Broadline Cat is an external antiparasitic product for cats, which has action against cestodes, nematodes and ectoparasites, with effect within 24 hours of application.

INGREDIENTS:

Excipients:

Butylhydroxytoluene (E321) 1 mg/ml.

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Spot-on solution.

Clear, colourless or yellow solution.

CLINICAL PARTICULARITIES

Target species

Cats.

Indications for use, specifying target species

For cats infested or at risk of being infested with cestodes, nematodes and ectoparasites. The product is particularly indicated when all three groups are targeted at the same time.

Ectoparasites

• Treatment and prophylaxis of flea infestations (Ctenocephalides felis). Eliminates fleas within 24 hours of application. One treatment provides protection against new infestation for at least one month.
• Prevents environmental contamination with fleas by inhibiting the development of fleas in all stages of development (eggs, larvae and pupae) for over a month.
• The product may be part of a treatment strategy to control flea allergy dermatitis (FAD).
• Treatment and prophylaxis of tick infestations (Ixodes ricinus). Eliminates ticks within 48 hours of application. One treatment provides protection against new infestation for up to 3 weeks.

tapeworms

• Treatment of infestations with flatworms (Cestodes) (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis).

nematodes

• Treatment of gastrointestinal nematode infestations (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancyclostoma tubaeforme and adult forms of Toxocara leonina and Ancyclostoma brazilienze).
• Treatment of bladder worm infestations (Capillaria plica).
• Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.

Contraindications

Do not use on sick or convalescent animals.

Not for use in rabbits.

Do not use in case of hypersensitivity to the active substances or any of the excipients.

Special warnings for each target species

When applying the product, special attention must be paid to long-haired breeds to ensure that the product is applied directly to the skin and not to the fur, otherwise the product will have reduced bioavailability and thus reduced effectiveness.

It is very important that the veterinary medicinal product is applied to the skin in an area where the animal cannot lick the product. Also, ensure that animals do not lick each other after treatment.

There are no data available on the effect of bathing/shampooing on the efficacy of the product in cats. However, brief exposure of the animal to water once or twice a month after application of the product is unlikely to significantly reduce the efficacy of the product. As a precautionary measure, it is recommended that the animal is not bathed for 2 days after application of the product.

After treatment with BROADLINE, ticks are generally killed within 48 hours of infestation without carrying out haematophagous activity. However, it is possible that some ticks may remain on the animal and for this reason, the transmission of infectious diseases cannot be completely excluded.

Flatworm infestation can recur if intermediate hosts such as fleas, mice, etc. are not controlled.

Parasite resistance to a particular class of antiparasitic drugs may develop as a result of frequent use of a compound from that class. Therefore, available information on the current susceptibility of the target species should be taken into account to limit the possibility of future selection for resistance.

Cats living in areas endemic for cardiovascular heartworm disease or those that have traveled to

such areas may be infested with adult heartworms. Although the product can be administered to cats infected with adult heartworms, no therapeutic effect against adult heartworms Dirofilaria immitis has been established. It is therefore recommended that all cats aged 6 months or over, living in areas endemic for cardiovascular heartworm disease, be tested for adult heartworm infestation before the prophylactic product is applied.

Special precautions for use

Special precautions for use in animals

For spot-on application only. Do not inject, administer orally or by any other route of administration. Avoid contact with the cat's eyes.

The safety of the product has not been tested for intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or 7 weeks of age.

The product is not intended for use in dogs. Certain breeds of dogs may have an increased susceptibility to macrocyclic lactones, which may produce neurotoxic effects. Ingestion by breeds such as Collies, English Sheepdogs and mixed breeds or related breeds should therefore be avoided.

Echinococcosis represents a risk to humans and is one of the diseases monitored by the World Organization for Animal Health (OIE).

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

Do not smoke, drink or eat while handling the product.

Wash hands thoroughly after use.

Unused applicators should be stored in the intact blister packaging.

Avoid contact of fingers with the contents of the applicator. If this happens, wash with soap and water. In case of accidental contact with eyes, rinse thoroughly with water as the product may cause mild eye irritation. If eye irritation persists or adverse effects occur, seek medical advice and show the package leaflet or the label to the physician.

