PENTOSAN 100 INJECTION

국가: 오스트레일리아

언어: 영어

출처: APVMA (Australian Pesticides and Veterinary Medicines Authority)

유효 성분:

PENTOSAN POLYSULFATE SODIUM

제공처:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

sodium pentosan polysulfate(100mg/mL)

약제 형태:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

구성:

PENTOSAN POLYSULFATE SODIUM MINERAL-SODIUM Active 100.0 mg/ml

패키지 단위:

10 x 20mL; 10mL; 2 x 20mL; 20mL; 3 x 20mL; 4 x 20mL; 6 x 20mL

수업:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

치료 그룹:

DOG | BITCH | CASTRATE | PUPPY

치료 영역:

MUSCULOSKELETAL SYSTEM

치료 징후:

INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE

제품 요약:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [INFLAMMATORY JOINT DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [INFLAMMATORY JOINT DISEASE]; An aid in the treatment of non infectious, inflammatory joint disease in dogs.Do not use in dogs with clotting defects, traumatic haemorrhage, infection, liver/kidney failure, or within 2 days of surgery.

승인 상태:

Registered

승인 날짜:

2023-07-01

환자 정보 전단

Product Name:
APVMA Approval No:
PENTOSAN 100 INJECTION
51175/140026
Label Name:
PENTOSAN 100 INJECTION
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL PENTOSAN POLYSULFATE SODIUM
Claims:
[Carton & Label only]
An aid in the treatment of non-infectious, inflammatory joint disease
in dogs.
[Leaflet only]
Pentosan 100 Injection is a sterile solution formulated as an aid in
the treatment of non-
infectious, inflammatory joint disease in dogs.
Net Contents:
10 x 20mL
10mL
2 x 20mL
20mL
3 x 20mL
4 x 20mL
6 x 20mL
Directions for Use:
Restraints:
Contraindications:
Do not use in dogs with clotting defects, traumatic haemorrhage,
infection, liver/kidney
failure, or within 2 days of surgery.
Precautions:
Side Effects: RLP APPROVED
Dosage and
Administration:
Use the contents of the vial within 3 months of initial broaching, and
discard any unused
portion.
Administer by intramuscular or subcutaneous injection.
DOSE RATE:
3 mg/kg on four occasions with an interval of 5-7 days between
injections.
General Directions:
If used in performance animals, the regulations of the relevant
authorities regarding
medication should be observed.
PHARMACOLOGY
Pentosan polysulfate is a semi-synthetic polysaccharide polymer which
possesses anti-
inflammatory, anti-arthritic and chondroprotective properties. These
beneficial effects arise
from:
a) Direct anti-inflammatory activity;
b) Inhibition of neutrophil migration into joints;
c) Stimulation of hyaluronic acid synthesis by synovial fibroblasts
which results in a marked
increase in synovial volume and viscosity;
d) Stimulation of chondrocytes and the biosynthesis of proteoglycans;
e) Strong fibrinolytic activity which improves the circulation of
subchondral bone and peri-
articular structures.
INDICATIONS
1) Osteo-arthritis - especially in conditions affecting multiple
joints;
2) Osteo-chondrosis dissecans;
3) Traumatic joint and peri-articular inflammation in dogs.
Withholding Periods:
Trade Advice:
Safety

제품 특성 요약

Pentosan 100 Injection
Creation Date: 2004
Revision Date: Jun 2011
Version: 2
Next revision due: Jun 2016
MATERIAL SAFETY DATA SHEET
_PENTOSAN 100 INJECTION_
Page 1 of 7
COMPANY DETAILS
COMPANY:
ADDRESS:
Ceva Animal Health Pty Ltd
11 Moores Road
ABN 54 002 692 426
Glenorie NSW 2157 Australia
TELEPHONE NUMBER:
FACSIMILE NUMBER:
[phone]
[phone]
EMERGENCY TELEPHONE NUMBER:
[phone] (Business Hours)
Poisons Information Centre: 131126
SUBSTANCE IDENTIFICATION
PRODUCT NAME:
_NV Pentosan 100 Injection _
OTHER NAMES:
_Pentosan 100 _
MANUFACTURER’S PRODUCT CODE:
PEM
UN NUMBER:
None allocated
DANGEROUS GOODS CLASS AND SUBSIDIARY RISK:
None allocated
HAZCHEM CODE:
None allocated
SUSDP POISONS SCHEDULE NUMBER:
S4
USE:
An aid in the treatment of non-infectious joint disease in dogs. For
animal treatment only.
STATEMENT OF HAZARDOUS NATURE:
Hazardous according to criteria of NOHSC Australia.
RISK PHRASES:
SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER
SECTION 2 – HAZARDS IDENTIFICATION
Pentosan 100 Injection
Creation Date: 2004
Revision Date: Jun 2011
Version: 2
Next revision due: Jun 2016
MATERIAL SAFETY DATA SHEET
_PENTOSAN 100 INJECTION_
Page 2 of 7
None.
SAFETY PHRASES:
None.
The substance is a complex mixture, including the following
ingredients.
INGREDIENTS:
CHEMICAL NAME
CAS NUMBER
PROPORTION
* Pentosan Polysulphate
37319-17-8
12.5% (125 mg/mL)
Sodium Hydroxide
1310-73-2
less than 10%
Benzyl Alcohol
100-51-6
less than 10%
Ingredients determined not to be hazardous
less than 10%
Water for Injection
to 100%
SWALLOWED:
First aid is (not generally required). However, if feeling unwell or
if any symptoms develop, contact a
doctor or Poisons Information Centre (Phone 131126) and show doctor a
copy of this MSDS.
EYE:
First aid is (not generally required). If in eyes, hold eyelids open
and flush gently with copious
quantities of water until substance is removed (up to 15 minutes).
SKIN:
Remove contaminated clothing. Wash skin gently with water and
non-abrasive soap. If irritation
devel