‫לרופא‬
‫בעלון לרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_________0111100____ ‫תאריך‬
___________Polio Sabin___‫שם תכשיר באנגלית‬
_______________150-01-10800_‫מספר רישום‬
_______________GSK (Israel) LTD_‫שם בעל הרישום‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
POLIO SABIN (oral) is contraindicated in subjects with known
hypersensitivity to neomycin or
polymyxin or to any other component of
the vaccine (see Formulations and
Strength, Excipients and Residues). A
history of contact dermatitis to
neomycin or polymyxin is not a
contraindication.
As with other vaccines, the
administration of Polio Sabin
(oral) should be postponed in
subjects suffering from acute
severe febrile illness, or
persisting diarrhoea or vomiting.
The presence of a minor
infection, however, is not a
contraindication for
immunisation.
Contraindications
POLIO SABIN (oral) is contraindicated
in subjects having shown signs of
hypersensitivity after previous
administration of GlaxoSmithKline
Biologicals’ oral poliomyelitis vaccines.
In general, POLIO SABIN (oral) should
not be administered to subjects
suffering from primary and secondary
immunodeficiencies. For those persons
it is recommended to use an inactivated
polio vaccine (IPV).
POLIO SABIN (ORAL) SHOULD
UNDER NO CIRCUMSTANCES BE
INJECTED.
POLIO SABIN (oral) is recommended
for routine immunization and epidemic
control.
POLIO SABIN (oral) may not prevent
or modify the course of the disease in
POLIO SABIN is contraindicated in subjects with known
systemic hypersensitivity to
neomycin or polymyxin or to
any other component of the
vaccine, but a history of contact
dermatitis to neomycin or
polymyxin is not a
contraindication.
POLIO SABIN (oral) should not
be administered to subjects
suffering from primary and
secondary immunodeficiencies.
For those persons it is
recommended to use the
enhanced inactivated polio
vaccine (eIPV).
Diarrhoea or vomiting
(including gastrointestinal
infections) may interfere with
the replication ("take" rate) of
the POLIO SABIN (oral)
vaccine.
Whenever POLIO SABIN (oral)
is administered to an individual,
it is good clinical practice to
Warnings and
Precautions
subjects already infected with a wild
Type poliovirus.
The administration of POLIO SABIN
(oral) should be postponed in subjects
suffering from acute severe febrile
illness, or persistent diarrhoea or
vomiting. However, the presence of a
minor infection, such as a cold, should
not result in the deferral of vaccination.
Episodes of diarrhoea and/or vomiting
(as well as any gastro-intestinal
infection) may hinder the administration
of POLIO SABIN (oral). In case of
diarrhoea, the dose received will not be
counted as part of the immunisation
schedule and should be repeated after
recovery.
The attenuated poliomyelitis viruses
multiply in the gut. The faecal excretion
of the vaccine viruses may persist for
several weeks and may also be
transmitted to the contacts of the
vaccinees; contacts of vaccinees should
therefore be warned about the need for
strict personal hygiene.
Non-immune persons in close contact
with a recently vaccinated subject may
very rarely be at risk of vaccineassociated paralytic poliomyelitis.
Whenever POLIO SABIN (oral) is
administered to an individual, it is good
clinical practice to offer immunisation
to presumably susceptible close contacts
(such as unvaccinated parents) at the
same time.
As with any vaccine, a protective
immune response may not be elicited in
all vaccines.
Previous vaccination with IPV is not a
contra-indication for the use of POLIO
SABIN (oral).
According to the Expanded Programme
on Immunisation (EPI)
recommendations symptomatic and
asymptomatic infection with human
immunodeficiency virus does not
contra-indicate immunisation with
offer immunisation to
presumably susceptible close
contacts (such as unvaccinated
parents) at the same time.
because of the risk (although
very small) of vaccine-contact
paralytic poliomyelitis disease.
Contacts of recent vaccinees
should be advised to observe
personal hygiene.
In some populations and groups
of vaccinees lower
seroconversion rates have been
observed after vaccination. Due
to various non-specific factors
all three vaccine viruses may not
replicate optimally in the gut of
susceptible subjects, even after
three doses of the POLIO
SABIN (oral).
