Certifect
fipronil / amitraz / (S)-methoprene
21
authorised
no
Medicinal
product no longer authorised
(Box of 3 pipettes)
Marketing authorisation holder: MERIAL
29, avenue Tony Garnier FR-69007 Lyon
France.
Manufacturer responsible for the batch release: MERIAL
4, Chemin du Calquet
FR-31000 Toulouse Cedex France
CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg
CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg
CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
Spot-on solution.
Clear amber to yellowish solution.
Each unit dose (dual cavity pipette) delivers:
CERTIFECT spot-on solution | Volume of unit dose (ml) | Fipronil (mg) | (S)-methoprene (mg) | Amitraz (mg) |
dogs 2-10 kg | 1.07 | 67.0 | 60.3 | 80.0 |
dogs 10-20 kg | 2.14 | 134.0 | 120.6 | 160.0 |
dogs 20-40 kg | 4.28 | 268.0 | 241.2 | 320.0 |
dogs 40-60 kg | 6.42 | 402.0 | 361.8 | 480.0 |
edic
inal
Excipients essential for proper administration: butylhydroxyanisole (0.02 %) and butylhydroxytoluene
M
(0.01 %).
Medicinal product no longer authorised
Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis).
Treatment of infestations by chewing lice (Trichodectes canis).
Prevention of environmental flea contamination by inhibiting the development of all flea immature stages.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for 5 weeks by ticks and for up to 5 weeks by fleas.
The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for 4 weeks.
Do not use on sick (e.g. systemic diseases, diabetes, fever) or convalescent animals. Do not use in rabbits and cats.
Transient skin reactions at the application site (skin discolouration, local hair loss, itching, redness) and general itching or hair loss may occur on rare occasions. Lethargy, ataxia, emesis, anorexia, diarrhoea, excessive salivation, hyperglycaemia, increased sensitivity to stimulation, bradycardia or bradypnea may be observed. Signs are transitory and generally resolve without treatment within 24 hours.
In very rare instances, certain sensitive dogs may develop skin irritation at the application site. Other forms of dermatitis including pemphigus-like conditions may occur in even rarer instances. Should this occur, contact your veterinarian promptly for treatment advice and discontinue use of the product.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reactions 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).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs
Medicinal product no longer authorised
The recommended minimum dose is 6.7 mg/kg bodyweight (b.w.) for fipronil, 6 mg/kg for (S)-methoprene and 8 mg/kg for amitraz.
Spot-on use
Monthly intervals throughout the tick and/or flea seasons, based on local epidemiological situations.
Separate one blister from the others by tearing along perforation.
Use a pair of scissors to cut the blister along the dotted line (or fold on the corner as shown and pull the foil away).
Remove the pipette and hold it upright. Cut off the pipette tip with a pair of scissors.
Part the coat until the skin is visible. Place the tip of the pipette on the skin. Squeeze pipette, apply about half of the contents half way down the neck between the base of the skull and the shoulder blades. Repeat the application at the base of the neck in front of the shoulder blades to empty pipette.
Apply onto dry skin where the animal cannot lick it off and make sure that animals do not lick each other following treatment.
CERTIFECT treatment causes detachment of ticks when applied to a dog with a pre-existing infestation, disrupts attachment and rapidly kills ticks within 24 hours thus inhibiting the blood meal and the concomitant risk of transmission of tick-borne pathogens. The risk of developing canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis for 4 weeks is thereby indirectly reduced.
Remains effective after exposure to sunlight or if the animal becomes wet after rain, bathing, or water immersion. However, shampooing or immersion of the animal in water directly after treatment or frequent shampooing may reduce the duration of activity. Treated animals should not be bathed until 48 hours after treatment. If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.
All stages of fleas can infest the dog'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.
After treatment with CERTIFECT, ticks will generally be killed and fall off the dog within 24 hours after infestation without having a blood meal. However the attachment of single ticks after treatment cannot be excluded. For this reason the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Not applicable
Keep out of the sight and reach of children. Store in the original package.
Medicinal product no longer authorised
Do not use after the expiry date stated on the outer package after EXP.
Special precautions for use in animals: Avoid contact with the dog's eyes.
For spot-on application only. Do not administer orally or via any other route. The treated area may appear wet or oily after treatment.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2weeks, do not treat puppies less than 8 weeks of age and dogs less than 2 kg bodyweight.
Dogs should be prevented from accessing streams and rivers for 48-hours following treatment.
Known side-effects of amitraz and its metabolites are due to alpha-2-adreno-receptor agonist effects. They may consist of hypersalivation, vomiting, lethargy, hyperglycaemia, bradycardia or bradypnea. Signs are transitory and generally resolve without treatment within 24 hours.
