Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Clodronate disodium tetrahydrate
Dechra Regulatory B.V.
QM05BA02
Clodronate disodium tetrahydrate
51 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
clodronic acid
Authorised
2015-09-03
Health Products Regulatory Authority 22 January 2021 CRN009G5F Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Osphos 51 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Clodronic acid 51.00 mg (Equivalent to clodronate disodium tetrahydrate 74.98 mg) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution, practically free from visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the alleviation of clinical forelimb lameness associated with the bone resorptive processes of the distal sesamoid (navicular bone) in adult horses. 4.3 CONTRAINDICATIONS Do not administer intravenously. Do not use in horses less than 4 years of age, due to the absence of data regarding use in growing animals. Do not use in horses with impaired renal function. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The veterinary medicinal product should be used only after a proper diagnosis combining a complete orthopaedic clinical examination including local analgesia and appropriate imaging techniques, in order to identify the cause of pain and the nature of bone lesions. Clinical improvement in lameness grade may not be accompanied by radiographic changes in the appearance of the navicular bone. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Use caution when administering bisphosphonates to horses with conditions affecting mineral or electrolyte homeostasis, e.g. hyperkalaemic periodic paralysis, hypocalcaemia. Adequate access to drinking water should be provided when using the product. If uncertainty exists about renal function, renal parameters should be assessed before administration of the product. Water consumption and urine output should be monitored after administratio Læs hele dokumentet