Description
Salmovir emulsion for injection for pigeons
Statement of the active substance(s) and other ingredient(s)
Each (0.2 ml) dose of the vaccine contains:
Active substances:
inactivated PMV-1 virus (La Sota strain) not less than 1 ELISA unit,
inactivated cells of Salmonella (serotypes: S. typhi, S. paratyphi A, S. paratyphi C, S. typhimuriumvar. Copenhagen, S. anatum, S. senftenberg) not less than 1 ELISA unit for each serotype.
1 ELISA unit – amount of antigen enabling seroconversion equal or higher than 1.8 in a vaccinated pigeon
Adjuvant:
Montanide ISA 763 A VG 0.14 ml
White emulsion.
Target species
Pigeons
Indications for use
Active immunisation of pigeons to reduce mortality and clinical signs of salmonellosis and pigeon paramyxovirus.
Onset of immunity: approx. 21 days after revaccination.
Duration of immunity: approx. 12 months.
Contraindications
Do not use in weak, infested and diseased birds.
Do not use in the moulting period.
Special warnings
Special warnings:
Vaccinate healthy animals only.
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 veterinary medicinal 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.
Laying birds:
Do not use the vaccine during the laying period.
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, therefore it is not recommended to administer other vaccines within 14 days before and after vaccination using this product.
Overdose:
No side effects other than listed in the adverse events section 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: pigeons
| Rare (1 to 10 animals/10 000 animals treated): | Apathy1 Loss of appetite2 Reaction at the injection site3 |
1 occurs within a few hours after product administration
2 transient event
3 reaction is transient and it takes the form of a small bump
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
Subcutaneous injection.
Dose for one pigeon is 0.2 ml of the oil-based emulsion to be injected subcutaneously in the middle of the neck.
The basic vaccination scheme for young pigeons unvaccinated against salmonellosis and PMV includes two injections at a 4-week interval. The first injection should be administered in pigeons 3 to 4 weeks of age, whereas the second not later than within 3 weeks before pigeon races.
Adult pigeons revaccinated many times with Salmovir should be administered a single injection annually, 2 to 3 weeks before pairing or exhibitions.
Advice on correct administration
Use sterile needs and syringes.
Once removed from the refrigerator, warm vaccine packages in ambient temperature and mix thoroughly before commencing the procedure.
During vaccination, mix package content from time to time.
Vaccination should be performed at outdoor temperature not lower than 0°C.
Once opened, do not store and reuse the package.
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). Do not freeze. Protect from light.
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: use immediately.
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
202/95
Pack sizes: 20 doses, 50 doses, 100 doses.
Date on which the package leaflet was last revised
17/01/2025
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 2025-01-17
2025-03-24
