Activyl
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
05-04-2019
Karatteristiċi tal-prodott
(SPC)
05-04-2019
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-02-2011
Ingredjent attiv:
indoxacarb
Disponibbli minn:
Intervet International BV
Kodiċi ATC:
QP53AX27
INN (Isem Internazzjonali):
indoxacarb
Grupp terapewtiku:
Dogs; Cats
Żona terapewtika:
Ectoparasiticides for topical use, incl. insecticides, indoxacarb
Indikazzjonijiet terapewtiċi:
Treatment and prevention of flea infestation.For dogs and cats: Treatment and prevention of flea infestation.The veterinary medicinal product can be used as part of a treatment strategy for flea-allergy dermatitis. Developing stages of fleas in the pet's immediate surroundings are killed following contact with Activyl-treated pets.
Sommarju tal-prodott:
Revision: 8
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2011-02-18
Fuljett ta 'informazzjoni
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET
ACTIVYL SPOT-ON SOLUTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl 100 mg spot-on solution for very small dogs
Activyl 150 mg spot-on solution for small dogs
Activyl 300 mg spot-on solution for medium dogs
Activyl 600 mg spot-on solution for large dogs
Activyl 900 mg spot-on solution for extra large dogs
indoxacarb
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
One ml contains 195 mg indoxacarb.
One pipette of Activyl delivers:
VOLUME (ML)
INDOXACARB (MG)
Activyl for very small dogs (1.5 - 6.5 kg)
0.51
100
Activyl for small dogs (6.6 – 10 kg)
0.77
150
Activyl for medium dogs (10.1 – 20 kg)
1.54
300
Activyl for large dogs (20.1 – 40 kg)
3.08
600
Activyl for extra large dogs (40.1 – 60 kg)
4.62
900
Also contains isopropyl alcohol 354 mg/ml.
A clear, colourless to yellow solution.
4.
INDICATION(S)
Treatment and prevention of flea infestation (
_Ctenocephalides felis_
). Efficacy against new infestations
with fleas persists for 4 weeks following a single application.
Developing stages of fleas in the pet’s immediate surroundings are
killed following contact with
Activyl treated pets.
29
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In very rare cases, a brief period of hypersalivation (drooling) may
occur if the animal licks the
application site immediately after treatment. This is not a sign of
intoxication and disappears within
some minutes without treatment. Correct application (see section 9)
will minimise licking of the
application site.
In very rare cases, application site reactions such as transitory
scratching,
erythema (redness of skin),
alope
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl 100 mg spot-on solution for very small dogs
Activyl 150 mg spot-on solution for small dogs
Activyl 300 mg spot-on solution for medium dogs
Activyl 600 mg spot-on solution for large dogs
Activyl 900 mg spot-on solution for extra large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
One ml contains 195 mg indoxacarb.
One unit-dose pipette delivers:
UNIT DOSE (ML)
INDOXACARB (MG)
Activyl for very small dogs (1.5 – 6.5 kg)
0.51
100
Activyl for small dogs (6.6 – 10 kg)
0.77
150
Activyl for medium dogs (10.1 – 20 kg)
1.54
300
Activyl for large dogs (20.1 – 40 kg)
3.08
600
Activyl for extra large dogs (40.1 – 60 kg)
4.62
900
EXCIPIENTS:
Isopropyl alcohol 354 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea infestation (
_Ctenocephalides felis_
). Efficacy against new infestations
with fleas persists for 4 weeks following a single application.
Developing stages of fleas in the pet’s immediate surroundings are
killed following contact with
Activyl treated pets.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should not be used in dogs younger than 8 weeks of age as
the safety of the product has
not been established in these dogs.
The product should not be used in dogs weighing less than 1.5 kg as
the safety of the product has not
been established in these dogs.
Ensure that the dosage (pipette) corresponds to the weight of the
treated dog (see section 4.9).
Apply the product only to the skin surface and on intact skin. Apply
the dose to an area where the dog
cannot lick it off, as described in section 4.9. Ensure that animals
do not groom each other
immediatel
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