SUMMARY OF PRODUCT CHARACTERISTICS 1
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pipette (1 ml) contains: Active substance: Fipronil Excipients: Butylhydroxytoluene (E321) Butylhydroxyanisole (E320) 75 mg 3.0 mg 3.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Light yellow to intensive yellow solution. 4. CLINICAL PARTICULARS 4.1 Target species Dogs. 4.2 Indications for use, specifying the target species For the treatment of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus, Dermacentor reticulatus) infestations. The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against Rhipicephalus sanguineus and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon. 4.3 Contraindications The product should not be used on puppies less than 2 months old and/or weighing less than 2 kg. Do not use on sick (systemic disease, fever etc.) or convalescent animals. Do not use in rabbits, as adverse drug reactions and even death could occur. This veterinary medicinal product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing. Do not use on animals with hypersensitivity to active substance or any other excipients. Do not apply on damaged skin of the animal. 4.4 Special warnings for each target species Prevent the animals form licking the site of application a few hours after treatment. All cats and dogs in the household should undergo the treatment. 2
When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other dogs and cats in the household are recommended. No data on the effect of bathing/shampooing on the efficacy of the product in dogs are available. Therefore, bathing/immersion in water within 2 days of application and more frequent bathing than once a week should be avoided. There may be an attachment of some ticks but ticks will be killed in the first 24-48 hours after attachment. This will be usually prior to full engorgement and therefore minimising but not excluding the risk of transmission of diseases. Fleas can be found also in places where animals stay (carpets, rugs). Those places should be regularly vacuumed and appropriate antiparasitic products should be used. 4.5 Special precautions for use Special precautions for use in animals For external use only. It is important to make sure that the product is applied to an area where the animal cannot lick it off. Do not allow recently treated animals to lick each other. Avoid contact with the animal's eyes. Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. Animals should be weighed accurately prior to treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contents coming into contact with the skin. If this occurs, wash hands with soap and water. Wash hands after use. This product can cause mucous membrane and eye irritation. Contact of the product with mouth and eyes should be avoided. In the case of accidental eye contact, immediately and thoroughly rinse the eyes carefully with plain water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician. In case of accidental ingestion of product seek medical advice immediately. Do not smoke, drink or eat during application. People with a known hypersensitivity to fipronil or excipients (see section 6.1.) should avoid contact with the veterinary medicinal product. Avoid contact with treated animals until the application site is dry. 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. Other precautions Product may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application (See section 6.6). 3
4.6 Adverse reactions (frequency and seriousness) If the animal licks the application site, hypersalivation, vomiting, or neurological symptoms (hypersensitivity or lethargy) may occur. Hair coat discolouration, local hair loss, irritation, itching or oily appearance may occur at the application site. 4.7 Use during pregnancy and lactation Laboratory studies in animals have not produced any evidence of a teratogenic or embryotoxic effect. No studies have been carried out on pregnant or lactating dogs using this veterinary medicinal product. Therefore its use during pregnancy and lactation should only be after a relevant benefit-risk analysis made by the treating veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction No data available. 4.9 Amounts to be administered and administration route Application: Application spot-on use. One pipette (1 ml) containing 75 mg of fipronil per dog weighing 2-10 kg. Animals should be weighed prior to treatment. Method of administration: Open the pipette by tearing off the tip. Part the fur between the shoulder blades and apply the pipette content onto the animal s skin. In the absence of safety studies, the minimum treatment interval is 4 weeks. The current epidemiological situation in the area concerned should always be taken into account. Following the manufacturer s instructions and warnings will reduce to a minimum the possibility of occurrence of adverse reactions. 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. 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. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary The risk of adverse reactions (see section 4.6) may be greater in the case of overdose. Overdose may cause muscular contractions and convulsions. In a few cases, agitation, sleepiness and hypersensitivity 4
