Very rare adverse reactions that have been reported after use include: transient skin reactions at the site of application, and
transient skin reactions at the site of application (skin discolouration, local hair loss, itching, redness), as well as
general itching or hair loss. After use, in very rare cases, excessive salivation, reversible nervous signs (increased sensitivity to the skin, increased sensitivity to the sun) have been observed.
(increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms.
respiratory symptoms.
In case of licking, a brief period of excessive salivation may be observed in very rare cases, mainly due to the nature of the excipient.
mainly due to the nature of the excipient.
The frequency of adverse reactions should be classified according to the following groups:
- Very frequently (more than 1 animal per 10 animals treated exhibits adverse reactions).
- Frequently (more than 1 but less than 10 animals per 100 animals treated)
- Infrequently (more than 1 but less than 10 animals per 1,000 animals treated)
- Rarely (more than 1 but less than 10 animals per 10,000 animals treated)
- Very rarely (less than 1 animal per 10,000 animals treated, including isolated cases).
Use during pregnancy, lactation or laying
The veterinary medicinal product may be used during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
Posology and route of administration
Solution for spot-on dorsal anointing.
Dosage:
- One 1.34 ml pipette per dog weighing over 10 kg and up to 20 kg.
This corresponds to a recommended minimum dose of 6.7 mg/kg fipronil and 6 mg/kg (S)-methoprene.
A monthly application is recommended when there is a high risk of re-infestation, if the dog is allergic to flea bites, or in the case of a high risk of re-infestation, or if the dog is allergic to flea bites.
flea bites, or in situations where tick control is required.
In the absence of safety studies, the minimum treatment interval is 4 weeks.
Method of administration:
Hold the pipette in an upright position. Tap the narrow end of the pipette to ensure that the contents remain inside the main body of the pipette.
remains inside the main body of the pipette. Detach the tip. Separate the animal's coat at the base of the neck in front of the shoulder blades.
Separate the animal's coat at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette several times to empty the pipette.
pipette several times until its contents are completely emptied directly onto the skin in a single spot.
When applying the veterinary medicinal product to the skin, avoid excessive wetting of the coat, as the treated area may become damp or greasy after application.
may become damp or greasy after application. If this effect occurs, it will disappear within 24 hours after application.
24 hours after application.
Overdosage (symptoms, emergency measures, antidotes), if necessary
No adverse reactions have been observed in safety studies in the target species, in puppies
8 weeks old, growing dogs weighing approximately 2 kg treated once at five times the recommended dose.
recommended dose. The risk of experiencing adverse reactions (see section 4.6) may still be increased when overdosed, so
when overdosed, so animals should always be treated with a pipette size appropriate to their body weight.
body weight.
Itching may occur after application.
Waiting time(s)
Not applicable .
PHARMACOLOGICAL PROPERTIES
The veterinary medicinal product is an insecticidal and acaricidal solution for topical use, containing an association of
an adulticidal active ingredient, fipronil, in combination with an ovicidal and larvicidal active ingredient, (S)-methoprene.
methoprene.
Pharmacotherapeutic group: topical ectoparasiticides QP53
