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CALF ROTAVIRUS DIARRHOEA VACCINE INACTIVATED Vaccinum

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CALF ROTAVIRUS DIARRHOEA VACCINE INACTIVATED Vaccinum Powered By Docstoc
					EUROPEAN PHARMACOPOEIA 5.0                                                      Calf rotavirus diarrhoea vaccine (inactivated)



is a significant reduction in diarrhoea and virus excretion a different dose. For each dose required, carry out the
in calves given colostrum and milk from vaccinated cows     test as follows. Vaccinate not fewer than 5 animals of a
compared to those given colostrum and milk from controls.   suitable species, free from specific antibodies against bovine
                                                            rotavirus, using 1 injection of a suitable dose. Maintain not
LABELLING                                                   fewer than 2 animals as unvaccinated controls. Where the
The label states the recommended schedule for administering recommended schedule requires a booster injection to be
colostrum and milk, post-partum.                            given, a booster vaccination may also be given in this test
                                                            provided it has been demonstrated that this will still provide
                                            01/2005:1954 a suitably sensitive test system. At a given interval not less
                                                            than 14 days after the last injection, collect blood from each
                                                            animal and prepare serum samples. Use a suitable validated
      CALF ROTAVIRUS DIARRHOEA                              test to measure the antibody response. The antibody level
           VACCINE (INACTIVATED)                            is not significantly less than that obtained with a batch that
                                                            has given satisfactory results in the test described under
   Vaccinum inactivatum diarrhoeae vituli Potency and there is no significant increase in antibody titre
                                                            in the controls.
                    rotaviro illatae
                                                                  IDENTIFICATION
DEFINITION
                                                                  Injected into animals free from specific antibodies against
Calf rotavirus diarrhoea vaccine (inactivated) is a preparation   bovine rotavirus, the vaccine stimulates the formation of
of one or more suitable strains of bovine rotavirus,              such antibodies.
inactivated in such a manner that immunogenic properties
are maintained. The vaccine is administered to the dam to       TESTS
aid in the control of rotavirus diarrhoea in offspring during
the first few weeks of life.                                    Safety. Use cattle not less than 6 months old and preferably
                                                                having no antibodies against bovine rotavirus or, where
PRODUCTION                                                      justified, use cattle with a low level of such antibodies
Each virus strain is grown separately in suitable cell cultures as long as they have not been vaccinated against bovine
(5.2.4). The viral suspensions of each strain are harvested     rotavirus and administration of the vaccine does not cause
separately and inactivated by a method that maintains           an anamnestic response. Administer to each of 2 animals
immunogenicity. The viral suspensions may be purified and a double dose of vaccine by a recommended route. After
concentrated.                                                   14 days, administer 1 dose to each animal. Observe the
                                                                animals for 14 days. No abnormal local or systemic reaction
The test for inactivation is carried out using 2 passages in
                                                                occurs.
cell cultures of the same type as those used for production
