elevet+ Ampiclox® Dry Cow Intramammary Antibiotic

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

06-09-2023

Summary of Product characteristics (SPC)

19-06-2017

Safety Data Sheet (SDS)

04-12-1996

Active ingredient:

AMPICILLIN TRIHYDRATE; CLOXACILLIN AS THE BENZATHINE SALT

Available from:

AVET HEALTH LIMITED

INN (International Name):

cloxacillin as benzathine(500mg/Sg) + others

Pharmaceutical form:

MISC. INTRA MAMMARY

Composition:

AMPICILLIN TRIHYDRATE ANTIBIOTIC Active 250.0 mg/Sg; CLOXACILLIN AS THE BENZATHINE SALT ANTIBIOTIC Active 500.0 mg/Sg

Units in package:

#20x3.8g; #syringes; 200x3.8g; syringes

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: MILK: DO NOT USE in lactating cows or wi thin 30 days of calving. After calving, milk from treated dry cows MUST NOT BE USED for human consumption or supplied f or processing for 96 hours (8 milkings) . If premature or unscheduled calving oc curs, consult the prescribing veterinar ian for advice on handling milk for bobb y calves. MEAT: DO NOT USE less than 30 days before slaughter for human consump tion. Any variation by the prescribing veterinarian to the approved dose, frequ ency, duration or target species may re quire extending the approved withholding period. EXPORT SLAUGHTER INTERVAL (ESI ): An ESI has not been established for t his product. Note – observing the meat withholding period may not be sufficient to mitigate potential risks to export trade. Trade advice should be sought fro m AVet Health Ltd on 1300 28 38 28 befo re using this product.; Host/pest details: COW-NOT LACTATING-PREG. NOT W/I 1MTH CAL: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE DRY: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE LACTATING: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 4; Withholding period: WHP: Milk: Do not use in lactating c ows or within 30 days of calving. After calving milk from treated dry cows mu st not be used for human consumption or supplied for processing for 96 hours ( 8 milkings). Meat: Do not use less tha n 30 days before slaughter for human co nsumption. EXPORT SLAUGHTER INTERVAL (E SI):This product does not have an ESI e stablished For advice on the ESI contac t Jurox Pty Ltd on 1800 023 312 before using this product.; Host/pest details: COW-NOT LACTATING-PREG. NOT W/I 1MTH CAL: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE DRY: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE LACTATING: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: COW-NOT LACTATING-PREG. NOT W/I 1MTH CAL: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE DRY: [ANTIBIOTIC - ANTI-INFECTIVE]; DAIRY CATTLE LACTATING: [ANTIBIOTIC - ANTI-INFECTIVE]; For treatment of bovine mastitis caused by organisms sensitive to ampicillin and cloxacillin, during the dry period.Not to be used in lactating cows or within 30 days of calving. If accidently administered within 30 days of calving or to a lactating animal, contact your prescribing veterinarian for advice. Do not use in cows exhibiting sensitivity to penicillin

