Porcilis ColiClos

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Clostridium perfringens, Escherichia coli

متاح من:

MSD Animal Health UK Limited

ATC رمز:

QI09AB08

INN (الاسم الدولي):

Clostridium perfringens, Escherichia coli

الشكل الصيدلاني:

Suspension for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Pigs

المجال العلاجي:

Inactivated Bacterial Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2012-06-14

خصائص المنتج

Issued: April 2022
AN: 02836/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ColiClos suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
_Escherichia coli _components:
- F4ab fimbrial adhesin

9.7 log
2
Ab titre
1
- F4ac fimbrial adhesin

8.1 log
2
Ab titre
1
- F5 fimbrial adhesin

8.4 log
2
Ab titre
1
- F6 fimbrial adhesin

7.8 log
2
Ab titre
1
- LT toxoid

10.9 log
2
Ab titre
1
_Clostridium perfringens_ component:
- Type C (strain 578) beta toxoid
≥20 IU
2
1
Mean antibody titre (Ab) obtained after vaccination of mice with a
1/20 or 1/40 sow
dose
2
International units of beta antitoxin according to Ph. Eur.
ADJUVANT:
dl-

-tocopheryl acetate
150 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
Aqueous, white to nearly white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive immunisation of progeny by active immunisation of sows
and gilts to
reduce mortality and clinical signs during the first days of life,
caused by those _E. coli_
strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5
(K99) or F6
(987P) and caused by _C. perfringens_ type C.
Issued: April 2022
AN: 02836/2021
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Protection of piglets is achieved by colostrum intake. Therefore, care
should be taken
to ensure that each piglet ingests a sufficient quantity of colostrum.
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)
_In laboratory studies