HY-50 Vet. 17 mg/ml solution for injection for horses

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Sodium hyaluronate

Dostopno od:

Dechra Regulatory B.V.

Koda artikla:

QM09AX01

INN (mednarodno ime):

Sodium hyaluronate

Odmerek:

17 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

hyaluronic acid

Status dovoljenje:

Authorised

Datum dovoljenje:

2016-01-22

Lastnosti izdelka

_[Version 8.1,01/2017] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HY-50 Vet. 17 mg/ml solution for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Sodium hyaluronate
17 mg
EXCIPIENTS:
For the 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
Horses.
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
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.
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
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been
established during pregnancy or
lactation. 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
For intra-articular and intravenous administration.
Intravenous injection: 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,