Description
Streptovac, emulsion for injection for pigs
Statement of the active substance(s) and other ingredient(s)
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.
Excipients:
Aluminium hydroxide gel
Water oil emulsion
Target species
Pigs
Indications for use
Passive immunisation of piglets via active immunisation of pregnant sows, and active immunisation of piglets, to reduce mortality, clinical signs and (or) pathogenic lesions caused by Streptococcus suis.
Onset of immunity: 2 weeks after vaccination.
Duration of immunity: has not been established.
Strength of immunity is to a large extent determined by proper nutrition and hygienic conditions.
Contraindications
Do not use in diseased animals.
Special warnings
Special precautions for safe use in the target species:
None
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.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established 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.
Overdose:
No adverse events have been observed after administration of a double dose.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Target species: pigs
| Frequency unknown, cannot be determined based on available data: | Fever1 |
| Frequency unknown, cannot be determined based on available data: | Inflammatory reaction2 |
1Core body temperature rises by 2°C within a few hours after product administration. Body temperature gets back to normal without administration of treatment.
2Occurs at the injection site, subsides spontaneously.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605, https://smz.ezdrowie.gov.pl.
Dosage for each target species, route(s) and method(s) of administration
The product should be administered as two 2 ml doses at the time interval of 2-3 weeks.
Piglets should be vaccinated immediately before weaning and 2-3 weeks later, using a dose of 2 ml injected intramuscularly in the neck area.
Pregnant sows should be immunised between 5 and 2 weeks before parturition.
Advice on correct administration
Before the start of vaccination, transfer the product to room temperature and thoroughly mix the bottle contents immediately before injection.
Use sterile needles and syringes. During vaccination, it is recommendable to mix the package content from time to time.
Vaccination should be planned so as to use the entire package contents during one day.
Withdrawal period(s)
Zero days.
Special storage precautions
Keep out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the immediate packaging is 1 day.
Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription
Marketing authorisation numbers and pack sizes
1709/06
Pack sizes:
50ml
100ml
Date on which the package leaflet was last revised
10/02/2025
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Contact details
Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel.: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel: + 48 (81) 888 91 33, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2025-02-10
2025-03-25
