Capstar 11.4 mg Tablets for Cats and Small 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:

Cats, Dogs

Terapeutické oblasti:

Ectoparasiticide

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2001-08-03

Súhrn charakteristických

Revised: September 2020
AN: 00756/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Capstar 11.4, mg tablets for cats and small dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Nitenpyram
11.4 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to light yellow, round, biconvex tablets, with bevelled edges,
imprinted
on one side with “RB”, on the other side with “CG”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog and cat.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (C. felis) on cats and dogs.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Do not use on animals less than 4 weeks old or weighing less than 1 kg
as these groups of animals were not studied.
Revised: September 2020
AN: 00756/2020
Page 2 of 5
(ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
For the first hour after administration, the pet may scratch more than
normal.
This effect is caused by the fleas reacting to the product. In very
rare cases this
may present as transient signs of hyperactivity, panting, vocalization
and
excessive grooming/ licking.
Transient neurological signs such as muscle tremors, ataxia, and
convulsions
have also been reported in very rare occasions.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals displaying adverse
reaction(s) during
the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated
reports).
4.7
USE DURING PREGNANCY,