Open menu Close menu Open Search Close search

AMERICAN DRUGS | ANATOMY | HEALTH TOPICS | HIV/AIDS GLOSSARY | DISEASES | HEALTH ARTICLES | GENOME | OCCUPATIONS

Porcilis PCV

Spanish Simplified Chinese French German Russian Hindi Arabic Portuguese















Summary for the public


What is Porcilis PCV?

Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection. It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2). The vaccine does not contain any live PCV2.


What is Porcilis PCV used for?

Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection. This helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.

The vaccine is given by injection into a muscle in the neck, in the area behind the ear. Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.


How does Porcilis PCV work?

Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD). It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease. PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).

Porcilis PCV is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Porcilis PCV contains small amounts of a protein from PCV2. When a pig is given the vaccine, the pig’s immune system recognises the protein as ‘foreign’ and reacts by building up an active immune response. Through this the immune system will be able to react more quickly when it is exposed to the virus. This active immune response helps to protect the pig against the disease caused by this virus.


How has Porcilis PCV been studied?

Porcilis PCV has been studied in pigs in a number of trials. These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems. Measures of effectiveness that were monitored included weight gain, mortality as well as faecal and nasal shedding. The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.


What benefit has Porcilis PCV shown during the studies?

The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal’s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.


What is the risk associated with Porcilis PCV?

In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination. Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Porcilis PCV 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.


What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days.


Why has Porcilis PCV been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Porcilis PCV

The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009. Information on the prescription status of this product may be found on the outer package.

Authorisation details
Name: Porcilis PCV
EMEA Product number: EMEA/V/C/000135
Active substance: Porcine circovirus type 2 ORF2 subunit antigen
INN or common name: Adjuvanted inactivated vaccine against Porcine circovirus
Species: Pigs
ATCvet Code: QI09AA07
Marketing Authorisation Holder: Intervet International BV
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 12/01/2009
Contact address:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