or in cells shown to be at least as sensitive. The quantity of Inactivation. Carry out a test for residual infectious virus
virus used in the test is equivalent to not less than 100 doses using 10 doses of vaccine and 2 passages in cell cultures of
of vaccine. No live virus is detected.                          the same type as those used for production of the vaccine
The vaccine may contain an adjuvant.                            or other cell cultures of suitable sensitivity. No live virus is
                                                                detected. If the vaccine contains an adjuvant which interferes
CHOICE OF VACCINE COMPOSITION                                   with the test, separate it if possible from the liquid phase of
The vaccine is shown to be satisfactory with respect to         the vaccine by a method that does not inactivate virus nor
safety (5.2.6) and efficacy (5.2.7) in the pregnant cow. The    interfere in any other way with detection of live viruses.
following tests may be used during demonstration of safety
and immunogenicity.                                             Extraneous viruses. Carry out tests for antibodies on the
Safety. Carry out the test for each proposed route of           cattle used for the safety test. Take a blood sample at the
administration. Administer by a proposed route and at the       end of the second observation period. The vaccine does not
proposed stage or stages of pregnancy, a double dose of         stimulate the formation of antibodies against bovine herpes
vaccine to each of not fewer than 10 pregnant cows that         virus 1 (BHV 1), bovine leukaemia virus (BLV) and bovine
have not been vaccinated against bovine rotavirus. After the viral diarrhoea virus (BVDV).
proposed interval, inject 1 dose into each cow. After each      Sterility. The vaccine complies with the test for sterility
injection, measure the body temperature on the day of the       prescribed in the monograph on Vaccines for veterinary
injection and on the 4 following days. Observe the cows until use (0062).
calving. No abnormal local or systemic reaction occurs ; any
effects on gestation and the offspring are noted.               POTENCY
Immunogenicity. The test described under Potency is             Use not fewer than 15 pregnant cows, where possible having
suitable to demonstrate immunogenicity of the strain.           no antibodies against bovine rotavirus. Where such cows
BATCH TESTING                                                   are not available, use cows that : have not been vaccinated
                                                                against bovine rotavirus ; come from a farm where there is no
Batch potency test. The test described under Potency is not recent history of infection with bovine rotavirus ; and have
carried out for routine testing of batches of vaccine. It is    a low level of antibodies against bovine rotavirus, the levels
carried out, for a given vaccine, on one or more occasions,     being comparable in all animals. Vaccinate not fewer than
as decided by or with the agreement of the competent            10 pregnant cows according to the recommended schedule.
authority ; where the test is not carried out, a suitable       Keep not fewer than 5 pregnant cows as unvaccinated
validated test is carried out, the criteria for acceptance      controls. Starting at calving, take the colostrum and then
being set with reference to a batch of vaccine that has given milk from each cow and keep it in suitable conditions.
satisfactory results in the test described under Potency. The Determine individually the protective activity of the
following test may be used after a suitable correlation with    colostrum and milk from each cow using calves born from
the test described under Potency has been established.          healthy cows, and which may be born by Caesarean section,
To obtain a valid assay, it may be necessary to carry out       and maintained in an environment where they are not
a test using several groups of animals, each receiving          exposed to infection by bovine rotavirus. Feed colostrum


