Patient leaflet - Broadline
B. PACKAGE LEAFLET
PACKAGE LEAFLET :
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats 2.5–7.5 kg
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release :
Boehringer Ingelheim Animal Health France SCS
4 Chemin du Calquet,
31000 Toulouse
FRANCE
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats 2.5–7.5 kg
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose (applicator) delivers:
| Volume of unit dose (ml) | Fipronil (mg) | (S)-methoprene (mg) | Eprinomectin (mg) | Praziquantel (mg) | |
| Cats <2.5 kg | 0.3 | 24.9 | 30.0 | 1.20 | 24.9 |
| Cats 2.5–7.5 kg | 0.9 | 74.7 | 90.0 | 3.60 | 74.7 |
Excipient: Butylhydroxytoluene (E321) 1 mg/ml. Spot-on solution.
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4. INDICATIONS
For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.
Ectoparasites
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– Treatment and prevention of infestations by fleas (Ctenocephalides felis). Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month.
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– Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.
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– The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
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– Treatment and prevention of infestations by ticks (Ixodes ricinus). Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks.
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– Treatment of notoedric mange (Notoedres cati ).
Cestodes
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– Treatment of infestations with tapeworms (Dipylidium caninum , Taenia taeniaeformis , Echinococcus multilocularis , Joyeuxiella pasqualei (adult), Joyeuxiella fuhrmanni (adult)).
Nematodes
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– Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati , adults of Toxascaris leonina , L4 larvae and adults of Ancylostoma tubaeforme and Ancylostoma ceylanicum , and adults of Ancylostoma brazilienze ).
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– Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior ).
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– Treatment of infestations with vesical worms (Capillaria plica ).
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– Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
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5. CONTRAINDICATIONS
Do not use in sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in rabbits.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
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6. ADVERSE REACTIONS
A temporary clumping or spiking of the hair and mild, transient skin reactions at the application site (itching, hair loss) have been commonly observed at the application site after treatment in clinical studies.
Temporary excessive salivation was commonly observed following licking the application site after treatment in clinical trials.
Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section ‘Special precautions for use in animals’ under SPECIAL WARNINGS). Transitory blindness or impaired vision have been observed in very rare cases based on post marketing safety experience.
Symptomatic treatment can be required if the signs do not resolve spontaneously within 24 hours. Correct application will minimise the occurrence of such events (see section DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION).
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cats
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For topical application onto the skin (spot-on).
The recommended minimum doses are 10 mg/kg bodyweight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel. Select the applicator size (or combination of applicators, for cats >7.5 kg) adapted to the cat’s weight.
The use of the veterinary medicinal product should exclusively be based on the confirmed mixed infestations or significant risk of such mixed infestation with ectoparasites and nematodes (including for heartworm disease prevention) and where concurrent treatment against cestodes is indicated. In the absence of risk of co-infestation, the use of a narrow spectrum parasiticide should be considered as a first line therapy.
The rationale for prescription should be tailored to the individual needs of the cat, based on clinical assessment, the animal’s lifestyle and on the local epidemiological situation (including zoonotic risks, where relevant) in order to address exclusively situations of mixed infestations/risk of infestation.
Treatment should not be extrapolated from one animal to the other without veterinary opinion.
Prevention of heartworm disease (Dirofilaria immitis larvae) should start within 1 month after the first expected exposure to mosquitoes.
For treatment against Aelurostrongylus abstrusus , a second administration one month after the initial treatment may be recommended.
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9. ADVICE ON CORRECT ADMINISTRATION
Use the applicator size adapted to the weight of the cat.
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– Use a pair of scissors to cut the blister along the dotted line, then pull the lid away.
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– Remove the applicator from the package and hold it upright.
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– Pull back the plunger slightly, twist and pull off the cap.
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– Part the hair on the midline of the neck, between the base of the skull and the shoulder blades
until the skin is visible.
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– Place the tip of the applicator on the skin and apply the entire content directly onto the skin in one spot.
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– The product should be applied to dry skin in an area where the cat cannot lick it off. In long hair breeds, special attention should be paid to apply the product onto the skin, and not on the hair to ensure optimal efficacy.
