Osphos 51 mg/ml solution for injection for horses

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Clodronate disodium tetrahydrate

Fáanlegur frá:

Dechra Regulatory B.V.

ATC númer:

QM05BA02

INN (Alþjóðlegt nafn):

Clodronate disodium tetrahydrate

Skammtar:

51 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

clodronic acid

Leyfisstaða:

Authorised

Leyfisdagur:

2015-09-03

Vara einkenni

Health Products Regulatory Authority
22 January 2021
CRN009G5F
Page 1 of 4
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 use in horses less than 4 years of age, due to the absence of
data regarding use in growing animals.
Do not use in 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.
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 and urine output should be
monitored after administratio