ADVANTAGE DOG 250MG 10-25KG 4 PIPETTES | ANTIPARASITIC DOGS

ADVANTAGE 400 FOR DOGS, solution for spot dorsal anointing.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active principle:
Imidacloprid 400 mg/pipette (4,0 mL of 10% solution)
Excipient:
Butylated hydroxytoluene (E 321) 4,0 mg/pipette
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Spot-on dorsal anointing solution.
Clear yellow to brownish solution.
4. CLINICAL DATA
4.1 Target species
Dogs.
4.2 Indications for use, specifying the species for which it is intended
For the prevention and treatment of flea infestations and treatment of chewing lice (Trichodectes canis) infestations in dogs weighing 25 kg and over.
For dogs weighing less than 25 kg, use the appropriate Advantage for Dogs product (see section 4.9).
The fleas in the dog are eliminated during the first 24 hours after the application of the medicine. One treatment prevents further flea infestation for four weeks. The drug can be used as part of a treatment strategy to control flea allergy dermatitis (FAD), when it has
previously diagnosed by a veterinarian.
4.3 Contraindications
Do not treat unweaned pups less than 8 weeks of age.
Do not use in animals with hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings
None.
4.5 Special precautions to be taken during use
Special precautions for use in animals
This medication should only be applied to the skin. Do not administer orally.
Contact of the pipette contents with the eyes or mouth of the recipient animal should be avoided.
Do not let newly treated animals lick each other.
Specific precautions to be taken by the person administering the medicinal product
to the animals
Wash hands after applying the medication.
Wash exposed skin with soap and water.
People with known skin hypersensitivity may be especially sensitive to
this medicine.
Avoid contact of the medication with the eyes and mouth.
In case of accidental eye contact, eyes should be washed with plenty of water. if it persists
eye or skin irritation, or if the medication is accidentally swallowed, go to the
doctor.
Do not eat, drink or smoke during application.
4.6 Adverse reactions (frequency and seriousness)
The medicine has a bitter taste and occasionally, if the dog licks the point of
application immediately after treatment, salivation may occur. This effect
It is not a sign of poisoning and disappears after a few minutes without the need for
treatment (see also section 4.9 Posology and method of administration).
On very rare occasions, skin reactions such as hair loss,
redness, itching and skin lesions. Agitation and
disorientation. Exceptionally, excessive salivation and signs of
Nervous disorders such as incoordination, tremor and depression.
4.7 Use during pregnancy, lactation or lay
Primary embryotoxic, teratogenic, or functional effects have not been observed.
during studies carried out with imidacloprid on rats and rabbits. The
Studies on pregnant and lactating bitches together with their litter are limited. Without
However, to date there is no evidence to suggest that effects should be expected.
adverse in these animals.
4.8 Interactions with other medicinal products and other forms of interaction
No incompatibility has been observed between this drug at twice the dose
recommended and the following commonly used veterinary drugs: fenthion,
lufenuron, milbemycin, febantel, pyrantel, and praziquantel. Also, it was demonstrated
drug compatibility with a wide range of routine treatments under
field conditions including vaccination.
4.9 Posology and method of administration
Dosage and Treatment Scheme
Dog (kg weight)
Medication Number of pipettes Imidacloprid
(mg/kg weight)
< 4 kg Advantage 40 for Dogs 1 x 0,4 ml minimum of 10
≥ 4 to <10 kg Advantage 100 for Dogs 1 x 1,0 ml minimum of 10
≥ 10 to <25 kg Advantage 250 for Dogs 1 x 2,5 ml minimum of 10
≥ 25 to <40 kg Advantage 400 for Dogs 1 x 4,0 ml minimum of 10
≥ 40 kg Advantage 400 for Dogs 2 x 4,0 ml minimum of 10
Reinfestations may continue to occur due to the appearance of new fleas in the environment
for six weeks or more after starting treatment. Consequently,
More than one treatment may be necessary, depending on the number of fleas on the
atmosphere. As an aid, the additional use in the animal's habitat of a
adequate treatment against adult fleas and their stages of development.
The medicine remains effective even if the animal gets wet, for example after bathing or
from exposure to heavy rain. However, in those cases where bathing is frequent,
Retreatment may be necessary depending on the presence of fleas in the environment.
In these cases, do not apply more frequently than once a week.
In case of chewing lice infestation, a 30 day veterinary examination is recommended
after treatment as some animals may require a second treatment.
Administration form
Remove a pipet from the case. For dogs weighing 40 kg and over, use two
pipettes. Keep the pipet upright, twist the cap and remove it. Use the cap placed in the direction
reverse to, by twisting, pierce the pipette.
For dogs weighing less than 25 kg:
