Program 40 mg Suspension for Injection

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Lufenuron

Fáanlegur frá:

Elanco Europe Ltd

ATC númer:

QP53BC01

INN (Alþjóðlegt nafn):

Lufenuron

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats

Lækningarsvæði:

Insect Growth Regulator

Leyfisstaða:

Authorized

Leyfisdagur:

1997-12-24

Vara einkenni

Revised: October 2020
AN: 00986/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROGRAM 40 mg Suspension for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE
SUBSTANCE:
Lufenuron
(INN),
40
mg
per
syringe
(0.4
ml
of
a
10%
suspension)
EXCIPIENT: Povidone 12 in an aqueous vehicle.
For the 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 6-month long-term prevention and
control of flea
infestations and the treatment of FAD (flea allergic dermatitis) in
cats. The product is
effective against the pre-adult stages of the dominant flea species, _
Ctenocephalides _
_felis_ and _C. canis_.
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 FOR EACH TARGET SPECIES
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: October 2020
AN: 00986/2020
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
accidental
self-injection,
a
local
reaction
may
occur.
In
such
circumstances seek medical advice immediately and show the package
leaflet or the
label to the physician.
Avoid contact with skin and eyes. In the even