Nasym

Ülke: Avrupa Birliği

Dil: İngilizce

Kaynak: EMA (European Medicines Agency)

Aktif bileşen:

live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56

Mevcut itibaren:

Laboratorios Hipra S.A.

ATC kodu:

QI02AD04

INN (International Adı):

bovine respiratory syncytial virus vaccine (live)

Terapötik grubu:

Cattle

Terapötik alanı:

Immunologicals for bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV)

Terapötik endikasyonlar:

Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.

Ürün özeti:

Revision: 3

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2019-07-29

Bilgilendirme broşürü

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET:
NASYM LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION OR NASAL
SPRAY 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:
Laboratorios Hipra, S.A.
Avda. la Selva 135
Amer, 17170 (Girona)
Spain
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NASYM lyophilisate and solvent for suspension for injection or nasal
spray for cattle.
Live attenuated bovine respiratory syncytial virus, strain Lym-56.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml contains:
ACTIVE SUBSTANCE:
Live attenuated bovine respiratory syncytial virus, strain Lym-56
................... 10
4.7 - 6.5
CCID
50
*
*Cell culture infectious dose 50%
SOLVENT:
Phosphate buffer solution
Lyophilisate: Whitish freeze-dried lyophilisate.
Solvent: Homogeneous clear solution.
4.
INDICATION(S)
Active immunisation of cattle to reduce virus shedding and respiratory
clinical signs caused by
bovine respiratory syncytial virus infection.
Onset of immunity:
21 days after administration of one dose by the nasal route.
21 days after the second dose of the two-dose intramuscular
vaccination
schedule.
Duration of immunity:
2 months after nasal vaccination.
6 months after intramuscular vaccination.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
23
6.
ADVERSE REACTIONS
Slight alteration of faecal consistency may be commonly observed
post-vaccination.
Calves may uncommonly display a peak in temperature of at least 1.7
°C two days after
vaccination that resolves the next day without treatment.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less tha

Ürün özellikleri

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NASYM lyophilisate and solvent for suspension for injection or nasal
spray for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Live attenuated bovine respiratory syncytial virus (BRSV), strain
Lym-56 ..... 10
4.7 - 6.5
CCID
50
*
*Cell culture infectious dose 50%
Solvent:
Phosphate buffer solution
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection or nasal spray.
Lyophilisate: Whitish freeze-dried lyophilisate.
Solvent: Homogeneous clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce virus shedding and respiratory
clinical signs caused by
bovine respiratory syncytial virus infection.
Onset of immunity:
21 days after administration of one dose by the nasal route.
21 days after the second dose of the two-dose intramuscular
vaccination
schedule.
Duration of immunity:
2 months after nasal vaccination.
6 months after intramuscular vaccination.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet
or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Slight alteration of faecal consistency may be commonly observed
post-vaccination.
Calves may uncommonly display a peak in temperature of at least 1.7°C
two days after vaccination
that resolves the next day without treatment.
The frequency of adverse reactions is defined using the following
co