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Activyl

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Summary for the public


What is Activyl?

Activyl is a medicine that contains the active substance indoxacarb. It is available as a clear, colourless to yellow solution presented as a ‘spot-on’ in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (5 sizes of pipettes for different dog weights and 2 sizes of pipettes for different cat weights).


What is Activyl used for?

Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea allergy dermatitis (an allergic reaction to flea bites). Activyl is given as a single treatment.

The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat’s neck at the base of its head, or between the shoulder blades and along the back of dogs.


How does Activyl work?

The active substance in Activyl, indoxacarb, is an ectoparasiticide. This means that it will kill parasites that live on the skin or in the fur of animals, such as fleas. After application, indoxacarb is eaten by the insects and activated in their gut into an active compound. This active compound interferes with the parasites’ nervous system and causes paralysis and death.


How has Activyl been studied?

Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment.
The effectiveness against the specified parasites was investigated in both laboratory studies and in five field studies (four for the spot-on for cats or dogs only and one for both cats and dogs). In the main field study, dogs and cats of various breeds, age groups, gender and different weights were treated either with Activyl or fipronil, another spot-on medicine which is authorised in the European Union for this indication. The effectiveness was measured by counting of fleas, flea allergy dermatitis assessment, observations on local reactions at the application site after treatment.


What benefit has Activyl shown during the studies?

The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Activyl is as effective as the comparator medicine. A reduction in symptoms of flea allergy dermatitis was recorded in both target species. Efficacy against flea infestations of more than 95% was achieved in dogs by 14 days post treatment and in cats by 42 days post treatment in the study. The studies also showed that Activyl helps with the management of allergic flea dermatitis.


What is the risk associated with Activyl?

Dogs and cats might salivate after treatment. This is thought to be the result of licking the application site straight after treatment. There might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the skin. These signs disappear without further treatment.

Activyl should not be allowed to enter surface water, as it may be harmful for aquatic organisms.

For a full list of all side-effects reported with Activyl, see the package leaflet.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Pet owners should avoid skin contact with the pipette contents. They should not smoke, eat or drink, and should wash their hands thoroughly after use. If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water. The product should be kept away from heat, sparks, open flames or other sources of ignition.

Animals should not be stroked, groomed or allow to groom each other, until the application site is dry, and they should not be allowed to swim or treated with shampoo within 48 hours after treatment. Care should be taken to ensure that the content of the pipette should not come into contact with the eyes of the recipient or other animals.


Why has Activyl been approved?

The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of
flea infestations in dogs and cats. Furthermore, the CVMP concluded that the product is effective as
part of a treatment strategy for flea allergy dermatitis and recommended that Activyl be given a
marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of
this EPAR.


Other information about Activyl:

The European Commission granted a marketing authorisation valid throughout the European Union, for
Activyl to Intervet International BV on 18/02/2011. Information on the prescription status of this
product may be found on the label/outer package.

Authorisation details
Name: Activyl
EMEA Product number: EMEA/V/C/000163
Active substance: Indoxacarb
INN or common name: Indoxacarb
Species: DogsCats
ATCvet Code: QP53AX27
Marketing Authorisation Holder: Intervet International BV
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 18/02/2011
Contact address:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE 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
    Activyl 100 mg spot-on solution for small cats
    Activyl 200 mg spot-on solution for large cats
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance:
    Each ml contains 195 mg indoxacarb.
    Each unit dose pipette delivers:
    Unit dose (ml)
    Indoxacarb (mg)
    Activyl spot-on solution for very small dogs
    0.51
    99.45
    Activyl spot-on solution for small dogs
    0.77
    150.15
    Activyl spot-on solution for medium dogs
    1.54
    300.30
    Activyl spot-on solution for large dogs
    3.08
    600.60
    Activyl spot-on solution for extra large dogs
    4.62
    900.90
    Activyl spot-on solution for small cats
    0.51
    99.45
    Activyl spot-on solution for large cats
    1.03
    200.85
    Excipients:
    Isopropyl alcohol 354 mg/ml
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Spot-on solution
    A clear, colourless to yellow solution.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs and cats
    4.2 Indications for use, specifying the target species
    For dogs and cats:
    Treatment and prevention of flea infestation ( Ctenocephalides felis )
    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.
    2
     
