HY-50 Vet 17 mg/ml Solution for Injection

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Sodium Hyaluronate

Tersedia dari:

Dechra Limited

Kode ATC:

QM09AX01

INN (Nama Internasional):

Sodium Hyaluronate

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Horses

Area terapi:

Anti Inflammatory

Status otorisasi:

Authorized

Tanggal Otorisasi:

1998-06-12

Karakteristik produk

Revised: March 2016
AN: 01470/2015
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HY-50 Vet 17 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Sodium Hyaluronate
17 mg/ml
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, viscous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horse.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For intra-articular and intravenous treatment of lameness caused by
joint
dysfunction associated with non-infectious synovitis.
4.3
CONTRAINDICATIONS
Do not use in cases of joint infection.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Radiographic evaluation should be carried out in cases of acute,
severe lameness to ensure that the joints are free from serious
fractures.
Revised: March 2016
AN: 01470/2015
Page 2 of 5
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient mild swelling and/or heat has been reported in treated
joints
(2,7%). These self-limiting local signs resolve spontaneously within
48
hours, and do not negate a successful therapeutic outcome.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Safety in pregnant and lactating mares has not been documented. Use
only according to the benefit/risk assessment by the responsible
veterinarian.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No data available.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Intravenous use: 3 ml intravenously repeated at weekly intervals for a
total of three treatments.
For single intra-articular injection: 3 ml (51 mg) intra-articularly
into
medium sized and large joints. Smaller joints such as intertarsal,
tarsometatarsal and interphalangeal joints can be treated with a 1.5
ml
dose (25.5