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Date: Tuesday, April 23, 2024 10:02

Release 2.95
Coglapix® suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Coglapix® suspension for injection for pigs
Product index: Coglapix
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each 2ml dose contains:
Active substances:
Actinobacillus pleuropneumoniae inactivated serotype 1 (strain NT3) and
Actinobacillus pleuropneumoniae inactivated serotype 2 (strains PO, U3, B4, SZ II)
expressing ApxI toxoid min. 28.9 ELISA unit / ml*,
ApxII toxoid min. 16.7 ELISA unit / ml and
ApxIII toxoid min. 6.8 ELISA unit / ml
* Elisa unit / ml calculated serological titre in sera of immunised rabbits
Adjuvant:
Aluminium hydroxide (Al3+) 4.85 mg
Excipient:
Thiomersal max 0.22 mg
For a full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Suspension for injection. Greyish-white, opaque liquid.
Clinical particulars
Target species
Pigs
Indications for use, specifying the target species
For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Onset of immunity: 21 days following second vaccination
Duration of immunity: 16 weeks following second vaccination
Contraindications
None.
Special warnings for each target species
No information is available on the efficacy of the vaccine in animals with maternally derived antibodies. However, these antibodies are usually not present in piglets at the age of vaccination.
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
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Adverse reactions to the vaccine include:
- a transient and mild swelling of maximum 2x3.2 cm is very common at the site of injection, persisting for at least 8 days.
- body temperature commonly increases by up to 1.8°C for 2 hours on days 1 or 2 after vaccination
Vaccinated pigs may show signs of prostration for a few hours after vaccination; however, this is uncommon.
Anaphylactic type reactions have been very rarely reported and appropriate symptomatic treatment is recommended.
Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.
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. The preferred site of administration is the neck region.
Dose: 2 ml
Vaccination schedule: 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Shake well before use.
Use sterile syringe and needle, respect aseptic conditions of vaccination.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of a double dose caused no other reactions than those described in section Adverse reactions; however, severity of the signs was increased e.g. transient and mild swelling of maximum 3x3 cm at the site of injection, regressing but persisting for at least 14 days; body temperature increases of up to 2.6°C for 2 hours on days 1 or 2 after vaccination.
Withdrawal period
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines for pigs. ATCvet code: QI09AB07
The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria. The total quantity is 20 x 109 inactivated germs per dose.
Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII. All the strains express also ApxII.
Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae. Efficacy was demonstrated under laboratory but not under field conditions.
Pharmaceutical particulars
List of excipients
Aluminium-hydroxide, thiomersal, sodium hydroxide, sodium chloride, water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months
Shelf life after first opening the immediate packaging: 10 hours
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Nature and composition of immediate packaging
Low density polyethylene vial of 100 ml volume, sealed with bromobutyl rubber stopper and aluminium cap.
Cardboard box containing 1 vial of 100 ml
Cardboard box containing 5 vials of 100 ml
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 products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4075
Significant changes
Date of the first authorisation or date of renewal
21 October 2015
Date of revision of the text
February 2022
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Coglapix 50D
GTIN:03411112111206