Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
acetylcysteine 2 g
CP Pharma Handelsgesellschaft mbH
QR05CB01
Oral powder
acetylcysteine
Horses Food
2011-09-06
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIMUCIN 2G, ORAL POWDER FOR HORSES DK, FI, NO: Equimucin VET 2g, oral powder for horses Acetylcysteine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 sachet of 6 g oral powder contains: _Active substance:_ Acetylcysteine 2000 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to pale yellow oral powder 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Reduction of viscosity of the tracheobronchial secretion in the supportive mucolytic treatment of chronic broncho-pulmonary diseases accompanied by abnormal secretion and mucostasis in the horse. 4.3 CONTRAINDICATIONS Do not administer the product in case of known hypersensitivity to acetylcysteine. See also section 4.8. 4.4 SPECIAL WARNINGSNone. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The product should not be used in horses suspected of suffering from gastric ulceration. As acetylcysteine is metabolised to sulphur containing products, use cautiously in horses known to be suffering from liver disease. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Persons should wear gloves during administration. 4..6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Hypersensitivity to acetylcysteine may occur. Should undesirable effects occur, withdraw the product and treat symptomatically. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Laboratory studies in rats and rabbits hav Read the complete document