EN - Anglická CZ - Česká SK - Slovenská PL - Polská RO - Rumunská RU - Ruská TR - Turecká UA - Ukrajinská
EN - Anglická
  • CZ - Česká
  • SK - Slovenská
  • PL - Polská
  • RO - Rumunská
  • RU - Ruská
  • TR - Turecká
  • UA - Ukrajinská

BIOSUIS Salm emulsion for injection for pigs

Homepage Products Veterinary products BIOSUIS Salm emulsion for injection for pigs

For the passive immunisation of piglets by the active immunisation of pregnant gilts and sows in order to induce colostral antibodies against strains of Salmonella enterica subsp.

type of preparative: Vaccines
target species animals: Pig

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STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

One vaccine dose (1 ml) contains:

Active substances:

Inactivated strains of:

Salmonella enterica subsp. enterica sv. Typhimurium                                                     RP ≥ 1*

Salmonella enterica subsp. enterica sv. Derby                                                                RP ≥ 1*

Salmonella enterica subsp. enterica sv. Infantis                                                              RP ≥ 1*

*) Relative potency (RP) is determined by comparison with the reference serum obtained after vaccination of mice with a vaccine batch that has successfully passed the challenge test in the target animals.


Adjuvant:

Montanide ISA 206 VG                                                                                     0.54 ml

Excipients:

Formaldehyde                                                                                                   max. 0.50 mg/ml

Thiomersal                                                                                                        0.1 mg/ml

Opaque, white emulsion.


INDICATION(S)

For the passive immunisation of piglets by the active immunisation of pregnant gilts and sows in order to induce colostral antibodies against strains of Salmonella enterica subsp. enterica serovar Derby, S. enterica subsp. enterica serovar Infantis and S. enterica subsp. enterica serovar Typhimurium. In suckling piglets passive immunisation leads to a decrease in colonisation of inner organs (ileo-caecal lymph nodes, ileal wall and colon wall) by the above Salmonella serovars.

Onset of immunity: passive protection commences from the start of colostrum intake

Duration of immunity: in naturally suckled piglets protection will persist for 30 days (in piglets weaned at 21 days of age)


CONTRAINDICATIONS

None.


ADVERSE REACTIONS

Application site reactions in the form of erythema occurred commonly in field studies and persist mostly 2 to 4 days. A transient increase in rectal temperature (mean increase not greater than of 0.7 °C but may be up to 1.2 °C in individual animals) may commonly occur in the first 24 hours after injection.

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).

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 inform your veterinary surgeon.

Alternatively you can report via your national reporting system {national system details}.


TARGET SPECIES

Pigs (pregnant gilts and sows)


DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

Vaccination dose: 1.0 ml

Administer the vaccine by deep intramuscular injection behind the ear. The site of injection should be clean, dry and aseptically treated.

Primary vaccination: The primary vaccination consists of two doses and is administered from 10 months of age: The first dose is administered 4 weeks before the expected parturition and the second dose 2 weeks later.

Revaccination: In subsequent gestation periods administer one dose of the vaccine 2 weeks before each expected parturition. The efficacy of the revaccination scheme has not been investigated by challenge of piglets, but by the evaluation of antibody levels in vaccinated gilts after the booster dose.


ADVICE ON CORRECT ADMINISTRATION

Allow the vaccine to reach room temperature (+15 °C to +25 °C) before use.

Shake well before use. The vaccine is an opaque, white emulsion with visible sediment which is evenly dispersed after shaking.

Use only sterile equipment, e.g. syringes and needles.


WITHDRAWAL PERIOD(S)

Zero days.


SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C–8 °C).

Do not freeze.

Store in the original container.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after first opening the container: 10 hours.


SPECIAL WARNING(S)

Special warnings for each target species

Vaccinate healthy animals only. Passive protection of piglets depends on adequate ingestion of colostrum as soon as possible after birth.

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 veterinary medicinal 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: Can be used during pregnancy.

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.

Incompatibilities: Do not mix with any other veterinary medicinal product.


SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

The vaccine is supplied in High-density polyethylene (HDPE) vials or type I glass vials with pierceable chlorobutyl rubber stoppers and aluminum caps or flip-off caps. The packing 1 x 10 ml, 1 x 50 ml and 1 x 100 ml are supplied in carton box. The packing 10 x 10 ml is supplied in plastic box with ten holes. 

Not all pack sizes may be marketed.


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