Hylartil Vet 10 mg/ml Solution for Injection

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Sodium Hyaluronate

Verfügbar ab:

Zoetis UK Limited

ATC-Code:

QM09AX01

INN (Internationale Bezeichnung):

Sodium Hyaluronate

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Horses

Therapiebereich:

Anti Inflammatory

Berechtigungsstatus:

Expired

Berechtigungsdatum:

1994-07-19

Fachinformation

Revised: April 2014
AN: 01715/2013
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HYLARTIL VET 10 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml syringe contains:
ACTIVE SUBSTANCE:
Sodium Hyaluronate
(MrM, mean relative molecular mass ≥ 3.0 x106) 20.00 mg (10mg/ml)
For full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Horses.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Hylartil Vet (10mg/ml) is indicated for use in horses as follows:
i)
For the local treatment of non-infectious inflammatory joint
disease in horses.
ii)
For the local treatment of tendinitis in horses.
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5.
SPECIAL PRECAUTIONS FOR USE
Please note the syringe is sealed with a membrane which must be
ruptured prior to use (see directions in carton).
i)
Special precautions for use in animals
None known.
Revised: April 2014
AN: 01715/2013
Page 2 of 4
ii)
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
Directly after use of this product, hands and exposed skin
should be washed thoroughly.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient swelling may occur at the injection site.
4.7.
USE DURING PREGNANCY, LACTATION OR LAY
Hylartil Vet can, as far is known, be used during pregnancy and
lactation.
4.8.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9.
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For intra-articular use and direct injection into tendons.
Two ml (20 mg) of Hylartil Vet is given intra-articularly in small and
medium size joints and can also be injected directly into tendons. In
the
treatment of larger joints/tendons the dosage may be increased to 4 ml
(40 mg). The injection should be given under strict aseptic
conditions.
The treatment may be repeated at weekly intervals f