ORBENIN DRY COW INTRAMAMMARY ANTIBIOTIC INFUSION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

CLOXACILLIN AS THE BENZATHINE SALT; BRILLIANT BLUE DYE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

cloxacillin as benzathine(500mg/Sg)

Pharmaceutical form:

MISC. INTRA MAMMARY

Composition:

CLOXACILLIN AS THE BENZATHINE SALT ANTIBIOTIC Active 500.0 mg/Sg; BRILLIANT BLUE DYE DYE-BLUE Other 25.0 mg/Sg

Units in package:

100x3g Syr; 200x3g Syr; 20x3g Syr; 400x3g Syr

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

MASTITIS | ORGANISMS SENSITIVE TO CLOXACILLIN | SUBCLINICAL MASTITIS

Product summary:

Poison schedule: 4; Withholding period: WHP: Do not use in lactating cows or c ows expected to calve within 30 days fo llowing treatment. WHP: Meat: Do not us e less than 30 days before slaughter fo r human consumption. WHP: Milk: Do not use in lactating cattle. Do not use le ss than 30 days before calving. Milk f rom treated cows must not be used for h uman consumption or supplied for proces sing for 96 hours (8 milkings) after ca lving.; Host/pest details: CATTLE: [MASTITIS, ORGANISMS SENSITIVE TO CLOXACILLIN]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [MASTITIS, ORGANISMS SENSITIVE TO CLOXACILLIN]; For the treatment of bovine mastitis caused by organisms sensitive to Cloxacillin during the dry period.Not to be used in lactating cows or cows expected to calve within 30 days following treatment. Do not administer to animals with a history of allergic reaction to penicillins,

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

IMMEDIATE CONTAINERLABEL
PRESCRIPTION ANIMAL
REMEDY
FOR ANIMAL TREATMENT ONLY
Orbenin*
Dry Cow
Intramammary Antibiotic Infusion
500 mg CLOXACILLIN as the Benzathine Salt
Also Contains: 25 mg BRILLIANT BLUE FCF
READ ENCLOSED LEAFLET BEFORE USE
DIRECTIONS FOR USE
One syringe per quarter immediately after the final milking of a
lactation.
WITHIIOLDING
PERIODS:
SEE LEAFLET FOR DETAILS.
DO NOT USE IN LACTATING COWS OR COWS EXPECTED TO CALVE
WITHIN 30 DAYS FOLLOWING TREATMENT
NRA:
35848/01
Store below
25oC
(Air Conditioning)
0
B
Exp:
Pfizer
*Registered
Trademark@
1995
LEAFLET
PRESCRIPTION ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT ONLY
Orbenin*
Dry Cow
Intramammary Antibiotic Infusion
For Treatment of Bovine Mastitis caused by Organisms Sensitive
to Cloxacillin during the Dry Period.
.
.
PRODUCT SUMMARY
Orbenin
Dry Cow Intr
amammary
Antibiotic
Infusion
is specially prepared for
treatment of the dry cow.
It maintains effective antibiotic levels in the udder for a period of
weeks and is non-
irritant.
It is bactericidal with activity against Penicillin resistant and
sensitive Staphylococci,
Streptococci and
_CORYNEBACTERIUMPYOGENES._
Treatment during the dry period avoids financial loss from discarded
milk.
DESCRIPTION
Orbenin
Dry Cow
Intramammary
Antibiotic Infusion is a stable suspension containing
SOOmg
per syringe of cloxacillin as the benzathine salt in a long acting
base.
The active material is chemically the benzathine salt of
6-[3-(2-chlorophenyl)-S-
methylisoxazole4carboxamido]
penicillanic acid. It is a semi-synthetic
penicillii
derived
from
the
penicillin
nucleus,
6-aminopenicillanic
acid.
It is presented in 3g syringes for intramamm
ary
infusion and is designed to be used in
the dairy cow at the point of drying off, that is, immediately after
the last milking of the
lactation.
The combined effects of the relatively insoluble benzathine salt and
the long acting
base give an extended period of activity for 3-4 weeks in the dry cow.
The preparation
is not suitable for treatment of the lacta

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Summary of Product characteristics

PRODUCT NAME: ORBENIN L.C. LACTATING COW INTRAMAMMARY ANTIBIOTIC
INFUSION WITH PROLONGED ACTION
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2011

MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)

- IDENTIFICATION OF THE MATERIAL AND SUPPLIER

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde  NSW  2114

Tel:     1800 814 883

Fax:    (02) 9850 3399

____________________________________

PFIZER AUSTRALIA PTY LTD

A.B.N. 50 008 422 348
CHEMICAL NATURE:
Blend of ingredients; active ingredient is an antibiotic.

TRADE NAME:
ORBENIN L.C. LACTATING COW INTRAMAMMARY ANTIBIOTIC INFUSION
WITH PROLONGED ACTION

PRODUCT USE:
Used to treat Bovine mastitis due to susceptible organisms in the
lactating cow.

CREATION DATE:
SEPTEMBER, 2006
THIS VERSION ISSUED:
AUGUST, 2011 and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
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: S45. In case of accident or if you feel
unwell, contact a doctor or Poisons Information Centre
immediately (show the label where possible).
SUSMP CLASSIFICATION: S4
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code.
UN NUMBER: None allocated
E
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E
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E
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N
N
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C
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Y
Y

O
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PHYSICAL DESCRIPTION & COLOUR: White to off-white coloured creamy
solution.
ODOUR: Mild odour.
MAJOR HEALTH HAZARDS: no significant risk factors have been found for
this product. A significant ingredient of this
product is an antibiotic. Any perso

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