BROMHEXINE TRIM/SULFA ORAL ANTIBACTERIAL & MUCOLYTIC POWDER

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
BROMHEXINE HYDROCHLORIDE; TRIMETHOPRIM; SULFADIMIDINE
Available from:
ADVANCED FEEDS PTY LTD
INN (International Name):
sulfadimidine(450mg/g)+trimethoprim(90mg/g)+bromhexine HCl(9mg/g)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
BROMHEXINE HYDROCHLORIDE GUANIDINE Active 9.0 mg/g; TRIMETHOPRIM PYRIMIDINE Active 90.0 mg/g; SULFADIMIDINE SULFANYL Active 450.0 mg/g
Units in package:
1kg; 2.5kg; 250g; 500g
Class:
VM - Veterinary Medicine
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ACTINOBACILLUS EQUULI | ESCHERICHIA COLI (E. COLI) | INFECTIONS OF THE RESPIRATORY TRACT | PASTEURELLA SPP. | SALMONELLA | STAPHYLOCOCCUS AUREUS | STAPHYLOCOCCUS INTERMEDIUS | STREPTOCOCCUS EQUI VAR EQUI | STREPTOCOCCUS ZOOEPIDEMICUS | ACUTE RESPIRATORY INFECTIONS | BRONCHISEPTICA | BRONCHITIS | DEEP PYODERMAS | INCLUDING B-LACTAMASE PRODUCIN | INCLUDING SECONDARY INVADERS | PASTERELLOSIS | PASTEURELLOSIS | PHARYNGITIS | PNEUMONIA | SALMONELLOSIS | SEBORRHOEIC DERMATITIS | TONSILLITIS
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat witholding Period (Horses): Do not use less than 28 days before sla ughter for human consumption.; Host/pest details: HORSE: [ACTINOBACILLUS EQUULI, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE RESPIRATORY TRACT, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS EQUI VAR EQUI, STREPTOCOCCUS ZOOEPIDEMICUS]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ACTINOBACILLUS EQUULI, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE RESPIRATORY TRACT, PASTEURELLA SPP., SALMONELLA, STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS EQUI VAR EQUI, STREPTOCOCCUS ZOOEPIDEMICUS]; For the treatment of respiratory infections in horses due to organisms susceptible to the combination of sulfadimidine and trimethoprim.
Authorization status:
Registered
Authorization number:
49762
Authorization date:
2020-07-01

DRAFT

LASED

Page 1 of 2

Appendix

registration

PRESCIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Bromhexine

Trim/Sulfa

Oral

Antibacterial

&

Mucolytic Powder

ACTIVE CONSTITUENTS:

Each

gram

contains

SULFADIMIDINE 450mg. TRIMETHOPRIM 90mg.

BROMHEXINE HYDROCHLORIDE 9mg.

N.R.A.

APPROVED

LABEL

(TEXT)

Label

Lf..r.Z~?./-Q.7-

q.l..

Date:

i!...

.I..) ..

"e.L"

Signature:

.......

fa""

......

"

Bromhexine Trim/Sulfa

Oral Antibacterial

&

Mucolytic Powder

Date:

directly into horses mouth.

One level

scoop contains Sulfadimidine 6.25g. Trimethoprim 1.25g and

Bromhexine Hydrochloride 125mg.

Horses:

One level scoop per 250kg bodyweight twice daily.

MEAT WITHHOLDING PERIOD(HORSES):

DO NOT USE

less than 28

days

before

slaughter

human

consumption.

READ THE ATTATCHED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE:

For oral

use only.

Mix well

with feed. May be mixed with molasses and syringed

1Y?~J~

Signature:

treatment

respiratory

infections

horses

due to

organisms

susceptible

combination

sulfadimidine

trimethoprim

Disposal:

Wrap empty container with paper and place in garbage.

[Break, crush or puncture and bury empty containers in a local

authority landfill.

If no landfill

is available, bury the containers below 500mm in a disposal

specifically marked and set up for this purpose clear of waterways vegetation

and roots. Empty containers and product should not be burnt.]

