Advantage 250 Spot-on solution for Dogs

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
24-09-2019

Aktivni sastojci:

Imidacloprid

Dostupno od:

Bayer Limited

ATC koda:

QP53AX17

INN (International ime):

Imidacloprid

Doziranje:

250 mg/pipette

Farmaceutski oblik:

Spot-on solution

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Dogs

Područje terapije:

imidacloprid

Terapijske indikacije:

Ectoparasiticide

Status autorizacije:

Authorised

Datum autorizacije:

2001-02-23

Svojstava lijeka

                                Health Products Regulatory Authority
23 September 2019
CRN0092T5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Advantage 250 Spot-on solution for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Imidacloprid 250 mg/pipette (2.5 ml of a 10 % solution)
EXCIPIENT(S):
Butylhydroxytoluene (E 321) 2.5 mg/pipette
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow to slightly brownish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of flea infestations and for the
treatment of biting lice _(Trichodectes canis)_ on dogs of 10 kg
to less than 25 kg body weight.
For dogs of less than 10 kg body weight or 25 kg body weight and
greater, use the appropriate Advantage for Dogs product
(see section 4.9).
Fleas on dogs are killed within one day following treatment. One
treatment prevents further flea infestation for four weeks.
The product can be used as part of a treatment strategy for the
control of Flea Allergy Dermatitis (FAD) where this has been
previously diagnosed by a veterinary surgeon.
4.3 CONTRAINDICATIONS
Do not treat unweaned puppies of less than 8 weeks of age.
Do not use in animals that are known to be hypersensitive to the
active substance or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
This product is for topical use and should not be administered orally.
Care should be taken to avoid the contents of the pipette coming into
contact with the eyes or mouth of the recipient animal.
Do not allow recently treated animals to groom each other.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands thoroughly after use.
Health Products Regulatory Authority
23 September 2019
CRN0092T5
Page 2 of 5
Wash off any skin contamination with soap and water.
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