EXCENEL POWDER FOR INJECTION INJECTABLE ANTIBIOTIC

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

CEFTIOFUR AS CEFTIOFUR SODIUM

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

ceftiofur as Na salt(50mg/mL)

Pharmaceutical form:

POWDER

Composition:

CEFTIOFUR AS CEFTIOFUR SODIUM ANTIBIOTIC Active 50.0 mg/ml

Units in package:

12x1g; 6x4g

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat - Cattle: 24 hours. Milk - C attle: 0 days Meat - Horses: 28 days. TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an E SI established.; Host/pest details: CATTLE: [INFECTIONS OF THE RESPIRATORY TRACT]; DOG: [INFECTIONS OF THE URINARY TRACTS]; HORSE: [INFECTIONS OF THE RESPIRATORY TRACT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [INFECTIONS OF THE RESPIRATORY TRACT]; DOG: [INFECTIONS OF THE URINARY TRACTS]; HORSE: [INFECTIONS OF THE RESPIRATORY TRACT]; For the treatment of respiratory infections in horses and cattle and urinary tract infections in dogs.Do not use for mass medication- for individual animal treatment only. Do not use by intramammary, topical or oral route in food producing animals. Do not use for the treatment of mastitis in dairy cattle

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PFIZER ANIMAL HEALTH
Product Name: EXCENEL® POWDER FOR INJECTION INJECTABLE ANTIBIOTIC
Date:
12
August 2010
P
age
1
of
2
Product Size:
1g
Descriplfon: Immediate Label
File number: 45748 50065 1g_immediate
MPL
V01 .doc
Versi
on
: May 2010
Text above this line and in italics between parallel lines is not
included
in
the label copy.
IMMEDIATE CONTAINER- Main Panel
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
EXCENEL®
POWDER TOR INJECTION
INJECTABLE ANTIBIOTIC
Active Constituent (when reconstituted as directed):
CEFTIOFUR (as CEFTIOFUR SODIUM) 50
mg/ml
For treatment of respiratory infections
in
horses and cattle and urinary tract infections
in dogs.
Please see insert.
1
g
NET
RECEIVED
BY
J WEBB E-LABELS
AT
10:22 AM,
AUG
_13; _
2010 RLP APPROVED
Info
PEST

Verified
PFIZER ANIMAL HEALTH
Product Name: EXCENEL® POWDER FOR INJECTION INJECTABLE ANTIBIOTIC
Date:
12
August 2010
Page 2
of
2
Product Size: 1g
Description: Immediate Label
File number: 45748 50065 1g immediate
MPL
V01
.doc
Version: May 2010
Text above this line and
in
italics between parallel lines is not included in the label copy.
IMMEDIATE CONTA
INER-
Right Panel
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE FOR MASS MEDICATION
·FOR
INDIVIDUAL ANIMAL TREATMENT ONLY.
DO
NOT
USE BY INTRAMAMMARY, TOPICAL OR ORAL ROUTE
IN
FOOD PRODUCING ANIMALS.
DO NOT USE FOR THE TREATMENT
OF
MASTI
TI
S
IN
DAIRY CATTLE.
DOSAGE AND ADMINISTRATION:
2 mg/kg ceftiofur for horses (IM) and dogs (SC), and 1 mg/kg for
cattle (IM).
WITHHOLDING PERIODS:
MEAT -
CATTLE:
24
HOURS
MILK-
CATTLE:
0 DAYS
MEAT-
HORSES:
28
DAYS
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an
ESI established.
For advice on the ESI, contact the manufacturer on 1800 814 883 before
using this product.
FIRST AID
:.
If
poisoning occurs contact a doctor
or
Poisons Information Centre,
AustraHa
13
11
26.
Store at
2°-
s
oc
(Refrigerate- do not freeze). Protect from light.
Disposal: Please refer to enclosed in

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Summary of Product characteristics

PRODUCT NAME: EXCENEL
® POWDER FOR INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: JUNE, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: (02)9850 3333
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: (02) 9850 3333
Fax: (02) 9850 3399
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Ceftiofur is a semisynthetic cephalosporin.
TRADE NAME:
EXCENEL
® POWDER FOR INJECTION
PFIZER MSDS CODE:
PRODUCT USE:
For treatment of respiratory infections in horses and cattle and
urinary tract infections
in dogs.
CREATION DATE:
DECEMBER, 2004
THIS VERSION ISSUED:
JUNE, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: White to light brown freeze dried solid, packed in 4 gram glass
vials.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that this
product is not harmful. However product may be mildly irritating,
although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
May cause mild

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