    4.3 Contraindications
    None
    4.4 Special warnings for each target species
    The safety of Activyl has not been established in dogs and cats younger than 8 weeks of age.
    The safety of Activyl has not been established in dogs weighing less than 1.5 kg and in cats weighing
    less than 0.6 kg.
    4.5 Special precautions for use
    Special precautions for use in animals
    Care should be taken to apply the dose to an area where the animal cannot lick it off, as described
    under section 4.9., and to ensure that animals do not groom each other immediately following
    treatment.
    Care should be taken to ensure that the content of the pipette or the applied dose does not come into
    contact with the eyes of the recipient and/or other animals.
    The product remains effective following shampoo treatment, water immersion (swimming, bathing)
    and exposure to sunlight.
    However, animals should not be allowed to swim or treated with shampoo within 48 hours after
    treatment.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    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. Keep the used pipette out of reach and sight of children.
    Wash hands immediately after use.
    This product contains indoxacarb. People with known hypersensitivity to indoxacarb should not use
    this product.
    As the veterinary medicinal product may cause moderate eye irritation, avoid contact with eyes. If this
    occurs, rinse slowly and gently with water.
    This product is highly flammable. Keep away from heat, sparks, open flame or other sources of
    ignition.
    4.6 Adverse reactions (frequency and seriousness)
    A brief period of hypersalivation may occasionally 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 4.9.) will minimise licking of the application site.
    Transitory scratching or hair loss 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.
    4.7 Use during pregnancy, lactation or lay
    Do not use in pregnant or lactating animals or in animals intended for breeding.
    3
    4.8 Interaction with other medicinal products and other forms of interaction
    None known
    4.9 Amounts to be administered and administration route
    Dosage schedule :
    Dogs : The recommended dose is 15 mg indoxacarb/kg bodyweight, equivalent to 0.077 ml/kg
    bodyweight. The following table defines the size of pipette to be used according to the weight of the
    dog:
    Weight of Dog
    (kg)
    Pipette size to be used
    Volume
    (ml)
    Indoxacarb
    (mg/kg)
    < 6.5
    Activyl Spot-on solution for very small dogs
    0.51
    Minimum of 15
    6.6 - 10
    Activyl Spot-on solution for small dogs
    0.77
    15-23
    10.1 - 20
    Activyl Spot-on solution for medium dogs
    1.54
    15-30
    20.1 - 40
    Activyl Spot-on solution for large dogs
    3.08
    15-30
    40.1 - 60
    Activyl Spot-on solution for extra large dogs
    4.62
    15-23
    > 60 kg
    The appropriate combination of pipettes should be used
    Cats : The recommended dose is 25 mg indoxacarb/kg bodyweight, equivalent to 0.128 ml/kg
    bodyweight. The following table defines the size of pipette to be used according to the weight of the
    cat:
    Weight of Cat
    (kg)
    Pipette size to be used
    Volume
    (ml)
    Indoxacarb
    (mg/kg)
     4
    Activyl Spot-on solution for small cats
    0.51
    Minimum of 25
    > 4
    Activyl Spot-on solution for large cats
    1.03
    Maximum of 50
    Method of administration :
    For spot-on use only.
    Open one sachet and remove the pipette.
    Step 1 : The animal should be standing for easy
    application. With one hand, hold pipette in an upright
    position away from your face and with the other hand,
    snap tip open by bending it and folding it back on itself.
    Step 2: Part the hair until the skin is visible and place pipette tip against the
    skin between the shoulder blades for dogs, or at the base of the skull for cats.
    Squeeze pipette firmly applying the entire contents directly to the skin.
    In larger dogs, the entire contents of the pipette(s) should be applied evenly to two or three or four
    spots, all located at different application sites along the backline from the shoulder to the base of the
    4
     