Avoid handling the animal until the area where the product was applied is dry, and children should not play with the animals during this period. Therefore, it is recommended that recently treated animals not sleep with their owners, especially children.

People with known hypersensitivity to any of the active substances or excipients should not handle this veterinary medicinal product.

Adverse reactions (frequency and severity)

After treatment, the fur may temporarily take on a sticky appearance at the application site.

Mild and transient skin reactions may occur at the site of product application (local alopecia, pruritus).

If the cat licks its fur after treatment, temporary excessive salivation may be observed.

Ingestion of the product may lead to vomiting and/or transient neurological symptoms such as ataxia, disorientation, apathy and pupil dilation.

All of these symptoms resolve spontaneously within 24 hours. Correct application will minimize the occurrence of these reactions (see section 4.9).

Use during pregnancy, lactation or laying

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies on each active substance in rats and rabbits have not shown any teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit/risk assessment by the veterinarian.

Interactions with other medicinal products or other forms of interaction

They don't know each other.

Amounts to be administered and route of administration

Spot-on administration.

The product should only be used if mixed infestation is confirmed or if there is a risk of mixed infestation with ectoparasites and nematodes (including for the prevention of heartworm disease) and when concomitant treatment against cestodes is indicated. In the absence of risk of concomitant contamination, a narrow-spectrum parasiticide is recommended as the first treatment solution.

The indication for use should be adapted to the needs of the cat determined by clinical evaluation, the animal's lifestyle and the local epidemiological situation (including zoonotic risks where applicable) so that it is used exclusively in situations of infestation or risk of mixed infestation.

Treatment should not be extrapolated from one animal to another without the advice of a veterinarian.

Dosage:

The minimum recommended doses are 10 mg/kg body weight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel.

Choose the appropriate applicator based on the cat's weight.

Method of administration:

Use scissors to cut the blister along the dotted line, then pull the foil off.

Remove the applicator from the packaging and hold it with the tip pointing upwards. Pull the plunger back slowly, twist and remove the cap. Make a path through the fur in the mid-neck area, between the base of the skull and the shoulder blades so that the skin is visible. Position the tip of the applicator on the skin and apply the entire contents directly to the skin in one spot.

To prevent cardiovascular heartworm disease (Dirofilaria immitis larvae), the product should be applied starting 1 month before the first exposure to mosquitoes.

Overdose (symptoms, emergency procedures, antidotes), as appropriate

Safe use has been demonstrated in healthy kittens aged 7 weeks or older who received a dose of up to 5 times the maximum tolerated dose (i.e. up to 15 times the recommended dose) treated up to 6 times at four week intervals. Safe use has also been demonstrated in healthy adult cats treated 3 times at 2 week intervals with a dose of up to 5 times the recommended dose. Transient neurological signs such as ataxia, disorientation, apathy and dilated pupils may be observed, which usually resolve spontaneously the next day. In isolated cases, transient salivation and/or vomiting may also occur in kittens and adult cats.

Cats infected with adult heartworms tolerated up to 3 times the maximum allowable dose (i.e. up to 9 times the recommended dose), 3 treatments at 4-week intervals, without any adverse effects.

Waiting time

That's not the case.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antiparasitic products; ATC veterinary code: QP54AA54.

This veterinary medicinal product is an insecticidal and acaricidal solution for topical use, containing the active ingredients fipronil (adulticide) and (S)-methoprene (ovicide and larvicide) in combination with the endectocide, eprinomectin and the cestocide praziquantel which completes the broad spectrum with action against gastrointestinal nematodes, lungworms, flatworms and bladderworms.

Pharmacodynamic properties

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil and its metabolite, fipronil sulfone, act at the level of ligand-activated chloride ion channels, in particular those activated by the neurotransmitter gamma amino butyric acid (GABA), as well as by desensitization (D) and non-desensitization (N) of glutamate-activated ion channels (Glu, the unique ligand-activated chloride ion channels of invertebrates), thus blocking the pre- and post-synaptic transfer of chloride ions across the cell membrane. This results in uncontrolled activity of the central nervous system of insects and mites, followed by their death.

