Capstar 57 mg Tablets for Large Dogs

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Nitenpyram

Dostupné z:

Elanco Europe Ltd

ATC kód:

QP53BX02

INN (Medzinárodný Name):

Nitenpyram

Forma lieku:

Tablet

Typ predpisu:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Ectoparasiticide

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2001-08-03

Súhrn charakteristických

Revised: August 2023
AN: 01990/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Capstar 57 mg tablets for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Nitenpyram
57 mg
EXCIPIENT:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
Microcristalline cellulose
Maize starch
Lactose monohydrate
Anhydrous silica
Magnesium stearate
White to light yellow, round, biconvex tablets, with bevelled edges,
imprinted on one
side with “HIH”, on the other side with “CG”.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of flea infestations (_C. felis_).
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Do not use on dogs weighing less than 11 kg.
Revised: August 2023
AN: 01990/2022
Page 2 of 5
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals:
None.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVERSE EVENTS
Dogs:
Very rare
(<1 animal / 10 000 animals
treated, including isolated
reports):
Excessive chewing, licking and/or grooming
1
,
Hyperactivity, Vocalisation
1
Neurological signs (e.g., muscle tremor, ataxia,
convulsion)
1
Panting
1
Increased scratching
2
1
Transient
2
For the first hour following administration; presumably caused by flea
response to
the veterinary medicinal product.
Reporting adverse events is important. It allows continuous safety
monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to
either the marketing authorisation holder or its local representative
or the national
competent authority via the national reporting system. See the package
leaflet for
respective contact details.
3.7
USE DURING PREGNANCY, LACTATION OR LAY
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Laboratory studies in rats