  • Drugs Alphabetically





    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis PCV emulsion for injection for pigs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 2 ml contains:
    Active substance:
    Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log 2 ELISA units*
    * Antibody titre obtained according to the in vivo potency test in chickens.
    Adjuvants
    Dl-α-tocopheryl acetate 25 mg
    Light liquid paraffin
    346 mg
    Excipient:
    Polysorbate 80
    For a full list of excipients, see section 6.1
    3.
    PHARMACEUTICAL FORM
    Emulsion for injection
    4. CLINICAL PARTICULARS
    4.1 Target species
    4.2 Indications for use, specifying the target species
    For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to
    reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
    Onset of immunity: 2 weeks
    Duration of immunity: 22 weeks
    4.3 Contraindications
    None
    4.4 Special warnings
    From the data provided, it can be concluded that a single dose regimen of vaccination breaks through
    up to medium levels and double dose regimen through medium to high levels of maternally derived
    antibodies in piglets.
    No data are available on the use of the vaccine in breeding boars.
    2
    Pigs
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate only healthy animals.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    To the user:
    This 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 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 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.
    4.6 Adverse reactions (frequency and seriousness)
    Transient local reactions at the injection site may occur after vaccination mainly in the form of a hard,
    warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously
    over a period of approximately 14-21 days without any major consequence on the general health status
    of the animals. Immediate systemic hypersensitivity-like reactions may occur after vaccination,
    resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve
    within minutes without requiring treatment. A transient increase in body temperature, normally not
    exceeding 1°C, may occur until 2 days after vaccination. Occasionally, an increase of rectal
    temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and
    show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of
    growth rate in the immediate period after administration of the vaccine.
    4.7 Use during pregnancy, lactation or lay
    Do not use during pregnancy and lactation.
    4.8 Interaction with other medicinal products and other forms of interaction
    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 decided on a case by case basis.
    4.9 Amounts to be administered and administration route
    Before using the vaccine, allow it to reach room temperature and shake well before use. Avoid
    multiple vial broaching. Use sterile syringes and needles. Avoid introduction of contamination. Avoid
    use of vaccination equipment with rubber parts.
    Vaccination
    Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear,
    according to the following schedule:
    3
    In the case of low to medium levels of maternally derived antibodies against PCV2 a single
    vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.
    When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the
    following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age
    of 3-5 days, the second injection (2 ml) 2-3 weeks later.
    High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when
    sows/gilts have recently been exposed to high levels of PCV2 virus. In such cases it is advised to
    perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination
    schedule. In case of doubt, apply the two shot vaccination schedule .
    4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
    Following the administration of a double dose of vaccine no side effects other than those described in
    section 4.6 have been observed.
    4.11 Withdrawalperiod
    Zero days
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Inactivated Porcine circovirus vaccine.
    ATCvet code: QI09AA07
    Vaccine to stimulate active immunity against Porcine circovirus type 2
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Polysorbate 80
    Simethicon
    Water for injections
    6.2 Incompatibilities
    Do not mix with any other veterinary medicinal product.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale: 2 years
    Shelf life after first opening the immediate packaging: 8 hours.
    6.4 Special precautions for storage
    Store in a refrigerator (2C– 8C).
    Do not freeze.
    Protect from light.
    4
    6.5 Nature and composition of immediate packaging
    Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.
    Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/091/001
    EU/2/08/091/002
    EU/2/08/091/003
    EU/2/08/091/004
    EU/2/08/091/005
    EU/2/08/091/006
    EU/2/08/091/007
    EU/2/08/091/008
    EU/2/08/091/009
    EU/2/08/091/010
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    12/01/2009
    10. DATE OF REVISION OF THE TEXT
    12/01/2010
    5
    ANNEX II
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D. STATEMENT OF THE MRLs
    6
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance
    Nobilon International B.V.
    Exportstraat 39B
    5831 AK Boxmeer
    Netherlands
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    Netherlands
    Name and address of the manufacturer responsible for batch release
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    Netherlands
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO SAFE AND EFFECTIVE USE
    Not applicable.
    D. STATEMENT OF THE MRLs
    The constituents of Porcilis PCV listed below are included in Annex II of Council Regulation (EEC)
    No. 2377/90 in accordance with the following table:
    Pharmacologically active substances
    Animal species
    Other provisions
    Light liquid paraffin
    All food producing species
    Dl-alpha-tocopherol acetate
    All food producing species
    Polysorbate 80 (Polyoxyethylene
    sorbitan monooleate)
    All food producing species
    Simethicone (dimethicone)
    All food producing species
    7
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8
    A. LABELLING
    9
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis PCV emulsion for injection for pigs
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml:
    Porcine Circovirus type 2 ORF2 subunit antigen:  4.5 log 2 ELISA units
    25 mg dl-α-tocopheryl acetate
    346 mg light liquid paraffin
    Polysorbate 80
    3. PHARMACEUTICAL FORM
    Emulsion for injection
    4. PACKAGE SIZE
    1 vial of 10,25,50,100,250 doses
    10 vials of 10,25,50,100,250 doses
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Vaccine against Porcine circovirus type 2
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    Intramuscular use
    Read the package leaflet before use
    8. WITHDRAWAL PERIOD
    Withdrawal period: zero days
    10
     
    9. SPECIAL WARNING(S), IF NECESSARY
    Accidental self-injection is dangerous. Read the package leaflet before use.
    Shake well before use.
    10. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 8 hours
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2 C – 8 C).
    Do not freeze. Protect from light.
    12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only – to be supplied only on veterinary prescription
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/091/001 20 ml 1 vial
    EU/2/08/091/002 50 ml 1 vial
    EU/2/08/091/003 100 ml 1 vial
    EU/2/08/091/004 200 ml 1 vial
    EU/2/08/091/005 500 ml 1 vial
    EU/2/08/091/006 20 ml 10 vials
    EU/2/08/091/007 50 ml 10 vials
    EU/2/08/091/008 100 ml 10 vials
    11
     
    EU/2/08/091/009 200 ml 10 vials
    EU/2/08/091/010 500 ml 10 vials
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    12
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    {100, 200, 500 ml bottles}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis PCV emulsion for injection for pigs
    2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 2 ml:
    PCV2 ORF2 subunit antigen:  4.5 log 2 ELISA units
    dl-α-tocopheryl acetate
    light liquid paraffin
    Polysorbate 80
    3. PHARMACEUTICAL FORM
    Emulsion for injection
    4. PACKAGE SIZE
    1 vial of 100, 200, 500 ml (50,100,250 doses)
    10 vials of 100, 200, 500 ml (50,100,250 doses)
    5.
    TARGET SPECIES
    Pigs
    6.
    INDICATION(S)
    Vaccine against Porcine circovirus type 2
    7. METHOD AND ROUTE(S) OF ADMINISTRATION
    Intramuscular use
    Read the package leaflet before use
    8. WITHDRAWAL PERIOD
    Withdrawal period: zero days
    13
     
