Chanhold 60 mg 3 pipettes for external deworming in dogs

CHANHOLD SPOTLIGHT SOLUTION FOR CATS AND DOGS

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each unit dose (pipette) contains:

Active substance:

· Chanhold 15 mg for cats and dogs 6% w/v solution Selamectin 15 mg

· Chanhold 30 mg for dogs 12% w/v solution Selamectin 30 mg

· Chanhold 45 mg for cats 6% w/v solution Selamectin 45 mg

· Chanhold 60 mg for cats 6% w/v solution Selamectin 60 mg

· Chanhold 60 mg for dogs 12% w/v solution Selamectin 60 mg

· Chanhold 120 mg for dogs 12% w/v solution Selamectin 120 mg

· Chanhold 240 mg for dogs 12% w/v solution Selamectin 240 mg

· Chanhold 360 mg for dogs 12% w/v solution Selamectin 360 mg

Excipients:

· Butylhydroxytoluene (E321) 0,08%.

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Spot-on dorsal anointing solution.

Clear colorless to yellow solution.

CLINICAL DATA

target species

Dogs and cats.

Indications for use, specifying the target species

· Cats and dogs:

Treatment and prevention of flea infestations produced by Ctenocephalides spp. for one month after administration of a single dose as a result of the adulticidal, larvicidal and ovicidal properties of this drug. Ovicidal activity persists for three weeks after administration. Monthly treatment of pregnant and lactating animals helps prevent flea infestations in the litter up to seven weeks of age by reducing the flea population. This medicine can be used as part of the strategic treatment of flea allergy dermatitis, and due to its ovicidal and larvicidal action it can help control existing flea infestations in the environment in areas to which the animal has access.

Prevention of filariasis produced by Dirofilaria immitis, through monthly administration.

This drug can be safely administered to animals infected with adult forms of the parasite, although in accordance with good veterinary practice all animals 6 months of age or older living in countries where the vector exists should be examined for the presence of the parasite. adult forms of the parasite before starting treatment with the drug. It is also recommended that, as an integral part of a heartworm prevention strategy, dogs be examined regularly for adult forms of heartworm infections, even if they have been treated with this drug on a monthly basis. This drug is not effective against adult forms of D. immitis.

Treatment of ear mites (Otodectes. Cynotis).

Cats:

Treatment of infestations by lice (Felicola subrostratus).

Treatment of roundworms in their adult forms (Toxocara cati)

Treatment of intestinal hookworms in their adult forms (Ancylostoma tubaeforme)

· Dogs:

Treatment of infestations by lice (Trichodectes canis).

Treatment of sarcoptic mange (Sarcoptes Scabiei).

Treatment of intestinal roundworms in their adult forms (Toxocara canis).

Contraindications

Do not use in animals less than 6 weeks.

Do not use on sick cats or cats that are debilitated and underweight for their size and age.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species

Animals can be bathed 2 hours after treatment without loss of efficacy.

Do not apply if the animal has wet hair. However, shampooing or wetting the animal 2 hours after the treatment has been applied will not reduce the effectiveness of the medication.

For the treatment of ear mites, do not apply directly to the ear canal.

It is important to dose as directed to minimize the amount the animal may lick off. If significant licking occurs, rarely, a brief period of hypersalivation may be observed in cats.

Special precautions for use

Special precautions for use in animals

This veterinary medicinal product should only be applied to the skin. Do not administer orally or parenterally.

Keep treated animals away from fire or other sources of ignition for at least 30 minutes or until the hair is dry.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This product is highly flammable. Keep away from heat, sparks, flames and other sources of ignition.

This medicine is an irritant to the skin and eyes. Do not smoke, eat or drink while handling the product.

Wash your hands after using the medicine and immediately remove any product residues that may be on the skin with soap and water. If accidental contact with eyes occurs, rinse immediately with water and seek medical advice immediately and show the package leaflet or label.

Avoid direct contact with treated animals until the application area is dry. On the day of treatment, children should not touch treated animals and animals should not be allowed to sleep with their owners, especially children. Used applicators should be disposed of immediately and out of the sight or reach of children.

