PROGRESSIS EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS)

ประเทศ: ไอร์แลนด์

ภาษา: อังกฤษ

แหล่งที่มา: HPRA (Health Products Regulatory Authority)

สารออกฤทธิ์:

INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN

มีจำหน่ายจาก:

Merial Animal Health Limited

รหัส ATC:

QI09AA05

INN (ชื่อสากล):

INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN

แบบฟอร์มเภสัชกรรม:

Emulsion for Injection

ประเภทใบสั่งยา:

POM: Prescription Only Medicine as defined in relevant national legislation

กลุ่มบำบัด:

Porcine

พื้นที่บำบัด:

porcine reproductive and respiratory syndrome (PRRS) virus

ข้อบ่งชี้ในการรักษา:

Immunological - Inactivated vaccine

สถานะการอนุญาต:

Authorised

วันที่อนุญาต:

2003-06-06

สรุปลักษณะสินค้า

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Progressis
Emulsion for injection for pigs (sows and gilts)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2-ml dose of vaccine contains:
ACTIVE SUBSTANCE:
Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS)
virus,
P120 strain
................................................................................................
2.5 log 10 IF* units.
*IF units: ImmunoFluorescence antibody titre obtained after 2
injections in pigs under specific laboratory conditions.
ADJUVANT:
O/w oily excipient (containing hydrogenated polyisobutene as adjuvant)
.... q.s. 1 dose of 2 ml.
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for Injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sows and gilts).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of the reproductive disorders caused by Porcine Reproductive
and Respiratory Syndrome virus (European
strain) in a contaminated environment:
vaccination reduces the number of early farrowings and the number of
still-
births.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In PRRS infected herds, viral infection is heterogeneous and varies
over time. In such context, the implementation of a
vaccination program is a tool to improve the reproductive parameters
and may contribute to the disease control in
conjunction with sanitary measures.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_