    9. SPECIAL WARNING(S), IF NECESSARY
    Accidental self-injection is dangerous. Read the package leaflet before use.
    Shake well before use.
    10. EXPIRY DATE
    EXP {month/year}
    Once broached, use within 8 hours
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2 C – 8 C).
    Do not freeze. Protect from light.
    12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only – to be supplied only on veterinary prescription
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Intervet International BV
    5831 AN Boxmeer
    The Netherlands
    14. MANUFACTURER’S BATCH NUMBER
    Lot
    14
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    {20,50 ml vial}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis PCV
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Per dose:
    PCV2 ORF2 subunit antigen:  4.5 log 2 ELISA units
    3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    20, 50ml (10, 25 doses)
    4.
    ROUTE(S) OF ADMINISTRATION
    i.m.
    Shake well before use
    5. WITHDRAWAL PERIOD
    Withdrawal period: zero days
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP:
    Once broached, use within 8 hours
    8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    15
     
    B. PACKAGE LEAFLET
    16
    PACKAGE LEAFLET FOR:
    PORCILIS PCV
    emulsion for injection for pigs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer:
    Intervet International BV
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Porcilis PCV emulsion for injection for pigs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
    Per dose of 2 ml:
    Porcine Circovirus type 2 ORF2 subunit antigen: at least 4.5 log 2 ELISA units as determined in the in
    vivo potency test in chickens
    Adjuvants:
    25 mg dl-α-tocopheryl acetate
    346 mg light liquid paraffin
    Polysorbate 80
    4.
    INDICATION(S)
    For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to
    reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
    Onset of immunity: 2 weeks
    Immunity will last: 22 weeks
    5.
    CONTRAINDICATIONS
    None
    6.
    ADVERSE REACTIONS
    Transient local reactions at the injection site may occur after vaccination mainly in the form of a hard,
    warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously
    over a period of approximately 14-21 days without any major consequence on the general health status
    of the animals. Immediate systemic hypersensitivity-like reactions may occur after vaccination,
    resulting in minor neurological symptoms such as tremors and/or excitation. This will normally
    resolve within minutes without requiring treatment. A transient increase in body temperature, normally
    not exceeding 1°C, may occur until 2 days after vaccination. Occasionally, an increase of rectal
    temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and
    17
    show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of
    growth rate in the immediate period after administration of the vaccine.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Pigs
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Administer one dose (2 ml), by intramuscular injection in the neck in the area behind the ear,
    according to the following schedule:
    In the case of low to medium levels of maternally derived antibodies against PCV2 a single
    vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.
    When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the
    following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age
    of 3-5 days, the second injection (2 ml) 2-3 weeks later.
    High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when
    sows/gilts have recently been exposed to high levels of PCV2 virus. In such cases it is advised to
    perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination
    schedule. In case of doubt, apply the two shot vaccination schedule.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.
    Avoid multiple vial broaching.
    Use sterile syringes and needles.
    Avoid introduction of contamination.
    Avoid use of vaccination equipment with rubber parts.
    10. WITHDRAWAL PERIOD
    Zero days
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store in a refrigerator (2 C – 8 C).
    Do not freeze. Protect from light.
    Shelf-life after first opening the container: 8 hours
    18
    12. SPECIAL WARNING(S)
    Vaccinate only healthy animals
    To the user:
    This 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 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 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.
    Do not use during pregnancy and lactation.
    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 decided on a case by case basis.
    Do not mix with any other veterinary medicinal product.
    Following the administration of a double dose of vaccine no side effects other than those described
    under “adverse reactions” have been observed.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    12/01/2010
    15. OTHER INFORMATION
    Pack sizes: 1 or 10 vials of 20, 50, 100, 200, 500 ml (10/25/50/100/250 doses).
    Not all pack sizes may be marketed.
    19


    Source: European Medicines Agency


    - Please bookmark this page (add it to your favorites).
    - If you wish to link to this page, you can do so by referring to the URL address below this line.

    https://theodora.com/drugs/eu/porcilis_pcv_veterinary.html

    Copyright © 1995-2021 ITA all rights reserved.