    tail. Do not apply an excessive amount of solution at any one spot which could cause some of the
    solution to run off the side of the animal.
    Treatment schedule :
    Following a single administration, the veterinary medicinal product will prevent further flea
    infestation for at least 4 weeks.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No adverse effects were observed in dogs and cats aged 8 weeks or older administered 5 times the
    recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose
    on 6 occasions at 2 weeks intervals.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Ectoparasiticides for topical use, ATCvet code: QP53AX27
    5.1 Pharmacodynamic properties
    Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family. After being converted
    into a metabolite, indoxacarb is active against adult, larval and egg stages of insects. In fleas, in
    addition to its adulticidal activity, indoxacarb activity on the developing larval stages in the immediate
    surroundings of the treated pet has been demonstrated.
    Indoxacarb is a pro-drug that requires bioactivation by the insect enzymes to exert its
    pharmacodynamic effects. It enters the insect primarily through ingestion but is also absorbed, to a
    lesser degree, through the insect cuticle. In the mid-gut of susceptible insect species, the insect’s
    enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically
    active form. The bioactivated metabolite acts as a voltage-dependent sodium channel antagonist in
    insects, by blocking the sodium channels that regulate the flow of sodium ions in the insect’s nervous
    system. This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by
    cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours
    5
    5.2 Pharmacokinetic particulars
    Following a single spot-on application of the product, indoxacarb can still be detected in both skin and
    hair coat after 4 weeks post-treatment. Absorption through the skin also occurs, but this systemic
    absorption is partial and not relevant for the clinical efficacy. The absorbed indoxacarb is extensively
    metabolised by the liver to a variety of metabolites. The major route of excretion is in faeces.
    Environmental properties
    See section 6.6.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Triacetin
    Ethyl acetoacetate
    Isopropyl alcohol
    6.2 Incompatibilities
    None known
    6.3 Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
    6.4. Special precautions for storage
    This veterinary medicinal product does not require any special temperature storage conditions.
    Store in the original package, in order to protect from moisture.
    6.5 Nature and composition of immediate packaging
    Cardboard box of 1 or 4 spot-on applicators, consisting of 0.51, 0.77, 1.03, 1.54, 3.08 and 4.62 ml
    pipettes. One size only per box. The pipette consists of a blister film (polypropylene/cyclic-olefin-
    copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into
    aluminium sachets.
    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.
    Activyl should not be allowed to enter surface waters as indoxacarb may have harmful effects on aquatic
    organisms.
    6
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/118/001-14
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    18/02/2011
    10 DATE OF REVISION OF THE TEXT
    18/02/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.ema.europa.eu/ .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    7
    ANNEX II
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D. STATEMENT OF THE MRLs
    8
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Intervet Productions S.A.
    Rue de Lyons
    27460 Igoville
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    Not applicable.
    D. STATEMENT OF THE MRLs
    Not applicable.
    9
    ANNEX III
    LABELLING AND PACKAGE INSERT
    10
    A. LABELLING
    11
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    CARTON BOX
    Activyl spot-on solution for very small dogs
    Activyl spot-on solution for small dogs
    Activyl spot-on solution for medium dogs
    Activyl spot-on solution for large dogs
    Activyl spot-on solution for extra large dogs
    1.
    NAME OF VETERINARY THE 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
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Indoxacarb 100 mg
    Indoxacarb 150 mg
    Indoxacarb 300 mg
    Indoxacarb 600 mg
    Indoxacarb 900 mg
    3.
    PHARMACEUTICAL FORM
    Spot-on solution
    4.
    PACKAGE SIZE
    1 pipette
    4 pipettes
    5.
    TARGET SPECIES
    Dogs less than 6.5 kg
    Dogs 6.6 to 10 kg
    Dogs 10 to 20 kg
    Dogs 20 to 40 kg
    Dogs 40 to 60 kg
    6.
    INDICATION(S)
    Read the package leaflet before use.
    12
     
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    For spot-on use.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP {month/year}
    11. SPECIAL STORAGE CONDITIONS
    Do not remove the pipette from the packaging until ready to use.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary product or waste materials derived from such veterinary medicinal product
    should be disposed of in accordance with local requirements.
    The veterinary product should not be allowed to enter surface waters.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription
    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
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    13
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/118/001
    EU/2/10/118/002
    EU/2/10/118/003
    EU/2/10/118/004
    EU/2/10/118/005
    EU/2/10/118/006
    EU/2/10/118/007
    EU/2/10/118/008
    EU/2/10/118/009
    EU/2/10/118/010
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    14
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    CARTON BOX
    Activyl spot-on solution for small cats
    Activyl spot-on solution for large cats
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Activyl 100 mg spot-on solution for small cats
    Activyl 200 mg spot-on solution for large cats
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Indoxacarb 100 mg
    Indoxacarb 200 mg
    3.
    PHARMACEUTICAL FORM
    Spot-on solution
    4.
    PACKAGE SIZE
    1 pipette
    4 pipettes
    5.
    TARGET SPECIES
    Cats less than 4 kg
    Cats more than 4 kg
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Apply topically to the skin at the base of the skull. Read the package leaflet for complete indications
    and directions for use.
    8.
    WITHDRAWAL PERIOD
    15
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP {month/year}
    11. SPECIAL STORAGE CONDITIONS
    Do not remove the pipette from the packaging until ready to use.
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary product or waste materials derived from such veterinary medicinal product
    should be disposed of in accordance with local requirements.
    The veterinary product should not be allowed to enter surface waters.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription
    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
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/10/118/011
    EU/2/10/118/012
    EU/2/10/118/013
    EU/2/10/118/014
    17. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    16
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Activyl spot-on solution for very small dogs
    Activyl spot-on solution for small dogs
    Activyl spot-on solution for medium dogs
    Activyl spot-on solution for large dogs
    Activyl spot-on solution for extra large dogs
    SACHET
    1.
    NAME OF VETERINARY THE 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
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    100 mg
    150 mg
    300 mg
    600 mg
    900 mg
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    0.51 ml
    0.77 ml
    1.54 ml
    3.08 ml
    4.62 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Spot-on use
    5.
    BATCH NUMBER
    Batch {number}
    6.
    WITHDRAWAL PERIOD
    17
     
