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Date: Tuesday, May 28, 2024 22:31

Release 5.68
FRONTLINE SPOT ON DOG 10% w/v Spot On Solution
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Fipronil
Product:Frontline Spot On Dog
Product index: Frontline Spot On Dog
Incorporating:
Qualitative and quantitative composition
Fipronil 10% w/v
Butylhydroxyanisole (E320) 0.02% w/v
Butylhydroxytoluene (E321) 0.01% w/v
Non-aqueous vehicle qs to 100%
For the full list of excipients, see "Pharmaceutical particulars" section.
Pharmaceutical form
Spot-on solution.
Clinical particulars
Target species
Dogs.
Indications for use
The treatment and prevention of infestations by fleas and ticks. The product controls infestations with Trichodectes canis biting lice on dogs
Contra-indications
Do not use on puppies less than 8 weeks old (and /or weighing less than 2kg) Do not use on animals that are unwell, are undergoing treatment for, or are recovering from illness.
Do not use in animals with known hypersensitivity to the active substance or to any of the other ingredients.
Do not use in rabbits, as adverse reactions and even death could occur.
This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.
Special warnings for each target species
When treating infestations of lice, all in-contact dogs should be treated with an appropriate product at the same time.
There may be an attachment of single ticks. For this reason transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.
FRONTLINE SPOT ON DOG does not prevent ticks from attaching to the animals, but ticks will be killed in the first 24-48 hours after attachment, before they are fully fed and therefore minimising the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may easily be removed by a gentle pull.
Bathing or shampooing the animal up to one hour prior to treatment does not affect the effectiveness of the product.
Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product.
Skin softening shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.
Special precautions for use
(i) Special precautions for use in animals
For external use only.
Animals should be weighed accurately prior to treatment.
It is important to make sure that the product is applied to an area where the animal cannot lick it off, and to make sure that animals do not lick each other following treatment.
Avoid contact with the animal’s eyes.
Do not overdose.
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to the animals
Keep stored pipettes in the original packaging until ready to use. In order to prevent children from getting access to used pipettes, dispose of used pipettes immediately.
This product can cause mucous membrane and eye irritation. Therefore, contact of the product with mouth and eyes should be avoided.
People with a known hypersensitivity to insecticides or alcohol should avoid contact with FRONTLINE SPOT ON DOG. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water.
After accidental ocular exposure the eye should be rinsed carefully with plain water.
Wash hands after use. Do not smoke, drink or eat during application.
Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.
(iii) Other precautions
The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.
Dogs should not be allowed to swim in watercourses for 2 days after application - see Disposal Section within "Pharmaceutical particulars".
Adverse reactions
If licking occurs, a brief period of excessive salivation/drooling may be observed due mainly to the solvents in the product.
Among the extremely rare suspected adverse reactions, short-lived skin reactions at the application site (skin discoloration, local hair loss, itchiness, reddening) and general itchiness or hair loss, have been reported after use. Exceptionally, excessive drooling, reversible nervous signs including hyperaesthesia (increased sensitivity to light and sound or overexcited or unusual behavior), depression, vomiting or respiratory signs have been observed after use.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies using fipronil have not revealed any evidence of toxicity to the embryo or developmental abnormalities in the young.
The safety of the product was demonstrated in breeding, pregnant and lactating bitches treated with multiple consecutive doses at up to 3 times the maximum recommended dose. The product can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Route of administration - By topical application to the skin according to bodyweight, as follows:
*1 pipette of 0.67 ml per dog weighing 2kg and up to 10kg bodyweight
*1 pipette of 1.34 ml per dog weighing over 10kg and up to 20kg bodyweight
*1 pipette of 2.68 ml per dog weighing over 20kg and up to 40kg bodyweight
*1 pipette of 4.02 ml per dog weighing over 40kg and up to 60 kg Bodyweight
For dogs over 60kg use two pipettes of 2.68ml
Method of administration - Hold upright. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Break back the snap-off top from the spot-on pipette along the scored line. Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette against the skin and squeeze gently at one or two spots to empty its contents directly onto the skin, preferably at two spots, one at the base of the skull and a second 2-3cms further back.
Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.
In the absence of safety studies, the minimum treatment interval is 4 weeks
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed in target animal safety studies in 8 week-old puppies, growing dogs and dogs weighing about 2 kg treated once at five times the recommended dose. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to bodyweight.
