OSPHOS 51 MG/ML SOLUTION FOR INJECTION FOR HORSES

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLODRONIC ACID (EQUIVALENT TO CLODRONATE DISODIUM TETRAHYDRATE PH. EUR.)

Available from:

Dechra Limited

ATC code:

QM05BA02

INN (International Name):

CLODRONIC ACID (EQUIVALENT TO CLODRONATE DISODIUM TETRAHYDRATE PH. EUR.)

Dosage:

51 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Equine - Food

Therapeutic area:

Clodronic acid

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2015-09-03

Summary of Product characteristics

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
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_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