Osphos

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Ministry for Primary Industries

العنصر النشط:

clodronate disodium tetrahydrate

متاح من:

Dechra Veterinary Products NZ Limited

تركيب:

clodronate disodium tetrahydrate 74.98 g/litre

المجال العلاجي:

Musculoskeletal modifier

الوضع إذن:

ACVM Registered

تاريخ الترخيص:

2017-07-04

خصائص المنتج

TEXT LABEL: Osphos A11429
2023 Apr 20
Carton and Vial Label
Text appearing above the Header and below the Footer lines is not
included in the label
Carton
Vial Label
TEXT LABEL: Osphos A11429
2022 Sep 02
Leaflet
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included in the label
Leaflet:
FOR ANIMAL TREATMENT ONLY
RESTRICTED VETERINARY MEDICINE
OSPHOS 51 mg/ml
Solution for Injection For horses
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS:
1 ml contains:
Active substance: Clodronic acid 51 mg (equivalent to clodronate
disodium tetrahydrate 74.98 mg)
Clear, colourless solution for injection.
INDICATION:
For the alleviation of clinical forelimb lameness associated with the
bone resorptive processes of the distal sesamoid
(navicular bone) in adult horses.
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.
ADVERSE REACTIONS:
In a clinical field study, administration of clodronic acid at 1.19
mg/kg to 142 horses resulted in the following
frequency of adverse reactions: nervousness, lip licking, yawning and
colic were common; head bobbing, transient
swelling and/or pain at the injection site, pawing the ground, hives
and pruritus were uncommon.
Episodes of renal insufficiency have been reported, rarely, during the
post-authorisation period, and were more
frequently observed in animals concurrently exposed to NSAIDs. In
these cases, appropriate fluid therapy should be
instituted and renal parameters monitored.
The frequency of adverse reactions is defined using the following
convention:
- common (more than 1 but less than 10 animals in 100 animals
displaying adverse reactions during the course of
one treatment)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in