Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
CLODRONIC ACID (EQUIVALENT TO CLODRONATE DISODIUM TETRAHYDRATE PH. EUR.)
Dechra Limited
QM05BA02
CLODRONIC ACID (EQUIVALENT TO CLODRONATE DISODIUM TETRAHYDRATE PH. EUR.)
51 Mg/Ml
Solution for Injection
POM
Equine - Food
Clodronic acid
Miscellaneous
Authorised
2015-09-03
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 administer to horses less than 4 years of age, due to the absence of data regarding use in growing animals. Do not administer to 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/11/2016_ _CRN 7024755_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Use caution when administering bisphosphonates to horses with conditions affect Perskaitykite visą dokumentą