Description
Inactivated vaccine against paramyxovirosis of pigeons
Emulsion for injection for pigeons
Active substance and excipient content
One dose (0.2 ml) of the vaccine contains:
Inactivated PMV-1 (Lasota strain) – no less than 1 ELISA unit
1 ELISA unit – the quantity of antigen sufficient to obtain seroconversion equal to or higher than 1.8 in a vaccinated pigeon
Adjuvant:
Liquid paraffin – 109 mg
Therapeutic indications
The vaccine is intended for active immunisation of pigeons in order to reduce mortality, clinical symptoms and pathological lesions induced by paramyxovirus. Postvaccinal immunity occurs 21 days after immunisation and remains for approximately 12 months.
Contraindications
Verminous pigeons should not be vaccinated as well as pigeons in the moulting period.
Do not use in pigeons treated with immunosuppressive agents.
Adverse reactions
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 that spontaneously disappears within several days.
Hypersensitivity reactions might occasionally occur. Proper treatment consisting in immediate administration of adrenaline and antihistamine drug should be applied in this case.
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).
Posology for each species, route and method of administration
The vaccine should be administered in a single subcutaneous injection.
1 dose equals to 0.2 ml of oil emulsion.
The vaccine is used in young pigeons aged over three weeks, but not later than two weeks before flights of the young or exhibitions.
Adult pigeons should be immunised every 12 months. The preferable time for vaccinations is the period of two-three weeks before mating.
The dose for one pigeon, regardless of the age, is 0.2 ml of the oil emulsion which should be injected subcutaneously in the middle of the dorsal part of the neck.
Recommendations for proper administration
Before administration, the phial with the vaccine should be warmed to room temperature and mixed thoroughly.
Administration procedures should be performed at an ambient temperature not lower than 0°C.
Annual re-vaccination of the birds is recommended.
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 precautions for persons administering the medicinal veterinary product to animals:
For the user:
This medicinal veterinary product contains mineral oil. Accidental self-injection may cause excessive pain and swelling, especially when injected into a joint or a finger, and in rare cases may lead to the loss of the finger if immediate medical aid is not provided. In the case of accidental self-injection of the medicinal veterinary product, immediately seek medical advice even if only a small dose of the product has been injected and show the package leaflet to the physician. If the pain remains longer than 12 hours after medical aid is provided, consult the physician again.
For the physician:
This medicinal veterinary product contains mineral oil. Even if only a very small dose of the product has been injected, it may cause excessive pain and swelling and, in consequence, digital infarct or even a loss of the finger. Professional and IMMEDIATE surgical aid involving early incision and irrigation of the injection site, especially if it concerns the digital pulp or the tendon, is indispensible.
Laying period:
The vaccine should not be used during the laying period.
Interaction with other medicinal products and other forms of interaction:
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, procedures concerning immediate help and antidotes):
After administration of a double dose, no other adverse effects occurred than those specified in the section concerning adverse reactions.
Pharmaceutical incompatibilities:
Since no conformity studies of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary 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.
Shelf life
18 months
Available containers
20 ml glass bottle containing 100 vaccine doses, closed with a bromobutyl rubber stopper and secured with an aluminium cap, packaged single in a cardboard box.
For animal treatment only.
Subject to medical prescription – prescription drug.
Tobe administered under veterinary supervision.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Biowet Puławy Sp. z o.o.
ul. H. Arciucha2, 24-100 Puławy
tel./fax 81 886 33 53, e-mail: sekretariat@biowet.pl
www.biowet.pl
2015-02-12 SPC
31.08.2017 r.
