TILMICOSIN AC SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TILMICOSIN (TILMICOSIN PHOSPHATE)

제공처:

BIO AGRI MIX LP

복용량:

250MG

약제 형태:

SOLUTION

구성:

TILMICOSIN (TILMICOSIN PHOSPHATE) 250MG

관리 경로:

ORAL

패키지 단위:

240/960 ML

처방전 유형:

Prescription

치료 그룹:

SWINE (PIGS)

제품 요약:

Active ingredient group (AIG) number: 0121139004

승인 상태:

APPROVED

승인 날짜:

2018-11-01

환자 정보 전단

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