If symptoms are severe or persist alternatively use antidote (atipamezole hydrochloride).
The risk of experiencing adverse reactions may increase with overdosing, so animals should always be treated with the correct pipette size adapted to the body weight.
This veterinary medicinal product contains amitraz, which is a monoamine oxidase inhibitor (MAOI); therefore, in the absence of studies, this veterinary medicinal product should not be used on dogs treated with MAOI.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product may cause skin sensitisation, allergic reactions and mild eye irritation in humans. Animals or persons with a known hypersensitivity to any of the active ingredients or excipients should avoid contact which, on very rare occasions, can cause respiratory irritation and dermal reactions in certain individuals. The use of protective gloves is recommended. Avoid direct contact with the application site. Children should not be allowed to play with treated dogs until the application site is dry. It is therefore recommended that dogs are not treated during the day, but during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
This veterinary medicinal product contains amitraz, which can lead to neurological side-effects in humans.
Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOI-containing medication should take particular care and avoid direct contact with the product.
To minimise the potential for inhalation, apply in the open air or in a well ventilated area. Do not smoke, drink or eat whilst handling.
Wash hands thoroughly after use.
Used pipettes should be disposed of immediately. Stored pipettes must be kept in the intact foil package.
In case of accidental spillage onto skin, wash off immediately with soap and water. If its accidentally gets into the eyes, they should be thoroughly flushed with water.
In case of incorrect use, seek medical advice immediately and show the package leaflet or the label to the physician.
If side effects are noted, seek immediate medical assistance and show the package leaflet or label to the physician.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Medicinal product no longer authorised
Overdose:
Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.Safety has been also demonstrated with up to 5 times the recommended dose in healthy adult dogs (treated up to 6 times at two-week intervals) and in puppies (aged 8 weeks treated once).
Medicines should not be disposed of via wastewater or household waste.
Any unused veterinary medicinal product or waste materials derived from it should be disposed of in accordance with local requirements and should not enter water courses as this may be dangerous for fish and aquatic organisms.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency
Each strength of the veterinary medicinal product is available in cards with 1 pipette and in carton boxes of 3 pipettes.
Not all pack sizes may be marketed. For animal treatment only.
To be supplied only on veterinary prescription.
product no longer authorised
(Card of 1 pipette)
Marketing authorisation holder MERIAL
29, avenue Tony Garnier FR-69007 Lyon
France.
Manufacturer responsible for the batch release: MERIAL
4, Chemin du Calquet
FR-31000 Toulouse Cedex France
CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg
CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg
CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
Spot-on solution.
Clear amber to yellowish solution.
Each unit dose (dual cavity pipette) delivers:
CERTIFECT spot-on solution | Volume of unit dose (ml) | Fipronil (mg) | (S)-methoprene (mg) | Amitraz (mg) |
dogs 2-10 kg | 1.07 | 67.0 | 60.3 | 80.0 |
dogs 10-20 kg | 2.14 | 134.0 | 120.6 | 160.0 |
dogs 20-40 kg | 4.28 | 268.0 | 241.2 | 320.0 |
dogs 40-60 kg | 6.42 | 402.0 | 361.8 | 480.0 |
edic
inal
Excipients essential for proper administration: butylhydroxyanisole (0.02 %) and butylhydroxytoluene
M
(0.01 %).
Medicinal product no longer authorised
Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis).
Treatment of infestations by chewing lice (Trichodectes canis).
Prevention of environmental flea contamination by inhibiting the development of all flea immature stages.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for 5 weeks by ticks and for up to 5 weeks by fleas.
The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for 4 weeks.
Do not use on sick (e.g. systemic diseases, diabetes, fever) or convalescent animals. Do not use in rabbits and cats.
Transient skin reactions at the application site (skin discolouration, local hair loss, itching, redness) and general itching or hair loss may occur on rare occasions. Lethargy, ataxia, emesis, anorexia, diarrhoea, excessive salivation, hyperglycaemia, increased sensitivity to stimulation, bradycardia or bradypnea may be observed. Signs are transitory and generally resolve without treatment within 24 hours.
In very rare instances, certain sensitive dogs may develop skin irritation at the application site. Other forms of dermatitis including pemphigus-like conditions may occur in even rarer instances. Should this occur, contact your veterinarian promptly for treatment advice and discontinue use of the product.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reactions 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).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs
Medicinal product no longer authorised
The recommended minimum dose is 6.7 mg/kg bodyweight (b.w.) for fipronil, 6 mg/kg for (S)-methoprene and 8 mg/kg for amitraz.
Spot-on use
Monthly intervals throughout the tick and/or flea seasons, based on local epidemiological situations.
Use a pair of scissors to cut the blister along the dotted line (or fold the blister on the corner as shown, and pull the foil away).
