Osphos 51 mg/ml solution for injection for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clodronic acid

Available from:

Dechra Ltd

ATC code:

QM05BA02

INN (International Name):

Clodronic acid

Dosage:

51 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

clodronic acid

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2015-09-03

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2018
CRN000X4P
Page 1 of 5
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.
Health Products Regulatory Authority
16 January 2018
CRN000X4P
Page 2 of 5
Clinical improvement in lameness grade may not be accompanied by
radiographic
changes in the appearance of the navicular bone.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Use caution when administering bisphosphonates to horses with
conditions affecting
mineral or electrolyte homeostasis, e.g. hyperkalaemic periodic
paralysis,
hypocalcaemia.
Adequate access to drinking water should be provided when using the
product. If
uncertainty exists about renal function, renal parameters should be
assessed before
administration of the product. Water consumption an