Prac-tic
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
06-09-2018
Vara einkenni
(SPC)
06-09-2018
Opinber matsskýrsla
(PAR)
27-09-2013
Virkt innihaldsefni:
pyriprole
Fáanlegur frá:
Elanco GmbH
ATC númer:
QP53AX26
INN (Alþjóðlegt nafn):
pyriprole
Meðferðarhópur:
Dogs
Lækningarsvæði:
Ectoparasiticides for topical use, incl. insecticides
Ábendingar:
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis) in dogs. Efficacy against new infestations with fleas persists for a minimum of 4 weeks.Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs. Efficacy against ticks persists for 4 weeks.
Vörulýsing:
Revision: 10
Leyfisstaða:
Authorised
Leyfisdagur:
2006-12-18
Upplýsingar fylgiseðill
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET:
PRAC-TIC 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:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer for the batch release:
Elanco France S.A.S.
26, Rue de la Chapelle
68330 Huningue
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prac-tic 56.25 mg spot-on solution for very small dogs
Prac-tic 137.5 mg spot-on solution for small dogs
Prac-tic 275 mg spot-on solution for medium dogs
Prac-tic 625 mg spot-on solution for large dogs
Pyriprole
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains 125 mg pyriprole as a colourless to yellow, clear
solution for external application to
the skin.
One pipette delivers:
UNIT DOSE
PYRIPROLE
Prac-tic for very small dogs
0.45 ml
56.25 mg
Prac-tic for small dogs
1.1 ml
137.5 mg
Prac-tic for medium dogs
2.2 ml
275 mg
Prac-tic for large dogs
5.0 ml
625 mg
The solution also contains 0.1 % Butylhydroxytoluene (E321)
35
4.
INDICATION(S)
Treatment and prevention of flea infestation (
_Ctenocephalides_
_canis and C. felis_
.).
Treatment and prevention of tick infestation (
_Ixodes ricinus, Ixodes scapularis, Dermacentor _
_variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus,
Amblyomma americanum_
).
Treatment and prevention of flea infestation: Prac-tic is effective
against new infestations with fleas
for a minimum duration of 4 weeks.
Treatment and prevention of tick infestation: Prac-tic is effective
against ticks for 4 weeks.
5.
CONTRAINDICATIONS
Do not use in dogs less than 8 weeks of age or weighing less than 2
kg.
Do not use in case of known hypersensitivity to phenylpyrazole class
compounds or to any of the
excipients.
Do not use on sick animals or on animals recovering from disease.
The veterinary medicinal product is specifically developed for dogs.
Do not use in cats, as this could lead to overdosing.
Do not use in rab
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prac-tic 56.25 mg spot-on solution for very small dogs
Prac-tic 137.5 mg spot-on solution for small dogs
Prac-tic 275 mg spot-on solution for medium dogs
Prac-tic 625 mg spot-on solution for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Pyriprole 125 mg
One pipette delivers:
UNIT DOSE
PYRIPROLE
Prac-tic for very small dogs
0.45 ml
56.25 mg
Prac-tic for small dogs
1.1 ml
137.5 mg
Prac-tic for medium dogs
2.2 ml
275 mg
Prac-tic for large dogs
5.0 ml
625 mg
EXCIPIENTS:
0.1% Butylhydroxytoluene (E321)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Colourless to yellow, clear spot-on solution for external application
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea infestation (
_Ctenocephalides_
_canis and C. felis_
) in dogs. Efficacy
against new infestations with fleas persists for a minimum of 4 weeks.
Treatment and prevention of tick infestation (
_Ixodes ricinus, Rhipicephalus sanguineus, Ixodes _
_scapularis, Dermacentor reticulatus, Dermacentor variabilis,
Amblyomma americanum_
) in dogs.
Efficacy against ticks persists for 4 weeks.
3
4.3
CONTRAINDICATIONS
Do not use in dogs less than 8 weeks of age or with a body weight of
less than 2 kg.
Do not use in cases of known hypersensitivity to phenylpyrazole class
compounds or to any of the
excipients.
Do not use on sick (e.g. systemic diseases, fever) animals or animals
recovering from disease.
This veterinary medicinal product is specifically developed for dogs.
Do not use in cats, as this could lead to overdosing.
Do not use in rabbits.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
This veterinary medicinal product is for the treatment of ticks and
adult fleas. All dogs in a household
should be treated.
In cases of heavy infestation prior to treatment, the dog’s
surrounding should be vacuumed and treated
with a suitable
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