Osphos 51 mg/ml Solution for Injection for Horses

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Clodronic Acid

Διαθέσιμο από:

Dechra Limited

Φαρμακολογική κατηγορία (ATC):

QM05BA02

INN (Διεθνής Όνομα):

Clodronic Acid

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Horses

Θεραπευτική περιοχή:

Musculoskeletal

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2015-09-02

Αρχείο Π.Χ.Π.

Revised: February 2021
AN: 01364/2019
Page 1 of 5
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.
Revised: February 2021
AN: 01364/2019
Page 2 of 5
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