Bob Martin Clear Spot On Solution 134mg for Medium Dogs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

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SPC SPC (SPC)
21-01-2020

active_ingredient:

Fipronil

MAH:

Bob Martin (UK) Ltd

ATC_code:

QP53AX15

INN:

Fipronil

pharmaceutical_form:

Spot-on solution

prescription_type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

therapeutic_group:

Dogs

therapeutic_area:

Ectoparasiticide

authorization_status:

Authorized

authorization_date:

2011-05-27

SPC

                                Revised: June 2017
AN: 00104/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK: Bob Martin Clear Spot On Solution 134 mg for Medium Dogs
ES: Bob Martin Clear Fipronil 134 mg solution spot on for Medium Dogs
FR: Bob Martin Vetcare Spot On Fipronil solution 134 mg for Medium
Dogs
IT: Fleaclear Spot-on Solution 134 mg for Medium Dogs
NL: Kruidvat Flea Drops 134 mg solution for Medium Dogs
PL: Bob Martin Clear 134 mg Spot On Solution for Medium Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1.34 mL pipette contains:
ACTIVE SUBSTANCE:
Fipronil
134.000 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.268 mg
Butylhydroxytoluene (E321)
0.134 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, pale amber solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (_Ctenocephalides_ _ felis_).
Insecticidal efficacy
against new infestations with adult fleas persists for 8 weeks.
Treatment of tick (_Rhipicephalus sanguineus_ and _Ixodes ricinus_)
infestations.
The product has persistent acaricidal efficacy for up to 4 weeks
against ticks
(_Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus_).
If _Dermacentor reticulatus_ ticks are already present when the
product is
applied, not all of the ticks may be killed within 48 hours, but they
will be killed
within a week.
Page 1 of 7
Revised: June 2017
AN: 00104/2017
4.3
CONTRAINDICATIONS
Do not use on puppies less than 2 months old and /or weighing less
than
10kg. DO NOT USE IN RABBITS! Adverse drug reactions and even death could
occur. This product is specifically developed for dogs. Do not use in
cats, as
this could lead to overdosing.
Do not use on animals with known hypersensitivity to the active
substance or
to any of the excipients.
Do not use in animals that are unwell, are undergoing treatment for or
are
recovering from illness.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid
frequent
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