Slentrol
dirlotapide
15
authorised
no
Medicinal
Medicinal product no longer authorised
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
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
Slentrol 5 mg/ml oral solution for dogs Dirlotapide
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.
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.
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
Medicinal product no longer authorised
vomiting event and up to 12% showed any of the other signs) and decreased continuously during the course of treatment. Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average). If your dog suffers from repeated vomiting, diarrhoea or significantly reduced appetite and excessive weight loss, you should consult your veterinary surgeon who may advise you to stop therapy.
Sporadic and mild ALT (alanine aminotransferase) elevations up to 4 times the upper reference range and not associated with histopathological liver lesions or noticeable changes in other liver parameters may be observed in some dogs during the course of treatment.
On rare occasions, reports of change of behaviour such as polyphagia, or very rarely reports of aggression associated with food and feeding have been observed in Slentrol-treated dogs. If these changes were observed, treatment should be stopped.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Dogs.
Advice for Dog Owner
The veterinarian will examine your dog at the beginning of treatment and recommend a starting dose. The veterinarian will advise you when dose adjustments become necessary.
Advice for Veterinarian
The recommended starting dose of Slentrol is 0.05 mg/kg (0.01ml/kg) by oral administration. After two weeks of therapy, the initial dose volume should be doubled. Following these initial 4 weeks of therapy, dose adjustments are made monthly according to effect as described in section 9.
Advice for Dog Owner
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.
Medicinal product no longer authorised
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 to 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 LOSS | |||
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 x 2 | |
3 (conditional) | First monthly weighing where bodyweight loss < 3% per month since previous weighing | Dose 3 = Dose 2 x 2 | |
4 (conditional) | Second monthly weighing where bodyweight loss < 3% per month since previous weighing | Dose 4 = Dose 3 x 1.5 | |
5 (conditional) | Third monthly weighing where bodyweight loss < 3% per month since previous weighing | Dose 5 = Dose 4 x 1.5 | |
6 (conditional) | Fourth monthly weighing where bodyweight loss < 3% per month since previous weighing | Dose 6 = Dose 5 x 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.
Not applicable
Medicinal product no longer authorised
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 bottle. Shelf life after first opening the container: 3 months
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.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
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 up to 4 times the upper reference range are not a reason for discontinuing therapy in the absence of any indication of liver dysfunction.
Medicinal product no longer authorised
Pregnancy and lactation:
Do not use in dogs during pregnancy and lactation. MTP inhibitors (microsomal trigylyceride transfer 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 calorie 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.
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency (/).
Polypropylene bottles of 20, 50 and 150 ml fitted with a low density polyethylene (LDPE) Press-In-bottle adapter and a child resistant closure.
Bottles of 20 ml are packed with two dosing devices of 1 ml.
Bottles of 50 ml are packed with two dosing devices of 3 ml. Bottles of 150 ml are packed with two dosing devices of 10 ml.
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.
Medicinal product no longer authorised
Zoetis Belgium SA
Tél/Tel.: +32 (0)2 746 81 78
Zoetis Lietuva UAB Tel: +370 525 12029
Zoetis Luxembourg Holding Sarl Teл: +359 2 970 41 72
Zoetis Belgium SA
Tél/Tel.: +32 (0)2 746 81 78
Zoetis Česká republika, s.r.o.
Tel: +420 283 004 111
Orion Pharma Animal Health Tlf: +45 49 12 67 65
Agrimed Limited Tel: +356 21 465 797
Zoetis Deutschland GmbH
Tel: +49 30 330063 0
Zoetis B.V.
Tel: +31 (0)10 4064 600
Zoetis Lietuva UAB
Tel: +370 525 12029
Orion Pharma Animal Health Tlf: +47 40 0041 90
Zoetis Hellas S.A.
Τηλ.: +30 210 6785800
Zoetis Österreich GmbH
Tel: +43 1 2701100 110
Zoetis Spain, S.L.
Tel: +34 91 4909900
Zoetis Polska Sp. z o.o.
Tel: +48 22 335 61 40
Zoetis France
Tél: +33 (0)1 58 07 46 00
Zoetis Portugal, Lda. Tel: +351 21 423 55 00
Zoetis Netherlands Holdings BV
Tel: +385 1 644 1460
Zoetis România SRL
Tel: +40 21 207 17 70
Zoetis Ireland Limited
Tel: +353 (0) 1 467 6650
Zoetis Luxembourg Holding Sarl
Tel: +386 (0) 1 52 11 670
Icepharma hf.
Sími: +354 540 80 00
Zoetis Luxembourg Holding Sarl, o.z. Tel: +421 2 5939 6190
Zoetis Italia S.r.l.
Tel: +39 06 3366 8133
Zoetis Finland Oy
Puh/Tel: +358 (0)9 4300 40
Zoetis Hellas S.A. Τηλ.: +30 210 6785800
Orion Pharma Animal Health Tel: +46 (0)8 623 64 40
Medicinal product no longer authorised
Zoetis Lietuva UAB Tel: +370 525 12029
Zoetis UK Limited
Tel: +44 (0) 845 300 8034