NV AMBROXOL INJECTION MUCOLYTIC FOR HORSES & DOGS

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes ativos:

AMBROXOL HYDROCHLORIDE

Disponível em:

CEVA ANIMAL HEALTH PTY LTD

DCI (Denominação Comum Internacional):

ambroxol HCl(6mg/mL)

Forma farmacêutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composição:

AMBROXOL HYDROCHLORIDE ANILIDE/ANILINE Active 6.0 mg/ml

Unidades em pacote:

100mL

Classe:

VM - Veterinary Medicine

Fabricado por:

CEVA ANIMAL HEALTH

Grupo terapêutico:

DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT

Área terapêutica:

RESPIRATORY SYSTEM

Indicações terapêuticas:

CATARRHAL INFLAMATION OF BRONCHI | UPPER RESPIRATORY TRACT AIRWAY

Resumo do produto:

Poison schedule: 4; Withholding period: WHP: MEAT (horses): 28 days; Host/pest details: DOG: [CATARRHAL INFLAMATION OF BRONCHI]; HORSE: [CATARRHAL INFLAMATION OF BRONCHI]; Mucolytic expectorant- an aid in the treatment of catarrhal inflammation of bronchi and upper respiratory tract airways.

Status de autorização:

Registered

Data de autorização:

2023-07-01

Folheto informativo - Bula

NV AMBROXOL INJECTION MUCOLYTIC FOR HORSES & DOGS
51134/130829
Product Name:
APVMA Approval No:
Label Name:
NV AMBROXOL INJECTION MUCOLYTIC FOR HORSES & DOGS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
6 mg/mL AMBROXOL HYDROCHLORIDE
Claims:
Mucolytic expectorant - an aid in the treatment of catarrhal
inflammation of bronchi and
upper respiratory tract airway in horses and dogs.
Net Contents:
100 mL
Directions for Use:
Restraints:
DO NOT USE in food-producing species of animals.
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
Use the contents within 6 months of first broaching of the vial.
Discard the unused portion.
Administer by intravenous injection.
Horses: 0.3 mg/kg (5 mL/100 kg) bodyweight twice daily.
Dogs: 0.6 mg/kg (1 mL/10 kg) bodyweight twice daily. RLP APPROVED
General Directions:
Pharmacology:
NV Ambroxol is an active metabolite of bromhexine. The mucolytic
action of NV Ambroxol
reduces the tenacity and viscosity of respiratory mucus, aiding
expectoration and assisting
in the maintenance of patent bronchioles and alveoli.
NV Ambroxol enhances the penetration of antibiotics into bronchial
secretions, increasing
their concentration at the target site.
Indications:
NV Ambroxol is a mucolytic agent indicated as an aid in the treatment
of respiratory
disorders associated with viscid mucus. In the therapy of bacterial
respiratory infections
concomitant use of NV Ambroxol with chemotherapeutic agents may
enhance
concentration of those agents at the target site and result in a more
rapid recovery when
compared with treatment with chemotherapeutic agents alone.
Withholding Periods:
MEAT WITHHOLDING PERIOD (HORSES): 28 DAYS.
Trade Advice:
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 13 11
26.
First Aid Warnings:
Additional User
Safety:
Environmental
Statements:
Disposal:
Dispose of container by wrapping with paper and putting

Características técnicas

AMBROXYL Injection 

Creation Date: January 2002 
Revision Date:  Oct 2011 
Version: 3 
Next revision due: Oct 2016 

MATERIAL SAFETY DATA SHEET 
_AMBROXYL INJECTION_

Page 1 of 7 

COMPANY DETAILS 

COMPANY: 

ADDRESS: 
Ceva Animal Health Pty Ltd 

11 Moores Road 
ABN 54 002 692 426  

Glenorie   NSW   2157  Australia 

TELEPHONE NUMBER: 

FACSIMILE NUMBER: 
[phone] 

[phone] 

EMERGENCY TELEPHONE NUMBER: 
[phone] (Business Hours) 
Poisons Information Centre: 131126 

SUBSTANCE IDENTIFICATION 

PRODUCT NAME:  
_NV Ambroxol Injection Mucolytic for Horses and Dogs_ 

OTHER NAMES:   

_Ambroxol_ 

MANUFACTURER’S PRODUCT CODE: 
5AMB 

UN NUMBER: 
None allocated 

DANGEROUS GOODS CLASS AND SUBSIDIARY RISK: 
None allocated 

HAZCHEM CODE: 
None allocated 

SUSDP POISONS SCHEDULE NUMBER: 
S4 

USE: 
Mucolytic expectorant as an aid in the
treatment of catarrhal inflammation of bronchi and upper 
respiratory tract airways in horses and dogs. For intramuscular
injection. For animal treatment only. 

STATEMENT OF HAZARDOUS NATURE:  
Hazardous according to criteria of NOHSC Australia. 

SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER 
SECTION 2 – HAZARDS IDENTIFICATION 
AMBROXYL Injection 

Creation Date: January 2002 
Revision Date:  Oct 2011 
Version: 3 
Next revision due: Oct 2016 

MATERIAL SAFETY DATA SHEET 
_AMBROXYL INJECTION_

Page 2 of 7 

RISK PHRASES:  
No risk phrases identified. 

SAFETY PHRASES:  
No safety phrases identified. 

The substance is a sterile aqueous injection, containing the
following ingredients.  

INGREDIENTS: 

CHEMICAL NAME 
CAS NUMBER 
PROPORTION 
Ambroxol Hydrochloride 
18683-91-5 
0.6% (6 mg/mL) 
Benzyl A