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

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Sodium hyaluronate

Tilgængelig fra:

Dechra Ltd

ATC-kode:

QM09AX01

INN (International Name):

Sodium hyaluronate

Dosering:

17 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Horses

Terapeutisk område:

hyaluronic acid

Terapeutiske indikationer:

Miscellaneous

Autorisation status:

Authorised

Autorisation dato:

2016-01-22

Produktets egenskaber

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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_2_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_1_
_7_
_0_
_9_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.7 USE DU