Velactis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-01-2021
Charakterystyka produktu
(SPC)
25-01-2021
Sprawozdanie z oceny publicznego
(PAR)
25-01-2021
Składnik aktywny:
cabergoline
Dostępny od:
Ceva Santé Animale
Kod ATC:
QG02CB03
INN (International Nazwa):
cabergoline
Dziedzina terapeutyczna:
Prolactine inhibitors, Genito urinary system and sex hormones, Other gynecologicals
Wskazania:
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.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-12-09
Ulotka dla pacjenta
Medicinal product no longer authorised
14
B. PACKAGE LEAFLET
Medicinal product no longer authorised
15
PACKAGE LEAFLET FOR
Velactis 1.12 mg/ml solution for injection for cattle.
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.
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
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.
Medicinal product no longer authorised
16
7.
TARGET SPECIES
Cattle (dairy cows)
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Intramuscular use.
The recommended dose is 5.6 mg of cabergoli
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Velactis 1.12 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Cabergoline
.......................................................................
1.12 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cows)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to cabergoline or to any of the
excipients.
4.4
SPECIAL WARNINGS
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.
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 in percentage of new intramammary infections during the dry
period between Velactis
tr
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