Otimectin Vet. 1 mg/g Ear Gel for Cats

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Ivermectin

Prieinama:

Le Vet B.V.

ATC kodas:

QS02QA03

INN (Tarptautinis Pavadinimas):

Ivermectin

Vaisto forma:

Ear gel

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Cats

Gydymo sritis:

Ectoparasiticide

Autorizacija statusas:

Authorized

Leidimo data:

2012-11-16

Prekės savybės

Revised: December 2013
AN: 00101/2013
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Otimectin vet. 1 mg/g ear gel for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH G CONTAINS
ACTIVE SUBSTANCE:
Ivermectin
1 mg
EXCIPIENTS:
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Ear gel.
Colourless to slightly yellow, slightly opalescent and viscous gel
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of ear mite (_Otodectes cynotis_) infestation in cats.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use if the tympanic membrane is perforated.
Do not use if the tympanic membrane cannot be fully visualized.
Do not use in cats with obstructed external ear canals due to chronic
inflammation.
Do not use in cats suffering from systemic disorders.
4.4
SPECIAL WARNINGS FOR THE TARGET SPECIES
All the cats housed together should be treated simultaneously against
O_todectes cynotis _
infestation. Other receptive companion animals (dogs, ferrets) in the
household should
be treated as well with another suitable product when the presence of
ear mite is
detected and confirmed.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Revised: December 2013
AN: 00101/2013
Page 2 of 5
In the absence of available information on safety the product should
not be used on cats
under 16 weeks of age.
Care should be taken to avoid that the product comes into contact with
the eyes or mouth
after administration.
Care should be taken to ensure that cats do not ingest the product by
mutual or self
grooming at the site of application.
Avermectins may not be well tolerated in all non target species. Cases
of intolerance are
reported in dogs, especially Collies, Old English Sheepdogs and
related breeds or
crosses, and also in turtles and tortoises.
Dogs and cats should not be allowed to ingest spilled gel or have
access to used
p