)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_________18.02.2007_______________ ‫תאריך‬
_____HEPATYRIX _______‫שם תכשיר באנגלית‬
___________132-37-30962________‫מספר רישום‬
__GlaxoSmithKline (ISRAEL) Ltd. __‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫לרופא‬
‫בעלון לרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
Hypersensitivity to the active substances or to any of
the excipients or neomycin.
Hypersensitivity after previous administration of
Hepatyrix, hepatitis A or Salmonella typhi vaccines.
In subjects with an impaired immune system,
adequate anti-HAV and anti-Vi antibody titres may
not be obtained after a single dose of Hepatyrix and
such patients may therefore require administration of
additional doses of vaccine. If possible, vaccination
should be delayed until the completion of any
immunosuppressive treatment. Subjects with
chronic immunodeficiency such as HIV infection
may be vaccinated if the underlying
immunodeficiency allows the induction of an
antibody response, even if limited.
Hepatyrix protects against typhoid fever caused by
Salmonella enterica serotype typhi. Protection is not
conferred against paratyphoid fever or infections with
any other serotypes of S. enterica.
As with any vaccine, a protective immune response
may not be elicited in all vaccinees.
If Hepatyrix is to be given at the same time as
(an)other injectable vaccine(s), the vaccines should
always be administered at different injection sites.
Concomitant administration of yellow fever vaccine
with Hepatyrix has not been specifically assessed.
However, based on data obtained from the
concomitant administration of various monovalent
vaccines (purified Vi polysaccharide typhoid vaccine
or inactivated hepatitis A vaccine) with yellow fever
vaccine, no interference with the immune responses
to any of these antigens would be expected.
The effect of concomitant administration of
immunoglobulins on the immunogenicity of
Hepatyrix has not been assessed. Therefore,
interference with the immune response cannot be
ruled out.
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‫פרק בעלון‬
Contraindic
ations
HIV infection is not considered as a contraindication for vaccination with Hepatyrix. In
subjects with an impaired immune system, adequate
anti-HAV and anti-Vi antibody titres may not be
obtained after a single dose of Hepatyrix and such
patients may therefore require administration of
additional doses of vaccine.
Hepatyrix protects against typhoid fever caused
by Salmonella typhi. Protection is not conferred
against paratyphoid fever or illness caused by noninvasive Salmonellae
When concomitant administration of other
vaccines is considered necessary, different
syringes and different injection sites must be
used.
It may be expected that in patients receiving
immunosuppressive treatment or patients with
immunodeficiency, an adequate response may
not be achieved. (see 4.4)
Page 1 of 2
Warnings
and
Precautions
Interactions
Pregnancy
Adequate human data on use during pregnancy
and adequate animal reproduction studies are not
available.
Hepatyrix should only be used after careful
consideration of the risk-benefit relationship.
Lactation
Adequate human data on use during lactation and
adequate animal reproduction studies are not
available.
Hepatyrix should be used during breastfeeding
only when clearly needed.

Pregnancy
Adequate human data on use during pregnancy
and adequate animal reproduction studies are
not available. However, as with all inactivated
viral vaccines and purified polysaccharide
vaccines, the risks to the foetus are considered
to be negligible.
Hepatyrix should be used during pregnancy
only when there is a clear risk of hepatitis A and
typhoid fever.
Pregnancy
and
Lactation
Lactation
Adequate human data on use during lactation
and adequate animal reproduction studies are
not available.
Although the risk can be considered as
negligible, Hepatyrix should be used in
breastfeeding women only when there is a high
risk of infection.
Postmarketing surveillance:
Immune system disorders:
Allergic reactions, including anaphylaxis and
anaphylactoid reactions
Nervous system disorders:
Syncope
Skin and subcutaneous tissue disorders:
Skin rashes

Experience with hepatitis A vaccine:
In controlled clinical studies with the
GlaxoSmithKline monovalent hepatitis A vaccine,
the following systemic adverse events have been
reported:
Adverse
Reactions
Gastrointestinal disorders:
Rare: vomiting
During postmarketing surveillance, the following
undesirable effects have been reported very rarely
with the GlaxoSmithKline monovalent hepatitis A
vaccine :
Nervous system disorders:
Convulsions, transverse myelitis, neuralgic
amyotrophy
Musculoskeletal and connective tissue disorders:
Arthralgia, myalgia
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