HY-50 VET. 17 MG/ML SOLUTION FOR INJECTION FOR HORSES
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
06-02-2016
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Ingredient activ:
HYALURONATE SODIUM
Disponibil de la:
Dechra Limited
Codul ATC:
QM09AX01
INN (nume internaţional):
HYALURONATE SODIUM
Dozare:
17 Mg/Ml
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Equine
Zonă Terapeutică:
Hyaluronic acid
Indicații terapeutice:
Miscellaneous
Statutul autorizaţiei:
Authorised
Data de autorizare:
2016-01-22
Caracteristicilor produsului
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/01/2016_
_CRN 7017092_
_page number: 1_
4.7 USE DURING PREGNANCY, LACTATION OR LAY
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
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