NexGard Single for Dogs 25.1 - 50kg
NEXGARD kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of paralysis tick infestations in dogs and puppies 8 weeks of age and older, weighing 2kg of body weight or greater, for one month.
Dosage and Administration:
NEXGARD is given orally once a month, at the minimum dosage of 2.5 mg/kg.
NEXGARD can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, re-dose with another full dose. If a dose is missed, administer NEXGARD and resume a monthly dosing schedule.
Paralysis tick, a unique Australian parasite.
Ixodes holocyclus is present along the east coast of Australia and poses a serious health risk to dogs. Each year thousands of dogs present to veterinary hospitals with signs of tick paralysis caused by this parasite.
Two Australian studies were performed to assess the efficacy of NEXGARDÂ® against this potentially deadly parasite. In each study, 50 ticks were infested onto each dog on day â€“ 1, 7, 14, 21, 28 and 35. NEXGARDÂ® was administered on day 0.
Tick counts were conducted on Days 1,2,3 (24, 48 and 72 hours after administration of NEXGARDÂ®) and thereafter at 24, 48 and 72 hours post each subsequent tick infestation. In both studies, there was significant mortality of ticks within 24 hours at all time-points and >98.5% of ticks were killed within 48 hours after NEXGARDÂ® administration and weekly infestations.
NEXGARDÂ® controls fleas within 8 hours of administration. One controlled study demonstrated 100% mortality of fleas within 6 hours of administration. NEXGARDÂ® has demonstrated rapid control of fleas for a full month. NEXGARDÂ® is indicated for the treatment and prevention of flea infestations and for the control of newly acquired adult fleas.
Two studies have examined the efficacy of NEXGARDÂ® throughout the
month and have demonstrated >95% mortality of fleas within 12 hours
for 3 weeks and >99.9% mortality of fleas within 24 hours for 5 weeks (following weekly flea infestations).
Important Safety Information:
NexGard is for use in dogs only. The most frequently reported adverse reactions include vomiting, dry/flaky skin, diarrhoea, lethargy, and lack of appetite. The safe use of NexGard in pregnant, breeding or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures.
Before developing the final formulation of NEXGARDÂ®, numerous studies were conducted with an experimental oral solution of afoxolaner during which all dogs were evaluated for adverse reactions. The results of these studies confirmed the potential for afoxolaner as a safe ectoparasiticide and led the way to additional target animal safety studies using the final formulation of the product.
A margin of safety study was conducted in healthy puppies as young as 8 weeks of age. NEXGARDÂ® was administered at approximately 1x, 3x and 5x the exposure dose of 6.3mg/kg for 3 monthly treatments followed by 3 fortnightly treatments. NEXGARDÂ® was well tolerated throughout the study period.
A total of six studies were conducted on dogs in Australia confirming the efficacy and safety of NEXGARDÂ® against fleas and ticks. There were no treatment related adverse events seen in any of these studies including in the field trial conducted in real homes across Australia. Safety data from a large scale US field study involving 415 dogs treated with NEXGARDÂ® and 200 dogs treated with ComfortisÂ® (spinosad) showed that the most frequently reported adverse event in both groups was vomiting, which tended to be self-limiting and of short duration. The incidence of vomiting was 3x higher in the spinosad-treated group.