With the dog in a standing position, part the hair between the shoulder blades until the skin is visible.
Place the top of the pipette on the skin and firmly squeeze the pipette several times
to deposit all its content.
For dogs weighing 25 kg or more:
To facilitate the application, the dog should be in a standing position. All content will be applied
of the pipette distributed evenly in three or four points on the dorsal line of the animal
from the scapular area to the base of the tail. Separate the hair from each point of application
until the skin is visible.
Place the top of the pipette directly on the skin and squeeze the pipette with
softness to deposit part of its content.
For all dogs:
Do not apply an excessive amount of the solution on the same point as it could slip
by the dog's side.
The medicine has a bitter taste and occasionally, if the dog licks the point of
application immediately after treatment, salivation may occur. This effect
It is not a sign of poisoning and disappears after a few minutes without the need for
treatment. A correct application will minimize the opportunity for the dog to lick the
medicine.
Apply only on healthy skin. Do not allow newly treated animals to lick each other.
others.
4.10 Overdose (symptoms, emergency procedures, antidotes), if
process
The application of individual doses of up to 200 mg/kg weight (five to eight times the dose
therapeutic), daily treatments with 100 mg/kg weight for five consecutive days and
weekly treatments of five times the maximum dose for 8 consecutive weeks, not
have produced adverse clinical signs.
In rare cases, nervous system disturbances (symptoms such as
twitching, tremor, ataxia, mydriasis, miosis, lethargy) in case of overdose or if the
animal licks the treated area.
Poisoning in the animal is unlikely to occur after accidental ingestion of the
medicine. If this were the case, the treatment should be symptomatic under care
vet. No specific antidote is known, but ingestion of charcoal may be beneficial.
activated.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic classification group: Antiparasitic, insecticide and repellent product.
ATCvet code: QP53AX17
5.1 Pharmacodynamic properties
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine* is an ectoparasiticide
belonging to the group of chloronicotinyl compounds. Chemically, it is described more
exactly like a chloronicotinyl nitroguanidine.
* CAS No.: 138261-41-3
The active principle has a high affinity for the nicotinergic receptors of the
acetylcholine in the postsynaptic region of the central nervous system (CNS). The subsequent
Inhibition of cholinergic transmission in insects causes paralysis and death. Imidacloprid
has virtually no effect on the mammalian CNS because interaction with
mammalian nicotinergic receptors is weak and their poor ability to cross the
blood brain barrier. The minimal pharmacological activity in mammals is confirmed by
safety studies conducted that include systemic administration of doses
sublethal to rabbits, mice and rats.
In addition to its efficacy as an adulticide against fleas, other studies have shown its
efficacy as a larvicide in the environment of the treated animal. The larvae present in the environment of the
animal die after contact with the treated animal.
5.2 Pharmacokinetic data
The drug is indicated for application on the skin. After cutaneous application on
dogs, the solution is rapidly distributed over the animal. Acute dermal studies in
rat, overdose studies in the target animal, and kinetic studies in
serum, have shown that systemic absorption is very low, transient and of no importance
for clinical efficacy. This has also been demonstrated by a study conducted on
treated animals whose skin and fur were subsequently cleaned of active product, and the
fleas did not die after ingesting blood from these animals.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Butylated hydroxytoluene E 321
benzyl alcohol
propylene carbonate
6.2 Incompatibilitydades
None known.
6.3 Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 5 years.
6.4 Cautionis conservation specials
It does not require any special storage conditions.
Keep away from food, drink and feed.
6.5 Natureay composition of the primary packaging
Pack size 4,0 ml solution per pipette
Blister containing 2, 3, 4, or 6 single-dose pipettes.
Container material White polypropylene pipette and stopper.
Not all formats may be marketed.
6.6 Special precautions to be observed when disposing of the medicinal product
unused veterinarian or, where appropriate, its residues
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
7. HOLDER OF THE AUTHORIZATION OF COMERCIALIZATION
BAYER HISPANIA, SL
Avda. Baix Llobregat 3 and 5
08970 – Sant Joan Despi
Spain
8. MARKETING AUTHORIZATION NUMBER
1270 ESP
9. DATE OF THE FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION
May 10, 1999 / April 15, 2005.
10. DATE OF REVISION OF THE TEXT
May 10th 2011
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Veterinary use
Dispensing conditions: Medicine not subject to veterinary prescription

See technical sheet

ADVANTAGES