Hyonate 10 mg/ml solution for injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium hyaluronate

Предлага се от:

Merial Animal Health Limited

АТС код:

QM09AX01

INN (Международно Name):

Sodium hyaluronate

дозиране:

10 milligram(s)/millilitre

Лекарствена форма:

Solution for injection

Вид предписание :

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Терапевтична група:

Horses

Терапевтична област:

hyaluronic acid

Терапевтични показания:

N.S.A.I.D.

Статус Оторизация:

Authorised

Дата Оторизация:

2015-07-10

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hyonate 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE CONSTITUENTS
Sodium hyaluronate
10 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of lameness in horses due to non-infectious
inflammation of joints
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
This product does not contain an antimicrobial preservative.
Any solution remaining in the vial following withdrawal
of the required dose should be discarded.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
See 4.9 below regarding special precautions in administration
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
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4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases, horses may show a transient flare reaction after
intra-articular injection.
This may present as a
diffuse swelling lasting 24 – 48 hours resulting from irritation by
the needle while in the joint space. These may be
acute but will ge