SENSIBLEX 40MG/ML SOLN FOR INJ CATTLE 50ML

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sensiblex 40 mg/ml solution for injection for cattle (AT, BG, CY, CZ, DE, EE, EL, ES, HR, HU, IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK) Sensiblex Solution Injectable Pour Bovins (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Denaverine hydrochloride 40.0 mg (equivalent to 36.5 mg Denaverine) Excipients: Benzyl alcohol (E1519) 20.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 Target species Cattle (cows, heifers) 4.2 Indications for use, specifying the target species Cows, heifers: - Promotes dilation of the soft tissues of the birth canal in cases where the birth canal is insufficiently opened. - Regulates uterine contractions in animals with hypertonic muscular contractions of the uterus. Heifers: - Promotes dilation of the soft tissues of the birth canal to facilitate parturition. 4.3 Contraindications Do not administer in cases of mechanical obstetrical disorders. 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 The product is ineffective if no part of the foetus has entered the cervical canal and if abdominal pressing has not started. Before administering the product it is important to ensure there are no mechanical obstructions (e.g. oversized foetus). If present, obstructions must be removed prior to product administration (e.g. correction of abnormal presentation or uterine torsion). 4.5 Special precautions for use Special precautions for use in animals None. Special precautions to be taken by the person administering the veterinary medicinal product to animals The product has a potential to affect uterine musculature. Therefore, pregnant women and those women who are attempting to conceive should not handle or administer the product. Administration should be performed with caution in order to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Accidental spillage onto skin or into the eyes should be thoroughly rinsed off with water. People with known hypersensitivity to denaverine hydrochloride or to any of the excipients should not administer the product. Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) Increased restlessness; swellings at the injection site; absent or insufficient effectiveness necessitating further obstetric measures. 4.7 Use during pregnancy, lactation or lay Use at the time of parturition only. Not for use during other stages of pregnancy or during lactation. 4.8 Interaction with other medicinal products and other forms of interaction The product should not be mixed with other veterinary medicinal products. In the case of additional administration of oxytocin or its analogues, the dose of this active substance must be carefully selected because denaverine may amplify its effects.