ORBENIN DRY COW

Main information

  • Trade name:
  • ORBENIN DRY COW INTRAMAMMARY ANTIBIOTIC INFUSION
  • Pharmaceutical form:
  • MISC. INTRA MAMMARY
  • Units in package:
  • 3g,20x3g
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • ZOETIS AUSTRALIA

Documents

Localization

  • Available in:
  • ORBENIN DRY COW INTRAMAMMARY ANTIBIOTIC INFUSION
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
  • Therapeutic area:
  • antibiotic
  • Therapeutic indications:
  • MASTITIS | ORGANISMS SENSITIVE TO CLOXACILLIN | SUBCLINICAL MASTITIS
  • Product summary:
  • 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,

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35848/01
  • Authorization date:
  • 22-08-1996
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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)

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

penicillin

nucleus,

6-aminopenicillanic

acid.

It is presented in 3g syringes for intramamm

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 lactating cow, since its persistence would involve

discarding milk with antibiotic residues over a long period.

r7-:u-.JKIRln:

J..,,.“.

LEAFLET(cont)

ACTION

Orbenin

is active against Cram-positive organisms associated with mastitis. It is highly

effective against Strqtococcus

agalactiae

and other Streptococcal species; penicillin

resistant and sensitive Staphylococci and

pyogenes. Unlike natural penicillins,

Orbenin

is not destroyed by staphylococcal penicillinase.

It is therefore active against

penicillin resistant Staphylococci which are an important cause of mastitis.

The benzathine salt of Cloxacillin retains its activity over a considerable period and in

the long-acting base, maintains effective antibacterial levels in the mammary gland of

the dry cow for approximately four weeks.

The antibiotic is bactericidal, causing the death of organisms at the concentrations

produced and it is

non-ir$tant

the udder tissues.

INDICATIONS

Mastitis due to Streptococciis still common but Staphylococci, many strains of which

are penicillin resistant, now account for a large proportion of cases.

The extent of sub-

clinical and latent infection in a herd is

frequently

unsuspected, but half the herd may

well be

affected,

although a much smaller number show clinical signs at any one time.

In untreated herds a significant build up of sub-clinical infection can occur during the

dry period, so that after a number of lactations the incidence of infection becomes

serious.

The influence of sub-clinical infection on milk yield, the risk of cross-infection

and the chance of clinical infection flaring up, make it necessary to treat the matter as a

herd problem.

While no single form of treatment will be likely to eliminate mastitis entirely, extensive

investigations have proved the value of treating the cows in a herd as they are dried

off, with

Orbenin

Dry Cow formulation.

When the cow is milked out for the last time,

one syringe of

Orbenin

Dry Cow Intramammary Antibiotic

InfUsion

is infused into each

quarter and allowed to remain.

It is desirable to use an antiseptic teat dip and other

routine hygienic measures to help maintain the control of infection in the herd.

While cases of mastitis, if they arise during lactation, will still require treatment with an

appropriate antibiotic such as

Orbenin

the use of the routine dry cow medication

has been shown to achieve very valuable control of herd infection at calving.

Since the

treatment is during the dry period it does not lead to loss

from

discarded milk.

DIRECTIONS FOR USE

Not to be used in lactating cows or cows expected to calve within 30 days

following

treatment.

accidentally

administered within 30 days of calving or to a lactating animal,

contact your prescribing Veterinarian for advice.

Do not administer to animals with a history of allergic reaction to penicillins.

DOSE: One syringe per quarter immedi

ADMINISTRATION: At the end of lactation milk the cow out normally.

Clean and

disinfect the teat using an approved teat disinfectant.

Infuse one syringe of

Orbenin

Dry Cow Intramammary Antibiotic Infusion into each quarter and leave it without

milking out. Wear clean rubber gloves when applying. Dip all teats after infusing in an

approved teat disinfectant.

It is normally unnecessary and undesirable to introduce any further treatment during

the dry period.

The cow can be milked as usual when she calves down.

WITHHOLDING PERIODS

MEAT

NOTUSE

LESS THAN 30 DAYS BEFORE SLAUGHTER FOR

HUMAN CONSUMPTION.

MILK

DO NOT

USEINLACTATING

CATTLE. DO NOT USE LESS THAN

30 DAYS BEFORE CALVING. MILK FROM TREATED COWS MUST NOT

BE USED FOR HUMAN CONSUMPTION OR SUPPLIED FOR PROCESSING

FOR 96 HOURS (8

MILKINGS)

AFTER CALVING.

NRA Approval Number:

35848/01

STORAGE

Store below

25OC

(Air Conditioning)

DISPOSAL

Dispose of empty syringes by wrapping with paper and putting in garbage.

AVAILABILITY

Orbenin

Dry Cow Intramammary Antibiotic Infusion is supplied in cartons of 20, 200

and 400 syringes, each syringe containing 5OOmg of cloxacillin as the benzathine salt.