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

elevet+
AMPICLOX DRY COW INTRAMAMMARY ANTIBIOTIC INFUSION
35842/140172
Product Name:
APVMA Approval No:
Label Name:
elevet+ Ampiclox Dry Cow Intramammary Antibiotic Infusion
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each 3.8 g syringe contains:
500 mg CLOXACILLIN (as the BENZATHINE SALT)
250 mg AMPICILLIN TRIHYDRATE
Claims:
For use by or under direction of a veterinarian.
For the treatment of bovine mastitis caused by organisms sensitive to
ampicillin and
cloxacillin during the dry period.
elevet+ Ampiclox Dry Cow Intramammary Antibiotic Infusion is active
against all major
causative organisms of mastitis, both Gram-positive and Gram-negative.
It is effective
against: Streptococcus agalactiae and other Streptococcus spp.,
Penicillin resistant
and sensitive Staphylococcus spp., Corynebacterium spp., Escherichia
coli and other
susceptible 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 Dry Cow Intramammary Antibiotic
Infusion could
contribute to the development of antibiotic resistance.
Net Contents:
20 X 3.8 g syringes
200 X 3.8 g syringes
Directions for Use:
Restraints:
DO NOT USE in lactating cows or within 30 days of calving.
If accidentally administered within 30 days of calving or to a
lactating animal, contact your
prescribing veterinarian for advice. RLP APPROVED
Contraindications:
Contraindicated for use in cows exhibiting sensitivity to penicillin.
Precautions:
Side Effects:
Dosage and
Administration:
Dose:
One syringe per quarter immediately after the final milking of a
lactation.
Administration:
At the final milking of a lactation, milk the cow normally. Clean and
disinfect the teat ends
using rubbing alcohol or iodophors or other suitable disinfectant.
Infuse the contents of one
syringe into each quarter and leave without further milking. Wear
clean ru

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Summary of Product characteristics

AMPICLOX DRY COW INTRAMAMMARY
Page 1 of 6
continued
ISSUED:
3 OCTOBER 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
AMPICLOX DRY COW INTRAMAMMARY ANTIBIOTIC
INFUSION
PRODUCT CODE:
503285 (200 x 3.8 g syringes)
RECOMMENDED USE:
For treatment of bovine mastitis caused by organisms sensitive to
Ampicillin and Cloxacillin, during the Dry Period.
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:
EYE IRRITATION CATEGORY 2B
RESPIRATORY SENSITIZER CATEGORY 1
SKIN CORROSION/IRRITATION CATEGORY 3
SKIN SENSITIZER CATEGORY 1
GHS PICTOGRAMS:
HEALTH HAZARD
EXCLAMATION MARK
SIGNAL WORD*:
DANGER
HAZARD STATEMENTS*:
H316
Causes mild skin irritation
H317
May cause an allergic skin reaction.
H320
Causes eye irritation
H334
May cause allergy or asthma symptoms or breathing difficulties if
inhaled.
PRECAUTIONARY STATEMENTS*:
PREVENTION
P261
Avoid breathing vapours.
P264
Wash hands thoroughly after handling.
P272
Contaminated work clothing should not be allowed out of the workplace.
P280
Wear protective gloves/protective clothing/eye protection/face
protection.
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.
P305+P351
IF IN EYES: Rinse cautiously with water for several minutes.
+P338
Remove contact lenses, if present and easy to do. Continue rinsing.
P333+P313
If skin irritation or rash occurs: Get medical advice.
P337+P313
If eye irritation persists: Get medical advice.
P342+P311
If experiencing respiratory symptoms: Call a POISON CENTER or
doctor.
P363
Wash contaminated clothing before reuse.
AMPICLOX DRY COW I

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Ampicillin (as trihydrate) 250 mg per syringe
Cloxacillin (as benzathine) 500mg 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® DC 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, especially during the critical first 4 weeks after
drying-off.
Ampiclox® DC is highly effective against _Streptococci_, penicillin
resistant and sensitive _Staphylococci, Corynebacterium pyogenes_ and
_Escherichia coli._
INDICATIONS
•
Routine treatment of cows at drying off, eliminating the majority of
existing infections and reducing the incidence of new
infections.
•
Treatment of dairy cows at drying off 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
DO NOT USE in lactating cows or within 30 days of calving.
AMPICLOX
®
DRY COW
Intramammary Antibiotic Infusion
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
PRECAUTIONS
If accidentally administered within 30 days of calving or to a
lactating animal, contact your prescribing veterinarian for advice.
This product should not be used in cows exhibiting sensitivity to
penicillin.
WITHHOLDING PERIODS
MILK: Do not use in lactating cows or within 30 days of calving. After
calving, milk taken from treated dry cows must not be used for
human consumption or supplied for processing for 96 hours (8
milkings). If premature or unscheduled calving

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