Yarvitan
mitratapide
16/20
authorised
no
Medicinal
Medicinal product no longer authorised
Read all of this leaflet carefully before you start administering the medicine to your dog:
Keep this leaflet. You may need to read it again
If you have further questions, please ask your veterinary surgeon or your pharmacist
This medicine has been prescribed for your dog only and you should not pass it on to others.
Janssen Pharmaceutica N.V. Turnhoutseweg 30
B-2340 Beerse Belgium
Yarvitan 5 mg/ml oral solution for dogs Mitratapide
Mitratapide 5 mg/ml
Butylated hydroxyanisole (E 320)
Yarvitan is a colourless to slightly yellow solution.
Yarvitan is indicated as an aid in the management of overweight and obesity in adult dogs. The treatment is part of an overall weight management programme which also includes a nutrition programme. Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Do not administer Yarvitan:
if your dog has impaired liver function.
if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients.
if your dog is pregnant or during lactation.
in dogs less than 18 months of age.
if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism.(this is due to a malfunction of the adrenal gland).
Medicinal product no longer authorised
Tell your veterinary surgeon if you notice any of the following:
significant loss of appetite. Loss of appetite may occur during treatment. This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days).
vomiting
diarrhoea
softened stools
In most of the cases, these side effects are mild and do not last very long. In case a side effect repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible. 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. Generally, the severity of these effects increased with increasing dose. Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs.
Always administer Yarvitan exactly as your veterinary surgeon has instructed you. You should check with your veterinary surgeon if you are unsure. The usual dose is once daily 0.63 mg mitratapide/kg bodyweight (1 ml of the product per 8 kg). The dosing pipettes provided with the product show graduations corresponding to the correct body weight of the dog.
Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Day 1-21 | Day 22-35 | Day 36-56 |
treatment | no treatment | treatment |
normal feeding | nutrition programme | nutrition programme |
In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Use the dosing pipette as provided with the product. Fill the syringe by pulling the plunger until it reaches the mark on the dosing pipette corresponding to the correct body weight of the dog.
Treatment should be given with food. Therefore, administer the product with the syringe onto a portion of the food. Once the dog has eaten the complete portion, give the remaining amount of food to the dog.
After each dose, the syringe should be removed from the bottle. The pipette should be washed and dried and the cap should be screwed back on tightly.
Medicinal product no longer authorised
During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged. Thereafter, your dog should follow a nutrition programme. Your veterinary surgeon will advise you on the type of food your dog will need. This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
In order to avoid rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Mitratapide therapy should be restricted to one treatment course for an individual dog.
Not applicable.
Keep out of the reach and sight of children. Do not refrigerate.
This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date stated on the label and carton (EXP.).
Shelf-life after first opening the container: 3 months.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use in dogs for breeding purposes has not been evaluated.
Please inform your veterinary surgeon if your dog is taking or has recently taken any other medicines, even those not prescribed. No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril). The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated. Your veterinary surgeon should monitor closely the intake of any other medicines in addition to the product.
In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible. 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 case of accidental overdosing, symptomatic therapy should be administered. No specific antidote is available.
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.
Medicinal product no longer authorised
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.
07/2007
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) https://www.emea.europa.eu/
Pack sizes – amber glass bottles containing : 55ml: 10 kg bodyweight, 120ml: 22 kg bodyweight, 210ml: 40 kg bodyweight.
Not all pack sizes may be marketed.