Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
CLODRONATE DISODIUM (UNII: N030400H8J) (CLODRONIC ACID - UNII:0813BZ6866)
Dechra Veterinary Products
CLODRONATE DISODIUM
CLODRONATE DISODIUM 60 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION
INDICATION: For the control of clinical signs associated with navicular syndrome in horses. CONTRAINDICATIONS: Horses with hypersensitivity to clodronate disodium should not receive OSPHOS. Do not use in horses with impaired renal function or with a history of renal disease.
HOW SUPPLIED: OSPHOS is supplied in cartons with each carton containing one clear glass 20 mL vial with 15 mL (900 mg) clodronate disodium (60 mg/mL) per vial. NDC 17033-460-15
New Animal Drug Application
OSPHOS- CLODRONATE DISODIUM INJECTION, SOLUTION DECHRA VETERINARY PRODUCTS ---------- OSPHOS (CLODRONATE INJECTION) Bisphosphonate CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian. For intramuscular use in horses only. DESCRIPTION: Clodronate disodium is a non-amino, chloro-containing bisphosphonate. Chemically, clodronate disodium is (dichloromethylene) diphosphonic acid disodium salt and is manufactured from the tetrahydrate form. The structural formula of clodronate disodium is: Molecular Formula: CH Cl Na O P Molecular Weight: 288.85 Active substance clodronate disodium tetrahydrate 74.98 mg/mL corresponds to clodronate disodium 60.0 mg/mL. Each mL contains 60 mg clodronate disodium, sodium hydroxide (to adjust pH) and water for injection. INDICATION: For the control of clinical signs associated with navicular syndrome in horses. DOSAGE AND ADMINISTRATION: Administer 1.8 mg/kg by intramuscular injection up to a maximum dose of 900 mg per horse. Divide the total volume evenly into three separate injection sites. Discard unused vial contents. OSPHOS is provided in a single use vial and does not contain a preservative. Clinical improvement is most evident at 2 months post-treatment (see EFFECTIVENESS). Of the horses that responded to treatment with OSPHOS in the field study, 65% maintained their level of improvement through the 6 month evaluation. If there is no response to initial therapy, the horse should be re-evaluated. For horses that initially respond to OSPHOS but do not maintain their clinical improvement for 6 months, OSPHOS may be re- administered at 3 to 6 month intervals based on recurrence of clinical signs. For horses that respond to OSPHOS and maintain clinical improvement for 6 months, OSPHOS should be re-administered after clinical signs recur. CONTRAINDICATIONS: Horses with hypersensitivity to clodronate disodium should not receive OSPHOS. Do not use in horses with impaired renal function or with a history of renal disease. WARNINGS: Do not use Lugege kogu dokumenti