NV PENTOSAN GOLD INJECTION FOR HORSES

Država: Australija

Jezik: engleski

Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktivni sastojci:

ACETYL GLUCOSAMINE; PENTOSAN POLYSULFATE SODIUM

Dostupno od:

CEVA ANIMAL HEALTH PTY LTD

INN (International ime):

sodium pentosan polysulfate(125mg/mL)+acetyl glucosamine(200mg/mL)

Farmaceutski oblik:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sastav:

ACETYL GLUCOSAMINE CARBOHYDRATE-GLUCOSE Active 200.0 mg/ml; PENTOSAN POLYSULFATE SODIUM MINERAL-SODIUM Active 125.0 mg/ml

Jedinice u paketu:

12mL; 50mL; 6 x 12mL

Razred:

VM - Veterinary Medicine

Proizveden od:

CEVA ANIMAL HEALTH

Terapijska grupa:

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

Područje terapije:

MUSCULOSKELETAL SYSTEM

Terapijske indikacije:

INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE

Proizvod sažetak:

Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE in horses intended for huma n consumption.; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; An aid in the treatment of non-infectious, inflammatory joint disease in horses.Contraindicated for use in horses with clotting defects, traumatic haemorrhage, infection, liver/kidney failure, or within 2 days of surgery. DO NOT use in horses intended for human consumption

Status autorizacije:

Registered

Datum autorizacije:

2023-07-01

Uputa o lijeku

NV PENTOSAN GOLD INJECTION FOR HORSES
63195/121964
Product Name:
APVMA Approval No:
Label Name:
NV PENTOSAN GOLD INJECTION FOR HORSES
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
125 mg/mL PENTOSAN POLYSULFATE SODIUM
200 mg/mL ACETYL GLUCOSAMINE
Claims:
An aid in the treatment of non-infectious, inflammatory joint disease
in horses.
1) Osteo-arthritis - especially in conditions affecting multiple
joints;
2) Osteo-chondrosis dissecans;
3) Traumatic joint and peri-articular inflammation in horses.
Net Contents:
12 mL
6 x 12 mL
50 mL
Directions for Use:
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
This product is contraindicated for use in horses with clotting
defects, traumatic
haemorrhage, infection, liver/kidney failure or within 2 days of
surgery.
This product should not be administered to horses within 24 hours of
high stress activities
or where physical injury may occur.
Precautions:
Safety studies on the product in horses have been done at up to 3x
recommended
dose rate, at weekly intervals for six weeks. Safety studies have not
been carried out
for longer term use. Safety studies have not been carried out in
pregnant, breeding or
lactating animals. Use of the product in these groups of animals is
not recommended.
A dose dependent increase in activated partial thromboplastin time
(aPTT) was seen
during the safety trials but levels returned to normal within 24 hours
post treatment. The RLP APPROVED
prescribing veterinarian should consider this where the patient may
have suspected or
diagnosed disorders that may affect haemostasis, or have concurrent
medications that
affect haemostasis. There was no significant difference between
pre-trial and post-trial
aPTT levels.
Side Effects:
Dosage and
Administration:
Administer by intramuscular injection.
Use the contents within 1 month of first broaching of the vial.
Discard the unused portion.
3 mg/kg Pentosan Polysulfate Sodium, 4.8 mg/kg Acety

Svojstava lijeka

PRODUCT NAME: NV PENTOSAN GOLD INJECTION FOR HORSES
PAGE: 1 OF 5
THIS VERSION ISSUED: AUGUST, 2016
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
CEVA ANIMAL HEALTH PTY LTD
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD
FAX: [phone]
GLENORIE NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Water solution of Pentosan Polysulphate Sodium and Acetyl Glucosamine.
TRADE NAME:
NV PENTOSAN GOLD INJECTION FOR HORSES
APVMA CODE:
63195
PRODUCT USE:
An aid in the treatment of non-infectious, inflammatory joint disease
in horses.
FOR VETERINARY USE ONLY.
CREATION DATE:
MARCH, 2016
THIS VERSION ISSUED:
AUGUST, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 25°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal serv