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Date: Saturday, May 18, 2024 15:28

Description: MSD-AH
Release 2.47
Porcilis® APP Suspension for injection
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® APP Suspension for injection
Product index: Porcilis® APP
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each 2 ml dose contains:
Active substance(s):
600 mg Actinobacillus pleuropneumoniae antigen concentrate containing:
OMP [outer membrane protein]
50 units*
Apx I toxoid
50 units
Apx II toxoid
50 units
Apx III toxoid
50 units
* units relative to an internal standard determined to be efficacious in pigs.
Adjuvant:
dl-α-tocopherol: 150 mg
Excipients
Formaldehyde (preservative): 0.02 % w/v.
For a full list of excipients, see section " Pharmaceutical particulars".
Pharmaceutical form
Suspension for injection.
Clinical particulars
Target species
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.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
It is not advisable to vaccinate animals immediately before and after feeding.
Operator warnings
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.
Adverse reactions
In laboratory studies and field trials:
Mild to moderate injection site reactions may very commonly occur in some animals, these resolve within 5 days post-vaccination. Anorexia and decreased activity/depression may be very commonly observed after vaccination. Transient increases in temperature (up to 2 °C), lower appetite, vomiting, increases in respiration rate with a change towards abdominal breathing and dyspnea may be commonly observed after vaccination. These reactions are transient and resolve within 24 hours after vaccination.
In post marketing experience:
More severe reactions such as anaphylaxis may very rarely occur.
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 or lactation
Do not use during pregnancy or lactation.
Interactions
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.
Overdose
No reactions other than those in section "Adverse reactions" were observed following a double dose, however the severity of clinical signs was increased.
Withdrawal periods
Zero days.
Pharmacological particulars
ATC vet code: QI09AB07
Pharmacotherapeutic group
Immunologicals for Suidae; Inactivated bacterial vaccines; Actinobacillus vaccine.
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.
Pharmaceutical particulars
Excipients
dl-α-tocopherol acetate
Polysorbate 80
Simethicone
Sodium chloride
Formaldehyde
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: 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.
Immediate packaging
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.
Disposal
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 Number
UK: Vm 01708/4606
Significant changes
Date of the first authorisation or date of renewal
11 February 2014.
Date of revision of the text
August 2020.
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 APP 1 x 100ml:
GTIN:08713184068705