOFTWARE: ADOBE CC
ILPM / PHN / PR#: BI UPDATE
INITIALS: Duluth (CW)
COLORS
MM = 73.025 X 25.4 mm
INCHES = 2.875” x 1”
_BY CATHERINE BARNES AT 12:46 PM, MAY 13, 2020_
_BY CATHERINE DUBOIS AT 11:40 AM, MAY 27, 2020_
_BY NORMAND PLOURDE AT 1:06 PM, MAY 27, 2020_
DATE SUBMITTED: MAY 28, 2020 (BOEHRINGER INGELHEIM ANIMAL HEALTH
CANADA INC.)
2020-2974-03
ACTIVE INGREDIENT PER ML:
50 µg of gonadorelin
diacetate tetrahydrate
Administer I