NV PENTOSAN EVOLUTION INJECTION FOR HORSES

البلد: أستراليا

اللغة: الإنجليزية

المصدر: APVMA (Australian Pesticides and Veterinary Medicines Authority)

العنصر النشط:

ACETYL GLUCOSAMINE; SODIUM HYALURONATE; PENTOSAN POLYSULFATE SODIUM

متاح من:

CEVA ANIMAL HEALTH PTY LTD

INN (الاسم الدولي):

acetyl glucosamine(120mg/mL)+sodium pentosan polysulfate(75mg/mL) + others

الشكل الصيدلاني:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

تركيب:

ACETYL GLUCOSAMINE CARBOHYDRATE-GLUCOSE Active 120.0 mg/ml; SODIUM HYALURONATE UNGROUPED Active 3.0 mg/ml; PENTOSAN POLYSULFATE SODIUM MINERAL-SODIUM Active 75.0 mg/ml

الوحدات في الحزمة:

20 mL; 6x 20mL

الفئة:

VM - Veterinary Medicine

المصنعة من قبل:

CEVA ANIMAL HEALTH

المجال العلاجي:

MUSCULOSKELETAL SYSTEM

ملخص المنتج:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; As an aid in the treatment of non-infectious inflammatory joint disease in horses.See restraints, contraindications and precautions on label.

الوضع إذن:

Registered

تاريخ الترخيص:

2023-07-01

نشرة المعلومات

Australian Government
Australian Pestiddes and
Veterinary Medicines Authority
RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
Iii
New Product (include
all
applicable RLPs)
OR
C
Variation (highlight instructions that are being varied). Approval no.
of label being varied:
Signal
heading:
Product
name:
Active
constituent/s:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
NV Pentosan Evolution Injection for Horses
120 mg/mL Acetyl glucosamine
75
mg/mL Pentosan polysulfate sodium
RLP
3 mg/mL Sodium hyaluronate
Approved
As
an aid
in
the treatment
of
non-infectious inflammatory joint disease
in
horses.
20
mL
[6
x
20
mL]
DIRECTIONS FOR USE
DO
NOT USE in
horses
that
may be used
for
human
consumption.
This product
is
contraindicated for use
in
horses with clotting defects, traumatic
haemorrhage, infection, liver or kidney failure or within 2 days of
surgery.
This product
is
contraindicated for use
in
horses within 24 hours of high stress
activities or where physical injury may occur.
This product
is
contraindicated for concurrent treatment with anticoagulant drugs.
This product has anticoagulant aciivity.
To
prevent haemorrhage it
is
recommended
to
use a
21
G needle and to press firmly
on
the site
of
injection for approximately 1
minute after administration.
Safety of this product has not been tested
in
horses less than two years
of
age.
Safety of this product has not been tested
in
pregnant, breeding or lactating animals.
Use of the product
in
these animals is not recommended.
Safety
studies
for
this
product
in
horses
were
conducted
at
up
to
3X
the
recommended dose rate
at
weekly intervals for
up
to
six weeks.
Safety of this
product for longer term use has not been tested.
Radiographic examination
to
rule out joint fractures should be conducted prior to
treatment.
A dose dependent increase
in
activated partial thromboplastin time (aPTT) was

خصائص المنتج

PRODUCT NAME: NV PENTOSAN EVOLUTION 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:
Blend of ingredients in saline solution.
TRADE NAME:
NV PENTOSAN EVOLUTION INJECTION FOR HORSES
APVMA CODE:
65881
PRODUCT USE:
An aid in the treatment of non-inflammatory joint disease in horses.
CREATION DATE:
NOVEMBER, 2015
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.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
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
P352: Wash with plenty of soap and 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.
P402+P404: Store in a dry place. Store in a closed container.
P403+P235: Store in a well-ventilated place. Keep cool (below 25°C).
DISPOSAL
P501: Dispose of small quantities and