Stronghold (selamectin) – Package leaflet - QP54AA05

PACKAGE LEAFLET FOR:

Stronghold spot-on solution

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA

Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Stronghold 15 mg spot-on solution for cats and dogs < 2.5 kg

Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg

Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg

Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg

Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg

Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg

Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg

Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg

Selamectin

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each single-dose (pipette) delivers:

 

 

 

Stronghold 15 mg for cats and dogs

6% w/v solution

Selamectin

15 mg

Stronghold 30 mg for dogs

 

12% w/v solution

Selamectin

30 mg

Stronghold 45 mg for cats

 

6% w/v solution

Selamectin

45 mg

Stronghold 60 mg for cats

 

6% w/v solution

Selamectin

60 mg

Stronghold 60 mg for dogs

 

12% w/v solution

Selamectin

60 mg

Stronghold 120 mg for dogs

 

12% w/v solution

Selamectin

120 mg

Stronghold 240 mg for dogs

 

12% w/v solution

Selamectin

240 mg

Stronghold 360 mg for dogs

 

12% w/v solution

Selamectin

360 mg

Excipients:

 

 

 

 

Butylated hydroxytoluene

0.08%.

 

 

 

Colourless to yellow solution.

 

 

 

 

4. INDICATION(S) Cats and dogs:

Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the veterinary medicinal product. The veterinary medicinal product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to

seven weeks of age. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.

Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly. This veterinary medicinal product is not effective against adult D. immitis.

Treatment of ear mites (Otodectes cynotis).

Cats:

Treatment of biting lice infestations (Felicola subrostratus)

Treatment of adult roundworms (Toxocara cati)

Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).

Dogs:

Treatment of biting lice infestations (Trichodectes canis)

Treatment of sarcoptic mange (caused by Sarcoptes scabiei)

Treatment of adult intestinal roundworms (Toxocara canis).

5.CONTRAINDICATIONS

Do not use in animals under 6 weeks of age. Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).

6.ADVERSE REACTIONS

Use of the veterinary medicinal product in cats has on rare occasions been associated with a mild transient alopecia at the site of application. On very rare occasions transient focal irritation may also be observed. The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.

On rare occasions in cats and dogs, application of the veterinary medicinal product may produce a local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder. This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.

Very rarely, as with other macrocyclic lactones, reversible neurological signs, including seizures, have been observed after use of the veterinary medicinal product in both dogs and cats.

The frequency of adverse reactions is defined using the following convention:

-very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

-common (more than 1 but less than 10 animals in 100 animals)

-uncommon (more than 1 but less than 10 animals in 1,000 animals)

-rare (more than 1 but less than 10 animals in 10,000 animals)

-very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Other information

Stronghold has been tested with no other adverse reactions in over 100 different pure and mixed breeds of dogs including Collies, and in mixed breeds and 16 pure breeds of cats.

7.TARGET SPECIES

Cats and dogs weighing 2.5 kg or less (Stronghold 15 mg spot-on solution for cats and dogs < 2.5 kg) Dogs weighing 2.6 kg–5.0 kg (Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg)

Cats weighing 2.6 kg–7.5 kg (Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg) Cats weighing 7.6 kg–10.0 kg (Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg) Dogs weighing 5.1 kg–10.0 kg (Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg)

Dogs weighing 10.1 kg–20.0 kg (Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg) Dogs weighing 20.1 kg–40.0kg (Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg) Dogs weighing 40.1 kg–60.0 kg (Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg)

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Spot-on use.

Apply to the skin at the base of the neck in front of the shoulder blades.

Stronghold should be administered topically as a single application of a single-dose delivering a minimum of 6 mg/kg selamectin. When concurrent infestations or infections in the same animal are to be treated with the veterinary medicinal product, only one application of the recommended 6 mg/kg dose should be administered at any one time. The appropriate length of the treatment period for individual parasites is specified below.

Administer Stronghold in accordance with the following table:

Cats (kg)

Pipette cap

mg of selamectin

Potency

Administered volume

 

colour

dispensed

(mg/ml)

(nominal pipette size, ml)

≤ 2.5

Rose

0.25

2.67.5

Blue

0.75

7.6–10.0

Taupe

1.0

> 10

 

Appropriate

Appropriate combination

 

 

combination of pipettes

 

of pipettes

Dogs (kg)

Pipette cap

mg of selamectin

Potency

Administered volume

 

colour

dispensed

(mg/ml)

(nominal pipette size, ml)

≤ 2.5

Rose

0.25

2.6–5.0

Violet

0.25

5.1–10.0

Brown

0.5

10.1–20.0

Red

1.0

20.1–40.0

Green

2.0

40.1–60.0

Plum

3.0

> 60

 

Appropriate

60/120

Appropriate combination

 

 

combination of pipettes

 

of pipettes

Flea treatment and prevention (cats and dogs)

Animals older than six weeks of age:

Following administration of the veterinary medicinal product to the animal, adult fleas and larvae are killed and no viable eggs are produced. This stops flea reproduction and may aid in the control of existing environmental flea infestations in areas to which the animal has access.

For the prevention of flea infestations, the veterinary medicinal product should be administered to the animal at monthly intervals throughout the flea season, starting one month before fleas become active. This ensures that fleas infesting the animal are killed, no viable flea eggs are produced by these fleas, and larvae (found only in the environment) are also killed. This breaks the flea life cycle and prevents flea infestations.

For use as part of a treatment strategy for flea allergy dermatitis the veterinary medicinal product should be administered at monthly intervals.

