CREDELIO 225 MG VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LOTILANER

متاح من:

EUROMAR LTD

الشكل الصيدلاني:

CHEWABLE TABLETS

تركيب:

LOTILANER 225 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ELANCO FRANCE S.A.S, FRANCE

الخصائص العلاجية:

For the treatment of flea and tick infestations in dogs.This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

تاريخ الترخيص:

2021-01-03

نشرة المعلومات

PACKAGE LEAFLET FOR VETERINARY MEDICINAL PRODUCT
This medicine is dispensed with a veterinarian’s prescription only
For veterinary use only
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Credelio 56 mg Veterinary
Credelio 112 mg Veterinary
Credelio 225 mg Veterinary
Credelio 450 mg Veterinary
Credelio 900 mg Veterinary
CHEWABLE TABLETS FOR DOGS
2.
COMPOSITION:
Each chewable tablet contains:
CREDELIO CHEWABLE TABLETS
LOTILANER (MG)
For dogs (1.3-2.5 kg)
56.25
For dogs (>2.5-5.5 kg)
112.5
For dogs (>5.5-11 kg)
225
For dogs (>11-22 kg)
450
For dogs (>22-45 kg)
900
Inactive ingredients: See Section 13
3.
WHAT IS THE MEDICINE INTENDED FOR
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent
killing
activity for one month for fleas (_Ctenocephalides felis _and _C.
canis_) as well
as ticks (_Rhipicephalus sanguineus_, _Ixodes ricinus_, _I.
hexagonus_, and
_Dermacentor reticulatus_).
Fleas and ticks must attach to the host and commence feeding in order
to
be exposed to the active ingredient.
This medicinal product can be used as part of a treatment strategy for
the
control of flea allergy dermatitis (FAD).
Therapeutic group:
Lotilaner, a pure enantiomer from the isoxazoline class, is active
against
fleas (_Ctenocephalides felis _and _Ctenocephalides canis_) as well as
the tick
species _Dermacentor reticulatus_,_ Ixodes hexagonus_, _Ixodes
ricinus_, and
_Rhipicephalus sanguineus_.
Lotilaner is a potent inhibitor of gamma-aminobutyric acid
(GABA)-gated
chloride channels, resulting in rapid death of fleas and ticks. The
activity of
lotilaner was not affected by resistance to organochlorines
(cyclodienes,
e.g., dieldrin), phenylpyrazoles (e.g., fipronil), neonicotinoids
(e.g.,
imidacloprid), formamidines (e.g., amitraz), and pyrethroids (e.g.,
cypermethrin).
For fleas, the onset of efficacy is within four hours of attachment
for one
month after administration of the medicinal product. Fleas found on
the
animal prior to administration of the medicinal prod

خصائص المنتج

1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Credelio 56 mg Veterinary
Credelio 112 mg Veterinary
Credelio 225 mg Veterinary
Credelio 450 mg Veterinary
Credelio 900 mg Veterinary
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each chewable tablet contains:
Credelio chewable tablets
lotilaner (mg)
for dogs (1.3–2.5 kg)
56.25
for dogs (>2.5–5.5 kg)
112.5
for dogs (>5.5–11 kg)
225
for dogs (>11–22 kg)
450
for dogs (>22–45 kg)
900
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet.
White to beige round chewable tablets with brownish spots.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent
killing activity for 1 month for fleas
(Ctenocephalides felis and C. canis)
and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and
Dermacentor reticulatus).
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to the active
substance.
The veterinary medicinal product can be used as part of a treatment
strategy for the control of flea allergy
dermatitis (FAD).
4.3 Contraindications
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4 Special warnings for each target species
Parasites need to start feeding on the host to become exposed to
lotilaner; therefore the risk of the
transmission of parasite borne diseases cannot be completely excluded.
4.5 Special precautions for use
Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies
8 weeks of age and older and 1.3
kg of body weight and greater. Use of this veterinary medicinal
product in puppies younger than 8 weeks
of age or less than 1.3 kg of body weight should be based on a
benefit-risk assessment by the responsible
veterinarian.
Special precautions to be taken by the person administering the
ve