    7.
    EXPIRY DATE
    month/year
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    18
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Activyl spot-on solution for small cats
    Activyl spot-on solution for large cats
    SACHET
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Activyl 100 mg spot-on solution for small cats
    Activyl 200 mg spot-on solution for large cats
    Indoxacarb
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    100 mg
    200 mg
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    0.51 ml
    1.03 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Spot-on use
    5.
    BATCH NUMBER
    Batch {number}
    6.
    WITHDRAWAL PERIOD
    7.
    EXPIRY DATE
    month/year
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    19
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Activyl spot-on solution for very small dogs
    Activyl spot-on solution for small dogs
    Activyl spot-on solution for medium dogs
    Activyl spot-on solution for large dogs
    Activyl spot-on solution for extra large dogs
    BLISTER (pipette label)
    1.
    NAME OF VETERINARY THE 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
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    3.
    EXPIRY DATE
    {month/year}
    4.
    BATCH NUMBER
    Batch {number}
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    20
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Activyl spot-on solution for small cats
    Activyl spot-on solution for large cats
    BLISTER (pipette label)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Activyl 100 mg spot-on solution for small cats
    Activyl 200 mg spot-on solution for large cats
    Indoxacarb
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    3.
    EXPIRY DATE
    {month/year}
    4.
    BATCH NUMBER
    Batch {number}
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    21
     
    B. PACKAGE LEAFLET
    22
    PACKAGE LEAFLET FOR
    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
    Marketing authorisation holder :
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer for the batch release :
    Intervet Productions
    Rue Lyons
    27460 Igoville
    France
    2.
    NAME OF VETERINARY THE 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:
    Each ml contains 195 mg indoxacarb.
    Each pipette of Activyl delivers:
    Volume (ml) Indoxacarb (mg)
    Activyl spot-on solution for very small dogs
    0.51
    100
    Activyl spot-on solution for small dogs
    0.77
    150
    Activyl spot-on solution for medium dogs
    1.54
    300
    Activyl spot-on solution for large dogs
    3.08
    600
    Activyl spot-on solution for extra large dogs
    4.62
    900
    Also contains Isopropyl alcohol 354 mg/ml.
    A clear colourless to yellow solution.
    23
     
    4.
    INDICATION(S)
    Treatment and prevention of flea infestation ( Ctenocephalides felis )
    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
    A brief period of hypersalivation may occasionally 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.
    Transitory scratching or hair loss 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.
    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(S) AND METHOD OF ADMINISTRATION
    The recommended dose for dogs is 15 mg indoxacarb/kg bodyweight, equivalent to 0.077 ml/kg
    bodyweight. 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
    < 6.5
    Activyl 100 mg spot-on solution for very small dogs
    6.6 - 10
    Activyl 150 mg spot-on solution for small dogs
    10.1 - 20
    Activyl 300 mg spot-on solution for medium dogs
    20.1 - 40
    Activyl 600 mg spot-on solution for large dogs
    40.1 - 60
    Activyl 900 mg spot-on solution for extra large dogs
    > 60 kg
    The appropriate combination of pipettes should be used
    24
     
