Patient leaflet - Activyl
B. PACKAGE LEAFLET
PACKAGE LEAFLET Activyl 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 :
Intervet International BV
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release :
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
-
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl 100 mg spot-on solution for very small dogs
Activyl 150 mg spot-on solution for small dogs
Activyl 300 mg spot-on solution for medium dogs
Activyl 600 mg spot-on solution for large dogs
Activyl 900 mg spot-on solution for extra large dogs indoxacarb
-
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
One ml contains 195 mg indoxacarb.
One pipette of Activyl delivers:
| Volume (ml) | Indoxacarb (mg) | |
| Activyl for very small dogs (1.5 – 6.5 kg) | 0.51 | 100 |
| Activyl for small dogs (6.6 – 10 kg) | 0.77 | 150 |
| Activyl for medium dogs (10.1 – 20 kg) | 1.54 | 300 |
| Activyl for large dogs (20.1 – 40 kg) | 3.08 | 600 |
| Activyl for extra large dogs (40.1 – 60 kg) | 4.62 | 900 |
Also contains isopropyl alcohol 354 mg/ml.
A clear, colourless to yellow solution.
-
4. INDICATION(S)
Treatment and prevention of flea infestation (Ctenocephalides felis ). Efficacy against new infestations with fleas persists for 4 weeks following a single application.
Developing stages of fleas in the pet’s immediate surroundings are killed following contact with Activyl treated pets.
-
5. CONTRAINDICATIONS
None.
-
6. ADVERSE REACTIONS
In very rare cases, a brief period of hypersalivation (drooling) may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application (see section 9) will minimise licking of the application site.
In very rare cases, application site reactions such as transitory scratching, erythema (redness of skin), alopecia (loss of hair) or dermatitis (inflammation of the skin) at the application site may occur. These effects will usually resolve without treatment.
The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site. A dry white residue may be also observed. This is normal and will generally resolve within a couple of days after administration. These changes do not affect the safety or efficacy of the veterinary product.
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).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
-
7. TARGET SPECIES
Dogs.
-
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Spot-on use. For application to the dog’s skin only.
The recommended dose is 15 mg indoxacarb/kg body weight, equivalent to 0.077 ml/kg body weight. The following table defines the pipette to be used according to the weight of the dog:
| Weight of dog (kg) | Pipette size to be used |
| 1.5 – 6.5 | Activyl 100 mg for very small dogs |
| 6.6 – 10 | Activyl 150 mg for small dogs |
| 10.1 – 20 | Activyl 300 mg for medium dogs |
| 20.1 – 40 | Activyl 600 mg for large dogs |
| 40.1 – 60 | Activyl 900 mg for extra large dogs |
| > 60 | The appropriate combination of pipettes should be used |
-
9. ADVICE ON CORRECT ADMINISTRATION
Open one sachet and remove the pipette.
Step 1 : The dog should be standing for easy application. Hold the pipette in an upright position away from your face. Snap the tip open by bending it and folding it back on itself.
Step 2: Part the hair until the skin is visible. Place the pipette tip against the skin between the shoulder blades. Squeeze the pipette firmly and apply the entire contents directly to the skin.
In larger dogs, the entire contents of the pipette(s) should be applied evenly to 2–4 spots along the backline from the shoulder to the base of the tail. Do not apply an excessive amount of solution at any one spot in order to prevent run-off.
-
10. WITHDRAWAL PERIOD
Not applicable.
-
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special temperature storage conditions.
Store the pipettes in the original package in order to protect from moisture.
Do not use after the expiry date stated on the carton, foil and pipette after “EXP”. The expiry date refers to the last day of that month.
-
12. SPECIAL WARNING(S)
Special warnings for each target species:
None.
Special precautions for use in animals :
The product should not be used in dogs younger than 8 weeks of age as the safety of the product has not been established in these dogs.
The product should not be used in dogs weighing less than 1.5 kg as the safety of the product has not been established in these dogs.
Ensure that the dosage (pipette) corresponds to the weight of the treated dog (see section 8).
