Program 40 mg Suspension for Injection for Cats

Страна: Великобритания

Език: английски

Източник: VMD (Veterinary Medicines Directorate)

Активна съставка:

Lufenuron

Предлага се от:

Elanco Europe Ltd

АТС код:

QP53BC01

INN (Международно Name):

Lufenuron

Лекарствена форма:

Suspension for injection

Вид предписание :

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Cats

Терапевтична област:

Insect Growth Regulator

Статус Оторизация:

Expired

Дата Оторизация:

1997-12-05

Данни за продукта

Revised: March 2016
AN: 01695/2015
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROGRAM 40 mg Suspension for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Lufenuron (INN), 40 mg per syringe (0.4 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 and weaned kittens less 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
Page 2 of 5
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