NEOMYCIN PENICILLIN 100/200 AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:

NEOMYCIN BASE (AS THE SULFATE); PROCAINE PENICILLIN

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

neomycin as sulfate(100mg/mL)+procaine penicillin(200mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

NEOMYCIN BASE (AS THE SULFATE) ANTIBIOTIC Active 100.0 mg/ml; PROCAINE PENICILLIN ANTIBIOTIC-PENICILLIN Active 200.0 mg/ml

Units in package:

100mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

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

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH | ACTINOMYCES SPP. | ANTIBIOTIC - ANTI-INFECTIVE | CLOSTRIDIA | ERYSIPELOTHRIX SPP. | ESCHERICHIA COLI (E. COLI) | INFECTIONS OF THE URINARY TRACTS | KLEBSIELLA SPP. | LEPTOSPIROSIS | MASTITIS | METRITIS | PASTEURELLA MULTOCIDA | PASTEURELLA SPP. | SALMONELLA | STAPHYLOCOCCUS AUREUS | STREPTOCOCCI | ABRASIONS | ABSCESSES | AIRSACCULITIS | ANTISEPTIC | AVIAN MYCOPLASMAS | BLACKHEAD | BODY ODOURS | BOWED TENDONS | BROAD SPECTRUM | BURNS | COCCIDIOSIS | COLIFORM COMPLEX | CONJUNCTIVITIS | COWPOX | CRACKS | CRUSTS | DANDRUFF | DERMATOLOGICAL DISORDERS | DERMATOSIS | DRY SKIN | DYSENTERY | ECZEMA | ENDOMETRITIS | ENTERIC DISEASES | ENZOOTIC PNEUMONIA | ESCHERICHIA COLI | FEED EFFICIENCY | FOWL CHOLERA | FUNGAL INFECTIONS | GIRTH GALLS | GROUP D STREPTOCOCCUS | INCLUDING B-LACTAMASE PRODUCIN | INFECTIONS | INFLAMMED PADS | ITCHING | KERATOLYTIC | KLEBSIELLA SPP. | L. HARDJO | L. INTERROGANS | L. POMONA | L. TARASSOVI | LACERATIONS | MASTITIS | MYCOPLASMAS | ODOURS | OPEN WOU

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Do not use in sheep or cattl e less than 35 days before slaughter fo r human consumption. Do not use in pig s or horses less than 100 days before s laughter for human consumption. Milk: Milk collected from animals within 36 h ours (single dose) 72 hours (multiple dose) following treatment must not be u sed for human consumption or processing or fed to bobby calves. ESI: THIS PRO DUCT DOES NOT HAVE AN ESI ESTABLISHED.; Host/pest details: CAT: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; CATTLE: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; DOG: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; HORSE: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; SHEEP: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; CATTLE: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; DOG: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; HORSE: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; SHEEP: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES SPP., ANTIBIOTIC - ANTI-INFECTIVE, CLOSTRIDIA, ERYSIPELOTHRIX SPP., ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., LEPTOSPIROSIS, MASTITIS, METRITIS, PASTEURELLA MULTOCIDA, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STREPTOCOCCI]; For infections caused by penicillin-neomycin sensitive micro-organisms in horses, cattle, sheep, pigs, dogs and cats.See leaflet for details.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

                                NEOMYCIN PENICILLIN 100/200
NEOMYCIN PENICILLIN
100/200
NEOMYCIN PENICILLIN 100/200
49x49x105mm
CYK
031599.011.880
EOSC0366/003
Batch No.:
Expiry Date:
FIRST AID:
If poisoning occurs, contact a doctor or Poisons
Information Centre. Phone Australia 131126.
DISPOSAL:
Dispose of empty container by wrapping with
paper and putting in garbage.
STORAGE:
Store between 2°C and 8°C.
(Refrigerate. Do not freeze).
Protect from light.
Use the contents of the vial within
28 days of initial broaching and
discard any unused portion.
APVMA Approval No.:
37241/100mL/0410
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USE.
Give by intramuscular injection daily for
a maximum of 3 days, using a different
site for each injection.
Horses, Cattle: 25 mL/500 kg BW
(1 mL/20 kg) IM
Pigs, Sheep: 2 mL/40 kg BW
(1 mL/20 kg) IM
Dogs, Cats: 1 mL/10 kg BW IM or SC
Any variation by the prescribing
veterinarian to the approved dose,
frequency, duration, route, disease or target
species may require extending the
approved withholding period.
WITHHOLDING PERIODS:
MEAT: DO NOT USE in sheep or cattle less
than 35 days before slaughter for human
consumption.
DO NOT USE in pigs or horses less than
100 days before slaughter for human
consumption.
MILK: Milk collected from animals within 36
hours (single dose), 72 hours (multiple
dose) following treatment MUST NOT BE
USED for human consumption or
processing, or fed to bobby calves.
TRADE ADVICE: EXPORT SLAUGHTER
INTERVAL (ESI): This product does not have an
ESI established. For advice on the ESI, contact
the manufacturer on 1800 033461 before using
this product.
NEOMYCIN
PENICILLIN
100/200
AQUEOUS SUSPENSION FOR
INTRAMUSCULAR INJECTION
ACTIVE CONSTITUENTS:
NEOMYCIN BASE
(as the sulfate)
100 mg/mL
PROCAINE PENICILLIN
200 mg/mL
For infections caused by
penicillin-neomycin sensitive
organisms in Horses, Cattle, Sheep,
Pigs, Dogs and Cats.
100 mL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NEOMYCIN
P
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                 
 
