SPUTOLOSIN ORAL POWDER 5 MG/G
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
SPC
(SPC)
31-12-2015
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active_ingredient:
DEMBREXINE HYDROCHLORIDE
MAH:
Boehringer Ingelheim Ltd
ATC_code:
QR05CB90
INN:
DEMBREXINE HYDROCHLORIDE
dosage:
5 mg/g
pharmaceutical_form:
Oral Powder
prescription_type:
POM
therapeutic_group:
Equine - Food
therapeutic_area:
Dembrexine hydrochloride
therapeutic_indication:
Respiratory Tract Preparations
authorization_status:
Authorised
authorization_date:
1990-10-01
SPC
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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/12/2015_
_CRN 7022424_
_page number: 1_
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 OT
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