)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
116..60.11
‫תאריך‬
BOOSTRIX ‫שם תכשיר באנגלית‬
121 34 30059 00 ‫מספר רישום‬
GlaxoSmithKline (Israel) Ltd ‫בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫לרופא‬
‫בעלון לרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
Addition:
Extremely rare cases of collapse or
shock-like state (hypotonichyporesponsiveness episode) and
convulsions within 2 to 3 days of
vaccination have been reported in
DTPa and DTPa combination vaccines.
Syncope (fainting) can occur following,
or even before, any vaccination as a
psychogenic response to the needle
injection. It is important that
procedures are in place to avoid injury
from faints.
‫טקסט נוכחי‬
‫פרק בעלון‬
Warning and
Precautions
Approximately 3000 vaccinees have
received a dose of Boostrix in clinical
studies. The safety profile presented
below is based on data from clinical
trials where Boostrix was administered
to 839 children (from 4 to 8 years of
age) and 1931 adults, adolescents and
children (from 10 to 76 years of age).
Approximately 3000
vaccinees have
received a dose of
Boostrix in clinical
studies.
The most common
events occurring after
vaccine administration
were local injection site
The most common events occurring
reactions (pain, redness
after Boostrix vaccine administration in and swelling) reported
both groups were local injection site
by 50-92% of subjects
reactions (pain, redness and swelling)
in each trial. These
reported by 23.7-80.650-92% of
usually had their onset
subjects in each trial. These usually had within the first 48
their onset within the first 48 hours
hours after vaccination.
after vaccination. All resolved without All resolved without
sequelae.
sequelae.
Adverse events with at least a
Adverse events with at
suspected causal relationship to
least a suspected causal
vaccination are listed below.
relationship to
vaccination are listed
Frequencies are reported as: Adverse
below.
Undesirable
reactions reported are listed according
to the following frequency:
Frequencies are
effects
reported as:
Very common: (1/10)
Very common: (1/10)
Common:
( 1/100 to < 1/10)
Common:
(
Uncommon:
( 1/1,000 to < 1/100)
Rare:
( 1/10,000 to < 1/100 to < 1/10)
Uncommon:
(
1/1,000)
1/1,000 to < 1/100)
Very rare:
(< 1/10,000)
Rare:
Within each frequency grouping,
(
undesirable effects are presented in
1/10,000 to < 1/1,000)
order of decreasing seriousness.
Very rare:
(<
1/10,000)
Clinical trials
Within each frequency
- For children from the age of 4 years
grouping, undesirable
onwards Subjects aged 4 – 8 years
effects are presented in
(N=839436)
order of decreasing
seriousness.
Clinical trials:
- For children from the
Infections and infestations
age of 4 years onwards
Uncommon: upper respiratory tract
(N=436)
infection
Clinical trials:
Metabolism and nutrition disorders
Common: anorexia
Psychiatric disorders
Very common: irritability
Nervous system disorders
Very common: somnolence
Common: headache
Uncommon: disturbances in attention
Eye disorders
Uncommon: conjunctivitis
Gastrointestinal disorders
Common: diarrhoea, vomiting,
gastrointestinal disorders
Skin and subcutaneous tissue disorders
Uncommon: rash
Metabolism and nutrition disorders
Very common: anorexia
General disorders and administration
site conditions
Very common: pyrexia (fever >
37.5°C), injection site reactions (such
as redness and/or swelling), injection
site pain, fatigue
Common: pyrexia (fever ≥37.5ºC
including fever >39.0ºC) oedematous
swelling of the injected limbextensive
swelling of vaccinated limb (sometimes
involving the adjacent joint), pyrexia
(fever  39.0°C),
Uncommon: other injection site
reactions (such as induration), pain
Psychiatric disorders
Very common: irritability
Post-marketing surveillance:
Nervous system disorders
Hypotonic-hyporesponsiveness
episodes, convulsion
Immune system disorders
Anaphylactic reaction, allergic reaction
- For adults and adolescents from the
age of 10 years onwards Subjects aged
Nervous system
