MOXYLAN READY-TO-USE INJECTION BROAD SPECTRUM ANTIBIOTIC

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

Safety Data Sheet (SDS)

31-03-2009

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

Available from:

JUROX 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

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Milk-Do not use less than 48 hours before collection of milk for human c onsumption or processing. This milk sh ould not be fed to bobby calves. Meat: Do not use less than 14 days in cattle or pigs before slaughter for human cons umption.; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL]; CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; For the treatment of bacterial infections sensitive to amoxycillin in dogs, cats, cattle and pigs.Amoxycillin should not be given to penicillin sensitive animals and should not be used orally or parenterally in very small herbivores such as rabbits or guinea pigs. Milk collected within 48 hours of treatment should NOT be fed to bobby calves.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Overall size 230mm x 242.5mm
is 100% size
230mm
242.5mm
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MOXYLAN
READY-TO-USE INJECTION
BROAD SPECTRUM ANTIBIOTIC
100ML
PRESCRIPTION
ANIMAL REMEDY
MOXYLAN
READY-TO-USE INJECTION
BROAD SPECTRUM ANTIBIOTIC
150mg/mL AMOXYCILLIN
(as Amoxycillin trihydrate)
100ML
FOR THE TREATMENT OF BACTERIAL
INFECTIONS SENSITIVE TO AMOXYCILLIN
IN DOGS, CATS, CATTLE AND PIGS
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PRESCRIPTION
ANIMAL REMEDY
MOXYLAN
READY-TO-USE INJECTION
BROAD SPECTRUM ANTIBIOTIC
150mg/mL AMOXYCILLIN
(as Amoxycillin trihydrate)
100ML
FOR THE TREATMENT OF BACTERIAL
INFECTIONS SENSITIVE TO AMOXYCILLIN
IN DOGS, CATS, CATTLE AND PIGS
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
APVMA FILE: 50608 _43796_100ML_PRIMARY_MPL_V01.PDF
Dimensions: primary pack = 230mm (wide) x 242.5 (high)
Scale: 100% of A3
Date: 16 - 2 - 2009
WITHHOLDING PERIODS:
MILK: DO NOT USE LESS THAN 48 HOURS BEFORE
COLLECTION OF MILK FOR HUMAN CONSUMPTION OR
PROCESSING.
THIS MILK SHOULD NOT BE FED TO BOBBY CALVES.
MEAT: DO NOT USE LESS THAN 14 DAYS IN CATTLE
OR
PIGS
BEFORE
SLAUGHTER
FOR
HUMAN
CONSUMPTION.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): THIS
PRODUCT DOES NOT HAVE AN ESI ESTABLISHED. FOR
ADVICE ON THE ESI CONTACT JUROX PTY LTD ON
1800 023 312 BEFORE USING THIS PRODUCT.
FIRST AID
If poisoning occurs, contact a doctor or Poisons
Information Centre. Phone Australia 131 126.
Made in Australia by:
Jurox Pty Ltd
85 Gardiner Rd,
Rutherford NSW 2320
Infoline 1800 023 312
Dispose of empty container by wrapping with
paper and putting in garbage.
Store below 30°C (Room Temperature). Contents
of broached vials may be stored if necessary at
25°C (Air Conditioning) for up to 28 days provided
contamination is avoided.
See base for batch and expiry.
APVMA No. 50608/100mL/0109
406327
B
EXP
READ ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT.
DIRECTIONS FOR USE:
FOR
INTRAMUSCULAR
OR
SUBCUTANEOUS
INJECTION ONLY.
SHAKE WELL BEFORE USE.
USE A DRY SYRINGE AND NEEDLE.
LOCAL REACTION MAY OCCUR AT THE SITE OF
INJECTION.

