ZIKYALL LARGE DOG 60 TABLETS

For the treatment of mixed infestations with the following nematodes and cestodes

SUMMARY OF PRODUCT FEATURES
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zikyall tablets for large dogs
2. QUANTITATIVE AND QUALITATIVE COMPOSITION

Each tablet contains:

Active substances:

Excipients:
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
pills.
Oval, biconvex, slightly greenish-yellow, edged tablets
bevelled and marked on both sides.
The tablets can be divided into equal halves.
4. CLINICAL DATA
4.1 Target species
Dogs (big and very big).
4.2 Indications for use, specifying the target species.
For the treatment of mixed infestations with the following nematodes and cestodes in dogs
Adults:
Nematodes:
Roundworms: toxocara canis, Toxascaris leonina (late immature form and mature form).
Hookworms: Uncinaria stenocephala, Ancylostoma caninum (Adults).
Cestodes:
You had: Taenia spp., Dipylidium caninum.
4.3 Contraindications
Do not use simultaneously with piperazine compounds.

Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
Do not exceed the established dose when treating pregnant bitches.
4.4 Special warnings for each target species
Fleas serve as an intermediate host for a common type of cestode Dipylidium
caninum. Tapeworm infestation is likely to recur unless controlled
to intermediate hosts such as fleas, mice, etc.
Parasitic resistance to a particular class of anthelmintics may develop after
frequent and repeated use of anthelmintics of this class.
4.5 Special precautions for use
Special precautions for use in animals
Its use in dogs weighing less than 17,5 kg of body weight is not recommended.
Partially used tablets should be discarded.
Special precautions to be taken by the person administering the medicinal product
vet to animals
For correct hygiene, people who administer the tablets directly to the dog
or add them to the dog's food, they should wash their hands after doing so.
In case of accidental ingestion, consult a doctor and show him the package leaflet.
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy, lactation or lay
Consult a veterinarian before deworming pregnant animals.
This veterinary medicinal product can be used during lactation (see sections 4.3 and 4.9).
Do not use in bitches during the first two thirds of pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with piperazines as the anthelmintic effects of pyrantel and
piperazine (used in many dog ​​nematocides) may be antagonists.
Simultaneous use with other cholinergic compounds may cause toxicity.
4.9 Amounts to be administered and administration route
For oral administration.
Posology
The recommended doses are: febantel 15 mg/kg body weight, pyrantel 14,4 mg/kg and
5 mg/kg praziquantel. This is equivalent to 1 tablet per 35 kg of body weight.

Tablets can be split to allow more precise dosing.
Administration and Duration of Treatment
It is not necessary to restrict access to food either before or after the administration of the
veterinary drug.
To ensure administration of the correct dose, body weight should be determined with
the highest possible precision.
For the control of Toxocara, bitches that have farrowed should be treated 2 weeks later
birth and every 2 weeks until weaning.
In the case of severe nematode infestation, the dose should be repeated after 14 days.
For adult dogs, a single dose may be used. Veterinary advice should be followed
in terms of the need and frequency of repeat treatment.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
This medication is well tolerated in dogs. In safety studies, vomiting has occurred
occasional after administering doses five times higher than those recommended.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic Group: Anthelmintics, Benzimidazoles and related substances.
ATCvet code: QP52AC55
5.1 Pharmacodynamic properties
The veterinary medicinal product contains anthelmintics active against nematodes and cestodes. He
veterinary medicinal product contains three active substances: febantel, pyrantel embonate
(pamoate) and praziquantel, a partially hydrogenated derivative of pyrazino-isoquinoline used
Widely used as an anthelmintic in both veterinary and human use.
Pyrantel acts as a cholinergic agonist. Its mechanism of action is to stimulate
the parasite's nicotinic cholinergic receptors, inducing a spastic paralysis and thus
mode is removed from the gastrointestinal system by peristalsis.
In mammals, febantel undergoes ring closure to form febendazole and oxfendazole.
It is these chemical structures that perform the anthelmintic effect by inhibiting the
tubulin polymerization. This prevents the formation of microtubules,
resulting in an alteration of vital structures for the normal functioning of the
helminth. Glucose uptake is impaired, leading to a decrease in ATP in the
cell. The parasite dies due to the depletion of its energy reserves, which occurs 2 or 3
days later.
Praziquantel is very rapidly absorbed and distributed throughout the parasite. Studies in

vitro e in vivo have shown that praziquantel causes severe damage to the integument of the
parasite, causing contractions and paralysis. There is almost simultaneously a
tetanic contraction of the parasite musculature and a rapid vacuolization of the integument
syncytial. This rapid contraction is explained by changes that occur in the flow of cations
divalents, especially calcium cations.
In this fixed combination veterinary medicinal product, pyrantel and febantel act
synergistically against all the most relevant nematodes in dogs. In particular, the
spectrum of activity coverstoxocara canis, Toxascaris leonina, Uncinaria stenocephala y
Ancylostoma caninum. The spectrum of activity of praziquantel also covers against species
of cestodes in dogs, in particular all species of Taenia spp. and Dipylidium caninum.El
Praziquantel acts against immature and adult forms of these parasites.
5.2 Pharmacokinetic data
Orally administered praziquantel is almost completely absorbed from the intestinal tract.
After absorption, the drug is distributed to all organs. Praziquantel is
metabolized to inactive forms in the liver and is secreted into the bile in more than 95% within
24 hours after administration. Only trace amounts of praziquantel are excreted without being metabolized.
Pyrantel pamoate salt has low water solubility, which reduces its intestinal absorption
and allows the drug to reach and be effective against parasites in the small intestine.
Due to the low systemic absorption of pyrantel pamoate, the risk of adverse reactions
or toxicity in the host is very little. After absorption, pyrantel pamoate is
rapidly and almost completely metabolized to inactive metabolites that are excreted
quickly in the urine.
Febantel is absorbed relatively quickly and is metabolized to active metabolites that
they include fenbendazole and oxfendazole, which have anthelmintic activity.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Lactose monohydrate
Cornstarch
Povidone K-30
sodium lauryl sulfate
Microcrystalline cellulose
colloidal anhydrous silica
Magnesium stearate
6.2 Incompatibilities
None known.
6.3 Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
6.4 Special precautions for storage
This veterinary medicinal product does not require special storage conditions.
6.5 Nature and composition of immediate packaging
OPA/Al/PVC-Al
Cardboard box containing 2, 4, 10, 12, 24, 30, 50, 60, 100 or 102 tablets.
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.
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto Slovenia
8. MARKETING AUTHORIZATION NUMBER
3337 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: November 27, 2015
Authorization renewal date: August 12, 2016
10. DATE OF REVISION OF THE TEXT
August 2016
PROHIBITION OF SALE, SUPPLY AND/OR USE
Veterinary use. Medicine subject to a veterinary prescription.
Administration under control or supervision of the veterinarian.

See technical sheet