Genestran Injection 20Ml

4.1 Target species Cattle, horses and pigs. 4.2 Indications for use, specifying the target species Cattle: - induction of luteolysis allowing resumption of oestrus and ovulation in cyclic females when used during dioestrus - synchronisation of oestrus (within 2 to 5 days) in groups of cyclic females treated simultaneously - treatment of suboestrus and uterine disorders related to a functioning or persistent corpus luteum (endometritis, pyometra) - treatment of ovarian luteal cysts - induction of abortion until day 150 of pregnancy - expulsion of mummified foetuses - induction of parturition (within the last two weeks of gestation). Horses: - induction of luteolysis in mares with a functional corpus luteum. Pigs: - induction or synchronisation of farrowing (generally within 24 to 36 hours) from day 113 of pregnancy onwards (day 1 of pregnancy is the last day of natural or artificial insemination). 4.3 Contraindications Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with spastic respiratory or gastro-intestinal diseases. Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use for intravenous administration. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals: To reduce the risk of anaerobic infections, which might be related to the pharmacological properties of prostaglandins, care should be taken to avoid injection through contaminated areas of skin. Clean and disinfect injection sites thoroughly before application. Avoid contamination of the product during use. Should any apparent growth or discoloration occur, the product should be discarded. Pigs: use only when precise date of insemination is known. Administer on day 113 of gestation, at the earliest. The product administered earlier, may impair the viability and weight of piglets. Special precautions to be taken by the person administering the veterinary medicinal product to animals: The product must be handled carefully to avoid accidental self-injection and direct contact with the skin or mucous membranes of the user.. Prostaglandins of the F2α type may be absorbed through the skin and may cause bronchospasm or miscarriage. Pregnant women, women of childbearing age, asthmatics and persons with other respiratory tract diseases should exercise caution when handling cloprostenol. Those persons should wear gloves during administration of the product. Accidental spillage on the skin should be washed immediately with soap and water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Should respiratory distress result from accidental inhalation or injection, a rapid acting bronchodilator, e.g. isoprenaline or salbutamol by inhalation is indicated. 4.6 Adverse reactions (frequency and seriousness) Anaerobic infections may occur if anaerobic bacteria are introduced into the tissue by the intramuscular injection. Cattle: Following induction of parturition with the product, an increased incidence of placental retention may be observed. Horses: After an injection of the product, slight sweating and diarrhoea may develop temporarily. Pigs: No undesirable effects have been reported. 4.7 Use during pregnancy, lactation or lay Pregnancy: Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Lactation: Can be used during lactation. 4.8 Interaction with other medicinal products and other forms of interaction Concurrent use of oxytocin and cloprostenol increases the effects on the uterus.
Vat Rate: 20%