Description
PM-VAC, emulsion for injection for pigeons
Statement of active substance(s) and other ingredient(s)
Each (0.2 ml) dose of the vaccine contains:
Active substance:
Inactivated PMV-1 (La Sota strain) – not less than 1 ELISA unit
1 ELISA unit – amount of antigen enabling seroconversion equal or higher than 1.8 in a vaccinated pigeon
Adjuvant:
Liquid paraffin – 109 mg
White emulsion.
Target species
Pigeons
Indications for use
The vaccine is intended for use in active immunisation of pigeons, to reduce mortality, clinical signs and paramyxovirus-induced lesions.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 1 year.
Contraindications
Do not vaccinate pigeons in the moulting period or infested birds.
Do not use in pigeons treated with immunosuppressants.
Special warnings
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:
None found. It is recommended not to administer other vaccines within 7 days before and after administration of the 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 |
Frequency unknown, cannot be determined based on available data: | Hypersensitivity reaction (anaphylaxis)4 |
1 occurs within a few hours after product administration
2 transient event
3 emerges as a bump spontaneously subsiding after a few days
4 if the event occurs, administer adrenalin and anti-histamine drugs immediately
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 administration.
1 dose is 0.2 ml of the oil-based emulsion.
The vaccine should be used in young pigeons less than 3 weeks of age, but not later than within 2 weeks before pigeon races or exhibitions.
Adult pigeons should be immunised every 12 months. The best vaccination time is 2-3 weeks before pigeon pairing.
Dose per one pigeon regardless of age is 0.2 ml of the emulsion, to be injected subcutaneously in the middle of the back part of the neck.
Advice on correct administration
Before the vaccination procedure, warm the vial with the vaccine to ambient temperature and mix thoroughly.
Vaccination should be planned so as to use the entire package contents during one day.
Vaccination should be performed at outdoor temperature not lower than 0°C.
Birds should be revaccinated every year.
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.
Use the contents of the immediate package within 10 hours.
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
743/99
Pack size: 20 ml bottle containing 100 vaccine 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
2025-03-21