to noise and light occurred. Also, transient vertigo, excessive salivation and vomiting were observed. At the site of product application, transient reddening or irritation of the skin may occur. To reduce their intensity, symptomatic treatment may be used. 4.11 Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Other ectoparasiticides for topical use ATCvet code: QP53AX15 5.1 Pharmacodynamic properties Fipronil, the active substance of the product, blocks the flow of chlorides to invertebrate nerve cells which is regulated by GABA receptors (gamma-aminobutyric acid) - the main inhibitory neurotransmitters in central nervous system. As a result of fipronil s activity, the flow of chloride ions through the chloride channels in blocked. Blocking of the inhibition processes leads to the occurrence of uncontrolled excitation which causes death of insects and acarids. 5.2 Pharmacokinetic particulars A hydrophobic substance, Fipronil is dissolved in the lipid layer which covers the skin. Thanks to translocation in the lipid layer, Fipronil is spread evenly over the entire skin surface, penetrates into sebaceous glands from where it is gradually secreted onto the surface of epidermis. The veterinary medicinal product distributes itself within 48 hours over the entire skin of the animal. The absorption of fipronil is negligible in dogs following topical application. The concentration of fipronil on the fur decreases over time. Environmental properties Not applicable. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Butylhydroxytoluene (E321) Butylhydroxyanisole (E320) Povidone Isopropanol Diethylene glycol monoethyl ether 6.2 Incompatibilities Non applicable. 6.3 Shelf life Shelf life for the veterinary medicinal product, packed in immediate packages, is 3 years. Shelf life after first opening the immediate packaging: use immediately. 5
6.4. Special precautions for storage Store below 25 o C. Do not refrigerate. 6.5 Nature and composition of immediate packaging LDPE/HDPE pipette 1 ml with HDPE tip, wrapped up in carton box. LDPE/HDPE pipette 1 ml with HDPE tip, 3 pipettes wrapped up in carton box. LDPE/HDPE pipette 1 ml with HDPE tip, individually wrapped up in carton box, subsequently 12 cartoon boxes wrapped up in one common carton box. Available packages: 1x1ml, 3x1ml, 12x1ml. 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 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. 7. MARKETING AUTHORISATION HOLDER VET-AGRO TRADING Sp. z o.o. Mełgiewska str. 18, 20-234 Lublin, Poland. 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT 6
ANNEX III LABELLING AND PACKAGE LEAFLET 7
A. LABELLING 8
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs Fipronil 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES One pipette (1 ml) contains: Active substance: Fipronil 75 mg Excipients: Butylhydroxytoluene (E 321) 3.0 mg Butylhydroxyanisole (E 320) 3.0 mg 3. PHARMACEUTICAL FORM Spot-on solution. 4. PACKAGE SIZE 1 x 1 ml 3 x 1 ml 5. TARGET SPECIES Dogs. 6. INDICATIONS For the treatment of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus, Dermacentor reticulatus) infestations. The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against Rhipicephalus sanguineus and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon. 7. METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. Application spot-on use. One pipette containing 75 mg of fipronil per dog weighing 2-10 kg. 9
8. WITHDRAWAL PERIOD Not applicable. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE Expiry date: {month/year} Once opened, use immediately. 11. SPECIAL STORAGE CONDITIONS Store below 25 o C. Do not refrigerate. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 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. 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VET-AGRO TRADING Sp. z o.o. Mełgiewska str. 18 20-234 Lublin Poland 16. MARKETING AUTHORISATION NUMBER 10
17. MANUFACTURER S BATCH NUMBER Batch: {number} 11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs Fipronil 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES One pipette (1 ml) contains: Active substance: Fipronil 75 mg Excipients: Butylhydroxytoluene (E 321) 3.0 mg Butylhydroxyanisole (E 320) 3.0 mg 3. PHARMACEUTICAL FORM Spot-on solution. 4. PACKAGE SIZE 12 x 1 ml 5. TARGET SPECIES Dogs. 6. INDICATIONS For the treatment of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus, Dermacentor reticulatus) infestations. The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against Rhipicephalus sanguineus and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon. 7. METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. Application spot-on use. One pipette containing 75 mg of fipronil per dog weighing 2-10 kg. 12
8. WITHDRAWAL PERIOD Not applicable. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE Expiry date: {month/year} Once opened, use immediately. 11. SPECIAL STORAGE CONDITIONS Store below 25 o C. Do not refrigerate. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 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. 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VET-AGRO TRADING Sp. z o.o. Mełgiewska str. 18 20-234 Lublin Poland 16. MARKETING AUTHORISATION NUMBER 17. MANUFACTURER S BATCH NUMBER 13
Batch: {number} 14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS pipette 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs Fipronil 2. QUANTITY OF THE ACTIVE SUBSTANCE Fipronil 75 mg/pipette 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml 4. ROUTE(S) OF ADMINISTRATION Spot-on use. 5. WITHDRAWAL PERIOD Not applicable. 6. BATCH NUMBER Batch: {number} 7. EXPIRY DATE EXP: {month/year} 8. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 15
B. PACKAGE LEAFLET 16
