BETAMOX INJECTION

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Koop het nu

Bijsluiter Bijsluiter (PIL)
19-06-2017
Productkenmerken Productkenmerken (SPC)
19-06-2017

Werkstoffen:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

Beschikbaar vanaf:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (Algemene Internationale Benaming):

amoxycillin as trihydrate(150mg/mL)

farmaceutische vorm:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samenstelling:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 150.0 mg/ml

Eenheden in pakket:

100mL

klasse:

VM - Veterinary Medicine

Therapeutische categorie:

CAT | CATTLE | DOG | HORSE | PIGS | SHEEP | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK |

Therapeutisch gebied:

ANTIBIOTIC & RELATED

therapeutische indicaties:

ACTINOBACILLUS EQUULI | ACTINOBACILLUS LIGNIERESII | ACTINOMYCES BOVIS | BACILLUS ANTHRACIS | BORDETELLA BRONCHISEPTICA | CLOSTRIDIUM SPP. | CORYNEBACTERIUM SPP. | ERYSIPELOTHRIX RHUSIOPATHIAE | FUSIFORMIS SPP. | HAEMOPHILUS SPP. | MORAXELLA SPP. | PASTEURELLA SPP. | PROTEUS MIRABILIS | STAPHYLOCOCCI | STREPTOCOCCI | ANTHRAX | BACTERIAL CANKER | CANINE COUGH SYNDROME | CLOSTRIDIUM BOTULINUM | CLOSTRIDIUM CHAUVOEI | CLOSTRIDIUM FALLAX | CLOSTRIDIUM FESERI | CLOSTRIDIUM HEMOLYTICUM | CLOSTRIDIUM NOVYI | CLOSTRIDIUM PERFRINGENS TYPES | CLOSTRIDIUM SEPTICUM | CLOSTRIDIUM SORDELLI | CLOSTRIDIUM SPOROGENES | CLOSTRIDIUM TETANI | HAEMOPHILUS AGNI | HAEMOPHILUS BOVIS | HAEMOPHILUS PARAINFLUENZAE | HAEMOPHILUS PARASUIS | HAEMOPHILUS PLEUROPNEUMONIAE | HAEMOPHILUS SOMNUS | HAEMOPHILUS SUIS | INCLUDING B-LACTAMASE PRODUCIN | INFECTIOUS TRACHEOBRONCHITIS | PASTERELLOSIS | PASTEURELLOSIS

Product samenvatting:

Poison schedule: 4; Withholding period: WHP: Milk: Cattle: Milk collected from cows within 48 hours within 72 hours ( 6 mikings) following treatment must not be used for human consumption or proce ssing. This milk should not be fed to bobby calves. Sheep: DO NOT USE in lact ating or pregnant ewes where milk or mi lk products may be used for human cons umption. Meat: Do not use less than 28 days before slaughter for human consum ption.; Host/pest details: CAT: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; CATTLE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; DOG: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; HORSE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; PIGS: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; SHEEP: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; CATTLE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; DOG: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; HORSE: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; PIGS: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; SHEEP: [ACTINOBACILLUS EQUULI, ACTINOBACILLUS LIGNIERESII, ACTINOMYCES BOVIS, BACILLUS ANTHRACIS, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ERYSIPELOTHRIX RHUSIOPATHIAE, FUSIFORMIS SPP., HAEMOPHILUS SPP., MORAXELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, STAPHYLOCOCCI, STREPTOCOCCI]; Treatment of infections caused by organisms sensitive to amoxycillin in horses, cattle, pigs, sheep, dogs and cats.Should not be used, “off-label”, orally or parenterally in rabbits, hamsters, gerbils and guinea pigs. Not suitable for intravenous injection. Animals with functionally mature rumens should only be treated parentally.

Autorisatie-status:

Registered

Autorisatie datum:

2023-07-01

Bijsluiter

                                Betamox Injection
100mL Bottle Label
Label
file name: 37049_48899_1 OOmL_immediate_MPL_V1.pdf
100% Actual
1:1
Size
=
49 x 131.75mm
(100%
when
printed on
A4
paper)
18/1/10
APPROVED
LABEL
Info
PEST

Verified
Betamox Injection
Leaflet
Label file name:
3704938899JeafleLMPL....V2.pdf
100% Actual
1:1
Size
=
105 x 14Bmm
(100%
when
printed on A4 paper)
2811/10
Page 2
of2
~"I'IIIIIIII:
.m:
IIIl
...
UlE
__
••
_
...........
-.
...
_,·
.g
_1:lIIilk
I
··_f4I1i
..
lII
··b_t
.urr
UIEII
...
_
..
_
••••
~
....,_
.......
ODIIDT
..
ln_
...-Il
__
..
I l
Il..-
_1io
. . . .
Ia'.
__
......
-_.
ElIPDIITIIAU.IIIBlIllBl'MLIElI~1bIo,.Hlll"'IIl"".
Ell
__
ror_
. . .
ElL_IIIII
__
...
,
•••
-.
. .......
11.
RIIITAlD:
Wpallon~g
aoc
. . . .
c.1IIICt
I
d._
... l'allanlllfll"mldlll
ea
.....
Phanl
_11131121.
~.
Sta
. .
boh""ZSOC
(Ai~Canlitianillll~
O.
nat!rNzo,
PralHtfran
light.
_IIIAL:
1lI
.....
1
a11..-,
CCIIIIIN'byWllpp~g
_
PIP.'
"'"
pulling
In
gull"",.
RIlIIIEllNi
:rJIIII:
Alii'
IbIarptian,
high
I
. . . . .
clln..,..lln
""
Ia,",d
in
10""""
1Ii....
livIr
ond
bill.
Am_lh
IItI
ropkI
h_rIcldllllctlan.
MI"""cturedlr(.
N.rI,,""
Lobarotari.Ullilod,lIC
Ilillbibulld
bY:
N.rI"lIOk
Lob.,«lIIrioIAurtnlio
Ply
liniIB
AC.N.OIllI71.-
lkit1/1
T
. . . . .
l'lltOrivo,
Tullll
. .
riIl
VIe
1M3
F1Hcll:1D1
••
AI'VMA
AppIOIIII
No.
37IMI'1'0I
_'''Ill
                                
                                Lees het volledige document
                                
                            

Productkenmerken

                                PRODUCT NAME: BETAMOX INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: SEPTEMBER, 2009
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:
Oil based antibiotic injection.
TRADE NAME:
BETAMOX INJECTION
APVMA CODE:
37049
PRODUCT USE:
For treatment of infections caused by organisms sensitive to
amoxicillin in horses,
cattle, pigs, sheep, dogs and cats.
CREATION DATE:
SEPTEMBER, 2009
THIS VERSION ISSUED:
SEPTEMBER, 2009
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.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S24/25. Wear suitable protective clothing. Avoid contact with
skin and 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
: Off-white suspension.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
an antibiotic preparation.
Any person with a history of allergies to this class of substances
should avoid all contact with this product as it may
cause sensitisation. This is also a physiologically active product and
so contact should be minimised, especially if the
user is taking a form of medication, as interactions can sometimes
give unexpected and undesired results.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LON
                                
                                Lees het volledige document
                                
                            

Bekijk de geschiedenis van documenten