Description
Inactivated vaccine against streptococcosis in swine
Quantitative and qualitative composition of active substances
Inactivated Streptococcus suis antigens:
serotype 2, concentration before inactivation min. 8.5 x 108 CFU/dose,
serotype 1/2, concentration before inactivation min. 8.5 x 108 CFU/dose.
Therapeutic indications
Passive immunisation of piglets through active immunisation of pregnant sows and active immunisation of piglets to reduce mortality, clinical symptoms and/or pathological lesions induces by Streptococcus suis.
Immunity occurs within two weeks after the vaccination. The degree of immunity largely depends on proper nutrition and zoohygienic conditions.
Contraindications
Do not use in sick animals.
Adverse reactions
Several hours after administration of the preparation, an increase in the internal body temperature by 2°C may occur. The temperature returns to the normal value without treatment. An inflammatory reaction may occur at the injection site.
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
The preparation is administered twice at an interval of 2 – 3 weeks in the dose of 2 ml. The preparation is administered to piglets directly before weaning and 2 – 3 weeks later in the dose of 2 ml in an intramuscular injection in the area of the neck.
Pregnant sows are immunised 5 and 2 weeks before labour.
Indications for proper administration
Before vaccinations, place the preparation ought in room temperature and thoroughly shake the content of the bottle directly before an injection.
Sterile needles and syringes should be used for vaccinations. During the vaccination, shaking the content of the container regularly is recommended.
The vaccination procedure should be scheduled in such a way as to use the whole content of the container in one day.
Withdrawal period
Zero days.
Special precautions for storage and transport
Keep out of the reach and sight of children.
Store in a refrigerator (+2 to +8°C). Protect from light. Do not freeze.
Do not use after the expiry date stated on the label.
Shelf life after the first opening of the direct container is one day.
Special warnings and precautions
In the case of accidental self-injection, immediately seek medical advice and show the package leaflet or the label to the physician.
Safety of the veterinary medicinal product used in pregnancy and lactation was not determined. There is no available information concerning safety and efficiency of the vaccine used in combination with other medicinal veterinary products. The decision to use this vaccine before or after administration of another medicinal veterinary product should be considered individually. Since no studies of the inconformity of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary 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.
Packaging
Glass bottles containing 100 ml of the vaccine packed individually in cardboard boxes.
Shelf life
1 year
For animal treatment only.
Subject to medical prescription – prescription drug
Tobe administered under veterinary supervision.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Name and address of the manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
ul. H. Arciucha 2, 24-100 Puławy
tel./fax (81) 886 33 53; e-mail:sekretariat@biowet.pl
2011-10-19 SPC
CPLW 2011.10.19
27.07.2017 r.
