Страна: Великобритания
Език: английски
Източник: VMD (Veterinary Medicines Directorate)
Denaverine Hydrochloride
Veyx-Pharma GmbH
QG02CX90
Denaverine Hydrochloride
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Neurological Agent uterine relaxant
Authorized
2017-06-15
Revised: September 2022 AN: 00358/2022 & 00360/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sensiblex 40 mg/ml solution for injection for cattle 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. Revised: September 2022 AN: 00358/2022 & 00360/2022 Page 2 of 5 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 precautions for use in Прочетете целия документ