Apply the product only to the skin surface and on intact skin. Apply the dose to an area where the dog cannot lick it off and ensure that animals do not groom each other following treatment. Keep treated animals separately until the application site is dry.
This product is for skin application on dogs only. Do not give the product by mouth or any other route. Care should be taken to avoid the product coming into contact with the dog’s eyes.
The product remains effective following shampoo treatment, water immersion (swimming, bathing) and exposure to sunlight. However, dogs should not be allowed to swim or treated with shampoo within 48 hours after treatment.
All dogs in a household should be treated with a suitable flea product.
A proper treatment of the pet's environment by additional chemical or physical measures is recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Keep pipettes in the original packaging until ready to use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
The sachet is child-resistant. Keep the product in the sachet until use, in order to prevent children from getting direct access to the product. Used pipettes should be disposed of immediately.
People with known hypersensitivity to indoxacarb should avoid contact with this product.
Local and/or systemic reactions have been observed in some people after exposure. To avoid adverse reactions:
- administer the product in a well-ventilated area;
- do not handle recently treated animals until the application site is dry;
- on the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children;
- wash hands immediately after use and wash off any product in contact with the skin immediately with soap and water;
- avoid contact with eyes, as the product may cause moderate eye irritation. If it occurs, the eyes should be rinsed slowly and gently with water.
If symptoms occur, seek medical advice and show the package leaflet to your physician.
This product is highly flammable. Keep away from heat, sparks, open flame or other source of ignition.
Pregnancy and Fertility :
Do not use on pregnant dogs and breeding dogs.
Lactation :
Do not use on lactating dogs.
Interaction with other medicinal products and other forms of interaction:
In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
Consult a veterinarian if you intend to use the product on dogs with other products or medication.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Activyl 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.
-
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency.
-
15. OTHER INFORMATION
Cardboard box with 1, 4 or 6 sachets; each sachet contains one unit-dose pipette.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
| Belgie/Belgique/Belgien: VIRBAC BELGIUM NV, Esperantolaan 4, BE-3001 Leuven, Tél/Tel: + 32 (0) 16 38 72 60 | Lietuva: OÜ ZOOVETVARU, Uusaru 5, 76505 Saue/Harjumaa, Estija, Tel: + 372 6 709 006 |
| Penyß^uKa Efc^rapua: EproH-MunaHOBa EOOfl, P Etnrapua, rp.Co^ua, >K.K.^ro.iHH 10, 6n.145, | Luxembourg/Luxemburg: VIRBAC BELGIUM NV, Esperantolaan 4, BE-3001 Leuven, Tel/Tel: + 32 (0) 16 38 72 60 |
| Česká republika: VIRBAC, 1ere avenue 2065 m – L.I.D., FR-06516 Carros, Francie, Tel: + 33 (0) 4 92 08 73 00 | Magyarorszag: VIRBAC, 1ere avenue 2065 m – L.I.D., FR-06516 Carros, Franciaorszag, Tel: + 33 (0) 4 92 08 73 00 |
| Danmark: VIRBAC Danmark A/S, Profilvej 1, DK-6000 Kolding, Tlf: + 45 7552 1244 | Malta: VIRBAC, 1ere avenue 2065 m – L.I.D., FR-06516 Carros, Franza, Tel: + 33 (0) 4 92 08 73 00 |
