Activyl® Spot-On Solution

Activyl® Spot-On Solution is used in the treatment and prevention of flea infestation (Ctenocephalides felis). Activyl® Spot-On Solution can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

FOR EXTERNAL ANIMAL USE ONLY

Reg. No. G4021 (Act 36/1947)
Namibia Reg. No. V14/18.3.10/1248 NS0

INDICATIONS

Activyl® Spot-On Solution is used in the treatment and prevention of flea infestation (Ctenocephalides felis). Activyl® Spot-On Solution can be used as part of a treatment strategy for flea allergy dermatitis (FAD). Developing stages of fleas (eggs and larvae) in the pet’s immediate surroundings are killed following contact with Activyl® Spot-On Solution treated pets.

TARGET SPECIES

Cats.

COMPOSITION

Contains: Indoxacarb 195 mg/mℓ.

Each unit dose (pipette) of Activyl® Spot-On Solution delivers:

 Unit Dose (mℓ)Indoxacarb (mg)
Activyl® Spot-On Solution for small cats0,5199,45
Activyl® Spot-On Solution for large cats1,03200,85

STORAGE

  • Store at or below 30 °C.
  • Do not remove the pipette from the packaging until ready to use.
  • Do not use after the expiry date stated on the foil.

WARNINGS

  • Withdrawal period: Not applicable.
  • Activyl® Spot-On Solution is highly flammable. Keep away from heat, sparks, open flames or other sources of ignition.
  • Do not eat, drink or smoke while handling the product.
  • This product contains indoxacarb. People with known hypersensitivity to indoxacarb should not handle this product.
  • Avoid contents coming into contact with eyes. If this occurs, rinse slowly and gently with water. Wash hands immediately after use.
  • The safety of Activyl® Spot-On Solution has not been established in kittens younger than 8 weeks of age, and in pregnant or lactating queens. The responsible veterinarian should make a benefit-risk assessment before using Activyl® Spot-On Solution in these cases.
  • The safety of Activyl® Spot-On Solution 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, 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.
  • Dispose of all empty containers as per local waste disposal regulations and do not reuse for any other purpose.
  • KEEP OUT OF REACH OF CHILDREN, ANIMALS AND UNINFORMED PERSONS.
  • Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, notify the registration holder.

CONTRA-INDICATIONS

None.

ADVERSE REACTIONS

A brief period of hypersalivation may occasionally occur in cats if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears without treatment. Correct application will minimise licking of the application site. In rare cases of licking the product, gastrointestinal signs (e.g. emesis, anorexia) or reversible neurological signs (e.g. incoordination, tremor, ataxia and mydriasis) have been observed in cats.

If you notice any serious effects or other effects not mentioned in this package insert, please inform your veterinarian.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage

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 usedVolume (mℓ)Indoxacarb (mg/kg)
≤ 4Activyl® Spot-On Solution for small cats0,51Minimum of 25
> 4Activyl® Spot-On Solution for large cats1,03Minimum of 50

Following a single administration, Activyl® Spot-On Solution will prevent further flea infestation for at least 4 weeks.

For optimal control of flea infestation, Activyl® Spot-On Solution can be safely administered at 2 to 4-week intervals throughout the flea season.

Advice on Correct Administration

Open 1 foil pouch and remove the pipette.

Ensure that the animal is calm and standing still for easy application.

Step 1: Opening of Pipette

With the 1 hand, hold the 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: Application of Activyl® Spot-On Solution

With 1 hand, part the hair and place pipette tip against the skin at the base of the skull. Squeeze pipette firmly, applying the entire contents of the pipette(s).

PRESENTATION

Activyl® Spot-On Solution is packaged in individual-dose pipettes in an outer foil package.

It is supplied in units of 1, 4 or 6 pipettes per cardboard box.

Not all pack sizes may necesssarily be marketed.

REGISTRATION HOLDER                                        

Intervet South Africa (Pty) Ltd.  
20 Spartan Road, Spartan        
1619, RSA           
Tel: +27 (0) 11 923 9300     
Fax: +27 (0) 11 392 3158                                                                                                                   

MANUFACTURER

Merck Animal Health
2667 West Dual Street, Baton Rouge
Louisiana 70814-4906, USA

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT

27 August 2015

SLEGS VIR UITWENDIGE DIEREGEBRUIK

ACTIVYL® SPOT-ON SOLUTION

Reg. Nr. G4021 (Wet 36/1947)

Namibië Reg. Nr. V14/18.3.10/1248 NS0

INDIKASIES

Activyl® Spot-On Solution word gebruik vir die behandeling en voorkoming van vlooibesmettings (Ctenocephalides felis). Activyl® Spot-On Solution kan gebruik word as deel van die behandelingstrategie vir vlooi allergiese dermatitis (VAD). Ontwikkelingstadia van vlooie (eiers en larwes), in die troeteldier se onmiddellike omgewing word doodgemaak deur hulle kontak met diere wat met Activyl® Spot-On Solution behandel is.

TEIKENSPESIES

Katte.

SAMESTELLING

Bevat: Indoksakarb 195 mg/mℓ.