PACKAGE LEAFLET Fiprex S 75 mg spot-on solution for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder : VET-AGRO TRADING Sp. z o.o. Mełgiewska str. 18 20-234 Lublin Poland Manufacturer for the batch release: Przedsiebiorstwo Wielobranzowe Vet-Agro Sp.z o.o. Gliniana str. 32, 20-616 Lublin Poland 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs Fipronil 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS One (1 ml) pipette contains: Active substances: Fipronil 75 mg Excipients: Butylhydroxytoluene (E321) 3.0 mg Butylhydroxyanisole (E320) 3.0 mg Light yellow to intensive yellow solution. 4. INDICATION(S) For the treatment of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus, Dermacentor reticulatus) infestations. The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against Rhipicephalus sanguineus and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary surgeon. 5. CONTRAINDICATIONS The product should not be used on dogs less than 2 months old and/or weighing less than 2 kg. Do not use on sick (systemic disease, fever etc.) or convalescent animals. 17
Do not use on rabbits, as adverse drug reactions and even death could occur. This veterinary medicinal product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing. Do not use on animals with hypersensitivity to the active substance or any other excipients. Do not apply on damaged skin of the animal. 6. ADVERSE REACTIONS If the animal licks the application site, hypersalivation, vomiting, or neurological symptoms (hypersensitivity or lethargy) may occur. Hair coat discolouration, local hair loss, irritation, itching or oily appearance may occur at the application site. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs. 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Method of application: Application spot-on use. One pipette (1 ml) containing 75 mg of fipronil per dog weighing 2-10 kg. Animals should be weighed prior to treatment. Method of administration: Open the tube by tearing off the tip. Part the fur between the shoulder blades and apply the tube content onto the animal s skin. In the absence of safety studies the minimum application interval is 4 weeks. The current epidemiological situation in the area concerned should always be taken into account. Following the manufacturer s instructions and warnings will reduce to a minimum the possibility of occurrence of adverse reactions. 9. ADVICE ON CORRECT ADMINISTRATION It is important to make sure that the product is applied to an area where the animal cannot lick it off. Animals should be weighed before treatment. 10. WITHDRAWAL PERIOD Not applicable. 11. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. Store below 25 o C. Do not refrigerate. Do not use after the expiry date stated on the piepette and carton. Shelf life after first opening the immediate packaging: use immediately. 12. SPECIAL WARNING(S) 18
Special precautions for use in animals Prevent the animals form licking the site of application a few hours after treatment. Do not allow recently treated animals to lick each other. For external use only. Avoid contact with the animal's eyes. Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. All cats and dogs in the household should undergo the treatment. Fleas can be found also in places where animals stay (carpets, rugs). Those places should be regularly vacuumed and appropriate antiparasitic products should be used. When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other cats and dogs in the household are recommended. There may be an attachment of some ticks but ticks will be killed in the first 24-48 hours after attachment. This will be usually prior to full engorgement and therefore minimising but not excluding the risk of transmission of diseases (disease transmitted by ticks). No data on the effect of bathing/shampooing on the efficacy of the product in dogs are available. Therefore, bathing/immersion in water within 2 days of application and more frequent bathing than once a week should be avoided. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contents coming into contact with the skin. If this occurs, wash hands with soap and water. Wash hands after use. This product can cause mucous membrane and eye irritation. Contact of the product with mouth and eyes should be avoided. In the case of accidental eye contact, immediately and thoroughly rinse the eyes carefully with plain water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician. In case of accidental ingestion of product seek medical advice immediately. Do not smoke, drink or eat during application. People with a known hypersensitivity to fipronil or excipients should avoid contact with the veterinary medicinal product. Avoid contact with the treated animals 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. Other precautions Product may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY 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 19
aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION Overdose The risk of adverse reactions may be greater in the case of overdose. Overdose may cause muscular contractions and convulsions. In a few cases, agitation, sleepiness and hypersensitivity to noise and light occurred. Also, transient vertigo, excessive salivation and vomiting were observed. At the site of product application, transient reddening or irritation of the skin may occur. To reduce their intensity, symptomatic treatment may be used. Use during pregnancy and lactation Laboratory studies in animals have not produced any evidence of a teratogenic or embryotoxic effect. No studies have been carried out on pregnant or lactating dogs using this veterinary medicinal product. Therefore its use during pregnancy and lactation should only be after a relevant benefit-risk analysis made by the treating veterinarian. LDPE/HDPE pipette 1 ml with HDPE tip, wrapped up in carton box. LDPE/HDPE pipette 1 ml with HDPE tip, 3 pipettes wrapped up in carton box. LDPE/HDPE pipette 1 ml with HDPE tip, individually wrapped up in carton box, subsequently 12 cartoon boxes wrapped up in one common carton box. Not all pack sizes may be marketed. Available pack sizes: 1 x 1 ml, 3 x 1 ml, 12 x 1 ml 20