SynVet-50; 50 mg solution for injection for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium hyaluronate

Available from:

Equi Pharma Ltd

ATC code:

QM09AX01

INN (International Name):

Sodium hyaluronate

Dosage:

50 mg/syringe

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

hyaluronic acid

Authorization status:

Authorised

Authorization date:

2014-07-18

Summary of Product characteristics

Health Products Regulatory Authority
15 October 2021
CRN009M05
Page 1 of 4
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
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.
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 cases of joint infections.
Do not use in cases of known hypersensitivity to exogenous sodium
hyaluronate or to any of the excipients of the product.
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.
Health Products Regulatory Authority
15 October 2021
CRN009M05
Page 2 of 4
In the event of accidental self-injection, seek medical advice
immediately and show the package leaflet of the label to the
physician.
Wash hands after use.
4.6 ADVERSE REACTION