Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
tiludronic acid disodium 50 mg
CEVA S.A.
QM05BA05
Powder and solvent for solution for injection
Tiludronic acid
Horses
2012-06-01
11823 TILDREN SPC RENEWAL-Final versionMarch 2007 1/5 Dokument1SPC renew al Final version Oct. 06 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TILDREN 5mg/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Powder vial: _ Active substance_: _ Tiludronic acid (as disodium salt) ................................................................. 50 mg Excipient q.s. ............................................................................................. 1 vial _Solvent vial _ Water for injections ..................................................................................... 10 ml _Solution after reconstitution _ Active substance: Tiludronic acid (as disodium salt) ............................................................ 5 mg / ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Appearance: White powder and clear colourless solvent. After reconstitution, the product is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses over 3 years of age. 4.2 INDICATIONS FOR USE, S PECIFYING THE TARGET SPECIES To aid in the treatment of lameness associated with osteolytic processes observed in bone spavin and in navicular syndrome of less than 6 months. 4.3 CONTRAINDICATIONS - In the absence of any data relating to the adverse effects of tiludronic acid on the skeleton of young animals, do not administer to horses less than 3 years old. - Do not use in horses producing milk for human consumption. - Do not administer to horses with renal dysfunction /5 Dokument1SPC renew al Read the complete document