10.
WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store the applicator in the blister package in order to protect from light.
Keep the unused applicator in the intact blister package.
Opened applicators should be disposed of immediately.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
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12. SPECIAL WARNINGS
Special warnings for each target species:
Avoid animals licking each other following treatment.
After treatment, ticks will generally be killed within 48 hours after infestation without having a blood meal. However there may be attachment of single ticks and transmission of infectious diseases cannot thus be completely excluded if conditions are unfavourable.
The effect of shampooing or immersion in water of the animal has not been tested and should be avoided. Brief contact of the animal with water within the month following application is unlikely to reduce the efficacy of the product. However, as a precaution, it is not recommended to bath animals within 2 days after treatment.
Tapeworm infestation may reoccur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
Parasite resistance to any particular class of antiparasitic drug may develop following frequent use of a compound of that class. Therefore, epidemiological information about current susceptibility of the target species should be taken into account in order to limit the possibility of a future selection for resistance.
In certain individual cats, Notoedres cati infestation may be severe or complicated by bacterial infections. In these severe cases concomitant treatment may be necessary.
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Although the product may be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis has been established. It is therefore recommended that all cats 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.
Some cats with patent Joyeuxiella spp. infestation may nevertheless harbour a high proportion of juvenile worms, which are not susceptible to the product; therefore a post-treatment follow-up is recommended in case of such infestations.
To reduce re-infestation from emergence of new fleas, it is recommended that all cats in a household be treated. Other animals living in the same household should also be treated with a suitable product.
All stages of fleas can infest the cat’s basket, bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.
Special precautions for use in animals:
Spot-on application only. Do not inject, do not administer orally or via any other route. Avoid contact with the cat's eyes.
It is important to apply the veterinary medicinal product to a skin area where the cat cannot lick it off: on the neck, in between shoulders. Avoid animals licking each other following treatment.
Oral ingestion of the veterinary medicinal product resulted in common to uncommon vomiting, hypersalivation and/or in transient neurological signs such as ataxia, disorientation, apathy and pupil dilation in safety studies. Muscle tremors have been reported in very rare cases based on post marketing safety experience. These signs usually resolve spontaneously within 24 hours. On very rare occasions, symptomatic treatment can be required.
The safety of the veterinary medicinal product has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age. The product is not for use in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
The veterinary medicinal product is not intended for use in dogs. Some dog breeds may present increased susceptibility to macrocyclic lactones, potentially leading to signs of neurotoxicity. Oral uptake by dogs, specifically by Collies, Old English Sheepdogs and related breeds or crossbreeds should thus be avoided.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not smoke, drink or eat during application.
Wear gloves when handling the veterinary medicinal product. Wash hands immediately after use.
Avoid contact of the applicator content with the fingers. If this occurs, wash off with soap and water. In case of accidental eye exposure, flush the eyes thoroughly with water as the product can cause slight mucous membrane and eye irritation. If eye irritation persists or if side effects are noted, seek medical advice and show the package leaflet or the label to the physician.
Handling of treated animals should be limited until the application site is dry. Children should not be allowed to play with treated animals during this period. Recently treated animals should not sleep with owners, especially children.
People with a known hypersensitivity to fipronil, (S)-methoprene, eprinomectin or praziquantel or to any of the excipients should avoid contact with the veterinary medicinal product.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with the individual ingredients in rats and rabbits have not produced teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit-risk assessment by the prescribing veterinarian.
Overdose (symptoms):
Safety has been demonstrated with up to 5 times the maximum exposure dose (i.e. up to 15 times the recommended dose) in healthy kittens aged 7 weeks and older treated up to 6 times at four-week intervals. It has also been confirmed in healthy adult cats treated 3 times at two-week intervals with up to 5 times the recommended doses. Mild and transient signs may be observed with spontaneous recovery the day after – see description in section ADVERSE REACTIONS.
Cats infected with adult heartworms tolerated up to 3 times the maximum exposure dose (i.e. up to 9 times the recommended dose), every 4 weeks for 3 treatments, without any adverse effects.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
BROADLINE or empty container should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DD/MM/YYYY
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION