PROGRAM ORAL SUSPENSION FOR LARGE CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:

LUFENURON

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

lufenuron(266mg/Amp)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

LUFENURON AMINE/AMIDE Active 266.0 mg/Amp

Units in package:

6 Ampoules; Amp = 3.8g

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

PARASITICIDES

Therapeutic indications:

CAT FLEA | FLEA ALLERGIC DERMATITIS

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CAT: [CAT FLEA, FLEA ALLERGIC DERMATITIS]; For the prevention and lasting control of flea infestation, and the treatment of flea allergic dermatitis in cats weighing between 4.6 and 9 kg.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

                                PRODUCT NAME
:
PROGRAM ORAL SUSPENSION FOR LARGE CATS:
DATE
: Wednesday, 20 October 1999
PAGE
: 1 of 6
PACK SIZES
: 6 AMPOULES
TYPE OF LABEL
: Carton, Sachet and Leaflet
FILE
: proglc1.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 2/8/99 ________
Carton – Front panel
FOR ANIMAL TREATMENT ONLY
PROGRAM ORAL SUSPENSION FOR LARGE CATS
Active Constituent: Each Ampoule Contains 266 mg LUFENURON in 3.8 g
Contents: 6 Ampoules
For the prevention and lasting control of flea infestation, and as an
aid in the control of flea
allergic dermatitis in cats weighing between 4.6 and 9 kg
NOVARTIS Animal Health Australasia Pty Limited,
ACN 076 745 198
140-150 Bungaree Road, Pendle Hill, NSW 2145
Licensed under the Animal Remedies Act 1967 No.6452
Licensed to Novartis New Zealand Limited, 43-45 Patiki Road, Avondale,
Auckland .
PRODUCT NAME
:
PROGRAM ORAL SUSPENSION FOR LARGE CATS:
DATE
: Wednesday, 20 October 1999
PAGE
: 2 of 6
PACK SIZES
: 6 AMPOULES
TYPE OF LABEL
: Carton, Sachet and Leaflet
FILE
: proglc1.doc
VERSION
: 2
REASON
: Trans-Tasman harmonisation
Text above this line is not included in the actual label.
Carton – Back panel
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
ADMINISTER ONE AMPOULE MONTHLY FOR CATS BETWEEN 4.6 AND 9 KG.
PROGRAM
must be given with a
FULL
meal. Either give
WITHIN
the food or
IMMEDIATELY
afterwards. It is essential that all dogs and cats in the household
(except unweaned puppies
or kittens), are treated for fleas with
PROGRAM.
For cats use
PROGRAM
suspension
and for dogs use
PROGRAM
tablets (ARB No. 6451).
1.
BEFORE FLEAS ARE SEEN ON THE CAT.
For best results, start giving
PROGRAM
before flea activity is anticipated and
continue all year round.
2.
WHEN CAT IS ALREADY INFESTED WITH FLEAS.
PROGRAM
does not kill adult fleas. Where adult fleas are present, it will be
necessary to also treat the dog with a product registered fo
                                
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Summary of Product characteristics

                                 
PRODUCT NAME: PROGRAM ORAL SUSPENSION FOR LARGE CATS
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2013
 
SAFETY DATA SHEET 
Issued by: Novartis Animal Health Australasia Pty Ltd. 
Phone: 02 9805 3555 (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 02 9805 3555 
(OFFICE HOURS)
54 WATERLOO RD 
FAX 02 9888 8387
NORTH RYDE, NSW  2113 
 
CHEMICAL NATURE:  
Water based suspension of Lufenuron in a single dose ampoule. 
TRADE NAME:  
PROGRAM ORAL SUSPENSION FOR LARGE CATS
 
PRODUCT USE:  
For the prevention and lasting control of flea infestation and as an
aid in the control of 
flea allergic dermatitis by a once a month oral dose to cats
weighing between 4.5 and 
9.0kg. 
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: 
 Xn, Harmful. 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 
                                
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