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Date: Wednesday, April 30, 2025 6:38

Description: MSD-AH
Release 2.100
Porcilis® Glässer Suspension for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Porcilis® Glässer Suspension for injection for pigs
Product index: Porcilis® Glässer
Pig - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active substance:
Glaesserella parasuis serotype 5, strain 4800, whole, inactivated**: 0.05 mg total nitrogen, inducing ≥ 9.1 Elisa Units*.
* mean antibody titre (log2 value) in the potency test in mice ** formerly known as Haemophilus parasuis
Adjuvant:
dl-α-tocopheryl acetate 150 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Aqueous, white or nearly white suspension.
Clinical particulars
Target species
Pigs and sows
Indications for use
Pigs:
Active immunisation of pigs to reduce typical lesions of Glässer’s disease caused by G. parasuis serotype 5.
Onset of immunity: 2 weeks after completion of vaccination.
Duration of immunity: 14 weeks after completion of vaccination.
Sows:
For passive immunisation of the progeny of vaccinated sows and gilts to reduce infection, mortality, clinical signs and typical lesions of Glässer disease caused by G. parasuis serotype 5 and to reduce clinical signs and mortality caused by G. parasuis serotype 4.
Onset of immunity: After birth and sufficient uptake of colostrum.
Duration of immunity: 4 weeks of age against serotype 4 and at 6 weeks of age against serotype 5.
Contraindications
None.
Special warnings for each target species
Vaccinate only healthy animals.
Special precautions for use
None.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Pigs:
Very common (>1 animal / 10 animals treated):
Elevated temperature1, Discomfort2, Decreased activity2, Depression2, Injection site swelling3, Injection site reddening3
Common (1 to 10 animals / 100 animals treated):
Vomiting2
Very rare (<1 animal / 10.000 animals treated, including isolated reports):
Anaphylactic-type reaction4
1 ≤ 2 °C.
2 May occur on the day of vaccination. The next day returning to normal.
3 Painless reddish swellings of 2.5 ‑ 7.5 cm 3 days after vaccination.
4 In the event of anaphylactic reaction consult your veterinarian. In such cases appropriate treatment should be administered without delay.
Sows:
1 Mean 0.9 °C, with individual animals displaying a temperature increase of above 2 °C.
2 May be observed 1 to 2 days after vaccination. All animals return to normal within 1 to 3 days after vaccination.
3 Mostly non-painful swellings < 10 cm in diameter. In some cases, swelling may be warm, red, and painful > 10 cm in diameter.
4 These reactions disappear or clearly diminish 14 days after vaccination.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy:
Can be used during pregnancy.
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
Intramuscular use. Allow vaccine to reach ambient temperature. Shake well before use.
Administer 2 ml (one dose) of the vaccine intramuscularly in the neck.
Vaccination scheme pigs:
Vaccinate pigs of at least five weeks of age twice with an interval of two weeks.
Vaccination scheme sows:
Vaccinate sows at 6 to 8 weeks before expected time of farrowing twice with an interval of four weeks.
Revaccination scheme sows:
For sows vaccinated during the previous pregnancy, a single revaccination at 4 to 2 weeks before farrowing is recommended.
Overdose
Pigs:
After vaccination with a twofold overdose, reactions are not different from those after the single dose.
Sows:
After vaccination with a twofold overdose, a transient increase in temperature may occur (mean 1.8 °C, with a maximum observed temperature of 41.3 °C). Other reactions are not different from those after a single dose.
Withdrawal period
Zero days.
Pharmacological particulars
ATCvet code: QI09AB07.
The product stimulates the development of active immunity against G. parasuis serotype 5. Serotype 5 is the most prevalent under the virulent serotypes of G. parasuis. There is some cross protection to the other virulent serotypes, but full cross protection cannot be assured. The product stimulates transfer of passive immunity against G. parasuis serotype 5 and 4 to the progeny after vaccination of pregnant sows. It contains an aqueous adjuvant.
The vaccine is of benefit when pigs and sows with no or low levels of antibodies against G. parasuis serotype 5 are mixed with animals from or in an environment with higher prevalence of Glässers disease or if the piglets from sows with no or low antibodies are reared in such environment. Vaccination of sows with moderate to high levels of antibodies has not been shown to provide additional protection of the offspring. The control of Glässers disease is also dependent on management factors and reduction of stress.
Antibodies against G. parasuis serotype 5 have been shown to be cross-reactive against H. parasuis serotype 4.
Pharmaceutical particulars
Excipients:
Phosphate buffer
Simethicone
Polysorbate 80
Water for injections
Major incompatibilities
Do not mix with any other vaccine or immunological product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
PET vials: 3 years.
Glass vials: 1 year.
Shelf-life after first opening the immediate packaging: use immediately.
Special precautions for storage
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Protect from light.
Immediate packaging
Vials of PET or Glass type I (Ph. Eur.) containing 20 ml (10 dose presentation), 50 ml (25 dose presentation) or 100 ml (50 dose presentation), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes:
Cardboard box containing 1, 6 or 12 vials of 20 ml, 50 ml or 100 ml.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
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 national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Intervet International B.V., represented by MSD Animal Health UK Limited
Marketing Authorisation Number
UK(GB) Vm 06376/5033
UK(NI) Vm 06376/3035
Significant changes
Date of the first authorisation or date of renewal
30 March 2008.
Date of revision of the text
September 2024.
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 Glasser 1x50ml:
GTIN:08713184032386