    Following a single administration, the veterinary medicinal product will prevent further flea infestation
    for at least 4 weeks.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Open one sachet and remove the pipette.
    Step 1 : The animal should be standing for easy application. With one
    hand, hold pipette in an upright position away from your face and with the
    other hand, snap tip open by bending it and folding it back on itself.
    Step 2: Part the hair until the skin is visible and
    place pipette tip against the skin between the
    shoulder blades. Squeeze pipette firmly applying the
    entire contents directly to the skin.
    In larger dogs, the entire contents of the pipette(s) should be applied
    evenly to two or three or four spots, all located at different application sites along the backline from
    the shoulder to the base of the tail.
    Do not apply an excessive amount of solution at any one spot which could cause some of the solution
    to run off the side of the animal.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special temperature storage conditions.
    Do not use after the expiry date stated on the carton, foil and pipette.
    Store in the original package in order to protect from moisture.
    12. SPECIAL WARNING(S)
    Keep the product in the sachet until use.
    25
    This product is highly flammable. Keep away from heat, sparks, open flame or other source of
    ignition.
    Do not eat, drink or smoke while handling the veterinary medicinal product.
    This product contains indoxacarb. People with known hypersensitivity to indoxacarb should not use
    this product.
    Avoid contents coming into contact with eyes. If this occurs , rinse slowly and gently with water.
    Wash hands immediately after use.
    The sachet is child–resistant. Keep the used pipette out of the reach and sight of children.
    Do not use in pregnant or lactating animals or in animals intended for breeding.
    The safety has not been established in dogs younger than 8 weeks of age.
    The safety has not been established in dogs weighing less than 1.5 kg.
    Care should be taken to apply the dose to an area where the animal cannot lick it off and to ensure that
    animals do not groom each other following treatment and that the content of the pipette or the applied
    dose does not come into contact with the eyes of the recipient and/or other animals.
    The product remains effective following shampoo treatment, water immersion (swimming, bathing)
    and exposure to sunlight. However, animals should not be allowed to swim or treated with shampoo
    within 48 hours after treatment.
    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.
    Medicines should not be disposed of via wastewater or household waste.
    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
    18/02/2011
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    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.
    Box of 1 pipette
    Box of 4 pipettes
    26
    PACKAGE LEAFLET FOR
    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
    Marketing authorisation holder :
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer for the batch release :
    Intervet Productions
    Rue Lyons
    27460 Igoville,
    France
    2.
    NAME OF VETERINARY THE 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:
    Each ml contains 195 mg indoxacarb.
    Each pipette of Activyl delivers:
    Volume (ml) Indoxacarb (mg)
    Activyl spot-on solution for small cats
    0.51
    100
    Activyl spot-on solution for large cats
    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 )
    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
    27
     
    6.
    ADVERSE REACTIONS
    A brief period of hypersalivation may occasionally 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.
    Transitory scratching or hair loss 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.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Cats
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    The recommended dose for cats is 25 mg indoxacarb/kg bodyweight, equivalent to 0.128 ml/kg
    bodyweight. 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 spot-on solution for small cats
    > 4
    Activyl 200 mg spot-on solution for large cats
    Following a single administration, the veterinary medicinal product will prevent further flea infestation
    for at least 4 weeks.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Open one sachet and remove the pipette.
    Step 1 : The animal should be standing for easy application. With one
    hand, hold pipette in an upright position away from your face and with the
    other hand, snap tip open by bending it and folding it back on itself.
    Step 2: Part the hair until the skin is visible and
    place pipette tip against the skin at the base of the
    skull. Squeeze pipette firmly applying the entire
    contents directly to the skin.
    28
     
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special temperature storage conditions.
    Do not use after the expiry date stated on the carton, foil and pipette.
    Store in the original package in order to protect from moisture.
    12. SPECIAL WARNING(S)
    Keep the product in the sachet until use.
    This product is highly flammable. Keep away from heat, sparks, open flame or other source of
    ignition.
    Do not eat, drink or smoke while handling the veterinary medicinal product.
    This product contains indoxacarb. People with known hypersensitivity to indoxacarb should not use
    this product.
    Avoid contents coming into contact with eyes. If this occurs , rinse slowly and gently with water.
    Wash hands immediately after use.
    The sachet is child–resistant. Keep the used pipette out of the reach and sight of children.
    Do not use in pregnant or lactating animals or in animals intended for breeding.
    The safety has not been established in cats younger than 8 weeks of age.
    The safety has not been established in cats weighing less than 0.6 kg.
    Care should be taken to apply the dose to an area where the animal cannot lick it off and to ensure that
    animals do not groom each other following treatment and that the content of the pipette or the applied
    dose does not come into contact with the eyes of the recipient and/or other animals.
    The product remains effective following shampoo treatment, water immersion (swimming, bathing)
    and exposure to sunlight. However, animals should not be allowed to swim or treated with shampoo
    within 48 hours after treatment.
    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.
    Medicines should not be disposed of via wastewater or household waste.
    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
    18/02/2011
    Detailed information on this product is available on the website of the European Medicines Agency
    29
    15. OTHER INFORMATION
    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.
    Box of 1 pipette
    Box of 4 pipettes
    30


    Source: European Medicines Agency


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