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Date: Saturday, May 21, 2022 5:22

Description: MSD-AH
Release 2.70
Porcilis® M Hyo ID ONCE emulsion for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® M Hyo ID ONCE emulsion for injection for pigs
Product index: Porcilis® M Hyo ID ONCE
Pig - meat: Zero days
Qualitative and quantitative composition
One dose of 0.2 ml contains:
Active substance:
Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 6.5 log2 Ab titre*
* Mean antibody titre (Ab) obtained after inoculation of mice with a 1/1,000 pig dose.
Excipients:
For the full list of excipients, see section “Pharmaceutical Particulars”..
Pharmaceutical form
Emulsion for injection.
White to nearly white emulsion with creamy appearance after shaking.
Clinical particulars
Target species
Pigs (finishing pigs).
Indications for use
For the active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by Mycoplasma hyopneumoniae.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 22 weeks after vaccination.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
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 administration 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.
Adverse reactions
A transient increase in body temperature (mean 0.7 °C, in individual pigs up to 2 °C), very commonly occurs on the day of vaccination. The animals return to normal 1 to 2 days after the peak temperature is observed. In individual animals mild systemic reactions may be observed on the day of vaccination consisting of a tendency of the animal to lie down and minor signs of discomfort. Transient local reactions mostly consisting of hard non-painful button-like swellings of a diameter of up to 4 cm can be very commonly observed. In individual pigs redness and/or a biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, may be observed. The local reactions disappear completely within approximately 7 weeks after vaccination.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 treated animals displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated )
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
Not applicable.
Interaction
Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis PCV ID at least 3 cm apart on the same day from 3 weeks of age. The possible adverse reactions are as presented in section 4.6, except for the size of the local reactions which may increase up to 6 cm in individual pigs. Redness and crusts at the local reaction may be very commonly observed. The product information of Porcilis PCV ID should be consulted.
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
Intradermal use.
Intradermal administration of 0.2 ml per animal preferably at the sides of the neck or along the muscles of the back using an multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2 ml ± 10%) through the epidermal layers of the skin. A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.
Safety and efficacy of Porcilis M Hyo ID ONCE have been demonstrated using the device IDAL.
Vaccination scheme:
Vaccinate once from an age of 2 weeks onwards.
Before using the vaccine allow it to reach room temperature (15–25 °C) and shake well before use.
Avoid introduction of contamination.
Overdose
No adverse reactions other than those mentioned under section ‘‘interactions’’ have been observed after administration of a double dose. However, these reactions may be more pronounced. A mean transient temperature increase of 1.0 °C may be observed. Local reactions may be observed with a maximum diameter of up to 7 cm. The local reactions disappear completely within approximately 9 weeks after vaccination.
Withdrawal period
Zero days.
Pharmacological particulars
ATCvet code: QI09AB13.
Pharmacotherapeutic group
Immunologicals for Suidae; inactivated bacterial vaccines for pigs.
Porcilis M Hyo ID ONCE is an inactivated bacterial vaccine containing whole cell concentrate of Mycoplasma hyopneumoniae strain 11. This antigen is incorporated in an adjuvant based on a combination of light liquid paraffin and dl-α-tocopheryl acetate in order to give a prolonged stimulation of immunity. The product stimulates the development of active immunity in pigs against Mycoplasma hyopneumoniae.
Pharmaceutical particulars
List of excipients
Light liquid paraffin
dl-α-tocopheryl acetate
Polysorbate 80
Simethicone
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injections.
Incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medical product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 hours.
Special precautions for storage
Store refrigerated (2 °C – 8 °C).
It has been demonstrated that transport at 30 °C for 3 days has no impact on the quality of the product. Do not freeze.
Protect from direct sunlight.
Immediate packaging
Cardboard boxes with 1, 5 or 10 glass vials (type I, Ph. Eur.) containing 10 or 20 ml corresponding to 50 and 100 doses respectively.
Cardboard boxes with 1, 5 or 10 PET vials containing 20 ml corresponding to 100 doses.
Vials are closed with a nitrile rubber stopper (type I, Ph. Eur.) and sealed with a coded aluminium cap.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4562
Significant changes
Date of the first authorisation or date of renewal
24 January 2012.
Date of revision of the text
August 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Porcilis M Hyo ID Once 1x50ds:
GTIN:08713184114785,
GTIN description:Porcilis M Hyo ID Once 1x100ds:
GTIN:08713184114792