TILMICOSIN AC Solution

Country: Kanada

Bahasa: Perancis

Sumber: Health Canada

Bahan aktif:

Tilmicosin (Phosphate de tilmicosine)

Boleh didapati daripada:

BIO AGRI MIX LP

Dos:

250MG

Borang farmaseutikal:

Solution

Komposisi:

Tilmicosin (Phosphate de tilmicosine) 250MG

Laluan pentadbiran:

Orale

Unit dalam pakej:

240/960 ML

Jenis preskripsi:

Prescription

Kumpulan terapeutik:

Porcs

Ringkasan produk:

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

Status kebenaran:

APPROUVÉ

Tarikh kebenaran:

2018-11-01

Risalah maklumat

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