Remove the pipette and hold it upright. Cut off the pipette tip with a pair of scissors.
Part the coat until the skin is visible. Place the tip of the pipette on the skin. Squeeze pipette, apply about half of the contents half way down the neck between the base of the skull and the shoulder blades. Repeat the application at the base of the neck in front of the shoulder blades to empty pipette.
Apply onto dry skin where the animal cannot lick it off and make sure that animals do not lick each other following treatment.
CERTIFECT treatment causes detachment of ticks when applied to a dog with a pre-existing infestation, disrupts attachment and rapidly kills ticks within 24 hours thus inhibiting the blood meal and the concomitant risk of transmission of tick-borne pathogens. The risk of developing canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis for 4 weeks is thereby indirectly reduced.
Remains effective after exposure to sunlight or if the animal becomes wet after rain, bathing, or water immersion. However, shampooing or immersion of the animal in water directly after treatment or frequent shampooing may reduce the duration of activity. Treated animals should not be bathed until 48 hours after treatment. If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.
All stages of fleas can infest the dog’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.
After treatment with CERTIFECT, ticks will generally be killed and fall off the dog within 24 hours after infestation without having a blood meal. However the attachment of single ticks after treatment cannot be excluded. For this reason the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Not applicable
Keep out of the sight and reach of children. Store in the original package.
Do not use after the expiry date stated on the outer package after EXP.
Medicinal product no longer authorised
Special precautions for use in animals: Avoid contact with the dog's eyes.
For spot-on application only. Do not administer orally or via any other route. The treated area may appear wet or oily after treatment.
In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2 weeks, do not treat puppies less than 8 weeks of age, and dogs less than 2 kg bodyweight.
Dogs should be prevented from accessing streams and rivers for 48-hours following treatment. Known side-effects of amitraz and its metabolites are due to alpha-2-adreno-receptor agonist effects.
They may consist of hypersalivation, vomiting, lethargy, hyperglycaemia, bradycardia or bradypnea.
Signs are transitory and generally resolve without treatment within 24 hours.
If symptoms are severe or persist alternatively use antidote (atipamezole hydrochloride).
The risk of experiencing adverse reactions may increase with overdosing, so animals should always be treated with the correct pipette size adapted to the body weight.
This veterinary medicinal product contains amitraz, which is a monoamine oxidase inhibitor (MAOI); therefore, in the absence of studies, this veterinary medicinal product should not be used on dogs treated with MAOI.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product may cause skin sensitisation, allergic reactions and mild eye irritation in humans. Animals or persons with a known hypersensitivity to any of the active ingredients or excipients should avoid contact which, on very rare occasions, can cause respiratory irritation and dermal reactions in certain individuals. The use of protective gloves is recommended. Avoid direct contact with the application site. Children should not be allowed to play with treated dogs until the application site is dry. It is therefore recommended that dogs are not treated during the day, but during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
This veterinary medicinal product contains amitraz, which can lead to neurological side-effects in humans. Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOI- containing medication should take particular care and avoid direct contact with the product..
To minimise the potential for inhalation, apply in the open air or in a well ventilated area. Do not smoke, drink or eat whilst handling.
Wash hands thoroughly after use.
Used pipettes should be disposed of immediately. Stored pipettes must be kept in the intact foil package.
In case of accidental spillage onto skin, wash off immediately with soap and water. If it accidentally gets into the eyes, they should be thoroughly flushed with water.
In case of incorrect use, seek medical advice immediately and show the package leaflet or the label to the physician.
If side effects are noted, seek immediate medical assistance and show the package leaflet or label to the physician.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Medicinal product no longer authorised
Overdose:
Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.
Safety has been also demonstrated with up to 5 times the recommended dose in healthy adult dogs (treated up to 6 times at two-week intervals) and in puppies (aged 8 weeks treated once).
Medicines should not be disposed of via wastewater or household waste.
Any unused veterinary medicinal product or waste materials derived from it should be disposed of in accordance with local requirements and should not enter water courses as this may be dangerous for fish and aquatic organisms.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency
Each strength of the veterinary medicinal product is available in cards with 1 pipette and in carton boxes of 3 pipettes.
Not all pack sizes may be marketed. For animal treatment only.
To be supplied only on veterinary prescription.
no
authorised
ANNEX IV
Medicinal
GROUNDS FOR ONE ADDITIONAL RENEWAL
Medicinal
no
authorised
The CVMP at their meeting on 18 February 2016 decided that one additional five-year renewal was required in view of the outstanding pharmacovigilance data that were undergoing evaluation at the time of the renewal procedure and to ensure that the MAH's pharmacovigilance system is adequate to enable collection and evaluation of adverse events in line with the requirements.