Capstar 57 mg Tablets for Large 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:

Dogs

থেরাপিউটিক এলাকা:

Ectoparasiticide

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2001-08-03

পণ্য বৈশিষ্ট্য

Revised: September 2020
AN: 00756/2020
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(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 “HIH”, on the other side with “CG”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (C. felis) on 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 dogs weighing less than 11 kg.
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,
vocalisation, 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, LACTATION OR LAY
Pregnancy :
Can be used during pregnancy.
Lactation:
Can be used during lactation.
L