ZYDAX 100 INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PENTOSAN POLYSULFATE SODIUM

Available from:

PARNELL TECHNOLOGIES PTY LTD

INN (International Name):

sodium pentosan polysulfate(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

PENTOSAN POLYSULFATE SODIUM MINERAL-SODIUM Active 100.0 mg/ml

Units in package:

20mL

Class:

VM - Veterinary Medicine

Manufactured by:

PARNELL TECHNOLOGIES

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [INFLAMMATORY JOINT DISEASE]; An aid in the treatment of non-infectious, inflammatory joint disease in dogs.DO NOT USE in food producing species of animals. Do not use in dogs suffering from clotting defects, traumatic haemorrhage, infection or liver or kidney failure.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Company:
PARNELL Laboratories (Aust) Pty Ltd
File Name:
57751_47204_20mL_carton_MPL_01
Dimensions:
33mm x 33mm x 66mm
Scale:
100% (if printed on A4 sheet)
Date:
30/04/2009
Colours:
CYAN
MAGENTA
YELLOW
BLACK
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE IN FOOD PRODUCING
SPECIES OF ANIMALS.
CONTRAINDICATED FOR USE IN DOGS
SUFFERING FROM CLOTTING
DEFECTS,
TRAUMATIC HAEMORRHAGE,
INFECTION OR
LIVER OR KIDNEY FAILURE.
3 mg/kg (1mL/33kg) bodyweight by
SC or
IM injection on four occasions 5 - 7 days apart.
Store between 2
O
C and 8
O
C.
(Refrigerate. Do not freeze). Protect
from light. Use within 28 days of first
broaching vial.
APVMA Approval No:
57751/20mL/0409
PARNELL LABORATORIES (AUST) PTY. LTD.
4/476 Gardeners Road, Alexandria NSW 2015
50243-01
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ACTIVE CONSTITUENT:
PENTOSAN POLYSULFATE SODIUM 100mg/mL
AN AID IN THE TREATMENT OF
NON-INFECTIOUS INFLAMMATORY
JOINT DISEASE IN DOGS.
20ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ACTIVE CONSTITUENT:
PENTOSAN POLYSULFATE SODIUM 100mg/mL
AN AID IN THE TREATMENT OF
NON-INFECTIOUS INFLAMMATORY
JOINT DISEASE IN DOGS.
20ML
NB. text in PMS 690 not to be printed (3 x instances)
barcode
batch & expiry
pharmacode
APPROVED
LABEL
Info
PEST


Verified
Company:
PARNELL Laboratories (Aust) Pty Ltd
File Name:
57751_47204_20mL_label_MPL_01
Dimensions:
32mm x 96mm
Scale:
100% (if printed on A4 sheet)
Date:
30/04/2009
Colours:
CYAN
MAGENTA
YELLOW
BLACK
PARNELL LABORATORIES(AUST) PTY. LTD.
4/476 Gardeners Road, Alexandria NSW 2015
APVMA No: 57751/20mL/0409
Store between 2
O
C and 8
O
C.
(Refrigerate. Do not freeze).
READ ENCLOSED LEAFLET BEFORE USING
THIS PRODUCT.
DIRECTIONS FOR USE: RESTRAINTS:
DO NOT USE IN FOOD PRODUCING SPECIES
OF ANIMALS. CONTRAINDICATED FOR USE IN
DOGS SUFFERING FROM CLOTTING DEFECTS,
TRAUMATIC HAEMORRHAGE, INFECTION,
OR LIVER OR KIDNEY FAILURE.
3mg/kg (1mL/33kg) bodyweight by SC or IM
injection o

Summary of Product characteristics

PAGE 1 OF 2
MATERIAL SAFETY DATA SHEET:
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
PRODUCT NAME : Zydax 100 Injection & Zydax 250 Injection_ _
OTHER NAMES : PPS, PPS Injection, Pentosan, Pentosan Polysulfate,
Cartrophen
RECOMMENDED USE: FOR ANIMAL TREATMENT ONLY.
An aid in the treatment of non-infectious joint disease in dogs (Zydax
100) /horses (Zydax 250)
MANUFACTURER COMPANY DETAILS:
LICENSEE (NEW ZEALAND) DETAILS:
Parnell Manufacturing Pty Ltd
Parnell NZ Co
ADDRESS
ADDRESS
Unit 4, Century Estate
PO Box 73160
476 Gardeners Road
Auckland International Airport
Alexandria, NSW 2015
Manukau 2150
Australia
New Zealand
TELEPHONE NUMBER
TELEPHONE NUMBER
61 (0)2-9667 4411
0800 446 282 (Toll free within NZ)
EMERGENCY TELEPHONE NUMBER
EMERGENCY TELEPHONE NUMBER
61 (0)2-9667 4411 (Business Hours)
0800 446 282 (Business Hours)
FACSIMILE NUMBER
FACSIMILE NUMBER
61 (0)2-9667 4139
0800 727 533 (Toll free within NZ)
2. HAZARDS IDENTIFICATION
Hazardous substance according to criteria of Worksafe Australia.
3. COMPOSITION/INFORMATION ON INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Pentosan Polysulfate Sodium
116001-96-8
10% / 25% w/v
Antimicrobial Preservative
< 5% w/v
Buffers
< 5% w/v
Water
7732-18-5
to 100%
4. FIRST AID MEASURES
SWALLOWED: If poisoning occurs, contact a doctor or Poisons
Information Centre.
EYE: If in eyes, hold eyes open, flood with water for at least 15
minutes. Seek medical assistance if required.
SKIN: If skin contact occurs remove contaminated clothing and wash
skin thoroughly with soap and water.
INHALED: No specific requirements.
FIRST AID FACILITIES: No specific first aid facilities required.
ADVICE TO DOCTOR: Treat symptomatically as required.
5. FIRE-FIGHTING MEASURES
This material is not considered a fire hazard. Use standard fire
fighting techniques to extinguish fires involving
this material. Use water spray, dry chemical, carbon dioxide or foam.
6. ACCIDENTAL RELEASE MEASURES
Clean up spilled material with absorbent ensuring no contact with skin
during ope