Sputolosin Oral Powder 5 mg/g

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Dembrexine hydrochloride monohydrate

Tilgængelig fra:

Boehringer Ingelheim Vetmedica GmbH

ATC-kode:

QR05CB90

INN (International Name):

Dembrexine hydrochloride monohydrate

Dosering:

5 milligram(s)/gram

Lægemiddelform:

Oral powder

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

dembrexine hydrochloride

Autorisation status:

Authorised

Autorisation dato:

1990-10-01

Produktets egenskaber

Health Products Regulatory Authority
23 November 2018
CRN008QMY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sputolosin Oral Powder 5 mg/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, SPECIFYING THE TARGET SPECIES
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
None known.
Health Products Regulatory Authority
23 November 2018
CRN008QMY
Page 2 of 5
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.
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
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration in the food at a dose of 0.3 mg active
ingredient per kg
bodyweight twice daily; for example for a 500 kg horse, 30 g (6 le