Withdrawal periods
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Other ectoparasiticides for topical use.
ATCvet code: QP53AX15
Pharmacodynamic properties
Fipronil is an insecticide/acaricide in the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thereby blocking pre- and post-synaptic transfer of chloride ions across the membrane. This results in uncontrolled activity of the central nervous system and death in insects and acarids.
Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalides spp), ticks (Rhipicephalus spp, Dermacentor spp, Ixodes spp including Ixodes ricinus, important as the vector of Lyme disease) and lice (Trichodectes canis) in the dog.
FRONTLINE SPOT ON DOG is effective against flea infestation for approximately 2 months and against tick infestations for up to 1 month, depending on the level of challenge. Newly arriving fleas are killed within 24 hours of landing on the animal.
Pharmaceutical particulars
List of excipients
Polyvidone K17
Polysorbate 80
Ethanol
Ethyl digol.
Major incompatibilities
No known incompatibility.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Store in the original package.
Store in a dry place.
Store below 25 °C.
Flammable.
Nature and composition of immediate packaging
A blue pipette composed of a heat-formed shell (polyacrylonitrile-methyl acrylate copolymer in contact with the solution / polypropylene) and a film (polyacrylonitrile-methyl acrylate copolymer in contact with the solution / aluminium / polyethylene terephthalate).
Or
A blue pipette composed of a heat-formed shell (polyethylene in contact with the solution / ethylene vinyl alcohol / polyethylene / polypropylene / cyclic-olefin-copolymer / polypropylene) and a film (polyethylene in contact with the solution / ethylene vinyl alcohol / polyethylene / aluminium / polyethylene terephthalate).
Frontline Spot On Dog is available in the following presentations:
- Blister card containing 1 pipette of 0.67ml of the solution.
- Foil blister strips containing 1 pipette of 0.67ml of the solution and two empty blister spaces. The foil blister strips are packed into cartons containing 1 pipette.
- Foil blister strips containing 3 pipettes of 0.67ml of the solution. The foil blister strips are packed into cartons containing 3 or 6 pipettes.
- Blister card containing 1 pipette of 1.34ml of the solution.
- Foil blister strips containing 1 pipette of 1.34ml of the solution and two empty blister spaces. The foil blister strips are packed into cartons containing 1 pipette.
- Foil blister strips containing 3 pipettes of 1.34ml of the solution. The foil blister strips are packed into cartons containing 3 or 6 pipettes.
- Blister card containing 1 pipette of 2.68ml of the solution.
- Foil blister strips containing 1 pipette of 2.68ml of the solution and two empty blister spaces. The foil blister strips are packed into cartons containing 1 pipette.
- Foil blister strips containing 3 pipettes of 2.68ml of the solution. The foil blister strips are packed into cartons containing 3 or 6 pipettes.
- Blister card containing 1 pipette of 4.02ml of the solution.
- Foil blister strips containing 1 pipette of 4.02ml of the solution and two empty blister spaces. The foil blister strips are packed into cartons containing 1 pipette.
- Foil blister strips containing 3 pipettes of 4.02ml of the solution. The foil blister strips are packed into cartons containing 3 or 6 pipettes.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container
Marketing Authorisation Number
Vm 08327/4132
Significant changes
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:Frontline Spot-On Dog 0.67 ml x 1
GTIN:3661103045212
GTIN description:Frontline Spot-On Dog 0.67 ml x 3
GTIN:3661103003441
GTIN description:Frontline Spot-On Dog 0.67 ml x 6
GTIN:3661103003755
GTIN description:Frontline Spot-On Dog 1.34 ml x 1
GTIN:3661103045229
GTIN description:Frontline Spot-On Dog 1.34 ml x 3
GTIN:3661103003434
GTIN description:Frontline Spot-On Dog 1.34 ml x 6
GTIN:3661103003748
GTIN description:Frontline Spot-On Dog 2.68 ml x 1
GTIN:3661103045236
GTIN description:Frontline Spot-On Dog 2.68 ml x 3
GTIN:3661103003427
GTIN description:Frontline Spot-On Dog 2.68 ml x 6
GTIN:3661103003731
GTIN description:Frontline Spot-On Dog 4.02 ml x 1
GTIN:3661103045243
GTIN description:Frontline Spot-On Dog 4.02 ml x 3
GTIN:3661103004615
GTIN description:Frontline Spot-On Dog 4.02 ml x 6
GTIN:3661103004608