Store below 30 C (Room Temperature).

Protect from light.

250g,

500g,[1 kg,

2.5kg]

ADVANCED FEEDS PTY LTD

13 Meliador Way Midvale WA 6056

Batch

Expiry

NRA Approval

49762/010

Appendix 1 for registration of

Bromhexine Trim/Sulfa

)1

L-\oral

Antibacterial

&

Mucolytic

Powder

Signature:

{/evvV

lI.-f1-hate:

<,!

DRAFT LEAFLET

PRESCIPTION

ANIMAL

REMEDY

KEEP

OUT OF

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

Bromhexine Trim/Sulfa Oral

Antibacterial

& Mucolytic Powder

Composition.

Each gm contains Sulfadimidine 450mg,

Trimethoprim 90mg,

Bromhexine Hydrochloride 9mg.

Sulfadimidine is a pyrimidine sulfonamide antimicrobial

agent.

Trimethoprim is a diaminopyrimidine antimicrobial

agent.

Bromhexine hydrochloride is a synthetic derivative of the alkaloid,

vasicine.

The combination of

antimicrobials,

blocks two sequential

steps in

microbial synthesis of folate.

This creates a synergistic action which

enhances the antimicrobial

activity of the combination when compared

to the individual

components.

This imparts some significant advantages in clinical

application;

- the combination is bacteriacidal

while each drug alone is bacteriostatic.

- the spectrum of antibacterial

activity is broadened.

- minimum inhibitory concentrations are lower than each agent alone.

Bromhexine acts on mucous producing goblet cells in the respiratory

tract

with

the following beneficial

effects;

1) Reduces viscosity and tenacity of

mucous to facilitate clearance.

2) Increases the permeability of the aveolar/capillary barrier,

increasing

antibacterial

concentrations in respiratory secretions.

3) Increases gamma-globulins IgA and IgG in bronchial

secretions.

The following bacteria of clinical

importance in horses have shown sensitivity to

the 5 : 1 combination of sulfadimidine and trimethoprim;

Actinobacillus equuli,

coli,

Pasteurella sp.,

Staph.

aureus,

Staph.

intermedius,

Strep. equi

var equi,

Strep.

zooepidemicus and Salmonella sp.

Resistance is generally shown by

Psuedomonas sp. and Rhodococcus equi.

Sulfadimidine and trimethoprim are readlity absorbed following oral

administration

and rapidly reach therapeutic levels in plasma.

Both are widely distibuted in body

tissues and fluids including CSF,

peritoneal,

pleural,

synovial

and ocular

fluids.

Bromhexine is also rapidly absorbed after oral

dosing and is quickly redistributed

from plasma to tissues including the respiratory system.

Recommended dose rates are based on

30mg/kg

body weight

of combined

antibacterial

agents twice daily.

Each dose should be mixed well

with feed or

be mixed to a paste and given

directly via the mouth.

MEAT

WITHHOLDING

PERIODIHORSES):

DO NOT USE

less

than

days

before

slaughter

human

consumption.

Store below 30 C (Room Temperature).

Protect

from light.

Disposal:

Wrap empty container with paper and place in garbage.

{Break, crush or puncture and bury empty containers in a local

authority landfill.

If no landfill

is available, bury the containers below

500mm

in a disposal

specifically marked and set

up for this purpose clear of waterways vegetation

and roots.

Empty containers and product should not

burnt.]

NRA Approval

49762

to-to

ADVANCED

FEEDS

13 Meliador

Midvale

6056

ADVANCED FEEDS

Date of Issue: 4

th

May 2005

Page:

1 of 3

MATERIAL SAFETY DATA SHEET

Not classified as hazardous according to criteria of NOHSC Australia.

