Hyonate 10 mg/ml solution for injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium hyaluronate

Предлага се от:

Boehringer Ingelheim Vetmedica GmbH

АТС код:

QM09AX01

INN (Международно Name):

Sodium hyaluronate

дозиране:

10 milligram(s)/millilitre

Лекарствена форма:

Solution for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

hyaluronic acid

Статус Оторизация:

Authorised

Дата Оторизация:

2015-07-10

Данни за продукта

Health Products Regulatory Authority
14 December 2018
CRN008RK0
Page 1 of 5
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
Health Products Regulatory Authority
14 December 2018
CRN008RK0
Page 2 of 5
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
None.
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 generally
resolve without sequelae within a few days.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product may be used safely in pregnant and lactating animals.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For intravenous or intra-articular use:
The recommended dose is:
_Intravenous administration_:4 ml corresponding to 40 mg sodium
hyaluronate
_Intra-articular administration_:2 ml corresponding to 20 mg sodium
hyaluronate
Treatment may be repeated at weekly intervals for