| Deutschland: VIRBAC Tierarzneimittel GmbH, Rögen 20, DE-22843 Bad Oldesloe, Tel: + 49 (4531) 805 111 | Nederland: VIRBAC NEDERLAND BV, Hermesweg 15, NL-3771 ND Barneveld, Tel: + 31 (0) 342 427 127 |
| Eesti: | Norge: |
| OÜ ZOOVETVARU, Uusaru 5, EE-76505 Saue/Harjumaa, Tel: + 372 6 709 006 | VIRBAC, 1ere avenue 2065 m – L.I.D., FR-06516 Carros, Frankrike, Tlf: + 33 (0) 4 92 08 73 00 |
| EMàôa: | Österreich: |
| VIRBAC HELLAS A.E., 13o x^M-. E0vik^ç OSoú A0nvœv-Aap.iaç, EL-144 52 MsTaMÔppœon, A0^va—EAAAAA, | VIRBAC Österreich GmbH, Hildebrandgasse 27, A-1180 Wien, Tel: + 43 (0) 1 21 834 260 |
Tql: + 30 210 6219520,
| España: VIRBAC ESPAÑA S.A., Angel Guimerá 179–181, ES-8950 Esplugues de Llobregat, | Polska: VIRBAC SP. Z O.O., Ul. Pulawska 314, PL-02 819 Warszawa, Tel.: + 48 22 855 40 46 |
| France: | Portugal: |
| VIRBAC France, 13ème rue – L.I.D. – BP 27, FR-06517 Carros, | VIRBAC DE PORTUGAL, LABORATÓRIOS LDA, R.do Centro Empresarial, Ed13-Piso 1– Esc.3, Quinta da Beloura, PT-2710–693 Sintra, Tel: + 351 219 245 020 |
| Hrvatska: | Romanía: |
| VIRBAC, 1ère avenue 2065 m – L.I.D., FR-06516 Carros, Francuska, Tel: + 33 (0) 4 92 08 73 00 | VIRBAC, 1ére avenue 2065 m – L.I.D., FR-06516 Carros, Franja, Tel: + 33 (0) 4 92 08 73 00 |
| Ireland: | Slovenija: |
| VIRBAC, 1ère avenue 2065 m – L.I.D., FR-06516 Carros, France Tel: + 33 (0) 4 92 08 73 00 | VIRBAC, 1ére avenue 2065 m – L.I.D., FR-06516 Carros, Francija, Tel: + 33 (0) 4 92 08 73 00 |
| Ísland: | Slovenská republika: |
| VIRBAC, 1ère avenue 2065 m – L.I.D., FR-06516 Carros, Frakkland, Sími: + 33 (0) 4 92 08 73 00 | VIRBAC, 1ére avenue 2065 m – L.I.D., FR-06516 Carros, Francúzsko, Tel: + 33 (0) 4 92 08 73 00 |
| Italia: | Suomi/Finland: |
| VIRBAC SRL, Via Ettore Bugatti, 15, IT-20142 Milano, Tel: + 39 02 40 92 47 1 | VIRBAC, 1ere avenue 2065 m – L.I.D., FR-06516 Carros, Ranska/Frankrike, Puh/Tel: + 33 (0) 4 92 08 73 00 |
Kvnpog:
VIRBAC HELLAS A.E.,
13o x^M-. E0viK^g O5ou AOnvo'jv-Ao^iiag, EL-144 52 MsTaioppoon, A0^va-EAAAAA,
Tql: + 30 210 6219520,
Sverige:
VIRBAC,
1ere avenue 2065 m – L.I.D.,
FR-06516 Carros,
Frankrike,
Tel: + 33 (0) 4 92 08 73 00
Latvija:
OU ZOOVETVARU,
Uusaru 5,
76505 Saue/Harjumaa, Igaunija,
Tel: + 372 6 709 006
United Kingdom:
VIRBAC Ltd,
Suffolk IP30 9 UP – UK, Tel: + 44 (0) 1359 243243
PACKAGE LEAFLET Activyl spot-on solution for cats
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Intervet International BV
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release :
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
-
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Activyl 100 mg spot-on solution for small cats
Activyl 200 mg spot-on solution for large cats indoxacarb
-
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
One ml contains 195 mg indoxacarb.
One pipette of Activyl delivers:
| Volume (ml) | Indoxacarb (mg) | |
| Activyl for small cats (< 4 kg) | 0.51 | 100 |
| Activyl for large cats (> 4 kg) | 1.03 | 200 |
Also contains isopropyl alcohol 354 mg/ml.
A clear, colourless to yellow solution.
-
4. INDICATION(S)
Treatment and prevention of flea infestation (Ctenocephalides felis ). Efficacy against new infestations with fleas persists for 4 weeks following a single application.
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Developing stages of fleas in the pet’s immediate surroundings are killed following contact with Activyl treated pets.
-
5. CONTRAINDICATIONS
None.
