Slentrol - patient leaflet, side effects, dosage

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15. NAME AND ADDRESS OF THE MARKE TING AUTHORISATION HOLDER

NATURE: 20 ml, 50 ml, 150 ml bottle

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Slentrol 5 mg/ml oral solution for dogs Dirlotapide

• 2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

  5 mg/ml

  
  

• 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

20ml

50ml

150ml

PACKAGE LEAFLET FOR:

Slentrol 5 mg/ml oral solution for dogs

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

Marketing authorisation holder:

Zoetis Belgium SA

Rue Laid Burniat 1 1348 Louvain-la-Neuve

Belgium

Manufacturer responsible for batch release:

Pfizer Service Company Hoge Wei 10 1930 Zaventem

Belgium

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Slentrol 5 mg/ml oral solution for dogs Dirlotapide

• 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

Dirlotapide 5 mg/ml is a colourless to pale yellow solution.

As an aid in the management of overweight and obesity in adult dogs. Your veterinary surgeon will identify a target weight and explain how Slentrol should be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice.

• 5. CONTRAINDI­CATIONS

Do not use in dogs in the growth phase.

Do not use during pregnancy or lactation.

Do not use in dogs with impaired liver function.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocor­ticism.

Do not use in cats due to the risk of development of hepatic lipidosis.

• 6. ADVERSE REACTIONS

Some dogs may show one or more vomiting events, sometimes accompanied by signs of tiredness, disinterest in food or diarrhoea, which reoccur occasionally during the course of treatment. These signs typically started during the first month of treatment (about 30% of dogs showed at least one

Withdraw the veterinary medicinal product from the bottle using the supplied dosing device and administer the veterinary medicinal product once daily directly into the mouth or on a small amount of food. The veterinary medicinal product can be administered with or without food. To ensure correct dosing during the treatment period the owner should seek advice from the responsible veterinarian in connection to each monthly dose adjustment.

Advice for Veterinarian

Dogs should undergo a physical examination before commencing treatment, and a desired bodyweight or a body condition score identified.

The recommended starting dose of the veterinary medicinal product is 0.05 mg/kg initial bodyweight per day (0.01 ml/kg/day). After two weeks of therapy, the initial dose (number of ml administered) should be increased by 100% (doubled). Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the veterinary medicinal product and dose adjustments are made monthly according to effect as described below.

At the end of each month of therapy, the percentage of bodyweight loss should be determined. If the bodyweight loss since previous monthly weighing has been >3% bodyweight per month (equivalent 0.1% bodyweight per day); the dose (number of ml administered) should be kept the same. If the |

bodyweight loss since previous monthly weighing has been <3% bodyweight per month, the dose should be increased without adjusting for the dog’s current bodyweight. The first time a conditional increase is required, the dose should be increased by 100%, (doubled). In subsequent required conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times the volume administered in the previous month) up to a maximum dose of the veterinary medicinal product of 0.2 ml/kg current bodyweight. These adjustments should be continued until the weight targeted at the start of therapy is achieved.

Although not observed in clinical trials, in the case where bodyweight loss since previous monthly weighing has been >12% per month (equivalent to 0.4% bodyweight per day), the dose should be reduced by 25%.

According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss therapy can be anticipated.

The duration of treatment with the veterinary medicinal product must not exceed 12 months and the dose of the veterinary medicinal product must not exceed a maximum of 0.2 ml/kg current bodyweight (1 mg/kg dirlotapide).

DOSE PROGRESSION TABLE DURING WEIGHT

Dose level	Trigger for increase	Volume to administer in ml
1 (start)	Not applicable	Dose 1 = Starting dose = Initial BW x 0.01 ml/kg
2 (automatic day 14 increase)	Not applicable (systematic)	Dose 2 = Dose 1 × 2
3 (conditional)	First monthly weighing where bodyweight loss < 3% per month since previous weighing	Dose 3 = Dose 2 × 2
4 (conditional)	Second monthly weighing where bodyweight loss < 3% per month since previous weighing	Dose 4 = Dose 3 × 1.5
5 (conditional)	Third monthly weighing where bodyweight loss < 3% per month since previous weighing	Dose 5 = Dose 4 × 1.5
6 (conditional)	Fourth monthly weighing where bodyweight loss < 3% per month since previous weighing	Dose 6 = Dose 5 × 1.5

3% bodyweight loss per month = 0.7% per week = 0.1% per day

The lowest validated dose for the dosing device is 0.05 ml. This is the starting dose for a 5 kg dog.

• 10. WITHDRAWAL PERIOD

Not applicable

• 11. SPECIAL STORAGE PRECAUTIONS

  
  

Keep out of the sight and reach of children.

Store in the original container in order to protect from light.

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

Shelf life after first opening the container: 3 months

• 12. SPECIAL WARNINGS

Advice for dog owner

Pregnancy and lactation :

Slentrol must not be used during pregnancy and lactation.

Fertility studies have not been conducted in the target species – use in dogs intended for breeding should be subject to a risk-benefit analysis by your veterinarian.

Incompatibili­ties:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Special precautions to be taken by the person administering the veterinary medicinal product to dogs : The veterinary medicinal product does not mix with water. Oral dosing devices used for measuring the dose may be cleaned with water but must be dried before re-use.

In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted. In order to avoid this rebound weight gain, it is necessary during treatment or at the end of treatment at the latest, to establish the appropriate level of food intake and physical activity needed to ensure long term maintenance of the bodyweight.

Wash hands after use. In case of contact with the skin, wash off any veterinary medicinal product immediately with soap and water.

Slentrol may cause eye-irritation. Avoid contact with eyes. If accidental eye exposure occurs, flush the eyes immediately with clean water.

When the veterinary medicinal product is drawn into syringe, administer immediately.

Where the veterinary medicinal product has been administered on food, discard unconsumed food immediately to avoid unintentional ingestion by other animals or persons in the household. Ingestion can be harmful to children and pregnant women.

seek medical advice immediately and show the package leaflet or the

Advice for Veterinarian :

The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated, before commencing treatment with the veterinary medicinal product. Dogs with evidence of liver dysfunction should not be treated with the veterinary medicinal product.

Any clinical suspicion of liver disease or dysfunction during treatment should be investigated through the evaluation of liver function. Because the veterinary medicinal product is contraindicated in cases

of liver dysfunction, any indication of progressive liver damage or dysfunction should result in the discontinuation of the treatment. Sporadic and mild serum alanine aminotransferase (ALT) elevations o 4 times the upper reference range are not a reason for discontinuing therapy in the absence of indication of liver dysfunction.

Pregnancy and lactation :

Do not use in dogs during pregnancy and lactation. MTP inhibitors (microsomal trigylyceride transfe protein inhibitors) as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental toxicity.

During treatment, because food intake is reduced as when using a traditional non-medical calori restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals supplied by the daily food ration meet minimal recommended requirements in order to ensure a complete and balanced nutritional supply.

In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the animals to maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term maintenance of the bodyweight.

If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment should be interrupted. Resolution of adverse reactions will occur shortly after the suspension of treatment. In case of excessive weight loss greater than 12% per month, the dose volume of the veterinary medicinal product should be reduced (by 25%).

Overdose up to 10 times the maximum authorised dose of 1 mg/kg current bodyweight may produce vomiting or diarrhoea or increased ALT/AST (alanine aminotransfera­te/aspartate aminotransferate) levels. These signs will resolve spontaneously following treatment discontinuation.

Interactions with other drug types have not been specifically investigated. Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be monitored closely.

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

  Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to disp help to protect the environment.

• 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 ).

• 15. OTHER INFORMATION