Broadline (eprinomectin, fipronil, praziquantel,...) – Summary of product characteristics - QP54AASY
Updated on site: 08-Feb-2018
|Substance:||eprinomectin, fipronil, praziquantel, (S)-methoprene|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Each unit dose applicator delivers:
unit dose (ml)
Cats <2.5 kg
Butylhydroxytoluene (E321) 1 mg/ml.
For the full list of excipients, see section 6.1.
Clear colourless to yellow to red/brown solution.
4.2Indications for use, specifying the target species
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.
-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.
-Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.
-The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
-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.
-Treatment of notoedric mange (Notoedres cati).
Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis , Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).
-Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancylostoma tubaeforme, and adult forms of Toxascaris leonina and Ancylostoma brazilienze).
-Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of
Aelurostrongylus abstrusus , L4 larvae and adults of Troglostrongylus brevior).
-Treatment of infestations with vesical worms (Capillaria plica).
-Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Do not use in sick or convalescent animals. Do not use in rabbits.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
4.4Special warnings for each target species
When applying the veterinary medicinal product, special attention should be paid in long hair breeds in order to ensure that it is applied directly to the skin and not on the hair, as this could lead to a lower bioavailability of the active substances and thus, to a reduced efficacy.
No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats is available. However, brief contact of the animal with water on one or two occasions within the month following application is unlikely to significantly reduce its efficacy. As a precaution, it is not recommended to bathe animals within 2 days after topical treatment.
After treatment with BROADLINE, ticks will generally be killed within 48 hours after infestation without having a blood meal. However, since the attachment of single ticks after treatment cannot be excluded transmission of infectious diseases cannot be completely ruled out.
Tapeworm infestation may reoccur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
In certain individual cats Notoedres cati infestation may be severe or complicated by bacterial infections. In these severe cases concomitant treatment may be necessary.
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.
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Although the veterinary medicinal 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
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.
4.5Special precautions for use
Special precautions for use in animals
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,
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 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 Collies, Old English Sheepdogs and related breeds or crossbreeds should thus be avoided.
Echinococcosis represents a hazard for humans, and is a notifiable disease to the World Organisation 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 during application.
Wash hands immediately after use or wear suitable gloves when applying the product to cat. Unused applicators must be stored in the intact blister package.
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, and children should not be allowed to play with treated animals during this period. It is therefore recommended that recently treated animals do not sleep with owners, especially children.
People with a known hypersensitivity to any of the active ingredients or excipients should avoid contact with the veterinary medicinal product.
4.6Adverse reactions (frequency and seriousness)
A temporary clumping or spiking of the hair and
mild and transient skin reactions at the application site (itching, hair loss) have been commonly observed at the application site after treatment in clinical studies.
If the cat licked the application site after treatment, common temporary excessive salivation was observed in clinical trials.
Oral ingestion of the product may result in digestive tract and/or in neurological disorders (see section 4.5).
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 4.9).
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals treated displaying adverse reaction(s))
-common (more than 1 but less than 10 animals in 100 animals treated)
-uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
-rare (more than 1 but less than 10 animals in 10,000 animals treated)
-very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7Use during pregnancy, lactation or lay
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
4.8Interaction with other medicinal products and other forms of interaction
4.9Amounts to be administered and administration route
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
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.
The recommended minimum doses are 10 mg/kg bodyweight for fipronil, 12 mg/kg for
Select the appropriate applicator size for the weight of the cat.
Volume of unit
< 2.5 kg
> 7.5 kg
appropriate combination of
Method of administration:
Use a pair of scissors to cut the blister along the dotted line, then pull the lid away.
Remove the applicator from the package and hold it upright. Pull back the plunger slightly, twist and pull off the cap. Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible. Place the tip of the applicator on the skin and apply the entire content directly onto the skin in one spot.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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
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.
4.11 Withdrawal period
Pharmacotherapeutic group: antiparasitic products, insecticides, avermectins, eprinomectin in combinations.
ATC vet code: QP54AA54.
The veterinary medicinal product is a
Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. Fipronil and its metabolite fipronil sulfone act at
Eprinomectin is a member of the macrocyclic lactone class of endectocides. Compounds of the class bind selectively and with high affinity to
Praziquantel is a synthetic
The ectoparasitic activity of fipronil and
Fipronil sulfone, as a photodegradation product of fipronil, is also found on the hair. The concentrations in the hair coat of fipronil, fipronil sulfone and
The peak plasma concentrations of the absorbed fraction of fipronil and
Eprinomectin and praziquantel act systemically, with plasma concentrations reaching a maximum within 48 hours and 6 hours after treatment, respectively, reaching mean maximum concentrations (Cmax) of 20.1 ng/ml for eprinomectin and 157 ng/ml for praziquantel.
Once absorbed, eprinomectin is highly bound to plasma proteins (> 99%), has low clearance from blood, and distributes well into tissues. Its metabolism is limited, and it is mainly excreted unchanged in the faeces. The average
In vitro metabolism assays and in vivo studies have demonstrated that there are no pharmacodynamic or pharmacokinetic interactions between fipronil,
6.1List of excipients
Disodium edetate (E385)
Propyl gallate (E310)
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
6.4Special precautions for storage
Store in the blister package in order to protect from light.
Stored applicators must be kept in the intact blister package.
Opened applicators should be disposed of immediately.
6.5Nature and composition of immediate packaging
Cardboard box containing 1, 3, 4 or 15 applicator(s) (0.3 ml each).
Cardboard box containing 1, 3, 4, 6 or 15 applicator(s) (0.9 ml each).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from it should be disposed of in accordance with local requirements.
Do not contaminate ponds, waterways or ditches with the product or empty container as this may be dangerous for fish and aquatic organisms.
7.MARKETING AUTHORISATION HOLDER
29, avenue Tony Garnier 69007 Lyon
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 04/12/2013
10.DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE