Bob Martin Clear Flea 57mg Tablets for Large Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Nitenpyram

Available from:

Elanco Europe Ltd

ATC code:

QP53BX02

INN (International Name):

Nitenpyram

Pharmaceutical form:

Tablet

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2009-01-12

Summary of Product characteristics

Revised: May 2021
AN: 00225/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bob Martin Clear Flea 57mg Tablets For Large Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Nitenpyram
57 mg
EXCIPIENTS:
For a 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.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
Revised: May 2021
AN: 00225/2021
Page 2 of 5
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
Nitenpyram can be used during pregnancy and lactation. Studies in
laboratory
an