elevet+ Ampiclox L.C. Lactating Cow Intramammary Antibiotic Infusion

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AMPICILLIN AS THE SODIUM SALT; CLOXACILLIN AS THE SODIUM SALT

Available from:

AVET HEALTH LIMITED

INN (International Name):

ampicillin as Na salt(75mg/Sg)+cloxacillin as Na salt(200mg/Sg)

Pharmaceutical form:

MISC. INTRA MAMMARY

Composition:

AMPICILLIN AS THE SODIUM SALT ANTIBIOTIC Active 75.0 mg/3gSy; CLOXACILLIN AS THE SODIUM SALT ANTIBIOTIC Active 200.0 mg/3gSy

Units in package:

20x3g Syr

Class:

VM - Veterinary Medicine

Therapeutic group:

CATTLE LACTATING | BOVINE

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

CORYNEBACTERIUM PYOGENES | ESCHERICHIA COLI (E. COLI) | STAPHYLOCOCCI | STREPTOCOCCI | INCLUDING B-LACTAMASE PRODUCIN

Product summary:

Poison schedule: 4; Withholding period: MILK: Milk taken from cows within 72 hou rs (6 milkings) following treatment MUST NOT BE USED for human consumption or p rocessing, or fed to bobby calves. MEAT : DO NOT USE less than 30 days before sl aughter for human consumption. Any vari ation by the prescribing veterinarian to the approved dose, frequency, duration or target species may require extending the approved withholding period. EXPOR T SLAUGHTER INTERVAL (ESI): An ESI has n ot been established for this product. N ote – observing the meat withholding per iod may not be sufficient to mitigate po tential risks to export trade. Trade ad vice should be sought from AVet Health L td on 1300 28 38 28 before using this p roduct.; Host/pest details: CATTLE LACTATING: [CORYNEBACTERIUM PYOGENES, ESCHERICHIA COLI (E. COLI), STAPHYLOCOCCI, STREPTOCOCCI]; Poison schedule: 4; Withholding period: WHP: Milk: Milk taken from cows withi n 72 hours following last treatment mus t not be used for human consumption or supplied for processing. WHP: Meat: Do not use less than 30 days before slaug hter for human consumption.; Host/pest details: CATTLE LACTATING: [CORYNEBACTERIUM PYOGENES, ESCHERICHIA COLI (E. COLI), STAPHYLOCOCCI, STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE LACTATING: [CORYNEBACTERIUM PYOGENES, ESCHERICHIA COLI (E. COLI), STAPHYLOCOCCI, STREPTOCOCCI]; For the treatment of mastitis in lactating cows caused by organisms sensitive to Ampicillin and Cloxacillin.Milk taken from cows with 72 hours of treatment also must not be fed to bobby calves.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

elevet+
AMPICLOX L.C. LACTATING COW INTRAMAMMARY ANTIBIOTIC INFUSION
35849/140173
Product Name:
APVMA Approval No:
Label Name:
elevet+ AMPICLOX L.C. LACTATING COW INTRAMAMMARY ANTIBIOTIC INFUSION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each 3 g syringe contains:
200 mg CLOXACILLIN AS THE SODIUM SALT
75 mg AMPICILLIN AS THE SODIUM SALT
Claims:
For use by or under direction of a veterinarian.
For the treatment of mastitis in lactating cows caused by organisms
sensitive to Ampicillin
and Cloxacillin.
Elevet+ Ampiclox L.C. Lactating Cow Intramammary Antibiotic is active
against Gram-
positive and Gram-negative bacteria associated with mastitis. It is
highly effective against
Streptococcus agalactiae and other streptococcal species, penicillin
resistant and sensitive
Staphylococci, Corynebacterium pyogenes, Escherichia coli and some
other Gram-
negative bacteria. Therefore, the formulation of the antibiotic
Infusion is
a broad spectrum antibiotic and is bactericidal at the concentrations
achieved in the udder
tissues.
Indiscriminate use of elevet+ Ampiclox L.C. Lactating Cow Intramammary
Antibiotic
Infusion could contribute to the development of antibiotic resistance.
Net Contents:
20 x 3 g syringes
Directions for Use:
Restraints:
Contraindications: RLP APPROVED
Precautions:
Side Effects:
Dosage and
Administration:
Dose
Apply one syringe every 12 hours for 3 treatments per affected
quarter.
Administration
After milking, clean and disinfect the teat with an approved teat
disinfectant, insert the
nozzle into the teat canal and apply gentle and continuous pressure on
the plunger until
all the suspension is expressed. Wear sanitised rubber gloves when
applying. Dip all teats
after infusing in an approved teat disinfectant.
The treated quarter(s) should be milked out at the next normal milking
and milk withheld
from the general collection. For advice on feeding calves with milk
taken during the
withholding period, contact your prescribing v

