Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Bromhexine Hydrochloride
Ceva Animal Health Ltd
QR05CB02
Bromhexine Hydrochloride
Powder for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Duck, Pigs, Turkeys
Respiratory mucolytic
Expired
2015-10-07
Revised: September 2022 AN: 01504/2022 Page 1 of 6 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Exflow 10 mg/g powder for use in drinking water for cattle (calves), pigs, chickens, turkeys and ducks 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Bromhexine................................................ 9.11 mg (as bromhexine hydrochloride 10.00 mg) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for use in drinking water White to slightly beige 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. Revised: September 2022 AN: 01504/2022 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In case of serious lungworm infection, the drug should only be used 3 days after the commencement of the anthelmintic treatment. In case of primary and/or secondary infection, the combination with antibiotics should be considered. When administered concomitantly with the product, antimicrobial agents should not be underdosed. 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 any of the excipients should avoid contact with the product. This product may cause irritation to the skin, eyes and mucous membranes. 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 Read the complete document