Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Bromhexine
SP Veterinaria, S.A.
QR05CB02
Bromhexine
10 milligram(s)/gram
Oral powder
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Chickens, Ducks, Pigs, Turkeys
bromhexine
Mucolytic
Authorised
2017-02-10
Health Products Regulatory Authority 03 December 2021 CRN00CFS8 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT TUDOMAX, 10 mg/g, powder for use in drinking water/milk 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains ACTIVE SUBSTANCE: Bromhexine 10.00 mg (As bromhexine hydrochloride 10.98 mg) EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for use in drinking water/milk White or cream coloured powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves), pigs, chickens, turkeys and ducks 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Mucolytic treatment of congested respiratory tract. 4.3 CONTRAINDICATIONS Do not use in cases of pulmonary oedema. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In case of serious lungworm infection, the product should only be used 3 days after the commencement of the anthelmintic treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals This product may cause hypersensitivity reactions (allergy). People with known hypersensitivity to bromhexine or to any of the excipients should avoid contact with the product. This product may cause irritation of the respiratory and gastrointestinal tracts if accidentally ingested or inhaled. During preparation and administration inhalation of dust particles should be avoided. Wear an appropriate dust mask (either a disposable half-mask respirator conforming to European Standard EN149) or a non-disposable respirator to European Standard EN 140 with a filter to EN 143), when handling the product. This product may cause irritation to the skin, eyes and mucous membranes. Avoid direct contact with the product. Wear gloves and protective glasses during the use of the product. Health Products Regulatory Authority Soma hati kamili