Porcilis ColiClos

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Clostridium perfringens, Escherichia coli

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI09AB08

INN (שם בינלאומי):

Clostridium perfringens, Escherichia coli

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

Inactivated Bacterial Vaccine

מצב אישור:

Authorized

תאריך אישור:

2012-06-14

מאפייני מוצר

Revised February 2024
AN: 03111/2022
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-α-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 suspension.
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.
Revised February 2024
AN: 03111/2022
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)
Pigs