Bovalto Ibraxion
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-08-2019
Charakterystyka produktu
(SPC)
13-08-2019
Sprawozdanie z oceny publicznego
(PAR)
13-08-2019
Składnik aktywny:
inactivated IBR virus
Dostępny od:
Merial
Kod ATC:
QI02AA03
INN (International Nazwa):
Infectious bovine rhinotracheitis vaccine (inactivated)
Grupa terapeutyczna:
Cattle
Dziedzina terapeutyczna:
Immunologicals for bovidae
Wskazania:
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion., The onset of immunity is 14 days and the duration of immunity is 6 months.,
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-03-09
Ulotka dla pacjenta
Medicinal product no longer authorised
15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET FOR
BOVALTO IBRAXION EMULSION FOR INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
MERIAL
29 avenue Tony Garnier -69007 Lyon
France
Manufacturer responsible for batch release
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation-69800 Saint Priest
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovalto Ibraxion emulsion for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each dose (2 ml) contains:
gE deleted inactivated IBR virus, at least
.............................................................................
0.75 VN.U*
adjuvant: light paraffin oil
...........................................................................................
449.6 to 488.2 mg
* VN.U: Vironeutralising antibody titre after vaccine injection in
guinea pigs.
4.
INDICATION(S)
Active immunisation of cattle to reduce the clinical signs of
infectious bovine rhinotracheitis (IBR)
and field virus excretion.
Onset of immunity: 14 days
Duration of immunity: 6 months.
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
The injection of the vaccine may cause a transient tissue reaction at
the site of injection, which may
persist for three weeks and rarely up to five weeks.
The vaccination may cause a slight rise in body temperature (less than
1°C) for a transient period (less
than 48 hours after injection) without any consequence to the health
or performance of the animal.
A hypersensitivity reaction may occur. These are rare and an
appropriate symptomatic treatment
should be administered.
Medicinal product no longer authorised
17
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
Przeczytaj cały dokument
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
Bovalto Ibraxion emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each dose of 2 ml contains:
gE deleted inactivated IBR virus, at least
.............................................................................
0.75 VN.U*
* VN.U: Vironeutralising antibody titre after vaccine injection in
guinea pigs.
ADJUVANT
light paraffin oil
..........................................................................................................
449.6 to 488.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce the clinical signs of
infectious bovine rhinotracheitis (IBR)
and field virus excretion.
Onset of immunity: 14 days
Duration of immunity: 6 months.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Medicinal product no longer authorised
3
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 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 more than 12 hours
after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small
amounts have been injected,
accidental injection
Przeczytaj cały dokument