Treatment of pregnant and lactating animals to prevent flea infestations in puppies and kittens:

Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age.

Prevention of heartworm disease (cats and dogs)

The veterinary medicinal product may be administered year-round or at least within one month of the animal’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. The final dose must be given within one month after the last exposure to mosquitoes. If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of the veterinary medicinal product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms. When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.

Treatment of roundworm infections (cats and dogs)

A single dose of the veterinary medicinal product should be administered.

Treatment of biting lice (cats and dogs)

A single dose of the veterinary medicinal product should be administered.

Treatment of ear mites (cats)

A single dose of the veterinary medicinal product should be administered.

Treatment of ear mites (dogs)

A single dose of the veterinary medicinal product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of hookworm infections (cats)

A single dose of the veterinary medicinal product should be administered.

Treatment of sarcoptic mange (dogs)

For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.

9.ADVICE ON CORRECT ADMINISTRATION

Remove the Stronghold pipette from its protective package.

Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap.

Part the hair at the base of your animal’s neck in front of the shoulder blades to expose a small area of skin.

Apply the tip of the Stronghold pipette directly to the skin without massaging.

Squeeze the pipette firmly to empty the contents in one spot. Avoid contact between the veterinary medicinal product and your fingers.

Do not apply when the hair coat is wet. However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the veterinary medicinal product.

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 30 °C. Store in the unopened foil package in a dry place.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

12.SPECIAL WARNING(S)

Special warnings for each target species:

Animals may be bathed 2 hours after treatment without loss of efficacy.

Do not apply when the animal’s hair coat is wet. However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.

For ear mite treatment, do not apply directly to the ear canal.

It is important to apply the dose as indicated to minimise the quantity that the animal can lick off. If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.

Special precautions for use in animals:

This veterinary medicinal product is to be applied to the skin surface only. Do not administer orally or parenterally.

Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition.

Do not smoke, eat or drink while handling the product.

Wash hands after use and wash off any product in contact with the skin immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid direct contact with 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. Used applicators should be disposed of immediately and not left within the sight or reach of children.

People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.

Other precautions:

Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.

Interactions with other medicinal products and other forms of interaction:

In extensive field testing no interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures were observed.

Overdose (symptoms, emergency procedures, antidotes):

Stronghold was administered at 10 times the recommended dose, and no undesirable effects were observed. The veterinary medicinal product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed. The veterinary medicinal product was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater.

Selamectin may adversely affect fish or certain water-borne organisms on which they feed. Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.

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 (http://www.ema.europa.eu/).

15.OTHER INFORMATION

Stronghold is available in packs of three pipettes (for all pipette sizes), six pipettes (for all pipette sizes except 15 mg selamectin), or fifteen pipettes (for 15 mg selamectin pipette size only). 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.

België/Belgique/Belgien

Lietuva

Zoetis Belgium SA

Oriola Vilnius UAB

Tél/Tel.: +32 (0) 800 99 189

Tel: +370 610 05088

Република България

Luxembourg/Luxemburg

Zoetis Belgium SA

Zoetis Belgium SA

Teл: +359 2 4775791

Tél/Tel.: +352 8002 4026

Česká republika

Magyarország

Zoetis Česká republika, s.r.o.

Zoetis Hungary Kft.

Tel: +420 257 101 111

Tel: +361 224 5222

Danmark

Malta

Orion Pharma Animal Health

Agrimed Limited

Tlf: +45 49 12 67 65

Tel: +356 21 465 797

Deutschland

Nederland

Zoetis Deutschland GmbH

Zoetis B.V.

Tel.: +49 30 330063 0

Tel.: +31 (0)10 714 0900

Eesti

Norge

Oriola Vilnius UAB

Orion Pharma Animal Health

Tel: +370 610 05088

Tlf: +47 40 00 41 90

Ελλάδα

Österreich

Zoetis Hellas S.A.

Zoetis Österreich GmbH

Τηλ.: +30 210 6791900

Tel: +43 1 2701100 110

España

Polska

Zoetis Spain, S.L.

Zoetis Polska Sp. z o.o.

Tel: +34 91 4191900

Tel: +48 22 223 4800

France

Portugal

Zoetis France

Zoetis Portugal, Lda.

Tél: +33 (0)810 734 937

Tel: +351 21 042 72 00

Hrvatska

România

Zoetis B.V., Podružnica Zagreb za promidžbu

Zoetis România SRL

Tel: +385 1 644 1460

Tel: +40 21 202 3083

Ireland

Slovenija

Zoetis Belgium SA

Zoetis B.V., Podružnica Zagreb za promidžbu

Tel: +353 (0) 1 256 9800

Tel: +385 1 644 1460

Ìsland

Slovenská republika

Icepharma hf.

Zoetis Česká republika, s.r.o.

Sími: +354 540 80 00

Tel: +420 257 101 111

Italia

Suomi/Finland

Zoetis Italia S.r.l.

Zoetis Finland Oy

Tel: +39 06 3366 8133

Puh/Tel: +358 (0)9 4300 40

Kύπρος

Sverige

Zoetis Hellas S.A.

Orion Pharma Animal Health

Τηλ.: +30 210 6791900

Tel: +46 (0)8 623 64 40

Latvija

United Kingdom

Oriola Vilnius UAB

Zoetis UK Limited

Tel: +370 610 05088

Tel: +44 (0) 845 300 8034

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