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Date: Thursday, June 13, 2024 18:07

Release 12.307
Entericolix, emulsion for injection for pigs
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Entericolix, emulsion for injection for pigs
Product index: Entericolix
Pig - meat: Zero days
Incorporating:
Presentation
Milky white homogenous emulsion for injection. One dose (2ml) of the inactivated vaccine contains:
Active substances:
Escherichia coli strain P4 (F6 adhesins), ≥ 1 RP*
Escherichia coli strain P5 (F18ab adhesins), ≥ 1 RP *
Escherichia coli strain P6 (F4ac adhesins), ≥ 1 RP *
Escherichia coli strain P9 (F18ac adhesins), ≥ 1 RP*
Escherichia coli strain P10 (F5 + F41 adhesins), ≥ 1 RP*
beta toxoid of Clostridium perfringens Type C (CZV13) ≥ 10 IU** of β antitoxin/ml of rabbit serum
* RP: Relative potency for each antigen according to a reference vaccine with satisfactory result in the immunogenicity test (Ph. Eur. monograph 0962).
** IU: International units of beta toxin (Ph. Eur. monograph 0363)
Adjuvant:
Light mineral oil 0.760 ml
Montanide 103 0.0425 ml
Sorbitan oleate 0.0425 ml
Excipients:
Thiomersal 0.2 mg
Uses
Vaccination of sows and gilts for the passive immunization of piglets against colibacillosis caused by enteropathogenic and enterotoxigenic E. coli strains expressing F4ac, F5, F6, F18ac and F41 adhesins, against oedema disease caused by E. coli strain expressing F18ab adhesin and against necrotic enteritis caused by C. perfringens type C.
Neonatal piglets
- The vaccine reduces mortality and clinical signs (severe diarrhoea) due to colibacillosis.
- The vaccine reduces mortality and clinical signs due to necrotic enteritis caused by C. perfringens type C.
Weaned piglets
- The vaccine reduces mortality and clinical signs due to oedema disease
- The vaccine reduces clinical signs (severe diarrhoea) of colibacillosis
- The vaccine reduces clinical signs of chronic enteritis due to C. perfringens type C
Duration of immunity:
− 21 days for infections caused by F4ac, F18ac (colibacillosis) and Clostridium perfringens type C (necrotic enteritis)
− 21 days for antibodies against F5, F6 and F41, however the protective efficacy of the antibody levels was not established
− 28 days for infections caused by F18ab (oedema disease)
Dosage and administration
Intramuscular use.
Shake vigorously before use and at intervals during use. Avoid introduction of contamination during use.
Doses: Sows and gilts: 2 ml.
Before use, allow the vaccine to reach room temperature and shake the bottle vigorously. Inoculate the corresponding dose by deep intramuscular injection in the neck muscles. It is very important to use needles of appropriate length according to the weight of the animal. It is recommended that the second dose should be given preferably on the alternate side.
Vaccination schedule: Pregnant sows: The initial course consists of two doses. Administer one dose 7 weeks before farrowing followed by a second dose 4 weeks before farrowing. Revaccinate with a single dose 4 weeks before farrowing in subsequent gestation periods.
Contra-indications, warnings, etc
Contraindications
Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients
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
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions (frequency and seriousness)
A transient increase in body temperature (maximum 2°C) can be observed between 4–24 hours after vaccination, this event is very common. Temperatures return to normal values within 24–48 hours. The vaccine can produce short term apathy between 1 and 2 days post-vaccination, this event is common. Apathy may last for up to 7 days after vaccination, however this event is uncommon. Injection site reactions (swelling and reddening) occurred rarely, with a maximum of 3 cm of diameter and a maximum of 10 days of duration.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Can be used during pregnancy. The vaccine should not be given in the 4 week period before the expected farrowing date.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of a double vaccine dose, a slightly higher transient temperature increase may be observed compared to that after a single vaccine dose (e.g. temperature increase of up to 2.5 °C after a double dose).
Withdrawal period: Zero days.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Pharmaceutical precautions
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening of the immediate packaging: 10 hours.
Store and transport refrigerated (2 °C – 8 °C). Protect from light . Do not freeze.
For animal treatment only. To be supplied only on veterinary prescription.
Keep out of the sight and reach of children.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated bacterial vaccines against Escherichia coli and Clostridium perfringens. ATC vet code. QI09AB08
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box with 1 multi-dose high-density polyethylene (HDPE) bottle of 50 ml (25 doses) with a perforable nitrile rubber stopper and aluminium seal.
Marketing Authorisation Holder (if different from distributor)
CZ Veterinaria, S.A.
La Relva s/n- Torneiros
36410 Porriño (Spain)
Further information
The vaccine contains inactivated strains of Escherichia coli expressing the adhesins F4ac, F5, F6, F18ab, F18ac and F41 which cause neonatal enterotoxicosis in piglets, as well as β-enterotoxin from Clostridium perfringens type C. The vaccine is formulated with an oily adjuvant. In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum containing Escherichia coli adhesin-specific and Clostridium perfringens anti-enterotoxin antibodies.
Marketing Authorisation Number
Vm 30824/4003
Significant changes
GTIN
GTIN description:Entericolix, emulsion for injection for pigs
GTIN:5012917040050