-
6. ADVERSE REACTIONS
In rare cases, neurological signs, such as incoordination, tremor (shakiness), ataxia (unsteady movement), convulsions, mydriasis (pupil dilation) and impaired vision, have been observed. Other signs observed include emesis (vomiting) in rare cases or anorexia (loss of appetite), lethargy (drowsiness), hyperactivity and vocalisation in very rare cases. All signs are generally reversible following supportive treatment.
In very rare cases, a brief period of hypersalivation (drooling) may occur if the cat licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application (see section 9) will minimise licking of the application site.
In rare cases, application site reactions such as transitory scratching, erythema (redness of skin), alopecia (loss of hair) or dermatitis (inflammation of the skin) at the application site may occur. These effects will usually resolve without treatment.
The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site. A dry white residue may be also observed. This is normal and will generally resolve within a couple of days after administration. These changes do not affect the safety or efficacy of the veterinary product.
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).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
-
7. TARGET SPECIES
Cats.
-
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Spot-on use. For application to the cat’s skin only.
The recommended dose is 25 mg indoxacarb/kg body weight, equivalent to 0.128 ml/kg body weight. The following table defines the pipette to be used according to the weight of the cat:
| Weight of cat (kg) | Pipette size to be used |
| < 4 | Activyl 100 mg for small cats |
| > 4 | Activyl 200 mg for large cats |
-
9. ADVICE ON CORRECT ADMINISTRATION
Open one sachet and remove the pipette.
Step 1 : The cat should be standing for easy application. Hold the pipette in an upright position away from your face.Snap the tip open by bending it and folding it back on itself.
Step 2: Part the hair until the skin is visible. Place the pipette tip against the skin at the base of the skull, where the cat cannot lick it off. Squeeze the pipette firmly and apply the entire contents directly to the skin.
10. WITHDRAWAL PERIOD
Not applicable.
-
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special temperature storage conditions. Store the pipettes in the original package in order to protect from moisture.
Do not use after the expiry date stated on the carton, foil and pipette after “EXP”. The expiry date refers to the last day of that month.
-
12. SPECIAL WARNING(S)
Special warnings for each target species:
The safety of the product has not been established in cats younger than 8 weeks of age.
The safety of the product has not been established in cats weighing less than 0.6 kg.
Special precautions for use in animals :
Ensure that the dosage (pipette) corresponds to the weight of the treated cat (see section 8).
Apply the product only to the skin surface and on intact skin. Apply the dose to an area where the cat cannot lick it off and ensure that animals do not groom each other following treatment. Keep treated animals separately until the application site is dry.
This product is for skin application on cats only. Do not give the product by mouth or any other route. Care should be taken to avoid the product coming into contact with the cat’s eyes.
The product remains effective following shampoo treatment, water immersion (swimming, bathing) and exposure to sunlight. However, cats should not be allowed to swim or treated with shampoo within 48 hours after treatment.
All cats in a household should be treated with a suitable flea product.
A proper treatment of the pet's environment by additional chemical or physical measures is recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Keep pipettes in the original packaging until ready to use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
The sachet is child-resistant. Keep the product in the sachet until use, to prevent children from getting direct access to the product. Used pipettes should be disposed of immediately.
People with known hypersensitivity to indoxacarb should avoid contact with this product.
Local and/or systemic reactions have been observed in some people after exposure. To avoid adverse reactions:
- administer the product in a well-ventilated area;
- do not handle recently treated animals until the application site is dry;
- on the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children;
- wash hands immediately after use and wash off any product in contact with the skin immediately with soap and water;
- avoid contact with eyes, as the product may cause moderate eye irritation. If it occurs, the eyes should be rinsed slowly and gently with water.
If symptoms occur, seek medical advice and show the package leaflet to your physician.
This product is highly flammable. Keep away from heat, sparks, open flame or other source of ignition.
Pregnancy and Fertility :
Do not use on pregnant cats and breeding cats.
Lactation :
Do not use on lactating cats.
Interaction with other medicinal products and other forms of interaction:
Consult a veterinarian if you intend to use the product on cats with other products or medication.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Activyl 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.
-
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency.
-
15. OTHER INFORMATION