Sputolosin Oral Powder 5 mg/g

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Dembrexine Hydrochloride Monohydrate

Disponibbli minn:

Boehringer Ingelheim Animal Health UK Ltd

Kodiċi ATC:

QR05CB90

INN (Isem Internazzjonali):

Dembrexine Hydrochloride Monohydrate

Għamla farmaċewtika:

Oral powder

Tip ta 'preskrizzjoni:

POM-V - Prescription Only Medicine – Veterinarian

Grupp terapewtiku:

Horses

Żona terapewtika:

Respiratory mucolytic

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

1985-07-30

Karatteristiċi tal-prodott

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