People with sensitive skin or known hypersensitivity to this type of medicinal product should handle the veterinary medicinal product with caution.

Other precautions

Do not allow treated animals to bathe in water courses until at least two hours after treatment is administered.

Adverse reactions (frequency and seriousness)

The use of the veterinary medicinal product in cats has been associated with rare transient mild alopecia at the application site. Transient local irritation has also been observed on very rare occasions. Alopecia and irritation usually resolve spontaneously but, in certain circumstances, symptomatic treatment may be appropriate.

If significant licking occurs, a brief period of hypersalivation may be observed in cats on rare occasions.

Application of the medicinal product to cats and dogs may rarely cause temporary clumping of hair at the application site and/or the occasional appearance of a small amount of white powder. This is normal and will usually disappear within 24 hours of treatment administration and will not affect the safety or efficacy of the veterinary medicinal product.

As with other macrocyclic lactones, reversible neurological signs, including seizures in very rare cases, may be observed following use of the veterinary medicinal product in dogs and cats.

The frequency of adverse reactions should be classified according to the following groups:

– Very frequently (more than 1 animal for every 10 animals treated presents 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)

– On very rare occasions (less than 1 animal per 10.000 animals treated, including isolated cases).

Use during pregnancy, lactation or lay

This veterinary medicine can be used in dogs and cats of childbearing age, during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

None known.

Dosage and route of administration

The drug must be administered in a single application of a unit dose supplying a minimum of 6 mg/kg of selamectin. When an animal is to be treated with this veterinary medicinal product for mixed infections or infestations, only one application of the recommended dose of 6 mg/kg should be administered at that time. The duration of the treatment period against individual parasites is specified below.

Administer according to the following table:

Cats (kg)

= 2,5: 1 pipette of Chanhold 15 mg for cats and dogs = 2,5 kg

2,6 – 7,5: 1 pipette of Chanhold 45 mg for cats 2,6-7,5 kg

7,6 – 10,0: 1 pipette of Chanhold 60 mg for cats 7,6-10,0 kg

> 10: Proper combination of pipettes

Dogs (kg)

= 2,5: 1 pipette of Chanhold 15 mg for cats and dogs = 2,5 kg

2,6 – 5,0: 1 pipette of Chanhold 30 mg for dogs 2,6-5,0 kg

5,1-10,0: 1 pipette of Chanhold 60 mg for dogs 5,1-10,0 kg

10,1 – 20,0: 1 pipette of Chanhold 120 mg for dogs 10,1-20,0 kg

20,1 – 40,0: 1 pipette of Chanhold 240 mg for dogs 20,1-40,0 kg

40,1 – 60,0: 1 pipette of Chanhold 360 mg for dogs 40,1-60,0 kg

> 60: Proper combination of pipettes

Chanhold Treatment and prevention of fleas (cats and dogs)

Following administration of the veterinary medicinal product to the animal, the adult fleas are killed, no viable eggs are produced and the larvae (found only in the environment) die. In this way the reproduction of fleas is stopped and the life cycle of the flea is broken and it can help to control existing flea infestations in the environment in areas to which the animal has access.

For the prevention of flea infestations, the veterinary medicinal product should be administered at monthly intervals during the flea season, beginning one month before flea activity begins. Due to the reduction in the flea population, monthly treatment of pregnant and lactating animals will help prevent flea infestations in the litter.

Used as part of the strategic treatment of flea allergy dermatitis, this veterinary medicinal product should be administered at monthly intervals.

Heartworm prevention (cats and dogs)

The veterinary medicinal product can be administered year-round or at least one month after the animal's first exposure to mosquitoes and once a month thereafter until the end of the mosquito season. The last dose should be administered one month after the last exposure to mosquitoes. If a dose is missed and the monthly interval between two doses is exceeded, immediate administration of the veterinary medicinal product and resumption of monthly doses will minimize the chances of development of adult forms of heartworms. When replacing another veterinary medicinal product for the prevention of heartworms, the first dose of the veterinary medicinal product should be administered during the month following the administration of the last dose of the previous medicinal product.

Treatment of roundworm infections (dogs and cats)

A single dose of the veterinary medicinal product will be administered.