PRODUCT NAME: NEOMYCIN PENICILLIN 100/200 AQUEOUS 
SUSPENSION FOR INTRAMUSCULAR INJECTION
 
MATERIAL SAFETY DATA SHEET
 
THIS REVISION ISSUED:   JULY, 2009
PAGE: 1 OF 6
 
 
MATERIAL SAFETY DATA SHEET  
Issued by: Intervet Australia Pty Limited Phone:
1 800 033 461 (Business Hours)  
Poisons Information Centre: 13 11 26 from anywhere in
Australia, (0800 764 766 in New Zealand)  
 
 
 
SUBSTANCE:  
A mixture of 208mg
procaine benzyl penicillin and 162mg neomycin sulfate per mL
in 
sterile injection.
 
TRADE NAME:  
NEOMYCIN PENICILLIN 100/200 AQUEOUS SUSPENSION FOR INTRAMUSCULAR 
INJECTION 
PRODUCT CODE: 
 22743 
RECOMMENDED USE:  
Injection to treat infections caused by penicillin and neomycin
sensitive organisms in 
horses, cattle, sheep, pigs, dogs and cats.
 
APVMA NO:  
37241
 
CREATION DATE: 
November, 2006
 
THIS VERSION ISSUED: 
July, 2009
 and is valid for 5 years from this date.
 
 
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, S45. Avoid contact with eyes. In case of accident or if you
feel unwell, contact a doctor or 
Poisons Information Centre immediately (show the label where possible).  
SUSDP CLASSIFICATION: 
S4 
ADG CLASSIFICATION: 
None allocated. Not a Dangerous Good under the ADG Code. 
UN NUMBER: 
None allocated 
 
PHYSICAL DESCRIPTION & COLOUR: 
White to cream coloured suspension - easy to homogenise.
 
ODOUR: 
Mildly alcoholic odour. 
MAJOR HEALTH HAZARDS: 
no significant risk factors have been found for this product. 
 
INHALATION: 
SHORT TERM EXPOSURE:
 Available data indicates that this product is not harmful.
In addition product is unlikely to 
cause any discomfort or i
                                
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Safety Data Sheet

                                NEOMYCIN PENICILLIN 100/200
NEOMYCIN PENICILLIN
100/200
NEOMYCIN PENICILLIN 100/200
49x49x105mm
CYK
031599.011.880
EOSC0366/003
Batch No.:
Expiry Date:
FIRST AID:
If poisoning occurs, contact a doctor or Poisons
Information Centre. Phone Australia 131126.
DISPOSAL:
Dispose of empty container by wrapping with
paper and putting in garbage.
STORAGE:
Store between 2°C and 8°C.
(Refrigerate. Do not freeze).
Protect from light.
Use the contents of the vial within
28 days of initial broaching and
discard any unused portion.
APVMA Approval No.:
37241/100mL/0410
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USE.
Give by intramuscular injection daily for
a maximum of 3 days, using a different
site for each injection.
Horses, Cattle: 25 mL/500 kg BW
(1 mL/20 kg) IM
Pigs, Sheep: 2 mL/40 kg BW
(1 mL/20 kg) IM
Dogs, Cats: 1 mL/10 kg BW IM or SC
Any variation by the prescribing
veterinarian to the approved dose,
frequency, duration, route, disease or target
species may require extending the
approved withholding period.
WITHHOLDING PERIODS:
MEAT: DO NOT USE in sheep or cattle less
than 35 days before slaughter for human
consumption.
DO NOT USE in pigs or horses less than
100 days before slaughter for human
consumption.
MILK: Milk collected from animals within 36
hours (single dose), 72 hours (multiple
dose) following treatment MUST NOT BE
USED for human consumption or
processing, or fed to bobby calves.
TRADE ADVICE: EXPORT SLAUGHTER
INTERVAL (ESI): This product does not have an
ESI established. For advice on the ESI, contact
the manufacturer on 1800 033461 before using
this product.
NEOMYCIN
PENICILLIN
100/200
AQUEOUS SUSPENSION FOR
INTRAMUSCULAR INJECTION
ACTIVE CONSTITUENTS:
NEOMYCIN BASE
(as the sulfate)
100 mg/mL
PROCAINE PENICILLIN
200 mg/mL
For infections caused by
penicillin-neomycin sensitive
organisms in Horses, Cattle, Sheep,
Pigs, Dogs and Cats.
100 mL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NEOMYCIN
P
                                
                                Read the complete document