Porcilis APP Suspension for injection for pigs 100m, 50 Dose.
Qualitative and quantitative composition
Each 2 ml dose contains:
600 mg Actinobacillus pleuropneumoniae antigen concentrate containing:
OMP [outer membrane protein]
Apx I toxoid
Apx II toxoid
Apx III toxoid
* units relative to an internal standard determined to be efficacious in pigs.
dl-a-tocopherol: 150 mg
Formaldehyde(preservative): 0.02 % w/v.
For a full list of excipients, see section " Pharmaceutical particulars".
Suspension for injection.
Pigs (weaned piglets).
Indications for use
For the active immunization of weaned piglets to reduce mortality, clinical signs and lesions of pleuropneumonia caused by Actinobacillus pleuropneumoniae.
Onset of immunity: 2 weeks after completion of the vaccination scheme.
Duration of immunity: 11 weeks after completion of the vaccination scheme.
Special warnings for each target species
Only healthy animals should be vaccinated.
Special precautions for use
Special precautions for use in animals
It is not advisable to vaccinate animals immediately before and after feeding.
In the case of accidental self-injection or ingestion seek medical advice immediately and show the package leaflet or the label to the physician. If spilled on the skin, wash with soap and water.
Mild to moderate injection site reactions may occur in some animals, these resolve within 5 days post-vaccination. Transient increases in temperature (up to 2 °C), anorexia, decreased activity/depression, lower appetite, vomiting, increases in respiration rate with a change towards abdominal breathing and dyspnea may be observed after vaccination. These reactions are transient and resolve within 24 hours after vaccination.
In addition to these reactions, more severe reactions such as anaphylaxis may occasionally occur.
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation.
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
Dose: 2 ml.
Route of administration: Deep intramuscular injection.
Allow the vaccine to reach ambient temperature (between 15 °C to 25 °C) before use.
Shake bottle vigorously before and at intervals during use.
Clean and sterile vaccination equipment should be used.
The use of automatic vaccination equipment is recommended.
Maximum protection should be achieved before the start of the fattening period.
Pigs may be vaccinated from 6 weeks of age.
Two doses at least 4 weeks apart are required.
It is advised to give these at 6 and 10 weeks of age.
No reactions other than those in section "Adverse reactions" were observed following a double dose, however the severity of clinical signs was increased.
Pharmacotherapeutic group: Immunologicals for Suidae; Inactivated bacterial vaccines; Actinobacillus vaccine.
ATC vet code: QI09AB07
The active ingredients (Apx I, Apx II, Apx III and OMP) induce antibodies, which help to protect pigs against pleuropneumonia caused by Actinobacillus pleuropneumoniae.
The antigens are incorporated in an aqueous adjuvant in order to enhance stimulation of immunity.
dl-a-tocopherol acetate, Polysorbate 80, Simethicone, Sodium chloride, Formaldehyde and Water for injection.
Do not mix with any other veterinary medicinal product.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store in a refrigerator (+2 °C to +8 °C). Do not freeze. Protect from light.
Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 20, 50, 100 or 250 ml (10, 25, 50 or 125 doses).
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.