Description
Mycosalmovir emulsion for injection for pigeons
Statement of the active substance(s) and other ingredient(s)
Each (0.2 ml) dose of the vaccine contains:
inactivated PMV-1 virus (La Sota strain) not less than 1 ELISA unit,
inactivated cells of Mycoplasma gallisepticum 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 per 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
Target species
Pigeon
Indications for use
Active immunisation of pigeons to reduce mortality and clinical signs of salmonellosis, mycoplasmosis and paramyxovirosis in pigeons.
Onset of immunity: 21 days after revaccination
Duration of immunity: 12 months
Contraindications
Do not use in weak, infested and diseased birds.
Do not use in the moulting period.
Special warnings
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
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.
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 a decision to use this vaccine before or after any other veterinary medicinal product needs to be made on a case-by-case basis.
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: pigeon
| 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:
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
E-mail: pw@urpl.gov.pl
Website: https://smz.ezdrowie.gov.pl
Dosage for each target species, route(s) and method(s) of administration
A dose for one pigeon is 0.2 ml of the oil-based emulsion to be injected subcutaneously in the middle of the neck.
The vaccine should be administered in pigeons 3 to 4 weeks of age. The basic vaccination scheme for young pigeons not immunised against salmonellosis, paramyxovirosis and mycoplasmosis includes two injections at a 4-week interval. The vaccination should be planned so as to administer the second injection not later than within 3 weeks before pigeon races. Adult pigeons immunised with the vaccine many times should be administered a single injection annually, 2 to 3 weeks before pairing or exhibitions.
Advice on correct administration
During vaccination, use sterile needs and syringes.
Once removed from the refrigerator, warm vaccine packages to room temperature and mix thoroughly before commencing the vaccination 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 precautions for storage
Keep out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
Shelf-life after first opening the immediate packaging: 10 hours.
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.
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 a veterinary prescription.
Marketing authorisation numbers and pack sizes
MA number: 986/00
Pack sizes:
20 doses
50 doses
100 doses
Date on which the package leaflet was last revised
16/05/2025
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, Tel: +48 509 750 444
e-mail: biowet@biowet.pl
SPC: 2025-05-16
2025-07-17
