PROGRAM 80 INJECTABLE SUSPENSION FOR CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

LUFENURON

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

lufenuron(80mg/Sg)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

LUFENURON AMINE/AMIDE Active 80.0 mg/Sg

Units in package:

10 Syrs; 2 Syringes; Unit=0.8mL

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

PARASITICIDES

Therapeutic indications:

FLEA | FLEA ALLERGIC DERMATITIS | CTENOCEPHALIDES SPP. | GROUND FLEAS

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CAT: [FLEA, FLEA ALLERGIC DERMATITIS]; For six months prevention and control of flea infestations and treatment of flea allergic dermatitis in cats weighing 4 kg to 8 kg.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRODUCT NAME
:
PROGRAM 80 INJECTABLE SUSPENSION FOR CATS:
DATE
: Tuesday, 19 October 1999
PAGE
: 1 of 8
PACK SIZES
: 2 SYRINGES, 10 SYRINGES
TYPE OF LABEL
: Carton (or envelope), Syringe
and Blister, Leaflet
FILE
: PINJ80label1.doc
VERSION
: 2
REASON
: Trans-Tasman harmonisation
Text above this line is not included in the actual label.
INFOPEST VERIFIES THAT THIS LABEL IS CONSISTENT WITH THE NRA
APPROVED TEXT LABEL OF 13/8/99 ________
Envelope/Carton – Front panel
FOR ANIMAL TREATMENT ONLY
PROGRAM 80 INJECTABLE SUSPENSION FOR CATS
Active Constituent: Each syringe contains 80 mg LUFENURON in 0.8 mL
For six months prevention and control of flea infestations
(_Ctenocephalides spp_.),
and as an aid in the control of flea allergic dermatitis, in cats
weighing 4 kg to 8 kg
Contents: 2 syringes / 10 syringes
PRODUCT NAME
:
PROGRAM 80 INJECTABLE SUSPENSION FOR CATS:
DATE
: Tuesday, 19 October 1999
PAGE
: 2 of 8
PACK SIZES
: 2 SYRINGES, 10 SYRINGES
TYPE OF LABEL
: Carton (or envelope), Syringe
and Blister, Leaflet
FILE
: PINJ80label1.doc
VERSION
: 2
REASON
: Trans-Tasman harmonisation
Text above this line is not included in the actual label.
Envelope/Carton – Back panel
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
PRESCRIPTION ANIMAL REMEDY (P.A.R.) CLASS 1.
FOR USE ONLY FOLLOWING A VETERINARY CONSULTATION.
DIRECTIONS FOR USE
TO BE USED BY, OR UNDER THE SUPERVISION OF, A REGISTERED VETERINARY
SURGEON.
ADMINISTER ONE SYRINGE EVERY 6 MONTHS FOR CATS WEIGHING 4 KG TO 8 KG.
TO MAXIMISE EFFECTIVENESS, THE WHOLE CONTENTS OF THE SYRINGE MUST BE
INJECTED SUBCUTANEOUSLY, DORSALLY ANTERIOR TO THE SHOULDER BLADES. IT
IS
RECOMMENDED THAT CATS BE RE-TREATED AT 6-MONTH INTERVALS TO ENSURE
CONTINUOUS EFFECTIVE CONTROL OF FLEA DEVELOPMENT.
THE SYRINGE MUST BE SHAKEN VIGOROUSLY TO RECONSTITUTE THE SUSPENSION
PRIOR
TO INJECTION. A palpable lump may develop at the injection site . This
should
disappear within one to four weeks.
It is essential that all cats and dogs in the household (except
unweaned kittens or
puppies) are treate

Summary of Product characteristics

PRODUCT NAME: PROGRAM® 80 INJECTABLE
SUSPENSION FOR CATS
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2013
SAFETY DATA SHEET
Issued by: Novartis Animal Health Australasia 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
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LTD.
ABN 64 076 745 198
TELEPHONE [phone]
(OFFICE HOURS)
54 WATERLOO RD
FAX [phone]
NORTH RYDE, NSW 2113
CHEMICAL NATURE:
Lufenuron is a benzoylurea derivative.
TRADE NAME:
PROGRAM
® 80 INJECTABLE SUSPENSION FOR CATS
PRODUCT USE:
For six months prevention and control of flea infestations, and as an
aid in the control
of flea allergic dermatitis in cats weighing between 4 kg and 8kg.
CREATION DATE:
AUGUST, 2013
THIS VERSION ISSUED:
AUGUST, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
N, Dangerous to the environment. Not classified as hazardous according
to the
criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES: R52. Harmful to aquatic organisms.
SAFETY PHRASES:
S25, S61. Avoid contact with eyes. Avoid release to the environment.
Refer to
special instructions/Safety Data Sheets.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
HAZARD STATEMENT:
H402: Harmful to aquatic life.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P391: Collect spillage.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P