|Dose Form||Tablet / Oral|
|Duration of Effect||1 month|
|Indication||Treatment and prevention of flea infestations (Ctenocephalides sp.), control of newly acquired adult fleas and control of flea allergy dermatitis. After administration, fleas are killed within six to eight hours. The rapid onset of action means newly acquired fleas are killed before they can lay eggs. NexGard treats and controls paralysis ticks ( Ixodes holocyclus ), brown dog ticks ( Rhipicephalus sanguineus ) and bush ticks ( Haemaphysalis longicornis ) for one month. NexGard provides effective control of pre-existing paralysis tick infestations within 24 hours. I. holocyclus ticks do not occur in Western Australia. In tick season, daily searching for, and removal of, any ticks found is recommended. Monthly administration is recommended. For use in puppies from 8 weeks of age.|
|Actions||Rapidly kills adult fleas. Treats and controls ticks (paralysis ticks, brown dog ticks, bush ticks). Controls flea allergy dermatitis.|
|Precautions||The safe use of NexGard Chewables in breeding males and females has not been evaluated.Do not swallow. Wash hands after use. Accidental ingestion of afoxolaner can be harmful to children. To avoid accidental ingestion, administer the chewable to the dog immediately after removal from the package. Keep out of reach of children.First Aid If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126.Disposal Dispose of empty pack by wrapping in paper and placing in garbage.|
|Dosage and Administration||The recommended dosage is afoxolaner 2.5 mg/kg bodyweight. Dogs 2 to 4 kg bodyweight. One 0.5 g chewable (afoxolaner 11.3 mg/chewable). 4.1 to 10 kg. One 1.25 g chewable (afoxolaner 28.3 mg/chewable). 10.1 to 25 kg. One 3 g chewable (afoxolaner 68.0 mg/chewable). 25.1 to 50 kg. One 6 g chewable (afoxolaner 136.0 mg/chewable). Offer the chewable(s) appropriate for your dog's weight at monthly intervals. For dogs over 50 kg, administer the appropriate combination of chewables.Remove only one chewable at a time from the foil-backed blister card. NexGard may be broken into pieces and fed to dogs who normally swallow treats whole. NexGard is a soft, highly palatable chewable and is readily consumed by dogs when offered as a treat. Alternatively, NexGard may be added to a small amount of dog food. Care should be taken that the dog consumes the complete dose and treated dogs should be observed for a few minutes to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, treat again with another full dose. If a dose is missed, administer the NexGard chewable(s) appropriate for the dog's weight and resume a monthly dosing regimen. For optimal performance, treat the dog on or about the same day each month. Safety to dogs. NexGard was shown to be safe in various breeds of dogs and in puppies 8 weeks and older. NexGard may be administered in conjunction with gastrointestinal worm or heartworm treatments administered according to label directions. General instructions. As NexGard is an oral treatment, there are no restrictions on swimming, bathing and shampooing before or after administration. Flea treatment and prevention. NexGard demonstrated rapid control of fleas for a full month. Treatment with NexGard may begin at any time of the year. Dogs become infested with fleas that originate from environmental infestation sites in the home or outdoors. Treatment and prevention of flea infestations is achieved by killing fleas on the dog before they can lay eggs and replenish an environmental infestation. If a severe environmental infestation exists, fleas can continue to emerge into the surroundings for weeks to months because of the continuing development of flea eggs, larvae and pupae already present at the time of treatment. Under conditions of moderate to heavy challenge, it may take more than one monthly treatment to achieve an acceptable level of efficacy against fleas. In areas where fleas are common year-round, monthly treatment with NexGard should continue throughout the year without interruption. To minimise the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Tick control. For the most effective control of paralysis ticks (I. holocyclus) and to minimise the risk of tick paralysis, NexGard should be used in conjunction with daily searching and removal of ticks. Treatment with NexGard alone will not entirely remove the risk of tick paralysis. Speak with a veterinarian for advice on tick searching and removal techniques. NexGard demonstrated > 95% efficacy for a full month against paralysis ticks, brown dog ticks and bush ticks. In Australian studies, paralysis ticks and brown dog ticks were killed (> 95% efficacy) by 48 hours. Bush ticks were killed (> 95% efficacy) by 72 hours. Dogs become infested with ticks that originate from sites which are primarily outdoors. In areas where ticks are common year round, monthly treatment with NexGard should continue throughout the year without interruption.|
|Storage||Store below 30°C (room temperature).|
|Manufacturer||Boehringer Ingelheim Animal Health Australia Pty Ltd|