LINCO-SPECTIN ANTIBIOTIC INJECTABLE SOLUTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

LINCOMYCIN AS LINCOMYCIN HYDROCHLORIDE; SPECTINOMYCIN AS SPECTINOMYCIN SULFATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

lincomycin as HCl(50mg/mL)+spectinomycin as sulfate(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

LINCOMYCIN AS LINCOMYCIN HYDROCHLORIDE ANTIBIOTIC Active 50.0 mg/ml; SPECTINOMYCIN AS SPECTINOMYCIN SULFATE ANTIBIOTIC Active 100.0 mg/ml

Units in package:

100mL Vial

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: TREATMENT OF INFECTIONS IN PIGS AND BR OILER CHICKENS CAUSED BY ORGANISMS SENS ITIVE TO THE ACTION OF LINCOMYCIN AND/O R SPECTINOMYCIN. WHP: MEAT: Do not use less than the following periods before slaughter for human consumption: pigs 2 1 days broiler chickens 10 days. ES I: This product does not have an ESI e stablished. For advice on the ESI con tact the manufacturer on 1800 814 883 before using this product.; Host/pest details: CAT: [INFECTIONS OF THE URINARY TRACTS, INFECTIONS OF UPPER RESPIRATORY TRACT, LOCALISED INFECTIONS, SECONDARY INFECTION]; DOG: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, SECONDARY INFECTION]; PIGS: [ENTERITIS ASSOCIATED WITH E.COLI, MYCOPLASMAL PNEUMONIA, SWINE DYSENTERY]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [CHRONIC RESPIRATORY DISEASE, ESCHERICHIA COLI (E. COLI), MYCOPLASMA GALLISEPTICUM]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [INFECTIONS OF THE URINARY TRACTS, INFECTIONS OF UPPER RESPIRATORY TRACT, LOCALISED INFECTIONS, SECONDARY INFECTION]; DOG: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, SECONDARY INFECTION]; PIGS: [ENTERITIS ASSOCIATED WITH E.COLI, MYCOPLASMAL PNEUMONIA, SWINE DYSENTERY]; POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [CHRONIC RESPIRATORY DISEASE, ESCHERICHIA COLI (E. COLI), MYCOPLASMA GALLISEPTICUM]; For the treatment of infections in pigs, broiler chickens, dogs and cats caused by organisms sensitive to the action of lincomycin and/or spectinomycin.contraindicated in animals previously found to be hypersensitive to either antibiotic or the combination. Linco-Spectin should not be administered to animals with known pre-existing monilial infections.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PFIZER ANIMAL HEALTH
Product Name: LINCO-SPECTIN
""
ANTIBIOTIC INJECTABLE SOLUTION
Date: 1 November
2011
Page 1
of
9
Product Size: 100
mL
Description: Composite
Label
File number: LAB0807 - Linco-Spectin
Ant
ibiotic
Version: 2
Injectable Soluti
on
- Nov
11
(highlighted).doc
Reason: Category
14-
Addition
of
In use shelf life, ESI statement and
ot
her
updates to comply with current
labelling requirements.
T
ex
t 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
LINCO-SPECTIN®
Antibiotic
Injectable
Solution
LINCOMYCIN
..
...
..
..
..
..
50
mg/ml
(as lincomycin hydrochloride)
SPECTINOMYCIN ..... 1
00
mg/ml
(as spectinomycin sulphate)
100
mL
IMMEDIATE CONTAINER- Right Panel
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
Dosage and
Administration
RLP
APPROVED
Use the contents within
28
days of first broaching
of
the vial.
Discard the unused
po
rtion.
WITHHOLDING PERIODS:
MEAT:
DO
NOT USE less
than
the
following
periods
before
slaughter
for
human
consumption
.
Pigs
Broiler
chickens
21
days
10
days
TRADE ADVICE: ESI
not
established.
FIRST AID:
If
poisoning occurs,
co
ntact a doctor or Poiso
ns
Information Centre.
Pho
ne
Australia
131
126.
APVMA Approval No. 38692/53703
Pfizer
Animal
Health
A division
of
Pfizer Australia
Pty
Ltd
38-42 Wha
rf
Road
West Ryde NSW 2114
Store below
30
°C (Room Temperature)
Batch:
Ex
ir :
PRIMARY
PACK-
Front Panel
Infopest
Verified
PFIZER ANIMAL HEALTH
Product Name: LINCO-SPECTIN
""
ANTIBIOTIC INJECTABLE SOLUTION
Date: 1 November
2011
Page 2
of
9
Product Size: 100
mL
Description: Composite Label
File number: LAB0807 - Linco-Spectin Antibiotic
Version: 2
Injectable
Solution-
Nov
11
(highlighted).
doc
Reason: Category
14-
Addition
of
In use shelf life, ESI statement and other updates to comply with
current
labelling requirements.
Text above this line and
in
italics between parallel lines is not included
in
the label cop

Read the complete document

Summary of Product characteristics

PRODUCT NAME: LINCO-SPECTIN
® ANTIBIOTIC INJECTABLE SOLUTION
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: (02)9850 3333
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
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
SUBSTANCE:
Active ingredients are antibiotics.
TRADE NAME:
LINCO-SPECTIN
® ANTIBIOTIC INJECTABLE SOLUTION
PFIZER MSDS CODE:
092
PRODUCT USE:
Antibiotic vaccine for use as described on the product label.
CREATION DATE:
JANUARY, 2005
THIS VERSION ISSUED:
APRIL, 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
: Colourless to slightly yellow solution. May have a slight haze.
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
Repeated overexposure to lincomycin may cause abdominal cramps,
diarrhoea and colitis. This may begin several
weeks after exposure has ceased. Some hematopoietic effects have been
reported with the use of lincomycin.
Hypersensitivity reactions have been reported in people known to be
sensitive to penicillin. Rare instances of
erythema multiforme, some resembling Stevens-Johnsone Syndrome, have
been associated with lin

Read the complete document