Patient leaflet - Yarvitan
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13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND US E, i f app l icable
For animal treatment only – to be supplied only on veterinary prescription.
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14. THE WORDS “KEEP OUT OF THE REA CH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
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15. NAME AND ADDRESS OF THE MAR KETING AUTHORISATION HOLDER
Janssen Pharmaceutica N.V. B-2340 Beerse, Belgium
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16. MARKETING AUTHORISATION NUMBER(S)
EU/0/00/000/001 55 ml\
EU/0/00/000/002 120 ml
EU/0/00/000/003 210 ml
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17. MANUFACTURER’S BATCH NUMBER
Lot
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT
LABEL AMBER GLASS BOTTLE 55 ML
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Yarvitan 5 mg/ml oral solution for dogs
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2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Mitratapide 5 mg/ml
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10. EXPIRY DATE
EXP:
Once opened, use within 3 months.
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11. SPECIAL STORAGE CONDITIONS
Do not refrigerate
S OR
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12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED P WASTE MATERIALS, IF ANY
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13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE,ble
HT OF CHILDREN
For animal treatment only – to be supplied only on veterinary pr
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14. THE WORDS “KEEP OUT OF THE REACH
AUTHORISATION HOLDER
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15. NAME AND ADDRESS OF THE MAR
Janssen Pharmaceutica N.V. B-2340 Beerse, Belgium
UMBER(S)
Lot:
EU/0/00/000/002
EU/0/00/000/003
120 ml
210 ml
16. MARKETING AUTHORISA
17. MANUFACTURER’
TCH NUMBER
PACKAGE LEAFLET
Yarvitan 5 mg/ml oral solution for dogs
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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.
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Yarvitan 5 mg/ml oral solution for dogs
Mitratapide
Yarvitan is indicated as an aid i treatment is part of an overall programme. Introducing appropri this weight management progr
Do not administer Y
Mitratapide 5 mg/ml
Butylated hydroxyanisole (E 320)
Yarvitan is a colourless to slightly
4. INDICATION(S)
5. CONTRAINDIC
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) management of overweight and obesity in adult dogs. The anagement programme which also includes a nutrition style changes (e.g. increased exercise), in conjunction with may provide additional benefits.
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6. ADVERSE REACTIONS
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. repeatedly occurs or in case the dog stops eating for two consecutive days, sto Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as 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.
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7. TARGET SPECIES
Dogs.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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 |
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9. ADVICE ON CORRECT ADMINISTRATION
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.
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 y the type of food your dog will need. This can be achieved either with a regular pet food or with calorie (diet) pet food.
imen
In order to avoid rebound weight gain, it is necessary to continue the feeding for mainten after the end of treatment with the product.
Mitratapide therapy should be restricted to one treatment course for an individual do
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not refrigerate.
This veterinary medicinal product does not require any special s Do not use after the expiry date stated on the label and carton ( Shelf-life after first opening the container: 3 months.
nditions.
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12. SPECIAL WARNING(S)
Special precautions for use in animals
The safety of the veterinary medicinal lactation. The use in dogs for breeding pu
product has not been established during pregnancy and oses has not been evaluated.
Please inform your veterinary surgeon if even those not prescribed. No drug i administered concomitantly with NSA benazepril). The absorption of li
investigated. Your veterinary addition to the product.
su
g is taking or has recently taken any other medicines, ions were observed in studies where Yarvitan was Ds (carprofen, meloxicam) or ACE inhibitors (enalapril, le drugs used concomitantly with mitratapide has not been ould monitor closely the intake of any other medicines in
In case vomiting, diarrhoea, consecutive days, stop t veterinary surgeon as recommended that wh
g stools repeatedly occurs or in case the dog stops eating for two inistration of Yarvitan to your dog and seek the advice of your s possible. Where treatment is interrupted due to vomiting, it is ent is resumed, the product should be administered after a meal. In
addition, treatment observed body wei
be interrupted and the advice of a veterinarian should be sought where the is severe and rapid.
In case of accidental overdosing, symptomatic therapy should be administered. No specific antidote is available.
Special animal
In case leaflet o f accid
ns to be taken by the person administering the veterinary medicinal product to
f accidental self-administration, seek medical advice immediately and show the package the label to the physician.
tal eye contact occurs, flush immediately with copious amounts of water.
Medicines should not be disposed of via wastewater or household waste.
07/2007
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPR
15. OTHER INFORMATION
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WAS MATERIALS, IF ANY
edicines Agency
120ml: < 22 kg bodyweight,
Ask your veterinary surgeon how to dispose of medicines no longer required. These meas help to protect the environment.
Detailed information on this product is available on the website of the Eur (EMEA)
Pack sizes – amber glass bottles containing : 55ml: < 10 kg bod 210ml: < 40 kg bodyweight.
Not all pack sizes may be marketed.
20/20