País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Clenbuterol Hydrochloride
Boehringer Ingelheim Limited
QR03CC13
Clenbuterol Hydrochloride
Granules
POM-V - Prescription Only Medicine – Veterinarian
Horses
Respiratory expectorant
Authorized
1994-08-22
Revised: December 2015 AN: 01175/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ventipulmin Granules 16 micrograms/gram 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains ACTIVE SUBSTANCE: Clenbuterol hydrochloride 16 micrograms EXCIPIENTS: For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Granules. White, finely grained free flowing granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of respiratory disease in horses where airway obstruction due to bronchospasm and/or accumulation of mucus is a contributing factor, and improved mucociliary clearance is desirable. To be used alone or as adjuvant therapy. In particular : i) Acute, sub-acute and chronic infections where the presence of mucus and/or micro- organisms may stimulate bronchospasm or cause airway obstruction and thus an increase in airway resistance. For example, bronchitis, bronchiolitis and bronchopneumonia alone, or associated with equine influenza and other viral respiratory diseases. ii) Acute, sub-acute and chronic respiratory allergies. iii) Chronic Obstructive Pulmonary Disease (COPD) in horses. In cases complicated by the presence of micro-organisms the simultaneous use of antimicrobial agents is indicated. 4.3 CONTRAINDICATIONS None known 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Page 1 of 4 Revised: December 2015 AN: 01175/2015 Do not use in horses with known cardiac disease 4.5 SPECIAL PRECAUTIONS FOR USE Not applicable. (i) Special precautions for use in animals Do not use in animals with known hypersensitivity to the active substance. Special precautions to be taken by the person administering the veterinary medicinal product to animals. This product contains clenbuterol, a beta-agonist.Take care to avoid skin contact. In case of skin contact wash affected area thoroughly. If irritation occurs/persists seek medical advice. Take care to avoid accidental eye contact. In the case of accidental eye cont Llegiu el document complet