Elke eenheidsdosis (pipet) van Activyl® Spot-On Solution lewer:

 Eenheidsdosis (mℓ)Indoksakarb (mg)
Activyl® Spot-On Solution vir klein katte0,5199,45
Activyl® Spot-On Solution vir groot katte1,03200,85

BERGING

  • Berg teen of benede 30 °C.
  • Moenie die pipet uit die verpakking haal voordat dit gebruik word nie.
  • Moenie gebruik na die vervaldatum wat op die foelie aangedui is nie.

WAARSKUWINGS

  • Onttrekkingsperiode: Nie van toepassing.
  • Activyl® Spot-On Solution is hoogs vlambaar. Hou weg van hitte, vonke, oop vlamme of ander bronne van ontbranding.
  • Moenie eet, drink of rook terwyl die produk hanteer word nie.
  • Hierdie produk bevat indoksakarb. Mense met hipersensitiwiteit vir indoksakarb moenie hierdie produk gebruik nie.
  • Vermy dat die inhoud in kontak met oë kom. Indien dit wel gebeur, spoel die oog stadig en saggies met water. Was hande dadelik na gebruik.
  • Die veiligheid van Activyl® Spot-On Solution is nie in katte jonger as 8 weke, of vir dragtige en lakterende wyfiekatte bepaal nie. Die verantwoordelike veearts behoort ‘n voordeel-risiko bepaling te maak voordat Activyl® Spot-On Solution in hierdie gevalle toegedien word.
  • Die veiligheid van Activyl® Spot-On Solution is nie in katte wat minder as 0,6 kg weeg bepaal nie.
  • Maak seker dat die dosis op ‘n liggaamsdeel toegedien word waar die dier dit nie kan aflek nie, dat diere mekaar nie lek na toediening nie, en dat die inhoud van die pipet nie in aanraking kom met die oë van ‘n dier nie.
  • Die middel bly effektief na sjampoebehandeling, wateronderdompeling (bad of swem) en blootstelling aan sonlig.
  • HOU BUITE BEREIK VAN KINDERS, ONINGELIGTE PERSONE EN DIERE.
  • Alhoewel hierdie middel breedvoerig onder ‘n wye verskeidenheid toestande getoets is, mag dit faal as gevolg van verskeie redes. Indien dit vermoed word, raadpleeg ‘n veearts en verwittig die registrasiehouer.

KONTRA-INDIKASIES

Geen.

ONGUNSTIGDE REAKSIES

‘n Kort periode van hipersalivasie mag soms voorkom by katte wat direk na behandeling aan die toedieningsplek lek. Dit is nie ‘n teken van vergiftiging nie en verdwyn binne minute sonder behandeling. Korrekte toediening sal die aflek van die middel tot die minimum beperk. In seldsame gevalle wanneer die produk gelek word, kan gastro-intestinale tekens (bv. braking, anoreksie) of omkeerbare neurologiese tekens (bv. gebrek aan koördinasie, tremors, ataksie en midriasis) in katte waargeneem word. Indien enige ander ernstige newe-effekte wat nie hier genoem word nie, opgemerk word, moet die veearts ingelig word.

GEBRUIKSAANWYSINGS – GEBRUIK SLEGS SOOS AANGEDUI

DOSERING

Die voorgestelde dosis is 25 mg indoksakarb/kg liggaamsgewig, gelykstaande aan 0,128 mℓ/kg liggaamsgewig. Die volgende tabel dui die grootte van die pipet aan wat volgens die gewig van die kat gebruik moet word:

Gewig van kat (kg)Grootte pipet om te gebruikVolume (mℓ)Indoksakarb (mg/kg)
≤ 4Activyl® Spot-On Solution vir klein katte0,51Minimum van 25
> 4Activyl® Spot-On Solution vir groot katte1,03Minimum van 50

Na ‘n enkele behandeling sal Activyl® Spot-On Solution verdere vlooibesmettings vir ten minste 4 weke voorkom.

Vir optimale beheer van vlooibesmetting, kan Activyl® Spot-On Solution gedurende die vlooiseisoen met veiligheid elke 2 tot 4 weke toegedien word.

Wenke vir Korrekte Toediening

Maak 1 foeliesakkie oop en verwyder die pipet.

Die dier moet kalm wees en stil staan om toediening te vergemaklik.

Stap 1: Oopmaak van die pipet

Met een hand, hou die pipet regop, weg van u gesig, en gebruik die ander hand om die punt oop te breek deur dit te buig en terug te vou.

Stap 2: Aanwending van Activyl® Spot-On Solution

Gebruik 1 hand om hare te verdeel en plaas pipet teen die vel by die basis van die skedel.

Druk die pipet ferm om al die inhoud uit te kry.

AANBIEDING

Activyl® Spot-On Solution is verpak in individuele dosis-pipette omhul met ‘n foeliesakkie. Dit is beskikbaar in eenhede van 1, 4 of 6 pipette per kartonhouer.

Nie alle verpakkingsgroottes word noodwendig bemark nie.

REGISTRSIE HOUER                                        

Intervet South Africa (Pty) Ltd.  
20 Spartan Road, Spartan        
1619, RSA           
Tel: +27 (0) 11 923 9300     
Fax: +27 (0) 11 392 3158                                                                                                                   

VERVAARDIGER

Merck Animal Health
2667 West Dual Street, Baton Rouge
Louisiana 70814-4906, USA

DATUM VAN PUBLIKASIE VAN VOUBILJET

27 Augustus 2015