TRIBRISSEN INJECTION-

Main information

  • Trade name:
  • TRIBRISSEN INJECTION-480
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 50mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • TRIBRISSEN INJECTION-480
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | HORSE | PIGS | SHEEP EWE - DRY | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CO
  • Therapeutic area:
  • antibiotic
  • Therapeutic indications:
  • BACTERIAL INFECTION | INFECTIONS OF THE ALIMENTARY TRACT | INFECTIONS OF THE RESPIRATORY TRACT | INFECTIONS OF THE UROGENITAL TRACT | ACUTE RESPIRATORY INFECTIONS | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | BRONCHISEPTICA | BRONCHITIS | CYSTITIS | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | METRITIS | NEPHRITIS | PHARYNGITIS | PNEUMONIA | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TONSILLITIS | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA
  • Product summary:
  • For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadiazine.DO NOT USE in female sheep which are producing or may in the future produce milk or milk products for human consumption.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 36120/0301
  • Authorization date:
  • 11-04-2001
  • Last update:
  • 15-06-2017

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

TRIBRISSEN INJECTION 480

PRIMARY PACK

PRESCRIPTION

ANIMAL

REMEDY

KEEP OUT OF

REACH

OF CHILDREN

FOR ANIMAL

TREATMENT

ONLY

TRIBRISSEN®

Injection - 480

TRIMETHOPRIM 80 mg/mL

SULFADIAZINE 400 mg/mL

For the treatment

of

infections

caused by organisms sensitive

to trimethoprim and sulfadiazine

50mL

JUROXLOGO

CARTON - FRONT

&

REAR

PANELS

File Name;

Tribrissen Injection 480 Cat

Preparation Date:

9.2.2001

Version:

Page 1

38 Milk WHP.DOC

Last Revised:

12.12.2000

(8/3/2001)

Prepared By:

L. Wirth

TRIBRISSEN

INJECTION

PRIMARY

PACK

CARTON

(RIGHT PANEL)

READ THE ACCOMPANYING LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE:SHAKE WELL BEFORE USE

DO NOT USE in female sheep which are producing or may in the future produce milk

or milk products for human consumption.

DOSE RATE:

1-1.5mL

30kg

bodyweight daily.

Cattle,

horses:

Inject intravenously

(slowly) or intramuscularly.

Sheep, pigs:

Inject intramuscularly.

WITHHOLDING PERIODS

MEAT:

DO NOT USE less than 28 days before slaughter for human consumption.

MILK (CATTLE):

Milk collected from cows

within 72 hours

following treatment

MUST NOT BE USED for human consumption or processing.

This milk should not be

fed to bobby calves.

MILK (SHEEP):

DO NOT USE in female sheep which are producing or may in the

future produce

milk

or milk products for human consumption.

TRIBRISSEN

INJECTION

PRIMARY

PACK

CARTON

(LEFT PANEL)

DISPOSE

container

wrapping with paper

putting in garbage.

® Schering-Plough

Ltd Registered Trademark

Made in Australia by:

Jurox

85 Gardiners Road,

Rutherford,

2320

Australia.

Under

Licence from:

Schering-Plough

STORE

below

2SoC

(Air Conditioning)

PROTECT

from light.

36120/

O'&J/

EXP.

File Name:

Tribrissen Injection 480 Cat

Preparation Date:

9.2.2001

Version:

Page 2

38 Milk WHP.DOC

Last

Revised:

12.12.2000

(8/3/2001 )

Prepared By:

L. Wirth

TRIBRISSEN INJECTION 480

PRIMARY PACK

TRIBRISSEN®

Injection - 480

TRllMETHOPRIM80mymL

SULFADIAZINE 400

mg/ml,

SOmL

CARTON (TOP PANEL)

FileName:

Tribrissen

Injection

480 Cat

Preparation

Date:

9.2.2001

Version:

2

Page 3

38 Milk WHP.DOC

Last Revised:

12.12.2000

(8/3/2001)

Prepared By:

Wirth

TRIBRISSEN INJECTION 480

IMMEDIATE CONTAINER

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL

TREATMENT

ONLY

TRIBRISSEN®

Injection - 480

TRIMETHOPRIM 80 mg/mL

SULFADIAZINE 400 mg/mL

JUROXLOGO

50mL

LABEL (FRONT PANEL)

File

Name:

Tribrissen

Injection 480 Cat

Preparation

Date:

9.2.2001

Version:

2

Page 4

38 Milk WHP.DOC

LastRevised:

12.12.2000

(8/3/2001)

Prepared By:

Wirth

TRIBRlSSEN INJECTION 480

IMMEDIATE CONTAINER

LABEL (RIGHT PANEL)

READ

ACCOMPANYING

LEAFLET

BEFORE

USING

THIS

PRODUCT.

For the treatment

infections caused by organisms sensitive to trimethoprim and

sulfadiazine.

DIRECTIONS

USE:

SHAKE

WELL

BEFORE

USE.

USE in female sheep which

producing

future

produce

milk

milk

products

human

consumption.

DOSE

RATE:

1-1.5mL per 30kg bodyweight daily.

Cattle, horses:

Inject intravenously

(slowly) or intramuscularly.

Sheep, pigs: Inject intramuscularly.

WITHHOLDING

PERIODS:

MEAT:

28 days.