(S)-Methoprene is an insect growth regulator (IGR) that belongs to the class of compounds known as juvenile hormone analogues that inhibit the development of immature insects. This compound mimics the action of juvenile hormone, affecting the development of immature fleas, ultimately leading to their death. The ovicidal activity of (S)-methoprene in the host animal occurs either by direct penetration of the shell of freshly laid eggs or by absorption through the cuticle of adult fleas. (S)-Methoprene is also effective in blocking the development of flea larvae and pupae, which prevents contamination of the environment in which treated animals live with immature fleas.

Eprinomectin is a member of the macrocyclic lactone class of endectocides. Compounds of this class bind selectively and with high affinity to chloride ion channels found in muscle and nerve cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cells resulting in paralysis and death of the parasite. The spectrum of efficacy of eprinomectin in cats has been shown to cover both gastrointestinal and extraintestinal nematodes.

Praziquantel is a synthetic pyrazino-isoquinoline derivative that has activity against flatworms. Praziquantel is rapidly absorbed by the parasites and affects the permeability of the cestode membrane by influencing the fluxes of divalent cations, especially the homeostasis of calcium ions, which is responsible for rapid muscle contraction and vacuolization. This leads to severe damage to the parasite's skin, contractions and paralysis, disruption of metabolism and ultimately death and detachment of the parasite. Disintegrated or partially digested fragments can occasionally be seen in the feces.

Pharmacokinetic features

The ectoparasitic action of Fipronil and (S)-methoprene is achieved by direct contact with the ectoparasites, not by systemic exposure. After a single topical application of the product, the active substances were detected in various areas of the cat's body, including the caudal region from the first day after application, indicating distribution from the application site (between the head and shoulder blades) throughout the animal's body.

Fipronil sulfone, a derivative of fipronil, is also found in the fur. Fur concentrations of fipronil, fipronil sulfone and (S)-methoprene decrease with time but remain detectable for at least 42 days after administration. Topical application, with potential oral exposure through licking, resulted in partial systemic absorption that decreased with time. Peak plasma concentrations of the absorbed fractions of fipronil and (S)-methoprene are reached in 8 to 9 hours.

Unlike other species, fipronil sulfone is not formed in cats. Fipronil is excreted mainly in the feces in unchanged form. (S)-methoprene, once absorbed, is rapidly metabolized and eliminated.

Eprinomectin and praziquantel act systemically, reaching peak plasma concentrations within 48 and 6 hours after treatment, respectively, with mean maximum concentrations (Cmax) of 20.1 ng/ml for eprinomectin and 157 ng/ml for praziquantel.

99%), is very poorly absorbed into the blood and is very well distributed in the tissues. Its metabolism is limited and it is mainly eliminated unchanged, through the feces. The average half-life of this compound is 4.75 days. Praziquantel is moderately distributed in the tissues and approximately 64-84% binds to plasma proteins. Praziquantel is metabolized in the liver and then excreted by the kidneys. The average half-life is 3.08 days for praziquantel.

In vitro metabolism tests and in vivo studies have demonstrated that there is no pharmacodynamic and pharmacokinetic interaction between fipronil, (S)-methoprene, eprinomectin and praziquantel.

PHARMACEUTICAL PARTICULARS

List of excipients

Glycerol formal

Disodium edetate (E385)

Propyl gallate (E310)

Thiodipropionic acid

Dimethyl Isosorbide

Butylated hydroxytoluene (E321)

incompatibility

They don't know each other.

Validity period

Shelf life of the veterinary medicinal product as packaged for sale: 24 months

Special precautions for storage

Store in the original packaging, protected from light.

Keep the applicator in the intact blister packaging.

Opened applicators should be disposed of as waste immediately.

Nature and composition of primary packaging

Dosage unit as a syringe applicator (transparent siliconized cycloolefin copolymer (COC)) containing 0.3 ml or 0.9 ml of product, closed with a polymer stopper and packaged in individual plastic blisters.

Cardboard box containing 1, 3 or 4 applicators (each 0.3 ml)

Cardboard box containing 1, 3, 4 or 6 applicators (each 0.9 ml)

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements.

Do not contaminate lakes or waterways with the product or empty packaging due to the danger to fish and other aquatic organisms.

ATTENTION: Available only on medical prescription.

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Age: Adult

Presentation type: Pipette

Action: Fleas, lice, Flea larvae

Pieces Set: 3 pieces

Cat Weight: No

Brand Name: Merial

Quantity: 3 Pipettes