Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

Yarvitan is a colourless to slightly yellow oral solution containing 5 mg/ml mitratapide. Other ingredients include sucralose, butylhydroxyanisole and polyethylene glycol.

Uses

As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight management programme which also includes appropriate dietary changes. Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.

Dosage and administration

Administer orally once daily

Dose

0.63 mg mitratapide/kg bodyweight (1 ml/8 kg). Use the dosing pipette as provided with the product. It is calibrated in kilograms.

Treatment schedule

Give for 2 periods of 21 days with a period of 14 days without treatment in between. (3 weeks-2 weeks-3 weeks)

During treatment

In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i.e. at the start of each treatment period). Treatment should be given with food. During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged. Thereafter, feeding should be in accordance with energy requirements for maintenance (to be calculated by the veterinarian). This can be achieved either with a regular pet food or with a low calorie (diet) pet food. Mitratapide therapy should be restricted to one treatment course for an individual dog.

Contra-indications, warnings, etc

Do not administer to dogs with impaired liver function Do not administer to dogs with hypersensitivy to the active substance or to any of the excipients. Do not administer to dogs during pregnancy and lactation. Do not administer to dogs less than 18 months of age. Do not administer to dogs whose overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism. The use in dogs for breeding purposes has not been evaluated. In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician. If accidental eye contact occurs, flush immediately with copious amounts of water.

Undesirable effects

A decreased appetite may occur during treatment. This is related to the mode of action of the product and should not be considered as an adverse event unless it becomes very significant. Vomiting, diarrhoea or softened stools may occur during treatment. In most cases, these effects are mild and transient. In case an adverse reaction repeatedly occurs or in case the dog stops eating for two consecutive days, treatment should be interrupted and the advice of a veterinary surgeon should be sought. Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal. In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid. In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose. In addition, hyperkalaemia was occasionally observed. Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.

The following adverse events were observed during clinical trials in 360 dogs during the 56 day treatment period (pooled data):

Clinical observation	Mitratapide	Placebo
Vomiting : occasional (< 3 x)	20.0 %	5.6 %
Vomiting : repeated (> 3 x)	10.0 %	2.2 %
Diarrhoea / soft stools	10.0 %	4.4 %
Anorexia / decreased appetite	17.8 %	10.0 %
Lethargy / weakness	5.2 %	2.2 %

Overdose

The following clinical signs were observed after overdosing by 3 to 5 times the recommended amount in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae. In case of accidental overdosing, symptomatic therapy should be administered. No specific antidote is available.

Disposal

Any unused product or waste material derived from this veterinary medicinal products should be disposed of in accordance with local requirements

Pharmaceutical precautions

Do not refrigerate. This veterinary medicinal product does not require any special storage conditions. After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly. For animal use only. Keep out of reach of children. Shelf-life after first opening the immediate packaging: 3 months.

Legal category

POM-V

Packaging Quantities

55 ml, 120 ml or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette. The dosing pipette has a gradation in body weight:

- up to 10 kg for the 55 ml bottle

- up to 22 kg for the 120 ml bottle

- up to 40 kg for the 210 ml bottle

Further information

Interactions with other drugs: No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril). Interactions with other drug types were not specifically investigated. The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated. Therefore, for dogs receiving treatments in addition to the product, drug interactions should be monitored closely.

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 continue the feeding for maintenance regimen after the end of treatment with the product. .

Marketing authorisation number

EU/2/06/063/001 (55 ml)

EU/2/06/063/002 (120 ml)

EU/2/06/063/003 (210 ml)

Significant Changes