PENETHAJECT ANTIBIOTIC INJECTION

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Last ned Preparatomtale (SPC)
01-07-2013
Last ned Sikkerhetsdatablad (SDS)
18-07-2006

Aktiv ingrediens:

PENETHAMATE HYDRIODIDE

Tilgjengelig fra:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

penethamate hydriodide(1000mg/g)

Legemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensetning:

PENETHAMATE HYDRIODIDE ANTIBIOTIC Active 15.0 g/Vi

Enheter i pakken:

1 x 15 g penethaject vial and 1 x 48 mL (min.) sterile diluent vial; 6 x 15 g penethaject vials and 6 x 48mL (min.) sterile dilu

Klasse:

VM - Veterinary Medicine

Produsert av:

BAYER AUSTRALIA

Terapeutisk gruppe:

COW | HORSE | PIG SOW (FEMALE) | SHEEP | BOVINE | COLT | DONKEY | ENDURANCE HORSE | EWE | FEMALE CATTLE | FEMALE PIG | FILLY | F

Terapeutisk område:

ANTIBIOTIC & RELATED

Indikasjoner:

FOOT ROT | INFECTIONS OF THE RESPIRATORY TRACT | MASTITIS | UTERINE INFECTIONS | ACUTE RESPIRATORY INFECTIONS | BRONCHISEPTICA | BRONCHITIS | PHARYNGITIS | PNEUMONIA | SUBCLINICAL MASTITIS | TONSILLITIS

Produkt oppsummering:

Poison schedule: 4; Withholding period: WHP: CATTLE SHEEP PIGS - MEAT: DO NOT USE less than 5 days before slaughter f or human comsumption MILK: Milk collect ed from cows within 36 hours following s ingle treatment and 72 hours after multi ple treatment MUST NOT BE USED for human comsumption or processing. HORSES - ME AT: 28 DAYS; Host/pest details: COW: [FOOT ROT, INFECTIONS OF THE RESPIRATORY TRACT, MASTITIS, UTERINE INFECTIONS]; HORSE: [FOOT ROT, INFECTIONS OF THE RESPIRATORY TRACT, MASTITIS, UTERINE INFECTIONS]; PIG SOW (FEMALE): [FOOT ROT, INFECTIONS OF THE RESPIRATORY TRACT, MASTITIS, UTERINE INFECTIONS]; SHEEP: [FOOT ROT, INFECTIONS OF THE RESPIRATORY TRACT, MASTITIS, UTERINE INFECTIONS]; For the treatment of infections due to gram positive bacteria that cause mastitis, uterine infections, respiratory infections and footrot.MUST NOT be injected intravenously.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

                                Penethaject™ Antibiotic Injection 
Version Controlled Draft Label 
Page 1 of 9 
Last Edited Thursday, 3 February 2011 
 
Page 1 of 9 
IMMEDIATE CONTAINER / PENETHAJECT  
 
 
PRESCRIPTION ANIMAL REMEDY 
KEEP OUT OF REACH OF CHILDREN 
FOR ANIMAL TREATMENT ONLY 
 
Penethaject

 Antibiotic Injection  
 
ACTIVE CONSTITUENT 
PENETHAMATE HYDRIODIDE 15g PER VIAL 
 
15g  
 
READ THE LEAFLET BEFORE USING THIS PRODUCT. 
 
DIRECTIONS FOR USE 
MUST NOT BE injected intravenously. 
 
DOSAGE AND ADMINSTRATION 
The reconstituted aqueous suspension is stable for 2 days when
stored 
below 25˚C (air conditioning) or for 1 week when stored between
2˚C and 
8˚C (Refrigerate. Do not freeze). 
 
SHAKE WELL BEFORE USE 
DOSE RATE: 10-15mg per kg bodyweight daily. Repeat dose for 1-5
days 
depending on conditions. 
 
COWS AND HORSES: 5g daily 
SOWS AND SHEEP: 2.5g daily 
 
WITHHOLDING PERIODS:  
MEAT: CATTLE, SHEEP, PIGS    5 days 
   HORSES  
 
 
 28 days 
 
MILK: 36 HOURS (1 treatment) 
 72 HOURS (multiple treatment) 
 
 
 
    RLP
     APPROVED
 
 
  
 
Info
 
PEST
 

 
 
 
Verified
 
Penethaject™ Antibiotic Injection 
Version Controlled Draft Label 
Page 2 of 9 
Last Edited Thursday, 3 February 2011 
 
Page 2 of 9 
TRADE ADVICE 
EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an 
ESI established. For advice on the ESI, contact the manufacturer on
02 
9987 4922 before using the product. 
 