POLIO SABIN (oral) is
recommended for epidemic
control. It should be realised
that the vaccine may not prevent
or modify disease in those
already infected with a wild type
poliovirus.
Previous vaccination with IPV is
not a contra-indication for the
use of POLIO SABIN (oral).
According to the Expanded
Programme on Immunisation
(EPI) recommendations
symptomatic and asymptomatic
infection with human
immunodeficiency virus does
not contra-indicate immunisation
with POLIO SABIN (oral).
Care should be taken not to
contaminate a multidose dropper
with saliva of a vaccinee.
POLIO SABINTM (oral) should
under no circumstances be
injected.
POLIO SABIN (oral).
POLIO SABIN (oral) can be
administered at the same time as
Haemophilus influenzae Type b
vaccine, hepatitis B vaccine, diphtheria,
pertussis and/or tetanus vaccine,
measles, rubella and/or mumps vaccine,
or BCG vaccine if this fits into the
vaccination schedule.
Concomitant administration of oral
poliomyelitis vaccine (OPV) and
rotavirus vaccine does not affect the
immune response to the polio antigens
but may slightly reduce the immune
response to rotavirus vaccine. A clinical
study in which OPV was coadministered with GlaxoSmithKline
Biologicals’ rotavirus vaccine (Rotarix)
showed that clinical protection against
severe rotavirus gastro-enteritis was
maintained.
EPI recommends concomitant
administration with other
antigens: D, T, P, BCG,
Hepatitis B and Hib.
Interactions
The vaccine can also be
administered at the same time as
the injectable measles, mumps
and rubella vaccines if this fits
conveniently in an immunisation
schedule. Otherwise, there
should be an interval of at least
one month between the
administration of two different
live attenuated virus vaccines.
If POLIO SABIN (oral) cannot be given
at the same time as other live attenuated
vaccines, an interval of at least one
month should be left between both
vaccinations.
Immunosuppressive treatment may
reduce the immune response, may
favour the multiplication of the vaccine
viruses and may increase the length of
excretion of the vaccine viruses in the
stools (see Warnings and Precautions).
Pregnancy
Pregnancy
Although there is no evidence that live
attenuated polioviruses have an adverse
effect on the foetus, in accordance with
general principles, the vaccine should
not be given to pregnant women unless
they are exposed to a definite risk of
infection with wild polioviruses.
Non immune woman of child-bearing
age should use contraception during 3
months following vaccination.
Non-specific signs and symptoms such
as fever, malaise, headache, vomiting
and diarrhoea have been described after
immunisation, but none have been
recognised as caused by the vaccine.
Pregnancy and
lactation
Although there is no evidence
that live attenuated polioviruses
have an adverse effect on the
foetus, in accordance with
general principles, the vaccine
should not be given to pregnant
women unless they are exposed
to a definite risk of infection
with wild polioviruses.
Non-specific signs and
symptoms such as fever,
vomiting and diarrhoea have
been described after
immunisation, but none have
Adverse Reactions
Temporal association between
immunisation with POLIO SABIN
(oral) and the development of signs and
symptoms of paralytic poliomyelitis has
been observed in vaccinees and
susceptible close contacts.
The frequency of this association is
however extremely low (less than one
case per 1 million doses administered).
The majority of post vaccinal paralytic
poliomyelitis occurred after the
administration of the first dose.
Very rare allergic reactions, including
anaphylactoid reactions, have been
reported.
been recognised as caused by the
vaccine.
Temporal association between
immunisation with POLIO
SABIN (oral) and the
development of signs and
symptoms of paralytic
poliomyelitis has been observed
in vaccinees and susceptible
close contacts.
The frequency of this association
is however extremely low.
Estimates vary between one case
of vaccine-associated paralytic
poliomyelitis in one to ten
million vaccinees and
susceptible close contacts. The
majority of post vaccinal
paralytic poliomyelitis occurred
after the administration of the
first dose.
Very rare allergic reactions,
including anaphylactoid
reactions, have been reported.
This medicinal product must not be
mixed with other medicinal products.
Incompatibilities