Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

F4ab (K88ab) fimbrial adhesin, F4ac (K88ac) fimbrial adhesin, F5 (K99) fimbrial adhesin, F6 (987P) fimbrial adhesin, LT toxoid

Available from:

Intervet International BV

ATC code:

QI09AB02

INN (International Name):

vaccine to provide passive immunity to the progeny against E. coli in pigs

Therapeutic group:

Pigs (gilts and sows)

Therapeutic area:

Immunologicals

Therapeutic indications:

For the passive immunisation of piglets by active immunisation of sows / gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

1996-02-29

Patient Information leaflet

B. PACKAGE LEAFLET
20/23
PACKAGE LEAFLET FOR
PORCILIS PORCOLI DILUVAC FORTE
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Porcoli Diluvac Forte suspension for injection
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Each dose of two ml contains the F4ab (K88ab) fimbrial adhesin, the
F4ac (K88ac) fimbrial adhesin,
the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and of
LT toxoid, which induce a mean
antibody titre of respectively
≥
9.0 log
2
Ab titre,
≥
5.4 log
2
Ab titre,
≥
6.8 log
2
Ab titre,
≥
7.1 log
2
Ab
titre, and 6.8 log
2
Ab titre after vaccination of mice with a 1/20 sow dose. The antigens
are adjuvanted
with 150 mg dl-
α
-tocopherol acetate per dose.
4.
INDICATION(S)
For the passive immunisation of piglets by active immunisation of
sows/gilts to reduce mortality and
clinical signs such as diarrhoea due to neonatal enterotoxicosis
during the first days of life, caused by
those
_E.coli_
strains
_,_
which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5
(K99) or F6
(987P).
5.
CONTRA-INDICATIONS
None
6.
ADVERSE REACTIONS
A mean transient increase in body temperature of about 1°C, in some
pigs up to 3
o
C, may occur in the
first 24 hours after vaccination. Reduced feed intake and listlessness
may occur in approximately 10%
of the animals on the day of vaccination, but returns to normal within
1-3 days. A transient swelling
and redness at the injection site may be observed in approximately 5%
of the animals. The diameter of
the swelling is in general below 5 cm, but in some cases a larger size
swelling may occur. Swelling
and redness at the injection site may occasionally last for at least
14 days.
If you notice any other side effects, please inform your veterinary
surgeon.
7.
TARGET SPECIES
Pigs (sows/gilts)
21/23
8.
DOSAGE FO

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1/23
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Porcoli
DILUVAC FORTE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of two ml:
ACTIVE SUBSTANCES:
- F4ab (K88ab) fimbrial adhesin
≥
9.0 log
2
Ab titre
1
- F4ac (K88ac) fimbrial adhesin
≥
5.4 log
2
Ab titre
1
- F5 (K99) fimbrial adhesin
≥
6.8 log
2
Ab titre
1
- F6 (987P) fimbrial adhesin
≥
7.1 log
2
Ab titre
1
- LT toxoid
≥
6.8 log
2
Ab titre
1
1
Mean antibody titre (Ab) obtained after vaccination of mice with a
1/20 sow dose.
ADJUVANT:
dl-
α
-tocopherol acetate
150 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
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 piglets by active immunisation of
sows/gilts to reduce mortality and
clinical signs such as diarrhoea due to neonatal enterotoxicosis
during the first days of life, caused by
those
_E.coli_
strains
_,_
which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5
(K99) or F6
(987P).
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
2/23
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Before using the vaccine allow it to reach room temperature (15-25
°
C) and shake well before use.
Use sterile syringes and needles.
Avoid introduction of contamination.
Vaccinate only healthy animals.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
In the case of accidental self-injection, seek medical advice
immediately and show the package leaflet
or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A mean transient increase in body temperature of about 1°C, in some
pigs up to 3°C, may occur in the
first 24 hours after vaccination. Reduced feed intake and listlessness
may occur in approximately 10%
of the animals on the day of vaccination, but returns to normal within
1-3 days. A transient swel