OSPHOS 51 MG/ML SOLUTION FOR INJECTION FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLODRONIC ACID AS DISODIUM CLODRONATE

Available from:

DECHRA LTD

INN (International Name):

clodronic acid(51mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CLODRONIC ACID AS DISODIUM CLODRONATE BISPHOSPHONATE Active 51.0 mg/ml

Units in package:

15mL

Class:

VM - Veterinary Medicine

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Product summary:

Poison schedule: 4; Withholding period: WHP: DO NOT USE in horses that may be used for human consumption.; Host/pest details: HORSE: [VASCULAR SYSTEM REACTANT]; For the improvement of lameness associtaed with navicular syndrome in horsesNot recommended for use in horses less than 4 years of age or horses with impaired renal function. Use with caution during pregnancy & lactation. See Contraindications, Precautions & Side Effects on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
I
Label Name:
Signal Headings:
Constituent
Statements:
Claims:
I
Net Contents:
I
Directions for Use:
Restraints:
Contraindications:
Precautions:
OSPHOS 51 MG/ML SOLUTION FOR INJECTION FOR HORSES
69825/115881
OSPHOS 51 MG/ML SOLUTION FOR INJECTION FOR HORSES
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
51 mg/ml CLODRONIC ACID (as clodronate disodium tetrahydrate 75 mg/ml)
For the improvement of lameness associated with navicular syndrome in
horses.
15ml
DO NOT USE in horses that may be used for human consumption.
This product is contraindicated for use in horses with impaired renal
function. It is
recommended that baseline renal function parameters are obtained
before commencing
treatment. Water consumption and urine output should be monitored
after administration.
This product is not recommended for use in horses less than 4 years of
age due to the lack
of studies on the side effects of OSPHOS on the skeleton of young
animals. The efficacy
and safety of OSPHOS has not been established in growing animals.
Use with caution during pregnancy or lactation. The safety of OSPHOS
for administration
during pregnancy and lactation has not been established. Therefore,
use only according to
the benefit/risk assessment by the responsible veterinarian.
Medications containing aminoglycosides or tetracyclines should not be
administered for
72 hours following administration of OSPHOS due to the potential for
the exacerbation
of toxicity by a reduction in serum calcium. Concurrent administration
of potentially
nephrotoxic drugs, such as NSAIDS, should be approached with caution
and renal function RLP APPROVED
Side Effects:
Dosage and
Administration:
General Directions:
should be monitored. Adequate access to drinking water should be
provided when using
the product.
There is potential for impaired micro-fracture healing associated with
clodronic acid
administration. Studies regarding the safety
of
administration to