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AstraZeneca

Velactis
cabergoline

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Medicinal product no longer authorised


PACKAGE LEAFLET FOR

Velactis 1.12 mg/ml solution for injection for cattle.


authorised

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


    Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale

    10 av. de La Ballastière 33500 Libourne FRANCE


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Velactis 1.12 mg/ml solution for injection for cattle. cabergoline


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    Each ml contains 1.12 mg of cabergoline. Clear pale yellow solution.


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  4. INDICATION


    For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to:

    • reduce milk leakage at drying off,

    • reduce the risk of new intramammary infections during the dry period,

    • reduce discomfort.


  5. CONTRAINDICATIONS


    Medicinal

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


  6. ADVERSE REACTIONS


    Slight injection site reactions (mostly swellings) were commonly observed after injection of the product and may persist for at least 7 days.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

    • common (more than 1 but less than 10 animals in 100 animals)

    • uncommon (more than 1 but less than 10 animals in 1,000 animals)

    • rare (more than 1 but less than 10 animals in 10,000 animals)

    • very rare (less than 1 animal in 10,000 animals, including isolated reports).


    If you notice any serious effects or any other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

  7. TARGET SPECIES


    Cattle (dairy cows)


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  8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION


    Intramuscular use.


    The recommended dose is 5.6 mg of cabergoline (corresponding to 5 ml of Velactis) per animal in one single injection at the day of drying-off after the last milking. The product should be injected within 4 hours after the last milking.


  9. ADVICE ON CORRECT ADMINISTRATION


    Normal aseptic procedures for administration of an intramuscular injection should be followed. Only use a dry sterile needle and avoid the introduction of humidity/water during use.


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  10. WITHDRAWAL PERIOD


    Meat and offal: 23 days

    Milk: - zero hours after calving when the dry period length is 32 days or more.

    - 4 days (8 milkings) after calving when the dry period length is less than 32 days


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  11. SPECIAL STORAGE CONDITIONS


    Keep out of the sight and reach of children.


    Do not use after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.


    This veterinary medicinal product does not require any special storage condition. Shelf-life after first opening the immediate packaging: 28 days.


    Medicinal

  12. SPECIAL WARNING(S)


    Velactis should be used as part of a comprehensive mastitis and milk quality control program under veterinarian advice which might include the need to use intramammary treatment.


    For cows considered likely to be free of subclinical mastitis at drying off, in which antibiotic use is not justified/permitted, Velactis can be used as a dry cow treatment. The cows should be diagnosed to be free of subclinical mastitis by using suitable criteria such as bacterial examination of milk, somatic cell count or other recognized tests.


    Special precautions for use in animals

    The product should only be used in dairy cows at the time of drying-off.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals

    The veterinary medicinal product may cause skin sensitisation and persons with a known

    hypersensitivity to cabergoline or any of the excipients should avoid contact with it.

    Pregnant or breastfeeding women and women attempting to conceive should avoid contact with the solution and should be prevented from an accidental self-injection. (There are no data on pregnancy outcome in humans following injection of cabergoline, but studies in laboratory animals have shown a risk for embryonic death following repeat oral exposure to cabergoline.)


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    authorised

    Administer the veterinary medicinal product with caution to avoid self-injection. In case of accidental self-injection, seek medical advice, and show this package leaflet or the label to the physician.

    Wash hands after use.


    Other precautions

    Cabergoline should not enter surface waters as it has harmful effects on aquatic species. Therefore, Velactis-treated cows should not be allowed to have access to open water, and should not contaminate watercourses with faeces until at least 5 days after administration.


    Use during pregnancy, lactation or lay

    Can be used during pregnancy. Velactis reduces milk production. Therefore, the product should only be administered to dairy cows at the time of drying-off.


    Interactions with other medicinal products and other forms of interaction

    In vitro, some macrolide antibiotics like erythromycin inhibited the activity of bovine Cytochrom P

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    450-enzymes (CYP3A4-subclass). This could theoretically decrease the metabolisation of cabergoline, and prolong its persistence in plasma from cows treated concomitantly with Velactis and such products. However, administration of tylosin concomitantly with Velactis in cows did not show any changes of Velactis pharmacokinetic properties.


    Overdose (symptoms, emergency procedures, antidotes), if necessary

    Overdoses resulted in some cases in slight and transient decrease of appetite. This was observed

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    following 1.5-2 times of the recommended dose and was more pronounced at higher doses. The administration of three or five times the recommended dose for 3 consecutive days (i.e.

    corresponding to 9 and 15 times the recommended dose, respectively) resulted in addition in some

    cases in transient and reversible digestive signs such as diarrhoea. At 9 times the recommended dose a decrease in ruminal activity may be observed. Fatal meteorism has been observed in a single cow following a second administration of 5 times the recommended dose. Three consecutive administrations of 1, 3 or 5 times the recommended dose may result in transient and reversible slight elevation of plasma glucose levels.


    Incompatibilities

    Medicinal

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


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


    Medicines should not be disposed of via wastewater or household waste. Velactis should not enter water courses as this may be dangerous for fish and other aquatic organisms.


    Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should 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


In a multicentric randomized clinical trial where dairy cows with no intramammary infections at the time of drying-off were administered either Velactis or placebo at the time of drying-off, the incidence of new intramammary infections within 7 days after subsequent calving was significantly lower among udder quarters of cows treated with Velactis (20.5%) as compared to placebo (26.0%). The difference percentage of new intramammary infections during the dry period between Velactis treated animals and the placebo group was 5.5% (95% confidence interval 0.5-10.4%). The efficacy of Velactis in reducing the risk of new intramammary infections during the dry period when administered concomitantly with antimicrobial treatment to cows with intramammary infections has not been investigated compared to antimicrobial treatment alone.


In the same study, incidence of milk leakage was significantly lower among Velactis treated animals (2.0%) as compared to placebo treated animals (10.7%). The difference between groups was 8.7% (95% confidence interval 4.9-12.6%).This was confirmed in another multicentric randomized clinical trial where incidence of milk leakage was significantly lower among Velactis treated animals (3.9%) as compared to placebo treated animals (17.6%). The difference between groups was 13.7% (95% confidence interval 6.4-21%).


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In a randomized and placebo controlled clinical study Velactis treated cows presented less signs of udder pain in comparison with controls on the first two days after drying-off. The difference in occurrence of pain was 9.9% (95% confidence interval 4-15.8%) between the Velactis treated cows compared to placebo treated animals. In a randomized and placebo controlled clinical study, reduced discomfort was demonstrated during the first day after drying-off by increasing daily lying time by 143 +/- 17 minutes in Velactis treated animals in comparison with untreated controls.



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Pack sizes


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Medicinal

Cardboard box with 1 vial of 5 ml, 25 ml or 50 ml, or 5 vials of 5 ml. Not all pack sizes may be marketed.