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Date: Saturday, May 18, 2024 14:44

Description: MSD-AH
Release 3.82
Porcilis® Porcoli Diluvac Forte
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® Porcoli Diluvac Forte
Product index: Porcilis® Porcoli
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Inactivated vaccine containing per dose (2 ml):≥9.0 log2 Ab titre1 F4ab (K88ab) fimbrial adhesion; ≥5.4 log2 Ab titre1 F4ac (K88ac) fimbrial adhesion; ≥6.8 log2 Ab titre1 F5 (K99) fimbrial adhesion; ≥7.1 log2 Ab titre1 F6 (987P) fimbrial adhesion; ≥6.8 log2 Ab titre1 LT toxoid. The vaccine also contains 150 mg dl-α-tocopherol acetate as an adjuvant.
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose.
For a full list of excipients see section 'Pharmaceutical particulars'.
Pharmaceutical form
Suspension for injection
Clinical particulars
Target species
Pigs (sows and gilts).
Indications for use
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).
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
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.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Adverse reactions
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 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 swelling may occur. Swelling and redness at the injection site may occasionally last for at least 14 days.
Use during pregnancy or lactation
The vaccine can be used during pregnancy.
Interactions
No information is available on the safety and efficacy from concurrent use of this vaccine with any other. It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with this product.
Amounts to be administered and administration route
Intramuscular injection in sows/gilts of 2 ml of the vaccine per animal in the neck in the area behind the ear.
Vaccination scheme:
Basic vaccination: Sows/gilts which have not yet been vaccinated with the product shall be given an injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4 weeks later.
Revaccination: A single revaccination shall be carried out during the second half of each subsequent pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.
Overdose
No undesirable effects other than those observed and mentioned in the “Adverse reactions” section have been observed.
Withdrawal period
Zero days.
Pharmacological particulars
ATC vet code: QI09AB02.
Pharmacotherapeutic group
Inactivated bacterial vaccine.
Vaccine to stimulate active immunity of sows/gilts in order to provide passive immunity to their progeny against E. coli strains that express the fimbrial adhesins F4ab, F4ac, F5 and F6.
The fimbrial adhesins F4ab, F4ac, F5, and F6 are responsible for the adhesion and the virulence of E.coli strains, which cause neonatal enterotoxicosis in piglets. These immunogens are incorporated in an adjuvant in order to enhance a prolonged stimulation of immunity. Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts.
Pharmaceutical particulars
Excipients
Polysorbate 80
Potassium Chloride
Potassium Dihydrogen Phosphate
Simethicone emulsion
Sodium chloride
Disodium Phosphate Dihydate
dl-alpha-Tocopherol Acetate
Water for injection
Major incompatibilities
Do not mix with any other vaccine or immunological product.
Shelf life
Shelf life: 2 years.
Shelf-life after first opening: 3 hours.
Special precautions for storage
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Immediate packaging
Cardboard box with 1 glass (hydrolytic type I) or 1 PET vial of 20, 50 or 100 ml with a halogenobutyl rubber stopper and a coded aluminium cap.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB) Vm 01708/5058
UK(NI): EU/2/96/001/003-008
Significant changes
Date of the first authorisation or date of renewal
10 April 2006.
Date of revision of the text
21st January 2019
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Porcilis Porcoli DF 1x20ml:
GTIN:08713184049575,
GTIN description:Porcilis Porcoli DF 1x50ml:
GTIN:08713184049889