Pfizer

Animal

Health

A division of Pfizer Pty. Limited

Wharf

Road

West Ryde NSW 2114

*Registered

Trademark

1995

20/100

SYRINGE

PRIMARY PACK (CARTON)

PRESCRIPTION ANIMAL

REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Orbenin*

Dry Cow

Intra’inammary

Antibiotic

Infksion

Each

syringe

contains:

5OOmg CLOXACILLIN as the Benzathine Salt

Also Contains: 25mg BRILLIANT BLUE FCF

For Treatment of Bovine Mastitis caused by Organisms Sensitive to Cloxacillin during

the Dry Period.

20/100

syringes each 3g

Pfizer

20/100

SYRINGE

PRIMARY

PACK (CARTON)

Orbenin*

Dry Cow

Intramammary

Antibiotic

Infksion

NRA Approval Number: 3 5

848/O

Store below

25OC

(Air Conditioning)

Exp:

20/100

SYRINGE

PRIMARY PACK (CARTON)

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE.

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 reactions to penicillins.

ORBENIN

DRY COW is accidentally administered within 30 days of calving or

to a lactating

anirmll_cytact

your prescribing veterinarian for advice.

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 such as

Orbenin

Teat Wipes.

Infuse the contents of one syringe into each

quarter and leave without further milking.

Wear clean rubber gloves when applying.

Dip all teats after infusion, in an approved teat disinfectant.

WITHHOLDING PERIODS

MEAT

DO NOT USE LESS THAN 30 DAYS BEFORE SLAUGHTER FOR

HUMAN CONSUMPTION.

MILK

DO NOT USE IN LACTATING CATTLE.

DO NOT USE LESS THAN

30 DAYS BEFORE CALVING. MILK FROM TREATED COWS MUST NOT

BE USED FOR HUMAN

CONSUMPTION OR SUPPLIED FOR PROCESSING

FOR 96 HOURS

[(8)

MILKINGS] AFTER CALVING.

DISPOSAL

Dispose of empty syringes by wrapping with paper and putting in garbage

20/100

SYRJNGE

PRIMARY PACK (CARTON)

Orbenin*

Dry Cow

Intramammary Antibiotic

InfUsion

Pfizer

Animal

Health

A division of Pfizer Pty. Limited

Wharf

Road

*West

Ryde NSW 2114

*Registered

Trademark@

1995

Pfizer

i

20/100

SYRINGE

PRIMARY PACK (CARTON)

Orbenin*

Dry Cow

Intramammaty Antibiotic

Infhsion

Pfizer

200/400

SYRINGE

PRIMARY PACK (PAIL)

PRESCRIPTION

ANTMAL

REMEDY

KEEP OUT OF REACH OF CHILDREN

ANIMAL

TREATMENT ONLY

Orbenin*

Dry Cow

Intramammary Antibiotic

Infbsion

Each syringe contains

500 mg CLOXACILLIN as the Benzathine Salt

Also Contains: 25 mg BRILLIANT BLUE FCF

For Treatment of Bovine Mastitis caused by Organisms Sensitive

to Cloxacillin During the Dry Period

200/400

SYRINGES EACH 3g

Pfizer

i

200/400

SYRINGE

PRIMARY PACK (PAIL)

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE

Not to be used in lactating cows or cows expected to calve within 30 days

following treatment.

If accidentally administered within 30 days of calving or to a lactating animal,

contact your prescribing Veterinarian for advice.

Do not administer to animals with a history of allergic reaction to penicillins.

DOSE:

syringepz:

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. end using rubbing alcohol or iodophors or other suitable

disinfectant such as

Orbenin

Teat Wipes.

Infuse the contents of one syringe into each

quarter and leave without further milking.

Wear clean rubber gloves when applying.

Dip all teats after

infusing

in an approved teat disinfectant.

WITHHOLDING PERIODS

MEAT

DO NOT USE LESS THAN 30 DAYS BEFORE SLAUGHTER FOR

HUMAN CONSUMPTION.

MILK

DO NOT USE IN LACTATING CATTLE.

DO NOT USE LESS THAN

30 DAYS BEFORE CALVING. MILK FROM TREATED COWS MUST NOT

BE USED FOR HUMAN

CONSUMPTION OR SUPPLIED FOR PROCESSING

FOR 96 HOURS (8 MILKINGS) AFTER CALVING.

Dispose of empty syringes by wrapping with paper and putting in garbage

NRA Approval Number:

35848/01

Store below

25OC

(Air Conditioning).

Exp:

200/400

SYRINGE

PRIMARY PACK (PAIL)

Pfizer

Animal

Health

A division of Pfizer Pty. Limited

Wharf

Road

West Ryde NSW 2114

A.P.N.

Pfizer

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

21-6-2016

Use of medicine for cows suspended

Use of medicine for cows suspended

Today, the Danish Medicines Agency has decided to suspend the use of the veterinary medicine Velactis, which is used to reduce milk production (drying-off) in dairy cows.

Danish Medicines Agency

There are no news related to this product.