Porcilis Glässer Suspension for injection for pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800
Available from:
Intervet Ireland Limited
ATC code:
QI09AB07
INN (International Name):
Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800
Dosage:
. enzyme-linked immunosorbent assay unit/dose
Pharmaceutical form:
Suspension for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
actinobacillus/haemophilus vaccine
Therapeutic indications:
Immunological - Inactivated Vaccine
Authorization status:
Authorised
Authorization number:
VPA10996/179/001
Authorization date:
2004-03-04

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Health Products Regulatory Authority

24 June 2019

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Glässer Suspension for injection for pigs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 2 ml

Active substance(s):

Inactivated whole bacterial cells of Haemophilus parasuis serotype 5, strain 4800: 0.05 mg total nitrogen, inducing ≥9.1 Elisa

Units

ELISA units = mean antibody titre (log2 value) in the potency test in mice.

Adjuvant:

150 mg dl-α-tocopheryl acetate

Excipients:

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suspension for injection.

Appearance: aqueous, white or nearly white suspension.

4 CLINICAL PARTICULARS

4.1 Target Species

Pigs and sows

4.2 Indications for use, specifying the target species

Pigs:

Active immunisation of pigs to reduce typical lesions of Glässer’s disease caused by Haemophilus 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 Haemophilus parasuis serotype 5 and to reduce clinical signs and mortality caused by

Haemophilus parasuis serotype 4.

Onset of immunity: After birth and sufficient uptake of colostrum.

Duration of immunity has been demonstrated at 4 weeks of age against serotype 4 and at 6 weeks of age against serotype 5.

4.3 Contraindications

None

4.4 Special warnings for each target species

None.

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4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals. In the event of anaphylactic reaction consult your veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician

4.6 Adverse reactions (frequency and seriousness)

Pigs:

A transient increase in temperature (≤ 2°C) in combination with signs of general discomfort, such as less activity, depression

and vomiting may occur on the day of vaccination. The next day the animals are back to normal. Local reactions (painless

reddish swellings of 2,5-7,5 cm) may be observed in some pigs until 3 days after vaccination. Systemic anaphylactic reactions

may occur in very rare cases (e.g. less than 1 animal in 10,000 animals).

Sows: A transient increase in temperature may occur (mean 0.9°C, with individual animals displaying a temperature increase of

above 2°C). A tendency to lie down, reduced feed and water intake and minor signs of illness may be observed 1 to 2 days

after vaccination. All animals return to normal within 1 to 3 days after vaccination. Transient local reactions consisting mostly of

non-painful swellings with a diameter smaller than 10 cm may be observed. In some cases swelling may be warm, red and

painful with a size larger than 10 cm. These local reactions disappear or clearly diminish 14 days after vaccination.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

4.8 Interaction with other medicinal products and other forms of interactions

No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product

when used with any other (either when used on the same day or at different times) has not been demonstrated

4.9 Amounts to be administered and administration route

Allow vaccine to reach ambient temperature. Shake well before use.

Administer 2 ml (one dose) of the vaccine intramuscularly in the neck of the pig.

The vaccine is of benefit when pigs and sows with no or low levels of antibodies against H. 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 H. parasuis serotype 5 have been shown to be cross-reactive against H. parasuis serotype 4.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Pigs:

After vaccination with a twofold overdose, reactions are not different from those after the single dose.

Health Products Regulatory Authority

24 June 2019

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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.

4.11 Withdrawal period(s)

Zero days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated bacterial vaccine.

ATC vet code: QI09AB07

The product stimulates the development of active immunity against Haemophilus parasuis serotype 5. Serotype 5 is the most

prevalent under the virulent serotypes of H. 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 Haemophilus parasuis

serotype 5 and 4 to the progeny after vaccination of pregnant sows. It contains an aqueous adjuvant.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Phosphate buffer

Simethicone

Water for injections

Polysorbate 80

6.2 Major incompatibilities

Do not mix with any other vaccine or immunological product

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale

PET vials: 2 years

Glass vials: 1 year

Shelf-life after first opening the immediate packaging

Use broached vials immediately

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Protect from light.

6.5 Nature and composition of 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.

Porcilis Glässer is presented in cartons containing 1, 6 or 12 vials of 20 ml, 50 ml or 100 ml.

Not all pack sizes may be marketed

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6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the

use of such products

Any unused product or waste material should be disposed of in accordance with national requirements

7 MARKETING AUTHORISATION HOLDER

Intervet Ireland Limited

Magna Drive

Magna Business Park, Citywest Road

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA10996/179/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 March 2004

Date of last renewal: 30 September 2007

10 DATE OF REVISION OF THE TEXT

August 2009

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