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Summary of Product characteristics

MOXYLAN RTU INJECTION
Page 1 of 5
continued
ISSUED:
13 AUGUST 2012
MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
MOXYLAN RTU INJECTION
PRODUCT CODE:
501625 (100 mL)
RECOMMENDED USE:
For the treatment of bacterial infections sensitive to amoxycillin in
dogs,
cats, cattle and pigs.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
RESPIRATORY SENSITIZER CATEGORY 1
SKIN SENSITIZER CATEGORY 1
GHS PICTOGRAMS:
EXCLAMATION MARK
HEALTH HAZARD
SIGNAL WORD:*
DANGER
HAZARD STATEMENTS:*
H317
May cause an allergic skin reaction.
H334
May cause allergy or asthma symptoms or breathing difficulties if
inhaled.
PRECAUTIONARY STATEMENTS:*
PREVENTION
P261
Avoid breathing vapours.
P272
Contaminated work clothing should not be allowed out of the workplace.
P280
Wear protective gloves e.g. PVC or vinyl.
P281
Use personal protective equipment as required.
P285
In case of inadequate ventilation wear respiratory protection.
RESPONSE
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P304+P341
IF INHALED: If breathing is difficult, remove victim to fresh air and
keep at rest in a position comfortable for breathing.
P333+P313
If skin irritation or rash occurs: Get medical advice / attention.
P342+P311
If experiencing respiratory symptoms: Call a POISON CENTRE or
doctor / physician.
P363
Wash contaminated clothing before reuse.
DISPOSAL
P501
Dispose of contents/container in accordance with local/national
regulations.
* N.B.: These statements are determined by Work Health and Safety
regulations and may not reflect Signal Headings and
First Aid and Safety statements on product labelling, which are
determined by a competent authority during assessment
for registration.
MOXYLAN RTU INJECTION
Page 2 of 5
continued
SECTION 3: COMP

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Amoxycillin (as trihydrate) 150 mg/mL.
ACTIONS
Amoxycillin is a broad spectrum semisynthetic penicillin which is
bactericidal against a wide range of Gram-positive and
Gram-negative bacterial pathogens, including the following:
_Actinobacillus equuli, Actinobacillus lignieresii, Actinomyces bovis,
_
_Bacillus anthracis, Bordetella _spp_., Clostridium _spp_.,
Corynebacterium _spp_., Erysipelothrix rhusiopathiae, Escherichia
coli, Fusiformis _spp_., _
_Fusobacterium necrophorum, Haemophilus _spp_., Moraxella _spp_.,
Pasteurella _spp_., Proteus mirabilis, Salmonella _spp_.,
Staphylococci_
(excluding penicillin-resistant strains) and _Streptococci._
INDICATIONS
Infections caused by amoxycillin-sensitive bacteria in dogs, cats,
cattle and pigs.
LOCAL INFECTIONS: Dermatitis, abscesses, infected wounds and ear
infections. Amoxycillin is also recommended for prophylactic use
postoperatively.
GENERAL INFECTIONS: Septicaemia, postparturient infections, joint and
navel-ill, foot conditions, mastitis–metritis–agalactia (MMA)
syndrome and erysipelas in pigs, and acute toxic mastitis in cattle.
GASTROINTESTINAL TRACT INFECTIONS: Gastritis, gastroenteritis and
enteritis.
RESPIRATORY TRACT INFECTIONS: Tonsillitis, pharyngitis, bronchitis and
pneumonia.
SECONDARY BACTERIAL INFECTIONS: Amoxycillin is effective against many
of the secondary bacterial infections associated with viral
diseases such as bovine viral pneumonia and feline influenza.
GENITOURINARY TRACT INFECTIONS: Cystitis, nephritis and metritis. The
high level of antibiotic obtained in urine makes amoxycillin
especially effective in urinary tract infections.
MOXYLAN RTU
Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
CONTRAINDICATIONS
Administration to small herbivores (e.g. guinea pigs) or animals with
a history of allergic reactions to penicillins.
PRECAUTIONS
Local re

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