BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLENBUTEROL HYDROCHLORIDE

Available from:

JUROX PTY LIMITED

INN (International Name):

clenbuterol as HCl(14.1ug/g)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

CLENBUTEROL HYDROCHLORIDE ANILIDE/ANILINE Active 16.0 ug/g

Units in package:

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:

RESPIRATORY SYSTEM

Therapeutic indications:

BRONCHOSPASM | RESPIRATORY - EXCESS MUCOID SECRETION | RESPIRATORY COND. - CONSTRICTED AIRWAYS | AIRWAY CONSTRICTION | CONSTRICTION OF AIRWAYS

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT: Not to be used in horses pr oducing meat for human consumption.; Host/pest details: HORSE: [BRONCHOSPASM, RESPIRATORY - EXCESS MUCOID SECRETION, RESPIRATORY COND. - CONSTRICTED AIRWAYS]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [BRONCHOSPASM, RESPIRATORY - EXCESS MUCOID SECRETION, RESPIRATORY COND. - CONSTRICTED AIRWAYS]; For the treatment of respiratory diseases in horses. All respiratory conditions which are characterised by airway obstruction due to bronchospasms or excess mucoid secretions. Whenever bronchodilation and increased muco-ciliary expectoration is desirable.Do not use in food producing species of animals. Should not be used in pregnant horses during the last 14 days of gestation as it may prevent uterine contractions.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES
Select appropriate:
1:1 New Product (include all applicable RLPs) OR
Variation (highlight instructions that are being varied). Approval no.
of label being
varied: 46957/01
Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES
Active constituent/s:
ACTIVE CONSTITUENT:
16 UG/G CLENBUTEROL HYDROCHLORIDE (EQUIVALENT TO 14.1 UG/G
CLENBUTEROL)
Statement of claims:
INDICATIONS:
FOR THE TREATMENT OF RESPIRATORY DISEASES IN HORSES.
ALL RESPIRATORY CONDITIONS WHICH ARE CHARACTERISED BY AIRWAY
OBSTRUCTION DUE TO
BRONCHOSPASM OR EXCESS MUCOID SECRETIONS.
WHENEVER
BRONCHODILATION
AND
INCREASED
MUCO-CILIARY
EXPECTORATION
IS
DESIRABLE.
Net contents:
500 G NET
Directions for Use
Heading:
DIRECTIONS FOR USE:
Restraints:
RESTRAINTS:
RLP
DO NOT USE IN FOOD PRODUCING SPECIES OF ANIMALS.
Approved
Contraindications:
BRONCOPULMIN WILL POTENTIATE THE ACTION OF CORTICOSTEROIDS. BETA
ADRENERGIC
AGENTS ADVERSELY AFFECT THE ACTION OF BRONCOPULMIN. THEREFORE
CONCURRENT
TREATMENT OF HORSES WITH THESE PRODUCTS IS NOT RECOMMENDED.
Precautions:
BRONCOPULMIN SHOULD NOT BE USED IN PREGNANT HORSES DURING THE LAST 14
DAYS OF GESTATION AS IT MAY PREVENT UTERINE CONTRACTIONS.
Side effects:
--
Dosage &
administration:
DOSE: THE ENCLOSED MEASURE HOLDS 10 G WHEN LEVEL.
ADMINISTER 5G OF BRONCOPULMIN PER 100 KG BODYWEIGHT TWICE DAILY FOR 10
—
14 DAYS.
THE DOSE SHOULD BE GIVEN ORALLY. IT MAY BE MIXED WITH A QUANTITY OF
FOOD THAT
WILL BE ENTIRELY CONSUMED BY THE HORSE. HORSES SUFFERING RESPIRATORY
DISEASE
MAY HAVE DEPRESSED APPETITE SO DOSAGE SHOULD BE ADMINISTERED IN A
SMALL
AMOUNT OF FOOD WHICH WILL BE READILY CONSUMED FOR EFFECTIVE TREATMENT.
General directions:
USE IN COMPLIANCE WITH THE RULES OF RACING.
Withholding Period/s:
MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES INTENDED
FOR HUMAN CONSUMPTION.
Trade Advice:
--
Safety Directions:
--
First Aid:
FIRST AID: IF POISONING OCCURS, CONTACT A DO

Summary of Product characteristics

BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES
Page 1 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
13 DECEMBER 2016
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT IDENTIFIER:
BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES
PRODUCT CODE:
50050 (500 g)
RECOMMENDED USE:
Oral bronchodilator for horses.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
EMAIL:
[e-mail]
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS: This product has been assessed according to
GHS and is classified as non-
hazardous.
SIGNAL WORD: None.
GHS PICTOGRAMS: None.
PRECAUTIONARY STATEMENTS: None.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Clenbuterol hydrochloride
21898-19-1
<0.01%
Ingredients not contributing to the hazards
-
To 100%
SECTION 4: FIRST AID MEASURES
GENERAL INFORMATION: Consult the National Poisons Centre on 13 1126 or
a doctor immediately in every case
of suspected chemical poisoning. Never give fluids or induce vomiting
if a patient is unconscious or
convulsing regardless of cause of injury. If medical advice/attention
is needed, have this SDS, product
container or label at hand.
SYMPTOMS AND EFFECTS OF EXPOSURE: Symptoms of exposure to clenbuterol
include tachycardia,
gastrointestinal disturbance, tremor, headache, dizziness, sweats,
muscle weakness and agitation.
Clenbuterol is a tocolytic agent and may arrest uterine contractions
in labour.
BRONCOPULMIN ORAL BRONCHODILATOR FOR HORSES
Page 2 of 6
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
INHALATION: If inhaled and symptoms do occur, remove patient to fresh
air. Lay patient down and ke

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Clenbuterol hydrochloride 16 µg/g
ACTIONS
Bronchodilator, expectorant. Clenbuterol is a sympathomimetic amine.
It has selectivity for the β2-receptor sites within the body,
which include the lungs and the uterus. This selectivity allows
intense bronchodilating properties with minimum direct effect on
the cardiovascular system. Clenbuterol also has a stabilising effect
on mast cells, preventing the release of histamine, serotonin and
bradykinin. Broncopulmin therefore has a beneficial effect on
mucociliary clearance by increasing the amount of mucus cleared by
the mucociliary escalator.
Where infection is present, the use of Broncopulmin Plus TMPS Oral
Powder may be indicated.
INDICATIONS
Respiratory conditions in horses characterised by airway obstruction
due to bronchospasm or excess mucoid secretions.
CONTRAINDICATIONS
DO NOT USE in food producing species of animals.
PRECAUTIONS
NOT TO BE USED in food producing animals.
Broncopulmin Oral Bronchodilator for Horses (known as Broncopulmin
Powder) should not be used in horses during the last 14 days
of gestation as uterine contractions may be prevented.
WITHHOLDING PERIODS
NOT TO BE USED in horses intended for human consumption.
BRONCOPULMIN
Oral Bronchodilator for Horses
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
INTERACTIONS
Broncopulmin Powder will potentiate the action of corticosteroids and
antagonise the effects of prostaglandin F2α and oxytocin.
β-Adrenergic agents adversely affect the action of Broncopulmin
Powder. Therefore, concurrent treatment of horses with these agents
is not recommended.
DOSAGE AND ADMINISTRATION
Give orally mixed with food. One level measure
≡
10 g.
HORSES: 5 g per 100 kg bodyweight twice daily for 10 to 14 days.
The dose may be mixed with a quantity of food that will be entirely
consumed by the horse.
Horses suffering respiratory disease may hav