Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Bromhexine hydrochloride
Boehringer Ingelheim Ltd
QR05CB02
Bromhexine hydrochloride
10 milligram(s)/gram
Oral powder
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Cattle, Dogs, Pigs
bromhexine
Respiratory Tract preparations
Authorised
1991-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bisolvon 10mg/g Oral Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: Active Substance Bromhexine Hydrochloride 10 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution or addition to feed. White crystalline powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an aid to the treatment of respiratory disease in cattle, pigs, dogs and cats where mucus is a complicating factor. 4.3 CONTRAINDICATIONS Not for use in cows producing milk for human consumption. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Avoid contact with the skin and eyes. In case of accidental eye contact, flush the affected eye with copious amounts of clean running water. Wash hands and exposed skin after administering the 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_ _ _ _0_ _7_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _4_ _2_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Not applicable. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Ma Read the complete document