CANIXIN Pi/L lyophilisate and suspension for suspension for injection for dogs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated

Sẵn có từ:

Virbac S.A.

Mã ATC:

QI07AI08

INN (Tên quốc tế):

Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated

Liều dùng:

.

Dạng dược phẩm:

Lyophilisate and suspension for suspension for injection

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Dogs

Khu trị liệu:

live canine parainfluenza virus + inactivated leptospira

Chỉ dẫn điều trị:

Immunological

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2017-04-13

Đặc tính sản phẩm

Health Products Regulatory Authority
31 January 2022
CRN00CHWY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIXIN Pi/L lyophilisate and suspension for suspension for injection
for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Lyophilisate:
Live attenuated canine parainfluenza virus (CPiV), Manhattan strain
10
4.8
-
10
6.9
CCID
50
*
* Cell culture infectious dose 50%
Suspension:
Inactivated _Leptospira interrogans_:
- serogroup Canicola serovar Canicola, strain 601903 4350 - 7330 U**
- serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain
601895 4250 - 6910 U**
** Antigenic mass ELISA units
EXCIPIENTS
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Lyophilisate: White lyophilisate.
Suspension: Translucent liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs from 8 weeks of age to:
- reduce respiratory clinical signs and viral excretion caused by
canine parainfluenza virus;
- prevent mortality and reduce infection, clinical signs, kidney
colonisation, renal lesions and urine shedding of _Leptospira _
Canicola;
- reduce infection, clinical signs, kidney colonisation and urine
shedding of _Leptospira_ Icterohaemorrhagiae;
Onset of immunity:
The onset of immunity has been demonstrated from 4 weeks after the
primary vaccination for CPiV, 5 weeks for _Leptospira_
Canicola and 2 weeks for _Leptospira_ Icterohaemorrhagiae_._
Duration of immunity:
The duration of immunity lasts for one year after the primary
vaccination for all components.
In the one-year duration of immunity studies there was no significant
difference between vaccinated and control dogs in viral
excretion for CPiV, in reduction of kidney colonisation for
_Leptospira_ Canicola and _Leptospira_ Icterohaemorrhagiae, nor in
renal
lesions and urine shedding for _Leptospira_ Canicola.
4.3