TILMICOSIN AC Solution

Krajina: Kanada

Jazyk: francúzština

Zdroj: Health Canada

Aktívna zložka:

Tilmicosin (Phosphate de tilmicosine)

Dostupné z:

BIO AGRI MIX LP

Dávkovanie:

250MG

Forma lieku:

Solution

Zloženie:

Tilmicosin (Phosphate de tilmicosine) 250MG

Spôsob podávania:

Orale

Počet v balení:

240/960 ML

Typ predpisu:

Prescription

Terapeutické skupiny:

Porcs

Prehľad produktov:

Numéro de groupe d'ingrédients actifs (GIA) :0121139004

Stav Autorizácia:

APPROUVÉ

Dátum Autorizácia:

2018-11-01

Príbalový leták

ABBREVIATED NEW DRUG SUBMISSION
TILMICOSIN AC (LIQUID CONCENTRATE FOR SWINE)
Page
1
of
8
Section 1.3.2 Inner and Outer Labels
BAM version October 19, 2018
1.3.2 INNER AND OUTER LABELS
The proposed English and French outer labels for TILMICOSIN AC (Liquid
Concentrate for
Swine) are provided below. There are no inner labels for TILMICOSIN
AC.
ABBREVIATED NEW DRUG SUBMISSION
TILMICOSIN AC (LIQUID CONCENTRATE FOR SWINE)
Page
2
of
8
Section 1.3.2 Inner and Outer Labels
BAM version October 19, 2018
_Proposed English Label Text for TILMICOSIN AC: _
The following is the package label for TILMICOSIN AC:
DIN XXXXXXXX
PR
TILMICOSIN AC
_TILMICOSIN PHOSPHATE ORAL CONCENTRATE _
FOR VETERINARY USE ONLY
ANTIBIOTIC
NET 240 ML
_BIO AGRI MIX LP_
AQUEOUS CONCENTRATE FOR ORAL SOLUTION
FOR USE IN SWINE DRINKING WATER ONLY
WARNINGS:
1)
Treated swine must not be slaughtered for use in food for at least 8
days after the
latest treatment with this drug.
2)
TILMICOSIN AC may cause irritation or sensitization by skin contact.
Avoid direct
skin contact. Wear overalls and impervious gloves when mixing and
handling the
product. Wash hands after handling the product. Wash affected parts if
skin contact
occurs. Avoid contact with eyes. If accidental eye occurs, immediately
rinse
thoroughly with water.
3)
To limit the development of antimicrobial resistance, TILMICOSIN AC
should only
be used in swine when an outbreak of SRD is confirmed.
4)
Keep out of reach of children.
5)
To report adverse event in users, call 1-800-265-1763. The safety data
sheet is
available at www.bioagrimix.com
REFER TO INSERT FOR ADDITIONAL INFORMATION
BIO AGRI MIX LP
PO Box 399
Mitchell, ON
N0K 1N0
LOT:
Exp.:
ABBREVIATED NEW DRUG SUBMISSION
TILMICOSIN AC (LIQUID CONCENTRATE FOR SWINE)
Page
3
of
8
Section 1.3.2 Inner and Outer Labels
BAM version October 19, 2018
The following is the insert label for TILMICOSIN AC:
DIN XXXXXXXX
PR
TILMICOSIN AC
_TILMICOSIN PHOSPHATE ORAL CONCENTRATE _
_ _
FOR VETERINARY USE ONLY
ANTIBIOTIC
NET 240 ML
ACTIVE INGREDIENT:
Tilmicosin (as tilmic