Description
Inactivated vaccine against respiratory tract infections in pigs caused by Actinobacillus pleuropneumoniae and Pasteurella multocida
Emulsion for intramuscular injection for pigs.
Active substance and excipient content
One dose (2 ml) contains:
Inactivated antigen: Pasteurella multocida not less than 1 ELISA* unit
Inactivated antigen: Actinobacillus pleuropneumoniae serotype 2 not less than 1 ELISA* unit
Inactivated antigen: Actinobacillus pleuropneumoniae serotype 6 not less than 1 ELISA* unit
Adjuvants:
Aluminum hydroxide gel 0.1 ml
Emulsigen (mineral oil) 0.2 ml
* 1 ELISA unit – amount of antigen sufficient to obtain antigen to antibody ratio (seroconversion) equal or above 1.8 in vaccinated mice.
Therapeutic indications
Passive immunization of piglets through active immunization of sows and gilts, as well as active immunization of weaners and fatteners, in order to reduce mortality, signs and lesions caused by Actinobacillus pleuropneumoniae serotype 2 or 6 and Pasteurella multocida.
Onset of immunity is observed 2 weeks after vaccination.
Degree of resistance is to a significant extent determined by proper nutrition and zoohygienic conditions.
Contraindications
Do not vaccinate sick animals.
Adverse reactions
A rare adverse reaction is body temperature increased by 2°C within a few hours after administration of the product. The temperature gets back to normal without any treatment. Inflammatory reaction may occur at the vaccination site, and it resolves spontaneously.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
2 ml of the product administered to piglets as intramuscular injection near the neck.
Vaccination plan for pig farms affected by infections caused by Actinobacillus pleuropneumoniae and Pasteurella multocida in piglets less than 10 weeks old.
Sows and gilts:
first vaccination: 6 – 8 weeks prior to farrowing
second vaccination: 3 – 4 weeks prior to farrowing
repeated vaccination: 3 – 4 weeks prior to next farrowing
Vaccination plan for facilities with mixed infections caused by Actinobacillus pleuropneumoniae and Pasteurella multocida reported in weaners and fatteners
Weaners:
after weaning or after piglet purchase, immunize animals twice with 3-week intervals
Instructions for use
Prior to vaccination operations, heat the product to ambient temperature and mix the bottle content thoroughly, immediately before injection.
Schedule vaccinations to use entire package content immediately after opening.
Withdrawal period
Zero days.
Special precautions for storage
Keep out of the sight and reach of children.
Store in a refrigerator (+2 to +8°C). Do not freeze. Protect from light.
Once opened, use the contents of the immediate package immediately.
Do not use this veterinary medicinal product after the use-by date given on the label.
Expiry date refers to the last day of a given month.
Special warnings
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.
Pregnancy:
There are no contraindications for using this product during pregnancy.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of the 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.
Pharmaceutical incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Other information
Available pack sizes:
One (type II) glass bottle, containing 100 ml of the vaccine, with a rubber stopper and aluminium cap, wrapped in a cardboard box.
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder:
Biowet Puławy Sp. z o.o.
24 – 100 Puławy, ul. Arciucha 2
Tel/Fax: +48 81 886 33 53, Tel.: +48 81 888 91 00, e-mail: sekretariat@biowet.pl
Shelf life
1 year.
For animal treatment only
Subject to medical prescription – prescription drug
Tobe administered under veterinary supervision.
2014-07-15 SPC
CPLW 2014.07.15
25.07.2017 r.