Treatment of pediculosis (dogs and cats)

A single dose of the veterinary medicinal product will be administered.

Treatment of ear mites (cats)

A single dose of the veterinary medicinal product should be administered.

Treatment of ear mites (dogs)

A single dose of the veterinary medicinal product will be administered. At the time of treatment, the detached crusts should be removed from the external ear canal. Since some animals may require a second treatment, a veterinary examination is recommended 30 days after the first.

Treatment of Hookworm Infections (Cats)

A single dose of the veterinary medicinal product will be administered.

Sarcoptic Mange Treatment (Dogs)

For complete elimination of mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.

Administration method:

Remove the pipette from its protective packaging.

Hold the pipet upright.

Touch the narrow part of the pipette to ensure that the contents remain within the main body of the pipette. Remove the tip.

Part the animal's hair at the base of the neck, in front of the shoulder blades, until the skin is visible. Place the pipette tip on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in a single point.

Apply to the skin at the base of the neck in front of the shoulder blades.

Avoid contact between the product and your fingers.

Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions were observed after administration of 10 times the recommended dose. Selamectin was administered up to 3 times the recommended dose to dogs and cats infected with adult forms of heartworms and no adverse reactions were observed. Selamectin was also administered up to 3 times the recommended dose to dogs and cats of breeding age, male and female, including pregnant and lactating females nursing litters and up to 5 times the recommended dose to ivermectin-sensitive Collies, and no adverse reactions were observed.

Timeouts

Not applicable.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antiparasitic products, insecticides and repellents, macrocyclic lactones.

ATCvet code: QP54AA05

Pharmacodynamic properties

Selamectin is a semisynthetic compound of the avermectin class. Selamectin paralyzes and/or kills a wide variety of invertebrate parasites by interfering with the conductivity of the chloride channel, causing disruption of normal neurotransmission. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods, causing paralysis and/or death.

Selamectin has adulticidal, ovicidal and larvicidal activity against fleas. Thus, it effectively breaks the flea life cycle by killing the adult forms (on the animal), preventing the incubation of eggs (on the animal and its environment), and killing the larvae (from the environment only). The desquamations of selamectin-treated animals kill flea eggs and larvae, which have not been previously exposed to selamectin, and thus may aid in the control of existing flea infestations in the environment in areas to which the animal has access.

Selamectin has also been shown to be effective against heartworm larvae.

Pharmacokinetic data

Selamectin is absorbed into the skin following dopple administration, reaching peak plasma concentrations approximately 1 and 3 days after administration to cats and dogs, respectively. Once absorbed through the skin, selamectin is distributed systemically and is slowly eliminated from plasma as evidenced by detectable plasma concentrations in dogs and cats 30 days after a single 6 mg/kg dermal dose. The long persistence and slow elimination of selamectin from plasma is reflected in the terminal elimination half-life values ​​of 8 and 11 days in cats and dogs, respectively. The systemic persistence of selamectin in plasma and the absence of extensive metabolism provide effective selamectin concentrations during the dosing interval period (30 days).

PHARMACEUTICAL DATA

List of excipients

Butylated hydroxytoluene (E321)

Dipropylene glycol methyl ether

Isopropyl alcohol

Major incompatibilities

Not applicable.

Period of validity

Shelf life of the veterinary medicinal product packaged for sale: 2 years.

Special storage precautions

This veterinary medicinal product does not require special storage conditions.

Nature and composition of the immediate packaging

This veterinary medicinal product is presented in a white plastic pipette consisting of a polypropylene/cyclic olefin copolymer/polypropylene layer with a polyethylene/ethylene vinyl alcohol/polyethylene layer.

The medicinal product is available as three pipets (all strengths), six pipets (all strengths except 15 mg) or fifteen pipets (15 mg strength only) in individual multi-layer sachets inside an outer carton.

Not all formats may be marketed.

Special precautions for disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use

Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance with local regulations.

Chanhold should not be discharged into water courses as it could be dangerous to fish and other aquatic organisms. Containers and waste must be disposed of with domestic waste to avoid contaminating watercourses.

PROHIBITION OF SALE, DISPENSATION AND/OR USE

Not applicable.

DATA SHEET 

CHANHOLD