Program 80 mg Suspension for Injection for Cats

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Lufenuron

Saatavilla:

Elanco Europe Ltd

ATC-koodi:

QP53BC01

INN (Kansainvälinen yleisnimi):

Lufenuron

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

Insect Growth Regulator

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

1997-12-05

Valmisteyhteenveto

Revised: March 2016
AN: 01695/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROGRAM 80 mg Suspension for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Lufenuron (INN), 80 mg per syringe (0.8 ml of a 10%
suspension)
EXCIPIENT(S): Povidone 12 in an aqueous vehicle.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
White to yellow suspension in a pre-filled single-dose syringe for
injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats equal to or greater than 4 kg bodyweight.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is intended for the prevention of flea multiplication in
cats by
inhibiting the development of flea eggs to adults for 6 months. The
product is
effective against eggs and larval stages of fleas.
Effective blood levels of Lufenuron are attained within 21 days.
4.3
CONTRAINDICATIONS
Do not use in dogs. The excipient Polyvinylpyrrolidone (Povidone) is a
potent
histamine releasing substance in dogs. A severe reaction may occur in
dogs that
is not observed in cats.
4.4
SPECIAL WARNINGS
If cats have flea infestation at the start of treatment, the use of a
flea adulticide is
recommended. It is essential that all cats (except for unweaned
kittens) living in a
household are treated with the product to stop flea infestation. Dogs
in the same
household should be treated as recommended by the prescribing
veterinary
surgeon.
Revised: March 2016
AN: 01695/2015
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The injection should be carried out under aseptic conditions.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In the case of self-inoculation a local reaction may occur. In such
circumstances
seek medical advice.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Adverse reactions are very rarely reported. On very rare occasions
injection with
the product may cause pain, oedema or alopecia at