País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Denaverine hydrochloride
Veyx-Pharma GmbH
QG02CX90
Denaverine hydrochloride
40.0 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
denaverine
Miscellaneous
Authorised
2017-06-30
ANNEX I 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, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK) Sensiblex Solution Injectable Pour Bovins (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 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 during parturition 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 obstructions. 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 already 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, malpresentation, uterine torsion). If present, obstructions must be removed prior to product administration (e.g. correction of abnormal presentation or uterine torsion). Signs of peripartum electrolyte imbalances (with special attention to calcium and phosphorus), as well as metabolic disturbances (e.g. ketosis), both possibly causing weak labour and thus insufficient dilation of the soft birth canal, require particular consideration and supportive measurements. 4.5 SPECIAL PRECAUTIONS FOR USE Special pr Llegiu el document complet