STORAGE: Store below 25°C (Air Conditioning). Protect from direct 
sunlight. The reconstituted aqueous suspension is stable for 2 days
when 
stored below 25˚C (air conditioning) or for 1 week when stored
between 
2˚C and 8˚C (Refrigerate. Do not freeze). 
 
 
Bomac Pty Ltd  
ABN 52 125 427 241 
15/36 Leighton Place  
Hornsby NSW 2077, Australia  
Orders and Product information Call 02 9987 4922  
www.bomac.net.au  
 
APVMA Approval Number:  59193/50933 
 
B 
 
DOM 

                                
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Preparatomtale

                                 
 
PAGE 1 OF 7
 
 
 
 
 
SAFETY DATA SHEET 
 
 
 
 
    
 
A18322/01/AUS
  
 
PENETHAJECT ANTIBIOTIC INJECTION 
 
SECTION 1 – IDENTIFICATION, CONTACTS, HAZARDOUS NATURE 
 
Bayer Australia Ltd 
875 Pacific Highway  
Pymble NSW 2073
 
EMERGENCY TELEPHONE NUMBER  
1800 033 111  
24 hour Emergency Service Australia Wide, Toll Free 
 
CONTACT POINT (FOR NON-EMERGENCY CALLS)  
Animal Health Division 
(02) 9391 6000  
Full Product Name 
PENETHAJECT ANTIBIOTIC INJECTION 
Other Names 
N/A
 
Product Use 
FOR ANIMAL TREATMENT ONLY 
For the treatment of infections due to gram-positive bacteria that
cause 
mastitis, uterine infections, respiratory infections and
footrot in cattle, 
sheep, pigs and horses.  
Creation Date 
7 August 2013
 
Revision Date 
New SDS 
 
SECTION 2 – HAZARDS IDENTIFICATION 
Hazard Classification 
HAZARDOUS SUBSTANCE 
NON-DANGEROUS GOODS according to the NOHSC Australia and 
the ADG code. 
Poison Schedule S4 
Risk Phrases 
R42/43 Irritating to eyes, skin & respiratory tract. Sensitization by 
inhalation and skin contact. 
Safety Phrases 
S2 Keep out of the reach of children. 
S23/63 Do not breathe vapour/spray. In case
of accident by inhalation; 
remove casualty to fresh air and keep at rest. 
S24/25/26 Avoid contact with eyes and skin. In
case of contact with 
eyes, rinse immediately with plenty of water and seek medical advice. 
S36 Wear suitable protective clothing. 
S60 This material and its container must be disposed
of as hazardous 
waste. 
 
 
 
A18322/01/AUS  PENETHAJECT ANTIBIOTIC INJECTION 
 
 
 
      PAGE 2 OF 7 
 
SECTION 3 – COMPOSITION 
INGREDIENTS 
CAS NO 
PROPORTION 
Penethamate hydroiodide 
808-71-9 
100% w/v 
 
Presented as:  Vial 1: White crystalline powder  
                       Vial 2 (Diluent): Clear,
colourless liqu
                                
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Sikkerhetsdatablad

                                Batch No.:
Expiry date:
86091550 09/17
LIMITATION OF LIABILITY
Failure to use the product strictly as directed may be illegal, prove
dangerous or render the product ineffective. Notwithstanding anything
else
contained on this label, and subject to any rights you have under the
Australian Consumer Law and any other applicable law, Bayer Australia
Limited’s liability is limited to replacing this product or
supplying equivalent
product or paying the cost of replacing this product, at its
discretion.
PENETHAJECT
®
is a registered trademark of the Bayer Group.
APVMA Approval No. 59193/108218
from anywhere in Australia
Monday to Friday
CUSTOMER INFORMATION LINE
1800 678 368
www.growsolutions.com.au
Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073
ACN 000 138 714
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Antibiotic Injection
ACTIVE CONSTITUENT: 15g/vial PENETHAMATE HYDRIODIDE
For the treatment of infections due to gram positive bacteria
that cause mastitis, uterine infections, respiratory infections and
footroot in cattle, horses, pigs and sheep.
6 x 15g Penethaject, 6 x 48mL Diluent
PENETHAJECT
®
WITHHOLDING PERIODS
CATTLE, SHEEP, PIGS
MEAT: DO NOT USE less than 5 days before slaughter for human
consumption
MILK: Milk collected from cows within 36 hours following a single
treatment
and 72 hours after multiple treatment MUST NOT BE USED for human
consumption or processing.
HORSES
MEAT: DO NOT USE less than 28 days before slaughter for human
consumption.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for
this product. Note – observing the meat withholding period may not
be
sufficient to mitigate potential risks to export trade. Trade advice
should be
sought from the Bayer website www.growsolutions.com.au or via the
APVMA
website at www.apvma.gov.au/residues or by calling Bayer Australia Ltd
on
1800 678 368 before using this product.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phon
                                
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