Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DEMBREXINE HYDROCHLORIDE
Boehringer Ingelheim Ltd
QR05CB90
DEMBREXINE HYDROCHLORIDE
5 mg/g
Oral Powder
POM
Equine - Food
Dembrexine hydrochloride
Respiratory Tract Preparations
Authorised
1990-10-01
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 Read the complete document