Selehold 360 mg spot-on solution for dogs 40.1–60.0 kg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Selamectin

Available from:

Krka, d.d., Novo mesto

ATC code:

QP54AA05

INN (International Name):

Selamectin

Dosage:

360 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

selamectin

Authorization status:

Authorised

Authorization date:

2019-05-17

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Selehold 360 mg spot-on solution for dogs 40.1–60.0 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3.0 ml pipette contains:
ACTIVE SUBSTANCE:
Selamectin
360 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Isopropyl alcohol
Butylhydroxytoluene (E321)
2.4 mg
Dimethyl sulfoxide
Clear, colourless to yellow to brown solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (40.1-60.0 kg)
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
•
TREATMENT AND PREVENTION OF FLEA INFESTATIONS
caused by
_Ctenocephalides _
spp. for one month
following a single administration. This is as a result of the
adulticidal, larvicidal and ovicidal
properties of the veterinary medicinal product. The veterinary
medicinal product is ovicidal for 3
weeks after administration. Through a reduction in the flea
population, monthly treatment of
pregnant and lactating animals will also aid in the prevention of flea
infestations in the litter up to
seven weeks of age. The veterinary medicinal product can be used as
part of a treatment strategy
for flea allergy dermatitis and through its ovicidal and larvicidal
action may aid in the control of
existing environmental flea infestations in areas to which the animal
has access.
•
TREATMENT OF EAR MITES
(
_Otodectes cynotis_
)
•
TREATMENT OF BITING LICE INFESTATIONS
(
_Trichodectes canis_
)
•
TREATMENT OF SARCOPTIC MANGE
(caused by
_Sarcoptes scabiei_
)
•
TREATMENT OF ADULT INTESTINAL ROUNDWORMS
(
_Toxocara canis_
)
•
PREVENTION OF HEARTWORM DISEASE
caused by
_Dirofilaria immitis _
with monthly administration
3.3
CONTRAINDICATIONS
Do not use in animals under 6 weeks of age.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
2
Do not apply when the animal’s hair coat is wet. Avoid frequent
swimming or shampooing the animal
becaus