BETAMOX L.A. INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

amoxycillin as trihydrate(150mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 150.0 mg/ml

Units in package:

100mL; 250mL; 500mL; 50mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ANTIBIOTICS - ORAL, PARENTERAL | BACILLUS ANTHRACIS | BACTERIAL INFECTION | BORDETELLA BRONCHISEPTICA | CLOSTRIDIUM SPP. | CORYNEBACTERIUM SPP. | ESCHERICHIA COLI (E. COLI) | FUSOBACTERIUM SPP. | PROTEUS MIRABILIS | SALMONELLA SPP. | STAPHYLOCOCCUS - NOT PENICILLIN RESIST | STREPTOCOCCI | AIRSACCULITIS | AMOXYCILLIN SENSITIVE BACTERIA | ANAEROBIC BACTERIA | ANAEROBIC BACTERIAL INFECTION | ANTHRAX | ASSOCIATED WITH VIRAL DISEASE | AVIAN MYCOPLASMAS | BACTERIAL CANKER | CANINE COUGH SYNDROME | CLAVULANIC ACID SENSITIVE | CLOSTRIDIUM BOTULINUM | CLOSTRIDIUM CHAUVOEI | CLOSTRIDIUM FALLAX | CLOSTRIDIUM FESERI | CLOSTRIDIUM HEMOLYTICUM | CLOSTRIDIUM NOVYI | CLOSTRIDIUM PERFRINGENS TYPES | CLOSTRIDIUM SEPTICUM | CLOSTRIDIUM SORDELLI | CLOSTRIDIUM SPOROGENES | CLOSTRIDIUM TETANI | COCCIDIOSIS | CORYZA | CRD | DERMATOSES | DIARRHOEA | ENDOMETRITIS | ENTERITIS | ENZOOTIC PNEUMONIA | ESCHERICHIA COLI | EUROPEAN BROOD DISEASE | EXCLUDING PENICILLIN RESISTANT | GENTAMICIN SENSITIVE | GRAM NEGATIVE ORGANISMS | GRAM POSITI

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCI]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCI]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACILLUS ANTHRACIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CLOSTRIDIUM SPP., CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), FUSOBACTERIUM SPP., PROTEUS MIRABILIS, SALMONELLA SPP., STAPHYLOCOCCUS - NOT PENICILLIN RESIST, STREPTOCOCCI]; For treatment of infections caused by organisms sensitive to amoxycillin in dogs and cats.Not suitable for intravenous administration.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

DRAFT TEXT LABEL – BETAMOX Injection
IMMEDIATE CONTAINER: FRONT PANEL
Text appearing above and below the header and footer lines is not
included in the label.
Info
PEST
9
Verified
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BETAMOX L.A. INJECTION
150 mg/mL AMOXYCILLIN (AS THE TRIHYDRATE)
For treatment of infections caused by organisms sensitive to
amoxycillin in dogs and cats.
100 ML [50ML, 250ML, 500ML]
[Norbrook Logo]
24 November 2003
Page 1 of 4
DRAFT TEXT LABEL – BETAMOX Injection
IMMEDIATE CONTAINER: REAR PANEL
Text appearing above and below the header and footer lines is not
included in the label.
READ THE ACCOMPANYING LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
Recommended dose rate is 15 mg/kg bodyweight repeated if necessary
after 48 hours, by
SUBCUTANEOUS OR INTRAMUSCULAR INJECTION.
DOGS
20 kg
2 mL
CATS
5 kg
0.5mL
Dispose of empty container by wrapping with paper and putting in
garbage.
APVMA Approval No. 51975/100ML[50ML, 250ML, 500ML]/0104
Manufactured by: Norbrook Laboratories Ltd, UK
Distributed by: Norbrook Laboratories Australia Pty Limited
A.C.N. 080 972 596
5/12 Ladd Road
New Gisborne, Vic 3438
Freecall: 1800 665 866
Store below 25
o
C (Air Conditioning). Protect from light.
Use the contents of the vial within 28 days of initial broaching and
discard any unused
portion.
(B):
Expiry:
24 November 2003
Page 2 of 4
DRAFT TEXT LABEL – BETAMOX Injection
LEAFLET (common to all pack sizes)
Text appearing above and below the header and footer lines is not
included in the label.
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BETAMOX L.A. INJECTION
PRESENTATION:
BETAMOX L.A. Injection is an off white suspension containing 150 mg/mL
amoxycillin (as
amoxycillin trihydrate).
INDICATIONS:
BETAMOX L.A. Injection is a broad spectrum semi-synthetic penicillin,
bactericidal in action.
_In-vitro_ it is effective against a wide range of amoxycillin
sensitive Gram-positive and Gram-
negative bacteria which include_ Bacillus anth

Summary of Product characteristics

PRODUCT NAME: BETAMOX L.A. INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 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:
Amoxycillin is an antibiotic.
TRADE NAME:
BETAMOX L.A. INJECTION
PRODUCT USE:
For treatment of infections caused by organisms sensitive to
Amoxycillin in cattle,
pigs, sheep, dogs and cats.
CREATION DATE:
JULY, 2009
THIS VERSION ISSUED:
JULY, 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:
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
: 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 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.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CON