General Notices (1) apply to all monographs and other texts                                                                 737
Canine adenovirus vaccine (inactivated)                                                EUROPEAN PHARMACOPOEIA 5.0



and then milk to each calf every 6 h or according to the       decided by or with the agreement of the competent authority.
recommended schedule. At 5-7 days after birth, challenge       Where the test is not carried out, a suitable validated
each calf by the oral administration of a suitable quantity    alternative test is carried out, the criteria for acceptance
of a virulent strain of bovine rotavirus. Observe the calves   being set with reference to a batch of vaccine that has given
for 7 days. Note the incidence, severity and duration of       satisfactory results in the test described under Potency.
diarrhoea and the duration and quantity of virus excretion.
The vaccine complies with the test if there is a significant   IDENTIFICATION
reduction in diarrhoea and virus excretion in calves given     When injected into susceptible animals, the vaccine
colostrum and milk from vaccinated cows compared to those      stimulates the formation of specific antibodies against the
given colostrum and milk from controls.                        type or types of canine adenovirus stated on the label.
LABELLING                                                      TESTS
The label states the recommended schedule for administering Safety. Use dogs of the minimum age recommended
colostrum and milk, post-partum.                               for vaccination and preferably having no canine
                                                               adenovirus-neutralising antibodies or, where justified, use
                                               01/2005:1298 dogs with a low level of such antibodies as long as they
                                                               have not been vaccinated against canine adenovirus and
      CANINE ADENOVIRUS VACCINE                                administration of the vaccine does not cause an anamnestic
                    (INACTIVATED)                              response. Administer a double dose of vaccine by a
                                                               recommended route to each of 2 dogs. Observe the dogs for
Vaccinum adenovirosis caninae inactivatum 14 days. No abnormal local or systemic reaction occurs.
                                                               Inactivation. Carry out a test for residual infectious canine
DEFINITION                                                     adenovirus using 10 doses of vaccine by inoculation into
Canine adenovirus vaccine (inactivated) is a suspension of     sensitive cell cultures ; make a passage after 6-8 days and
one or more suitable strains of canine adenovirus 1 (canine maintain the cultures for 14 days. No live virus is detected.
contagious hepatitis virus) and/or canine adenovirus 2,        If the vaccine contains an adjuvant, separate the adjuvant
inactivated in such a way that adequate immunogenicity is      from the liquid phase by a method that does not inactivate
maintained.                                                    or otherwise interfere with the detection of live virus.
PRODUCTION                                                     Sterility. The vaccine complies with the test for sterility
                                                               prescribed in the monograph on Vaccines for veterinary
The test for inactivation is carried out using a quantity      use (0062).
of virus equivalent to at least 10 doses of vaccine with
2 passages in cell cultures of the same type as those used     POTENCY
for production or in cell cultures shown to be at least as     Use 7 dogs of the minimum age recommended for vaccination
sensitive. No live virus is detected.                          and that do not have antibodies against canine adenovirus.
The vaccine may contain an adjuvant.                           Vaccinate 5 of the animals by a recommended route and
CHOICE OF VACCINE COMPOSITION                                  according to the recommended schedule. Keep the other
The vaccine is shown to be satisfactory with respect to safety 2 dogs as controls. 21 days later inject intravenously into
(5.2.6) and efficacy (5.2.7). The following tests may be used each of the 7 animals a quantity of a virulent strain of canine
during demonstration of safety and immunogenicity.             adenovirus sufficient to cause death or typical signs of
Safety. Carry out the test for each recommended route of       the disease in a susceptible dog. Observe the animals for
administration in animals of the minimum age recommended a further 21 days. Dogs displaying typical signs of serious
for vaccination. Use a batch of vaccine of the maximum         infection with canine adenovirus are killed humanely to
potency likely to be attained.                                 avoid unnecessary suffering. The test is invalid and must
                                                               be repeated if one or both of the controls do not die from
Use for each test not fewer than 10 dogs that do not have      or display typical signs of serious infection with canine
antibodies against canine adenovirus 1 or 2. Administer        adenovirus. The vaccine complies with the test if the
to each dog a double dose of vaccine. If the recommended       vaccinated animals remain in good health.
schedule requires a second dose, administer one dose after
the recommended interval. Observe the dogs for 14 days         LABELLING
after the last administration. No abnormal local or systemic The label states the type or types of canine adenovirus
reaction occurs.                                               present in the vaccine.
If the vaccine is intended for use in pregnant bitches,
vaccinate bitches at the stage of pregnancy or at different
stages of pregnancy according to the recommended
schedule. Prolong observation until 1 day after parturition.                                                   01/2005:1951
No abnormal local or systemic reaction occurs. No adverse
effects on the pregnancy and offspring are noted.                    CANINE ADENOVIRUS VACCINE
Immunogenicity. For vaccines intended to protect against                                  (LIVE)
hepatitis, the test described under Potency is suitable for
demonstration of immunogenicity. If the vaccine is indicated
for protection against respiratory signs, a further test to       Vaccinum adenovirosidis caninae vivum
demonstrate immunogenicity for this indication is also         DEFINITION
necessary.
                                                               Canine adenovirus vaccine (live) is a preparation of 1 or more
BATCH TESTING                                                  suitable strains of canine adenovirus 2. This monograph
Batch potency test. The test described under Potency is not applies to vaccines intended for active immunisation of dogs
carried out for routine testing of batches of vaccine. It is   against canine contagious hepatitis and/or respiratory
carried out for a given vaccine on one or more occasions as disease caused by canine adenovirus.


738                                                     See the information section on general monographs (cover pages)

				
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Description: CALF ROTAVIRUS DIARRHOEA VACCINE INACTIVATED Vaccinum