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Date: Monday, May 6, 2024 15:31

Description: MSD-AH
Release 2.61
Nobilis® Paramyxo P201
 
Species: Pigeons
Therapeutic indication: Immunological veterinary medical products: For pigeons
Active ingredient: Vaccine Antigens
Product:Nobilis® Paramyxo P201
Product index: Nobilis® Paramyxo P201
Withdrawal notes: Pigeons: Zero days
Incorporating:
Qualitative and quantitative composition
Per dose of 0.25 ml:
Active substance:
Pigeon Paramyxo virus-1 (PPMV-1) antigen strain P201, inactivated : inducing ≥ 6.8 log2 HI* and ≤ 10.2 log2 HI units in chickens
*Haemagglutination Inhibition
Excipient:
Liquid paraffin 138 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Emulsion for injection
Clinical particulars
Target Species
Pigeons
Indications for use
Active immunisation of pigeons to reduce clinical signs caused by virulent PPMV-1 infection. The vaccine has been shown to significantly reduce virus excretion after challenge.
Onset of immunity: 4 weeks after primary vaccination.
A duration of immunity of 1 year has been demonstrated.
Contraindications
Do not use in sick animals.
Special warnings for each target species
None
Special precautions for use
None.
Operator warnings
To the user:
This product contains mineral oil. Accidental injection/self injection could 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 the product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product may cause intensive 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 a finger pulp or tendon.
Adverse Reactions
No clinical signs have been observed after vaccination.
Use during pregnancy or lactation
Vaccination within 4 weeks of the start of the breeding season is not recommended. No information is available on the safety of this product during the reproduction period.
Interactions
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Allow the vaccine to reach ambient temperature (15-25°C) before use. Shake well before use. Use sterile syringes and needles.
Each animal should be given 0.25 ml of vaccine by subcutaneous injection into the lower back area of the neck.
Birds can be vaccinated from five weeks of age.
Annual revaccination is recommended.
Overdose
Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed.
Withdrawal periods
Zero days
Pharmacological particulars
ATC Vet Code: QI01EA01
Pharmacotherapeutic group
To stimulate active immunity against PPMV-1 infection in pigeons.
Pharmaceutical particulars
Excipients
Polysorbat 80
Sorbitan mono-oleate,
Glycine
Water for injection.
Major incompatibilities
Do not mix with any other vaccine/immunological products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening: immediate use after opening.
Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze.
Immediate packaging
Multidose container of 20, 50, and 250 ml of Polyethylene terephthalate (PET) and closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Not all pack sizes may be marketed.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4489
Significant changes
Date of the first authorisation or date of renewal
10 October 2002
Date of revision of the text
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Nobilis® Paramyxo P201 1x20 ml:
GTIN:08713184029324
GTIN description:Nobilis® Paramyxo P201 1x50 ml:
GTIN:08713184029331