Company:

Advanced Feeds Pty Limited

Address:

13 Meliador way Midvale WA

Telephone:

9250 5344

Fax:

9250 5355

1. PRODUCT IDENTIFICATION

Product name:

Bromohexine Trim/Sulfa Oral Antibacterial & Mucolytic

Powder

Other names:

None

Manufacturers code:

None

UN number:

None allocated

Dangerous goods class:

None allocated

Subsidiary Risk:

None allocated

Hazchem code:

None allocated

Poisons schedule:

Use:

Treatment of respiratory infections due to susceptible

organisms in horses.

Physical description & Properties

Appearance:

Fine white powder.

Boiling point/melting point:

Not relevant

Vapour pressure:

Not relevant

Specific gravity:

Not available

Flashpoint:

Not relevant – not flammable

Flammability limits:

Not relevant

Solubility in water:

Not relevant

Ingredients

Chemical name

CAS No

Proportion %

Trimethoprim

738-70-5

16.39

Ingredients determined

not to be hazardous

Not relevant

to 100%

ADVANCED FEEDS

Date of Issue: 4

th

May 2005

Page:

2 of 3

MATERIAL SAFETY DATA SHEET

2. HEALTH HAZARD INFORMATION

Health Effects

No specific data is available for the product for chronic exposure symptoms. The

ingredients are not listed as carcinogenic in Worksafe’s document “Exposure Standards

for Atmospheric Contaminants in the Occupational Environment” (May 1995), nor in

NOHSC’s “List of Designated Hazardous Substances” (April 1999).

Chronic exposure to trimethoprim may cause nausea, vomiting, skin rash and itchiness.

Acute

This is a pharmacologically active preparation, and contact should be avoided except

for its intended veterinary use.

Swallowed:

Data suggests that this product may cause gastric upset such as

nausea, headache and vomiting if swallowed and may be harmful

if swallowed in large quantities.

Eye:

This product may be irritating to the eyes.

Inhaled:

May be slightly irritating.

First Aid

Swallowed:

If poisoning occurs, contact a doctor or National Poisons

Information Centre, 131126 from anywhere in Australia.

Eye:

Irrigate with copious amounts of water.

Skin:

If skin irritation occurs, remove contaminated clothing and wash

skin thoroughly. If irritation occurs, seek medical attention.

Inhaled:

Remove from exposure.

3. PRECAUTIONS FOR USE

Exposure Standards: A time weighted average (TWA) concentration for an 8 hour

day, and 5 day week has not been established by NOHSC

Australia for the ingredients in the product. The ADI (Acceptable

Daily Intake) for Trimethoprim is set at 0.02mg/kg/day. The

corresponding NOEL (No-observable-effect-level) is set at

33mg/kg/day.

Personal Protection:

Impermeable protective gloves and an approved dust mask.

Flammability:

No information.

ADVANCED FEEDS

Date of Issue: 4

th

May 2005

Page:

3 of 3

ATERIAL SAFETY DATA SHEET

4. SAFE HANDLING INFORMATION

Storage & Transport: No special requirements. This product is an S4 poison and has no

UN classification. Observe all relevant regulations regarding

sale, transport and storage of S4 products. Store in cool, dry

place below 30

C. Avoid contamination with strong oxidising

agents Protect from light.

Spills & disposal:

In the event of a major spill, prevent product from entering any

drains or water courses. Sweep up spills and dispose of at

licensed landfill site. Dispose of only in accord with regulations.

Fire explosion hazard:There is no risk of an explosion from this product under normal

circumstances if it is involved in a fire.

5. OTHER INFORMATION

This MSDS is prepared in accord with the Worksafe Australia document “National

Code of Practice for the Preparation of Material Safety Data Sheets”, 1994.

Contacts

National Poisons Information Centre

13 11 26 (from anywhere in

Australia)

Advanced Feeds Pty Ltd

Tel: (08) 9250 5344

13 Meliador Way Midvale WA 6056

Fax: (08) 9250 5355

Please read all labels carefully prior to use.

The above information is based on our current knowledge of the product but no

warranty, express or implied is made. Particularly, this information does not dispense

users from fulfilling the legal obligations and formality for which they remain

responsible.

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