Summary of Product characteristics

AMPICLOX LACTATING COW INTRAMAMMARY
Page 1 of 4
ISSUED:
23 AUGUST 2011
MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
AMPICLOX L.C. LACTATING COW INTRAMAMMARY
ANTIBIOTIC INFUSION
PRODUCT CODE:
500935 (20 x 3 g syringes)
RECOMMENDED USE:
An intramammary infusion to treat mastitis in lactating cows.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Road
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (Monday – Friday, 9.00 a.m. – 5.00 p.m.)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS:
NOT CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO THE CRITERIA OF
NOHSC
AUSTRALIA.
NOT CONSIDERED A DANGEROUS GOOD ACCORDING TO THE CRITERIA OF THE
AUSTRALIAN
DANGEROUS GOODS (ADG) CODE.
POISONS SCHEDULE:
S4
RISK PHRASES:
Causes mild skin irritation
May cause an allergic skin reaction
Causes eye irritation
May cause allergy or asthma symptoms or breathing difficulties if
inhaled
SAFETY PHRASES:
Keep out of reach of children
Read label and safety data sheet before use
Avoid breathing vapours
Wash hands thoroughly after handling
Contaminated work clothing should not be allowed out of the workplace
Wear protective gloves
In case of inadequate ventilation wear respiratory protection
IF ON SKIN: Wash with plenty of soap and water
IF INHALED: If breathing is difficult, remove to fresh air and keep at
rest in a position
comfortable for breathing
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses,
if present and easy to do so. Continue rinsing.
Specific treatment: See Section 4.
If skin irritation or rash occurs or eye irritation persists: Get
medical advice/attention
If experiencing respiratory symptoms: Call a POISON CENTRE or
doctor/physician.
Wash contaminated clothing before reuse
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Cloxacillin sodium
7081-44-9
7.3 %
Ampicillin sodium
69-

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Ampicillin (as the sodium salt) 75 mg per syringe
Cloxacillin (as the sodium salt) 200 mg per syringe
ACTIONS
In combination, ampicillin and cloxacillin have a synergistic action
against Gram-positive and Gram-negative bacteria. Cloxacillin is
thought to bind to the β-lactamase enzyme and thus prevents the
enzyme acting on ampicillin. The two drugs are therefore able to
effectively control a range of Gram-positive and Gram-negative
organisms.
Ampiclox® L.C. is distributed well within the udder and shows
bactericidal activity at the concentrations achieved in the udder
against
all major Gram-positive and Gram-negative bacteria associated with
mastitis, with no irritant properties
Ampiclox® L.C. is highly effective against _Streptococci_, penicillin
resistant and sensitive _Staphylococci, Corynebacterium pyogenes _and
_Escherichia coli_ and other Gram-negative organisms.
It is therefore active against all major causative organisms of
mastitis.
INDICATIONS
•
Routine treatment of clinical mastitis in lactating dairy cows.
•
Treatment of clinical mastitis when the cause of infection is
unidentified or where the presence of coliforms are suspected or
known to be present as a problem on the farm.
CONTRAINDICATIONS
This product should not be used in cows exhibiting sensitivity to
penicillin.
PRECAUTIONS
Wear sanitized rubber gloves when infusing the suspension.
AMPICLOX
®
L.C.
Lactating Cow Intramammary Antibiotic Infusion
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
WITHHOLDING PERIODS
MILK: Milk taken from cows within 72 hours (6 milkings) following
treatment MUST NOT BE USED for human consumption or
processing, or fed to bobby calves.
MEAT: DO NOT USE less than 30 days before slaughter or human
consumption.
TRADE ADVICE
Export Slaughter Interval (ESI): This product does not have an ESI
established. For advice on the ESI, c