Program Oral Suspension For Large Cats 266 Mg
Revised: January 2016
AN: 01318/2015
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Program Oral Suspension for Large Cats 266 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient mg/ampoule
Lufenuron 266
Excipients
Methyl parahydroxybenzoate 4.56
Propyl parahydroxybenzoate 1.14
For a full list of excipients see section 6.1
PHARMACEUTICAL FORM;
Oral suspension
White aqueous suspension
CLINICAL PARTICULARS:
4.1 Target Species
Cats greater than 4.5kg bodyweight
4.2 Indications for use
For the prevention and lasting control of flea infestation in cats. Effective against the dominant flea species Ctenocephalides felis and C. canis
4.3 Contra-indications
None
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
None
Special precautions to be taken by the person administering the medicinal product to animals
Avoid contact with skin and eyes. If contact occurs wash the affected area with clean water immediately. Seek medical attention if irritation persists. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
On very rare occasions, malaise, itching, vomiting or diarrhoea have been reported in cats following treatment with Program Suspension.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
The minimum recommended dose rate is 30mg a.i./kg/month. This is achieved by giving cats over 4.5kg the contents of 1 ampoule
To be fully effective the suspension MUST be administered together with food. Shake the ampoule prior to opening. The suspension should be added to approximately half of the food ration. The rest of the food should be presented when all the dose has been eaten. If several cats are treated, ensure that each cat is fed individually. The product can also be administered by squeezing the suspension directly from the ampoule onto the back of the cat’s tongue after feeding.
To open the ampoule first hold the base tab (which has writing on it) and flick the pack. Then twist off the top portion and squeeze the ampoule several times to administer the suspension.
To prevent flea infestations the product should be administered at monthly intervals for at least six months during the flea season, starting two months before fleas become active. To ensure accurate dosing, cats should be weighed before treatment.
If the cat is already infested with fleas, no viable flea eggs are produced from 24 hours after the first administration. The speed of elimination of the pre-existing infestation is dependent upon the number of flea larvae and pupae in the environment when treatment starts and climatic conditions.
Program does not kill adult fleas. The product works by preventing the development of flea larvae. If cats have a high level of flea infestation at the start of the treatment, it is necessary to apply a product that is recommended for use against adult fleas during the first one or two months, or longer depending on the environmental challenge.
It is essential that all cats and dogs (except unweaned puppies and kittens) living in a household are treated to stop flea reproduction.
Overdose (symptoms, emergency procedures and antidotes) if necessary
Not known
Withdrawal period(s)
Not applicable
PHARMACOLOGICAL PROPERTIES
Lufenuron is an insect growth regulator belonging to the benzolyurea group which acts by interfering with the normal synthesis, polymerisation and deposition of chitin.
Pharmacodynamic properties
ATC vet code: QP53BC01
Fleas take up the active ingredient through the blood and transfer it to their eggs. The formulation of larval chitin structures, a process typical to insects is blocked and the development of their numerous offspring is stopped. A new infestation of the home with fleas is prevented.
Fleas picked up by the cat outside the home environment are prevented from causing a new infestation of the home.
Pharmacokinetic particulars
After administering orally to the cat, the active ingredient is quickly absorbed. Sufficient absorption is only achieved if administered on a full stomach. The low excretion rate ensures an effective concentration of the active ingredient in the blood for one month.
PHARMACEUTICAL PECULIARS
List of excipients
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Glycerol
Avicel RC 591 (Microcrystalline cellulose with Carmellose Sodium)
Water Purified
6.2 Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Special precautions for storage
Do not store above 25oC
Shake the ampoule prior to opening.
Nature and composition of the immediate packaging
Low density polyethylene ampoules each dispensing 3.8g suspension. Six or three ampoules are packed in a sealed aluminium foil sachet.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Elanco Europe Ltd
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
MARKETING AUTHORISATION NUMBER
Vm 00879/4022
DATE OF FIRST AUTHORISATION
16thMay 1995
DATE OF REVISION OF THE TEXT
January 2016
Approved: 13 January 2016
