SYNVET-50; 50 MG SOLUTION FOR INJECTION FOR HORSES.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYALURONATE SODIUM

Available from:

Equimed Europe Ltd

ATC code:

QM09AX01

INN (International Name):

HYALURONATE SODIUM

Dosage:

50 Milligram

Pharmaceutical form:

Sterile Solution

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Equine - Food

Therapeutic area:

Hyaluronic acid

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2014-07-18

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SynVet-50; 50 mg solution for injection for horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 adjunctive intra-articular treatment of joint disease associated with non-infectious synovitis in horses.
4.3 CONTRAINDICATIONS
Do not use in case of joint infections.
Do not use in case of known hypersensitivity to exogenous sodium hyaluronate
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The treated horse should be box-rested for 2 days before gradually resuming a normal exercise pattern.
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Excess synovial fluid should be removed whenever possible prior to injection.
The injection should be administered under strict aseptic conditions through healthy undamaged skin.
Appropriate investigations should be carried out in cases of acute, severe lameness to ensure that the joints are free
from fractures, OCD fragments and infections.
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
In case of accidental contact with skin, wash with soap and water.
In case of accidental contact with eyes, blurred vision may occur because of the viscous nature of the product. Rinse
immediately with plenty of clean water.
In the event of accidental self injection, seek medical advice.
ACTIVE SUBSTANCE:
Each 2.5 ml syringe contains:
Sodium Hyaluronate
50 mg
(equivalent to hyaluronic acid)
47 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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