Capstar 11.4 mg Tablets for Cats and Small Dogs

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

Nitenpyram

থেকে পাওয়া:

Elanco Europe Ltd

এটিসি কোড:

QP53BX02

INN (আন্তর্জাতিক নাম):

Nitenpyram

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রেসক্রিপশন টাইপ:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

থেরাপিউটিক গ্রুপ:

Cats, Dogs

থেরাপিউটিক এলাকা:

Ectoparasiticide

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2001-08-03

পণ্য বৈশিষ্ট্য

Revised: August 2023
AN: 02041/2022
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
Cats and dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (_C. felis_).
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: August 2023
AN: 02041/2022
Page 2 of 5
(ii) 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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Cats and 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.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Pregnancy:
Can be