Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ACETYLCYSTEINE
CP-Pharma Handelsgesellschaft mbH
QR05CB01
2 Grams
Oral Powder
Respiratory Tract Preparations
Equine - Food
2004-08-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equimucin 2g, Oral Powder for Horses. Acetylcysteine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 WARNINGS FOR EACH TARGET SPECIES None. 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. 1 sachet of 6g oral powder contains: ACTIVE SUBSTANCE Acetylcysteine 2000 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/08/2011_ _CRN 7010648_ _page number: 1_ 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 have not produced any evidence of a teratogenic effect. Safety of the product has not been established durin Read the complete document