Download SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
Suvaxyn Parvo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Porcine parvovirosis vaccine (inactivated)
Quantitative composition
Active Ingredients
Per 2 ml dose
Inactivated porcine parvovirus strain NADL-2
106.8 FAID50 *
Adjuvants
Carbopol 941
2 mg
Excipients
Sodium chloride
Thiomersal
Water for injection
11.3 mg
0.17 mg
qs 2 ml
* Titre before inactivation
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against porcine parvovirus.
ATCVet Code:
5.
QI09AA02
CLINICAL PARTICULARS
5.1
Target Species
Pigs (gilts and sows).
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5.2
Indications for use
For the active immunisation of gilts and sows to reduce parvovirus
related stillbirth, foetal mummification and embryonic death.
The onset of immunity is approximately 6 weeks after completion of
the primary vaccination course. The duration of immunity is at least
13 months.
5.3
Contra-indications
Do not vaccinate sick animals.
5.4
Undesirable effects, frequency and seriousness
Mild, transient local reactions, including slight visible redness, and
slight visible/palpable swelling (<2 cm) were observed in
approximately 50% of pigs treated. All reactions disappeared within
24 hours.
5.5
Special precautions for use
Avoid stress in the animal around the time of injection.
Animals that have received the corresponding antiserum or
immunosuppressive drugs (e.g. glucocorticoids) should not be
vaccinated until an interval of at least 4 weeks has elapsed.
5.6
Use during pregnancy and lactation
Can be used during lactation.
Use during pregnancy is not recommended.
5.7
Interactions with other vaccines and medicinal products when
administered in combination with the product
No information is available on the safety and efficacy from concurrent
use of this vaccine with any other. It is therefore recommended that no
other vaccine should be administered within 14 days before or after
vaccination with this product.
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5.8
Posology and method of administration
Shake the vial well before and during use.
Administer 2 ml by intramuscular injection in the neck behind the ear.
Syringes should not have been sterilised chemically or be above
ambient temperature. Use entire contents when first opened.
Vaccination Schedule
-
Primary vaccination:
Gilts: Gilts should receive the first vaccination at 6 months of age
or older and at least two weeks prior to mating.
-
Revaccination:
Sows: Vaccinate during each lactation period, or every 12 months
between pregnancies. The recommended interval between
vaccination and mating for sows is 2 weeks.
5.9
Overdose (symptoms, emergency procedures, antidotes)
Mild, transient local reactions, including slight visible redness and
slight visible/ palpable swelling (<2 cm), were observed in
approximately 79% of pigs treated. All reactions disappeared within
24 hours.
5.10
Special warnings for each target species
Maternally derived antibody (MDA) can interfere with the
development of active immunity. Where it is likely that recent field
infection or vaccination of the dam has stimulated a high antibody titre
and consequently a high level of MDA, the timing of the vaccination
programme should be planned accordingly.
In the event of an allergic or anaphylactic reaction immediate treatment
should be given with a soluble glucocorticoid intravenously (e.g.
dexamethasone sodium phosphate) or adrenaline intramuscularly.
In any animal population there will be a small number of individuals
which fail to respond fully to vaccination. Successful vaccination
depends upon correct storage and administration of the vaccine and the
animal's ability to respond. Immune competence can be influenced by
genetic factors, intercurrent infection, age, nutritional status,
concurrent drug therapy, stress, etc.
5.11
Withdrawal period(s)
Zero days.
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5.12
Special precautions to be taken by the person administering the
product to animals
None.
6.
PHARMACEUTICAL PARTICULARS
6.1
Major incompatibilities
Do not mix with any other vaccine/immunological product.
6.2
Shelf-life
2 years.
Once vial is broached use contents within 8 hours.
6.3
Special precautions for storage
Store and transport at +2 C to +8°C.
Do not freeze.
Protect from light.
6.4
Nature and contents of container
Nature:
Polyethylene bottles
Contents: 25 ml bottle containing 10 doses
Pack sizes: 1 x 10 doses
10 x 10 doses
Not all presentations may be placed on the market.
6.5
Special precautions for the disposal of unused product or waste
material, if any
Dispose of used container by incineration or after immersion in an
approved disinfectant.
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7.
NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED
PLACE OF BUSINESS OF THE MARKETING AUTHORISATION
HOLDER
Fort Dodge Animal Health Limited
Flanders Road
Hedge End
Southampton
SO30 4QH
United Kingdom
ADDITIONAL INFORMATION
Prohibition of sale, supply and/or use
Legal category:
Marketing Authorisation No:
POM
Vm 01596/4167
Date of renewal of the authorisation: 23 January 2001
Date of revision of the text:
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September 2005