Sputolosin Oral Powder 5 mg/g

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Dembrexine Hydrochloride Monohydrate

Disponível em:

Boehringer Ingelheim Animal Health UK Ltd

Código ATC:

QR05CB90

DCI (Denominação Comum Internacional):

Dembrexine Hydrochloride Monohydrate

Forma farmacêutica:

Oral powder

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Horses

Área terapêutica:

Respiratory mucolytic

Status de autorização:

Authorized

Data de autorização:

1985-07-30

Características técnicas

Revised: November 2018
AN: 00957/2018
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sputolosin Oral Powder 5mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE
Dembrexine hydrochoride monohydrate
5 mg
(Equivalent to 4.372 mg of dembrexine per g.)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder. Fine, white and free-flowing
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE
The product is indicated for the symptomatic treatment of acute,
sub-acute and chronic
respiratory disease of the upper and lower respiratory tract, where an
abnormal amount
of mucus of increased viscosity is present..
4.3
CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to the active
substance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None known.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Care/precautions should be taken when using this product to avoid skin
contact, eye
contact and/or inhalation of the dust. Medical advice should be sought
if you feel unwell
after using this product.
Revised: November 2018
AN: 00957/2018
Page 2 of 4
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Sputolosin has not been tested in pregnant mares, however,
reproduction studies using
dembrexine in laboratory animals show no teratogenic effect. Where
Sputolosin has
been administered to pregnant mares, no adverse effects have been
reported.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration in the food at a dose rate of 0.3 mg
dembrexine per kg bodyweight
twice daily: for example, for a 500kg horse, 30 g (6 level measures)
of powder twice daily.
For small horses, ponies and foals the do