Description
Inactivated vaccine against salmonellosis and paramyxovirosis in pigeons.
Emulsion for injection for pigeons
Active substance and excipient content
1 dose of the vaccine (0.2 ml) contains:
inactivated PMV-1 (La Sota strain) no less than 1 Elisa unit,
Inactivated S. typhi, S. paratyphi A, S. paratyphi C, S. typhimurium var. Copenhagen, S. anatum, S. senftenberg) cells no less than 1 ELISA unit for each serotype.
1 ELISA unit – the quantity of antigen sufficient to obtain seroconversion equal to or higher than 1.8 in a vaccinated pigeon
Adjuvant:
Montanide ISA 763 A VG 0.14 ml
Therapeutic indications
Active immunisation of pigeons in order to reduce mortality and clinical symptoms of salmonellosis and paramyxovirosis in pigeons.
The postvaccinal immunity occurs approx. 21 days after revaccination and remains for approximately 12 months.
Contraindications
Do not use in weak, verminous and sick birds. Do not use in moulting of pigeons.
Adverse effects
Rarely reported adverse effects are temporary lack of appetite and apathy occurring within several hours after administration of the product and a temporary local reaction in the form of a small tuber.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
The dose for one pigeon is 0.2 ml of the oil emulsion which should be injected subcutaneously in the middle of the neck.
The basic vaccination of young pigeons not immunised against salmonellosis and paramyxovirosis includes two injections at a four-week interval. The first vaccination should be performed in the third-fourth week of life and the successive vaccination no later than three weeks before migration.
Vaccination of adult pigeons which were immunised with Salmovir many times should be conducted annually 2-3 weeks before mating and exhibitions.
Instructions for use
Sterile needles and syringes ought to be used for vaccinations. Warm containers with the vaccine to room temperature after taking them from a refrigerator and mix the content thoroughly before beginning the procedures. During the vaccination procedure, mix the content of the container regularly. Conduct the procedures at an ambient temperature not lower than 0°C. Once the container is opened, the product cannot be stored and used again.
Withdrawal period
Zero days.
Special precautions for storage
Keep out of the reach and sight of children.
Store in a refrigerator (2-8°C). Do not freeze. Protect from light.
The content of the immediate container should be used within 10 hours after opening.
Do not use the veterinary medicinal product after the expiry date stated on the label. The expiry date refers to the last day of the given month.
Special warnings
Special warnings per target species:
Only vaccinate healthy animals.
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 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.
Laying period:
The vaccine should not be used during the laying period.
Interactions with other medicinal products or other types of interactions:
There is no information concerning safety and efficiency of the vaccine used in combination with other medicinal veterinary products. Therefore, the decision to use this vaccine before or after administration of another medicinal veterinary product should be considered individually.
Overdose (symptoms, emergency procedures, antidotes):
After administration of a double dose, no other adverse effects occurred than those specified in the section concerning adverse reactions.
Pharmaceutical incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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.
Size of the container
20 doses, 50 doses, 100 doses.
Shelf life
18 months
Durability after the first opening: use within one day.
For animal treatment only.
Subject to medical prescription – prescription drug
To be administered under veterinary supervision.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Marketing Authorisation Holder:
Biowet Puławy Sp. z o.o.
ul. Arciucha 2, 24-100 Puławy
tel./fax (81) 886 36 11
(81) 888 91 01
2015-03-25 SPC
CPLW 2015.06.23
27.07.2017 r.