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Date: Saturday, June 15, 2024 0:55

Release 2.59
Enteroporc COLI AC lyophilisate and suspension for suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Enteroporc COLI AC lyophilisate and suspension for suspension for injection for
pigs
Product index: Enteroporc COLI AC lyophilisate and suspension for suspension for injection for
pigs
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (2 ml) contains:
Active substances: Lyophilisate:
Clostridium perfringens type A/C toxoids: alpha toxoid ≥ 125 rU/ml* beta1 toxoid ≥ 3354 rU/ml* beta2 toxoid ≥ 794 rU/ml*
Suspension: Inactivated fimbrial adhesins of Escherichia coli: F4ab ≥ 23 rU/ml* F4ac ≥ 19 rU/ml* F5 ≥ 13 rU/ml* F6 ≥ 37 rU/ml*
* toxoid and fimbrial adhesins content in relative units per ml, determined by ELISA against an internal standard Adjuvant: Aluminium (as hydroxide) 2.0 mg/ml For the full list of excipients, see Pharmaceutical Particulars.
Pharmaceutical form
Lyophilisate and suspension for suspension for injection. Beige to brown lyophilisate. Yellowish suspension.
Clinical particulars
Target species
Pigs (pregnant sows and gilts)
Indications for use, specifying the target species
For the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:
- Clinical signs (severe diarrhoea) and mortality caused by Escherichia coli strains expressing the fimbrial adhesins F4ab, F4ac, F5 and F6
- Clinical signs (diarrhoea during the first days of life) associated with Clostridium perfringens type A expressing alpha and beta2 toxins
- Clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by Clostridium perfringens type C expressing beta1 toxin
Onset of immunity (after uptake of colostrum):
E. coli F4ab, F4ac, F5, F6: within 12 hours after birth
C. perfringens type A and C: First day of life
Duration of immunity (after uptake of colostrum):
E. coli F4ab, F4ac, F5, F6: first days of life
C. perfringens type A: 14 days of life
C. perfringens types C: 21 days of life
Contraindications
None
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
Adverse reactions (frequency and seriousness)
A transient increase in body temperature (mean 0.5 °C, in individual pigs up to 2 °C) occurred very commonly on the day of vaccination which returned to normal within 24 hours. A transient swelling and redness at the injection site (mean 2.8 cm, in individual pigs up to 8 cm) was very commonly observed which disappeared without treatment within 7 days. A slightly depressed behaviour was commonly observed on the days of vaccination.
Use during pregnancy, lactation or lay
Can be used during pregnancy
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Intramuscular use. Inject one dose (2 ml) of vaccine into the neck muscles in the area behind the ear of each pig.
Vaccination scheme:
Primary vaccination:
First vaccination: one dose 5 weeks before the expected date of farrowing.
Second vaccination: one dose 2 weeks before the expected date of farrowing.
Revaccination (before each subsequent farrowing): one dose 2 weeks before the expected date of farrowing.
Preparation of the vaccine:
1. To reconstitute the vaccine, use an appropriately sized sterile syringe to withdraw approximately 5 ml of the suspension and transfer it into the vial containing the lyophilisate.
2. Shake gently until the lyophilisate is completely dispersed in the suspension.
3. Then withdraw all the contents of the lyophilisate vial into the same syringe and transfer them back into the suspension vial.
4. Shake well until thoroughly mixed.
5. Withdraw approximately 5 ml of the reconstituted vaccine suspension and transfer it into lyophilisate vial. Shake the vial. Then withdraw the contents and transfer them back into the vaccine suspension vial.
The vaccine is ready to use. The reconstituted vaccine is a yellowish brown to reddish brown suspension
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period(s)
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines. ATC vet code: QI09AB08.
The active immunisation of pregnant sows and gilts induces the formation of antibodies against the alpha, beta1 and beta2 toxins of C. perfringens types A and C and against E. coli fimbrial adhesins F4ab, F4ac, F5 and F6. The piglets are then passively immunised by the uptake of colostrum that contains those specific antibodies.
Efficacy of the vaccine has been demonstrated upon intraperitoneal challenge with a combination of alpha and beta2 toxins from C. perfringens type A. This toxin pattern is representative for the majority of C. perfringens type A isolates in the field associated with neonatal enteritis. Both toxins have been proposed to play a role in the pathogenesis.
Pharmaceutical particulars
List of excipients
Lyophilisate: Sucrose Suspension: Aluminium hydroxide Sodium chloride Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the suspension supplied for use with the veterinary medicinal product
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after reconstitution according to directions: 8 hours. Until use the reconstituted vaccine should be stored at 2-8 °C.
After removal of the reconstituted vaccine from storage at 2-8 °C, the vaccine should be used immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light. Do not freeze
Nature and composition of immediate packaging
Lyophilisate: 10 ml glass (type I) vials containing 10 or 25 doses
Suspension: 25 ml PET or glass (type I) vials containing 10 doses (20 ml) 50 ml PET or glass (type II) vials containing 25 doses (50 ml)
The vials are closed with bromobutyl rubber stoppers and sealed with aluminium crimp caps.
Pack sizes:
10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (20 ml) of suspension 10 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (20 ml) of suspension 25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 glass vial (50 ml) of suspension.
25 doses: Cardboard box containing 1 glass vial of lyophilisate and 1 PET vial (50 ml) of suspension Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK (GB) :Vm 15052/5002
UK (NI): Vm EU/2/20/262/001-004
Significant changes
Date of the first authorisation or date of renewal
09 December 2020
Date of revision of the text
October 2022
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:ENTEROPORC AC COLI 25D HR/GBIE
GTIN:03411113069254