disorders
Very common:
somnolence
Gastrointestinal
disorders
Common: diarrhoea,
vomiting,
Metabolism and
nutrition disorders
Very common: anorexia
General disorders and
administration site
conditions
Very common: pyrexia
(fever > 37.5°C),
injection site reactions
(such as redness and/or
swelling), injection site
pain,
Common:
oedematous swelling of
the injected limb
pyrexia (fever 
39.0°C),
Psychiatric disorders
Very common:
irritability
Post-marketing
surveillance:
Nervous system
disorders
Hypotonichyporesponsiveness
episodes, convulsion
Immune system
disorders
Anaphylactic reaction,
allergic reaction
- For adults and
adolescents from the
age of 10 years
10 – 76 years (N = 19311,515)
onwards (N = 1,515)
Clinical trials:
Clinical trials:
Infections and infestations
Uncommon: upper respiratory tract
infection, pharyngitis
Blood and lymphatic system disorders
Uncommon: lymphadenopathy
Nervous system disorders
Very common: headache
Common: dizziness
Uncommon: hypertonia syncope
Respiratory, thoracic and mediastinal
disorders
Uncommon: cough
Gastrointestinal disorders
Common: nausea, gastrointestinal
disorders
Uncommon: diarrhoea, vomiting
Skin and subcutaneous tissue disorders
Uncommon: hyperhidrosis,
pruritispruritus, rash
Musculoskeletal and connective tissue
disorders
Uncommon: arthralgia, myalgia, joint
stiffness, musculoskeletal stiffness
Infections and infestations
Uncommon: pharyngitis
General disorders and administration
site conditions
Very common: injection site reactions
(such as redness and/or swelling),
malaise, fatigue, injection site pain
Common: pyrexia (fever  37.5°C),
injection site reactions (such as
injection site mass and injection site
abscess sterile) malaise, fatigue
Uncommon: pyrexia (fever > 39.0°C),
influenza like illness injection site
mass, injection site abscess sterile, pain
Post-marketing surveillance
Blood and lymphatic
system disorders
Uncommon:
lymphadenopathy
Nervous system
disorders
Very common:
headache
Common: dizziness
Uncommon: hypertonia
Gastrointestinal
disorders
Uncommon: vomiting
Skin and subcutaneous
tissue disorders
Uncommon:
hyperhidrosis, pruritis
Musculoskeletal and
connective tissue
disorders
Uncommon: myalgia,
joint stiffness,
Infections and
infestations
Uncommon:
pharyngitis
General disorders and
administration site
conditions
Very common: injection
site reactions (such as
redness and/or
swelling), injection site
pain
Common: pyrexia
(fever  37.5°C),
malaise, fatigue
Uncommon: pyrexia
(fever > 39.0°C),
Because these events were reported
spontaneously, it is not possible to
reliably estimate their frequency.
Blood and lymphatic system disorders
Angioedema
Immune system disorders
Allergic reactions, including
anaphylactic and anaphylactoid
reactions
Nervous system disorders
Hypotonic-hyporesponsiveness
episodes, convulsions (with or without
fever)
Skin and subcutaneous tissue disorders
Urticaria
General disorders and administration
site conditions
Oedematous swelling of the injected
limb Asthenia
Immune system disorders
Anaphylactic reaction, allergic reaction
Data on 146 subjects suggest that there
might be a small increase in local
reactogenicity (pain, redness, swelling)
with repeated vaccination according to
a 0, 1, 6 months schedule in adults (>
40 years of age).
Data suggest that in subjects primed
with DTP in childhood a booster dose
might give an increase of local
reactogenicity.
Following administration of tetanus
toxoid containing vaccine
injection site mass,
injection site abscess
sterile, pain
Post-marketing
surveillance
General disorders and
administration site
conditions
Oedematous swelling
of the injected limb
Immune system
disorders
Anaphylactic reaction,
allergic reaction
Data on 146 subjects
suggest that there
might be a small
increase in local
reactogenicity (pain,
redness, swelling) with
repeated vaccination
according to a 0, 1, 6
months schedule in
adults (> 40 years of
age).
Following
administration of
tetanus toxoid
containing vaccine