NOAH Compendium

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Date: Thursday, July 18, 2024 3:06

Release 5.132
Stronghold spot-on solution for cats & dogs
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs, For cats, Pharmaceuticals: Endectocides: For companion animals, Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs, Anthelmintics for cats
Active ingredient: Selamectin
Product:Stronghold® spot-on solution
Product index: Stronghold
Incorporating:
Presentation
Active substance:
Stronghold <2.5 kg:
Selamectin 15 mg
Stronghold 2.6 - 5.0 kg:
Selamectin 30 mg
Stronghold 2.6 - 7.5 kg:
Selamectin 45 mg
Stronghold 7.6 - 10 kg:
Selamectin 60 mg
Stronghold 5.1 - 10 kg:
Selamectin 60 mg
Stronghold 10.1 - 20.0 kg:
Selamectin 120 mg
Stronghold 20.1 - 40.0 kg:
Selamectin 240 mg
Stronghold 40.1 - 60.0 kg:
Selamectin 360 mg respectively.
Uses
Dogs and Cats:
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 product. The 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 for up to seven weeks of age.
The 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.
Treatment of ear mites (Otodectes cynotis).
Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. The veterinary medicinal product may be safely administered to animals infected with adult heartworms, however, it is recommended in accordance with good veterinary practise, 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 the administration of the veterinary medicinal product.
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 the veterinary medicinal product has been administered monthly. This product is not effective against D. immitis.
Dogs:
Treatment of adult intestinal roundworms (Toxocara canis).
Treatment of sarcoptic mange (caused by Sarcoptes scabiei).
Treatment of biting lice infestations (Trichodectes canis).
Cats:
Treatment of adult roundworms (Toxocara cati).
Treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Treatment of biting lice infestations (caused by Felicola subrostratus).
Dosage and administration
This veterinary medicinal product should be administered 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 in accordance with the following table:
Dogs (kg)
Pipette cap colour
mg of selamectin dispensed
Potency (mg/ml)
Administered volume (nominal pipette size, ml)
< 2.5
Rose
15
60
0.25
2.6 - 5.0
Violet
30
120
0.25
5.1 - 10.0
Brown
60
120
0.5
10.1 - 20.0
Red
120
120
1.0
20.1 - 40.0
Green
240
120
2.0
40.1 - 60.0
Plum
360
120
3.0
> 60
Appropriate combination of pipettes
60 / 120
Appropriate combination of pipettes
Cats (kg)
Pipette cap colour
mg of selamectin dispensed
Potency (mg/ml)
Administered volume (nominal pipette size, ml)
< 2.5
Rose
15
60
0.25
2.6 - 7.5
Blue
45
60
0.75
7.6 - 10.0
Taupe
60
60
1.0
> 10
Appropriate combination of pipettes
60
Appropriate combination of pipettes
Flea treatment and prevention (cats and dogs)
For the prevention of flea infestations in dogs and cats, the veterinary medicinal product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
For use as part of a treatment strategy for flea allergy dermatitis, the veterinary medicinal product should be administered at monthly intervals.
Treatment of roundworm infections (cats and dogs)
A single dose of the veterinary medicinal product should be administered.
Treatment of hookworm infections (cats)
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 sarcoptic mange (dogs)
For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months.
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 the time of treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
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 veterinary medicinal 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.
Method and route of administration:
Spot-on use.
Apply to the skin at the base of the neck in front of the shoulder blades.
How to apply:
Remove the pipette from its protective package
Description: Picture1
Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap
Description: Picture2
Part the hair at the base of the animal's neck in front of the shoulder blades to expose a small area of skin
Description: Picture3
Apply the tip of the pipette directly to the skin without massaging. Squeeze the pipette firmly to empty the contents in one spot. Avoid contact between the product and your fingers
Description: Picture4
Contra-indications, warnings, etc
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).
This veterinary medicinal product is to be applied to the skin surface only. Do not administer orally or parenterally.
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.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
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.
Dogs:
Rare
(1 to 10 animals / 10,000 animals treated:
application site hair changes1
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
neurological signs (including seizures2)
1Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder which typically disappear within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
2Reversible as with other macrocyclic lactones.
Cats:
Rare
(1 to 10 animals / 10,000 animals treated):
application site alopecia1,2, application site hair changes3
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
application site irritation1,4, neurological signs (including seizures5)
1Normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
2Mild and transient.
3Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder which typically disappear within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
4Transient and focal.
5Reversible as with other macrocyclic lactones.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section "Contact details" of the package leaflet.
User warnings:
Wash hands after use and wash off any product in contact with the skin immediately with soap and water. In case of accidental eye exposure, flush the eyes immediately with water, seek medical advice immediately and show the package leaflet or the label to the physician.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Do not smoke, eat or drink while handling the product.
Pharmaceutical precautions
For animal treatment only.
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package in a dry place.
This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Legal category
Legal category: POM-V
Packaging quantities
The veterinary medicinal product 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).
The veterinary medicinal product is in translucent polypropylene single-dose pipettes in an aluminium and aluminium/PVC blister overwrap.
Not all pack sizes may be marketed.
Further information
Following administration of the veterinary medicinal product, the adult fleas on the animal are killed, no viable eggs are produced, and larvae (found only in the environment) are also killed. This stops flea reproduction, breaks the flea life cycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
The veterinary medicinal product was administered at 10 times the recommended dose, and no undesirable effects were observed.
Can be used in breeding, pregnant and lactating cats and dogs. The veterinary medicinal product was 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.
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.
In extensive field testing no interactions between this veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Marketing Authorisation Number
UK(GB): Vm 42058/5060-70
UK(NI): EU/2/99/014/001-016 and EU/2/16/204/003-006
Significant changes
GTIN
GTIN description:15 mg x 3 tubes:
GTIN:05013457078497
GTIN description:15 mg x 15 tubes:
GTIN:05414736013435
GTIN description:30 mg x 3 tubes:
GTIN:05013457078510
GTIN description:30 mg x 6 tubes:
GTIN:05414736018461
GTIN description:45 mg x 3 tubes:
GTIN:05013457078503
GTIN description:45 mg x 6 tubes:
GTIN:05013457079449
GTIN description:60 mg (dog) x 3 tubes:
GTIN:05013457078527
GTIN description:60 mg (cat) x 3 tubes:
GTIN:05414736029146
GTIN description:60 mg x 6 tubes:
GTIN:05414736018478
GTIN description:120 mg x 3 tubes:
GTIN:05013457078534
GTIN description:120 mg x 6 tubes:
GTIN:05414736018454
GTIN description:240 mg x 3 tubes
GTIN:05013457078541
GTIN description:240 mg x 6 tubes:
GTIN:05414736018447
GTIN description:360 mg x 3 tubes:
GTIN:05414736029153