HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)

Država: Avstralija

Jezik: angleščina

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Prenos Navodilo za uporabo (PIL)
12-07-2023

Aktivna sestavina:

SODIUM HYALURONATE

Dostopno od:

DECHRA LTD

INN (mednarodno ime):

sodium hyaluronate(17mg/mL)

Farmacevtska oblika:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sestava:

SODIUM HYALURONATE UNGROUPED Active 17.0 mg/ml

Enote v paketu:

1 x 3 mL

Razred:

VM - Veterinary Medicine

Terapevtska skupina:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Terapevtsko območje:

MUSCULOSKELETAL SYSTEM

Terapevtske indikacije:

INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE

Povzetek izdelek:

Poison schedule: 4; Withholding period: Zero (0) days; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: WHP:Not to be used in horses intended for human consumption.; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; An aid to the management of non-infectious inflammatory joint diseases in horses only - for intra-articular administration.NOT TO BE USED in horses intended for human consumption

Status dovoljenje:

Registered

Datum dovoljenje:

2023-07-01

Navodilo za uporabo

                                HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)
53840/137307
Product Name:
APVMA Approval No:
Label Name:
HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
17 mg/mL Sodium Hyaluronate
Claims:
To be used by, or under the supervision of, a registered veterinary
surgeon.
For intra-articular or intravenous administration, as an aid in the
management of non-
infectious inflammatory joint diseases in horses only.
Net Contents:
1 x 3 mL
Directions for Use:
Restraints:
Contraindications:
This product should not be administered to horses with a history of
hypersensitivity to
sodium hyaluronate.
This product should not be administered intra-articularly when joint
sepsis and/or fractures
are present or suspected.
Precautions:
In cases of severe acute lameness, radiographic evaluation should be
carried out prior to
HY-50 treatment to ensure that the joints are free from serious
intra-articular fractures.
Effects on fertility and reproductive function in breeding mares and
stallions have not been
evaluated. RLP APPROVED
Side Effects:
Transient, mild swelling and/or heat were observed in 2.7% of joints
treated intra-articularly
in an open field trial. These self-limiting local signs resolve
spontaneously within 48 hours,
and do not negate a successful therapeutic outcome.
Dosage and
Administration:
DISCARD UNUSED PORTION IN THE CONTAINER 24 HOURS AFTER BROACHING.
Intravenous use: 3 mL intravenously (for a 450-500 kg horse).
Single intra-articular injection: 3 mL intra-articularly into medium
and large size joints.
Smaller joints such as intertarsal, tarsometatarsal and
interphalangeal joints can be treated
with a 1.5 mL dose. More than one joint may be treated at the same
time.
Treatment may be repeated after one or more weeks if necessary, but
should not exceed
three consecutive weekly intravenous injections, or four consecutive
weekly injections in
the same joint.
Remove product from refrigerato
                                
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