NOROCLAV 500 MG TABLETS FOR DOGS AND CALVES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

amoxycillin as trihydrate(400mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 400.0 mg/Tb; CLAVULANIC ACID ANTIBIOTIC Active 100.0 mg/Tb

Units in package:

#100 Tabs; #250 Tabs; #Tub; *100 Tabs; *250 Tabs; *50 Tabs; *500 Tabs; *Blister

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: (calves): MEAT: DO NOT USE less t han 4 days before slaughter for human c onsumption. Not for use in bobby calves .; Host/pest details: CALF: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; DOG: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; DOG: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in dogs and calves.This product is contraindicated for use in small herbivores (e.g. rabbits, guinea pigs) or animals with a history of allergic reactions to penicillins. NOT FOR USE IN BOBBY CALVES.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

50
TABLETS
Norbrooli
~
File Name:
55507 _ 4733_50C_Iabei_MPL_Ol
Date Prepared:
16/ 6/09
Carton Dimensions (in mm):
79 x 66 x 118
Scale when printed
on
A4 paper:
66%
Scale when printed
on
A3
paper:
100%
APPROVED
LABEL
Info
PEST

Verified
100 Tablets
Norbrooll
:S
File
Name:
55507
_
4733
_
100C
_
Iabei_MPL
_
01
Date
Prepared:
16/6/09
Carton
Dimensions
(in
mm):
115
x
83
x
124
Scale
when
printed
on
A4
paper:
66%
Scale
when
printed
on
A3
paper:
100%
100 Tablets
Norbrooll
:S
APPROVED
LABEL
File
Name
:
5550
7
_
4
733
_1
O
OT
_
labei_
MP
L_
01
Date
Prepared
:
16
/6
/09
Label
Dimensions
(in
mm)
:
1
31.75
x 49
Scale
when
printed
on
A4
paper:
1
00%
(~
NORBROOLI
i
APPROVED
LABEL
APPROVED
LABEL
File
Name:
Date
Prepared:
Label
Dimensions
(in
mm):
Scalewhen printed onA4
paper:
55507
4733
250T
label
MPL
01
16/6/09
-
-
-
-
150
x
50
100%
Expiry:
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
This
product
is conb'aindieated
for
use in small
herbivores (eg. rabbits, guinea pigs) or animals
with
a
p::c:.~r:3~~~:r:i~C;::~~.to
penicillins.
Dogs:
12.5
mg/kg bodyweight
twice daily
(1
tablet
per
40
kg)
for
5-7
days or
48
hours after clinical
signs have
subsided.
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tr;'~~i~:I~~~~~%~:~~~r:~
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after clinical signs have
Any
variation
by
the prescribing veterinarian to the
approved
dose, frequency, duration, route,
disease
t:.f1~H~'6L"8~~~~%[l'~c"~~f"nding
the approved
withholding
period.
MEAT:
DO NOT USE less than 4 days
before
slaughter
for
human
consumption.
Not
for
use in
bobby
calves.
TRADE ADVICE:
~.:rm:,iA~~::'~~~~~~~
~~
~s=~~°u"~,:"'~~:";':~u~~
established. For advice on the
FIRST AID: If
POisoni~
occurs contact a doctor or Poisons
I~rmatlon
centre.
Phone Australia 131 126.
~::::I~We2~
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~~~~i~n'fr,rar.Ping
with
paper and putting in garbage.
.
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Norbrook Laboratories Australia
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limited
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ACN. 080 972 596
NORBROOLL
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TrialCode
123
APPROVED
LABEL
55507
_
4733_500C_labe

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Summary of Product characteristics

PRODUCT NAME: NOROCLAV 500MG TABLETS FOR DOGS AND CALVES
PAGE: 1 OF 4
THIS REVISION ISSUED: AUGUST, 2008
MATERIAL SAFETY DATA SHEET
Issued by: Norbrook Laboratories Australia Pty Ltd
Freecall: 1800 665 866
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
NORBROOK LABORATORIES AUSTRALIA PTY LTD
FREECALL: 1800 665 866
UNIT 7/1 TRADE PARK DRIVE
TULLAMARINE, VIC 3043 AUSTRALIA
SUBSTANCE:
Clavulanic acid is biosynthetically generated from the amino acid
arginine and the
sugar glyceraldehyde 3-phosphate. Amoxycillin is a moderate-spectrum,
bacteriolytic,
β-lactam antibiotic.
TRADE NAME:
NOROCLAV 500MG TABLETS FOR DOGS AND CALVES
PRODUCT USE:
Oral treatment of bacterial infections caused by susceptible organisms
in dogs and
calves.
CREATION DATE:
AUGUST, 2008
REVISION DATE:
AUGUST, 2008
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25. Avoid contact with eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Circular, pink tablets.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
Significant ingredients in this
product are antibiotics. Any person with a history of allergies to
antibiotics should avoid contact with this product as it
may cause sensitisation.
POTENTIAL HEALTH EFFECTS
Persons with a history of allergies to antibiotics should avoid
contact with this product as it may cause sensitisation.
INHALATION:
SHORT TERM EXPOSURE:
Long term inhalation of high amounts of any nuisance dust may overload
lung clearance
mechanism. Available data indicates that this product is not harmful.
In

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