País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Dembrexine hydrochloride
Boehringer Ingelheim Ltd
QR05CB90
Dembrexine hydrochloride
5 milligram(s)/gram
Oral powder
POM: Prescription Only Medicine as defined in relevant national legislation
Horses
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _6_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _4_ _2_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4. Leia o documento completo