KILTIX ANTIPARASITIC COLLAR MEDIUM DOG

TECHNICAL SHEET OR SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
KILTIX
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of necklace contains:
Active substances:

For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Necklace.
4. CLINICAL DATA
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
For the control of ticks (Ixodes ricinus, Rhipicephalus sanguineus) and fleas
(Ctenocephalides canis/felis) in the dog.
On medium and large dogs, efficacy against ticks and fleas lasts up to 7 months if
the necklace is worn continuously.
On small dogs, efficacy against ticks and fleas lasts up to 6 months if the collar is
is carried continuously.
4.3 Contraindications
Do not use in dogs with skin lesions or in sick or convalescent dogs.
4.4 Special warnings for each target species
Not applicable.
4.5 Special precautions for use
Special precautions for use in animals
The Kiltix Dog Collar is intended for external use only.
It is recommended to remove the collar when bathing the animal and put it back on when the hair is
dry.
Special precautions to be taken by the person administering the medicinal product
vet to animals
Propoxur is a cholinesterase inhibitor. Do not use this medicine if the doctor has
indicated that it cannot work with anticholinesterase substances.
People with a known hypersensitivity to propoxur, flumethrin, or any of the
excipients should avoid all contact with the veterinary medicinal product.
If you feel unwell after using this medicine, consult a doctor immediately and
show him the package insert or label.
Avoid excessive contact with the collar during placement Remove the collar from the bag
protector just before use. Cut off the excess collar with scissors and remove it neatly.
appropriate, do not dispose of it in the trash or the environment. Wash your hands well with soap and water
after use. In case of accidental contact with the eyes, rinse with plenty of water.
Avoid repeated or prolonged contact with the animal's hair after placement of the
necklace. Extreme precautions are recommended if the dog lives with children: prevent the
children touch the necklace, play with it, bite it or put it in their mouths. pets that
Wearing collars should not sleep in bed with their owners, especially children.
Do not eat, drink or smoke while using the product.
Keep away from foodstuffs, beverages and feed.
4.6 Adverse reactions (frequency and seriousness)
Occasionally, a slight itching can be observed in the first days after the placement of the
necklace.
4.7 Use during pregnancy, lactation or lay
Laboratory studies carried out on various species have not yielded any evidence of
Adverse effects.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
As a general precaution, also for other antiparasitic agents, it is recommended not to
use other insecticides on the dog when it is wearing the collar.
4.9 Amounts to be administered and administration route
Small dogs (3 – 10 kg in weight) must wear a single collar of 12,5 g in weight and
Approximate length 38 cm.
Medium dogs (11 – 20 kg in weight) must wear a single collar of 30,2 g in weight and
Approximate length 53 cm.
Large dogs (from 21 kg in weight) must use a single collar of 45 g in weight and
Approximate length 70 cm.
Remove the collar from the protective bag and remove the plastic strips from the inside of the collar
to unroll it. Place the collar loosely around the dogs neck and pass the
end of it through the buckle.
Owners should check the fur in the collar area for the first few days to
make sure that it is not too tight (between the collar and the neck a gap should be left).
two-finger space).
The collar must be worn continuously. It is effective regardless of whether the animal moves
or if you are resting.
Effectiveness against ticks and fleas begins within 24 hours of application
from the collar and lasts up to 7 months in medium and large dogs, and 6 months in small dogs.
The duration and level of protection depend on the length and condition of the coat, the activity
of the animal and the degree of infestation.
Occasionally while wearing the collar tick infestation may be observed, but
they die at the latest after 3 days normally without having sucked blood.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Due to the pharmaceutical form and method of application, symptoms of
overdose. Extensive controlled studies applying two collars simultaneously
Kiltix in dogs of different breeds, ages and weights did not produce any indication of
local or systemic intolerance related to treatment.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: QP53AC55
ATCvet code: Ectoparasiticide for skin use.
The Kiltix collar is an antiparasitic medicine for the control of ticks and fleas in
dogs containing two active substances propoxur and flumethrin.
5.1 Pharmacodynamic properties
Propoxur is an ectoparasiticide of the carbaminic acid type.
Due to the inhibition of the enzyme cholinesterase, a toxic accumulation of the
neurohormone acetylcholine in cholinergic nerve endings, as a consequence of the
which produces the death of fleas, ticks and other harmful ectoparasites. However, the
toxicity to mammals is low.
Flumethrin is an ectoparasiticide from the group of synthetic pyrethroids.
Based on current knowledge, synthetic pyrethroids interfere with the channels of the
sodium from the nerve cell membrane, producing a delay in the repolarization of the
nerve fiber. The group of alpha-cyanos (type II pyrethroids) such as flumethrin appear to be
much more powerful in this action causing series of repetitive downloads of long
duration in nerve cells.
In studies carried out on the structure-activity relationship of some pyrethroids, it was observed
an interference with receptors of a certain chiral conformation causing, therefore,
a selective action on ectoparasites.
No anticholinesterase activity has been observed in these compounds.
Flumethrin has remarkable acaricidal activity.
5.2 Pharmacokinetic data
The active ingredients are continuously released from the collar formulation. The
insecticidal concentrations of both active ingredients are present in the coat of the
dog throughout the period of efficacy.
The association of propoxur and flumethrin significantly intensifies the efficacy against
ticks and fleas compared to each treatment individually. This also remains
demonstrated by a considerable extension of the period of efficacy.
Dermal absorption of both active ingredients does not occur in significant amounts
since the dermal LD50 of the formulation was determined to be greater than 5000 mg/kg bw and
clinical, hematological, biochemical (including cholinesterase) and urinary parameters did not
were affected by the product when it was tested in safety studies on the
target animal.
6. PHARMACEUTICAL DATA
6.1 List of excipients
di-n-butyladipate
Propylene glycol dicaprylocaprate
epoxidized soybean oil
Stearic acid
Titanium dioxide (E-171)
yellow iron oxide
Polyvinyl chloride
6.2 Incompatibilities
They have not been described.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 5 years.
6.4. Special storage precautions
This veterinary medicinal product does not require special storage conditions.
6.5 Nature and composition of immediate packaging
Individual box containing one collar in a sealed polyester/polyethylene or plastic bag.
polyester / aluminum / polyethylene.
Formats:
Box with 1 collar for small dogs
Box with 1 collar for medium dogs
Box with 1 collar for large dogs
Not all formats may be marketed
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
This medicine is very toxic to aquatic organisms, birds and bees.
The Kiltix collar should not come into contact with watercourses as it could be
Dangerous for fish and other aquatic organisms.
Prevent dogs from entering water or swimming in ponds or streams with the collar on.
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
Bayer Hispania, SL
Av. Baix Llobregat, 3 – 5
08970 – Sant Joan Despí (Barcelona)
8. MARKETING AUTHORIZATION NUMBER
1170 ESP
9. DATE OF THE FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION
September 1, 1997 / March 6, 2008
10. DATE OF REVISION OF THE TEXT
May 6th 2015
PROHIBITION OF SALE, DISPENSATION AND/OR USE

See technical sheet