Eravac
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
17-08-2021
Данни за продукта
(SPC)
17-08-2021
Доклад обществена оценка
(PAR)
05-02-2020
Активна съставка:
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037
Предлага се от:
Laboratorios Hipra, S.A.
АТС код:
QI08AA
INN (Международно Name):
Rabbit haemorrhagic disease vaccine (inactivated)
Терапевтична група:
Rabbits
Терапевтична област:
Inactivated viral vaccines
Терапевтични показания:
For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2)
Каталог на резюме:
Revision: 6
Статус Оторизация:
Authorised
Дата Оторизация:
2016-09-22
Листовка
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
CARTON
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAVAC emulsion for injection for rabbits.
2.
STATEMENT OF ACTIVE SUBSTANCES
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain
V-1037 …..≥70% cELISA40*
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres
equal to or higher than 40.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
PACKAGE SIZE
10 x 1 dose (0.5 ml)
1 x 10 doses (5 ml)
1 x 40 doses (20 ml)
1 x 200 doses (100 ml)
_ _
_ _
5.
TARGET SPECIES
Rabbits
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Shake well before administration.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD(S)
Withdrawal period(s): Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Accidental injection is dangerous.
12
10.
EXPIRY DATE
EXP {month/year}
Once broached use immediately.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
_ _
Keep the vial(s) in the outer carton in order to protect from light.
12.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read the package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only.
To be supplied only on veterinary prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Laboratorios Hipra S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/16/199/001 (5 ml)
EU/2/16/199/002 (20 ml)
EU/2/16/199/003 (0.5 ml)
EU/2/16/199/004 (100 ml)
17.
MANUFACTURER’S BATCH NUMBER
Batch{number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial label (1, 10, 40 or 200 doses)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAVAC emulsion for injection for rabbits
2.
QUANTITY O
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Данни за продукта
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAVAC emulsion for injection for rabbits.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml contains:
ACTIVE SUBSTANCE:
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2),
strainV-1037……≥70% cELISA40*
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres
equal to or higher than 40.
ADJUVANT:
Mineral oil…………104.125 mg
EXCIPIENTS:
Thiomersal…………0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Whitish emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits from the age of 30 days to reduce
mortality caused by the rabbit
haemorrhagic disease type 2 virus (RHDV2).
Onset of immunity: 1 week.
Duration of immunity: 12 months demonstrated by challenge
_ _
_ _
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvant or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine provides protection only against RHDV2, cross protection
against classical RHDV has
not been demonstrated.
Vaccinate healthy animals only.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccination is recommended where RHDV2 is epidemiologically relevant.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-injection may result
in severe pain and swelling, particularly if injected into a joint or
finger, and in rare cases could result
in the loss of the affected finger if prompt medical attention is not
given. If you are accidentally
injected with this veterinary medicinal product, seek prompt medical
advice even if only a very small
amount is injected and take the package leaflet with you. If pain
persists for
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