MILK

(CATTLE):

Milk

collected from cows

within 72

hours

following

treatment

MUST

BE USED

human

consumption

processing.

This

milk should

fed to

bobby

calves.

TRIBRlSSEN INJECTION 480'

IMMEDIATE CONTAINER

LABEL (LEFT PANEL)

DISPOSE

container by wrapping with paper and putting in garbage.

Made in Australia by:

Jurox Pty Ltd.

85 Gardiners Road,

Rutherford,

NSW 2320 Australia.

Under Licence from:

Schering-Plough Pty Ltd

Schering-Plough Pty Ltd Registered Trade Mark.

STORE below 25°C (Air Conditioning)

PROTECT from light.

EXP.

36120/030\

File Name:

Tribrissen Injection 480 Cat

Preparation Date:

9.2.2001

Version:

Page 5

38 Milk WHP.DOC

Last

Revised:

12.12.2000

(8/312001)

Preoared Bv:

Wirth

TRIBRISSEN INJECTION 480

PACKAGE INSERT

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

TRIBRISSEN®

Injection - 480

TRIMETHOPRIM 80 mg/ml.

SULFADIAZINE 400

rng/rnl,

LEAFLET

Tribrissen Injection contains 80

mglmL

trimethoprim,

a synthetic antibacterial

developed in

the Wellcome Research Laboratories,

and 400

mglmL

sulfadiazine.

Tribrissen is effective

against most Gram-positive and Gram-negative bacteria.

The two components

Tribrissen

produce a sequential double blockade

bacterial

metabolism giving a level

activity many

times greater than that obtained from either drug alone.

Indications:

Tribrissen Injection may be used in the treatment

a wide range

diseases and conditions

ofbaeterial origin in cattle, sheep, pigs and horses.

Tribrissen Injection is indicated for the systemic treatment of:

Respiratory infections

bacterial

origin including pneumonia,

bronchitis and secondary

bacterial infections following virus pneumonia.

Urogenital

tract

infections including cystitis, vaginitis,

urethritis, nephritis and metritis.

Alimentary

tract

infections including

E.coli

infections and salmonellosis.

Other infections,

such

foul-in-the-foot,

severe mastitis,

bacterial

agalactia of sows,

post-

operative and post-parturient uses,

wound infections and septicaemias.

Tribrissen

is active

in vitro

against

Gram-positive and Gram-negative organisms

including

Actinomyces

spp.,

Bacillus anthracis,

Bordetella

spp.,

Brucella

spp.,

Clostridium

spp.,

Cornyebacterium

spp.,

Diplococci,

Enterococci,

Escherichia coli,

Haemophilus

spp.,

Klebsiella

spp.,

Shigella

spp.,

Staphylococci,

Streptococci

Vibrio

spp.

Note

Erysipelothrix,

Leptospira

Pseudomonas

organisms are not

sensitive to Tribrissen,

Mycobacterium tuberculosis.

DIRECTIONS

USE:

SHAKE

WELL

BEFORE

USE.

USE in female sheep which

producing

future

produce

milk

or milk

products

human

consumption.

cattle,

sheep,

pigs

and horses

30kg bodyweight

daily.

The maximum

recommended dose is 1.5mL per 30kg bodyweight daily.

FileName:

Tribrissen Injection 480 Cat

Preparation Date:

9.2.2001

Version:

Page 6

38 Milk WHP.DOC

Last

Revised:

12.12.2000

(8/3/200 I)

Prepared By:

Wirth

TRIBRISSEN INJECTION 480

PACKAGE INSERT

LEAFLET (continued)

Average doses:

Calves and foals

Pigs

Young cattle

5-IOmL

Sheep

Adult cattle

10-15mL

Adult horses

1O-15mL

Animals may be treated by injection alone or the initial

injection may be followed by daily

administration

the oral

Tribrissen formulations,

except

in cattle with functional

rumens.

Administration

Intramuscular injection is recommended for sheep and pigs.

Cattle and horses may be injected intravenously or intramuscularly.

Intramuscular injections

should be made into the neck as less pain is caused at this site than at others.

Intravenous

injections should be administered slowly.

Note

Tribrissen

well

tolerated.

Very

occasionally,

effects

site

injection

encountered.

These are seen as local irritating swellings

a temporary nature.

WITHHOLDING

PERIODS

MEAT:

USE less

than

28 days before

slaughter

human

consumption.

MILK

(CATTLE):

Milk

collected from cows

within 72

hours

following

treatment

MUST

BE USED

human

consumption

processing.

This

milk

should

fed to

bobby

calves.

MILK

(SHEEP):

USE in female sheep which

producing

in the

future

produce

milk

milk

products

human

consumption.

DISPOSE

container by wrapping with paper and putting in garbage.

STORE below 25°C (Air Conditioning).

PROTECT from light.

Made in Australia by:

Jurox Pty. Ltd.

85 Gardiners Road,

Rutherford, NSW 2320 Australia.

Under Licence from Schering-Plough Pty Ltd

Schering-Plough Pty Ltd Registered Trademark

Schering-Plough Pty Ltd 2000

NRA 36120/

ObC,

File Name:

Tribrissen Injection 480 Cat

Preparation Date:

9.2.2001

Version:

Page 7

38 Milk WHP.DOC

Last Revised:

12.12.2000

(8/3/2001 )

Prepared By;

Wirth

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

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