よむ、つかう、まなぶ。
資料１－３ ワクチンの安全性に関する評価について (14 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会（令和3年度 第3回 3／11）《厚生労働省》 |
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別添１ 海外添付文書等における心筋炎等の記載状況
（コミナティ筋注）
米国添付文書（2021 年 11 月）※
英国添付文書（2021 年 11 月）
※12 歳以上
欧州添付文書（2021 年 11 月）
5 WARNINGS AND PRECAUTIONS
4.4 Special warnings and precautions for
4.4 Special warnings and precautions for
5.2 Myocarditis and Pericarditis
use
use
Postmarketing data demonstrate increased
General recommendations
General recommendations
risks of myocarditis and pericarditis,
Myocarditis and pericarditis
Myocarditis and pericarditis
particularly within 7 days following the
Very rare cases of myocarditis and pericarditis
Very rare cases of myocarditis and pericarditis
second dose. The observed risk is higher
have been observed following vaccination
have been observed following vaccination
among males under 40 years of age than
with Comirnaty. These cases have primarily
with Comirnaty. These cases have primarily
among females and older males. The observed
occurred within 14 days following
occurred within 14 days following
risk is highest in males 12 through 17 years of
vaccination, more often after the second
vaccination, more often after the second
age. Although some cases required intensive
vaccination, and more often in younger men.
vaccination, and more often in younger men.
care support, available data from short-term
Available data suggest that the course of
Available data suggest that the course of
follow-up suggest that most individuals have
myocarditis and pericarditis following
myocarditis and pericarditis following
had resolution of symptoms with conservative
vaccination is not different from myocarditis
vaccination is not different from myocarditis
management. Information is not yet available
or pericarditis in general.
or pericarditis in general.
about potential long-term sequelae. The CDC
Healthcare professionals should be alert to the
Healthcare professionals should be alert to the
has published considerations related to
signs and symptoms of myocarditis and
signs and symptoms of myocarditis and
myocarditis and pericarditis after vaccination,
pericarditis. Vaccinees should be instructed to
pericarditis. Vaccinees should be instructed to
including for vaccination of individuals with a
seek immediate medical attention if they
seek immediate medical attention if they
history of myocarditis or pericarditis
develop symptoms indicative of myocarditis or develop symptoms indicative of myocarditis or
14
（コミナティ筋注）
米国添付文書（2021 年 11 月）※
英国添付文書（2021 年 11 月）
※12 歳以上
欧州添付文書（2021 年 11 月）
5 WARNINGS AND PRECAUTIONS
4.4 Special warnings and precautions for
4.4 Special warnings and precautions for
5.2 Myocarditis and Pericarditis
use
use
Postmarketing data demonstrate increased
General recommendations
General recommendations
risks of myocarditis and pericarditis,
Myocarditis and pericarditis
Myocarditis and pericarditis
particularly within 7 days following the
Very rare cases of myocarditis and pericarditis
Very rare cases of myocarditis and pericarditis
second dose. The observed risk is higher
have been observed following vaccination
have been observed following vaccination
among males under 40 years of age than
with Comirnaty. These cases have primarily
with Comirnaty. These cases have primarily
among females and older males. The observed
occurred within 14 days following
occurred within 14 days following
risk is highest in males 12 through 17 years of
vaccination, more often after the second
vaccination, more often after the second
age. Although some cases required intensive
vaccination, and more often in younger men.
vaccination, and more often in younger men.
care support, available data from short-term
Available data suggest that the course of
Available data suggest that the course of
follow-up suggest that most individuals have
myocarditis and pericarditis following
myocarditis and pericarditis following
had resolution of symptoms with conservative
vaccination is not different from myocarditis
vaccination is not different from myocarditis
management. Information is not yet available
or pericarditis in general.
or pericarditis in general.
about potential long-term sequelae. The CDC
Healthcare professionals should be alert to the
Healthcare professionals should be alert to the
has published considerations related to
signs and symptoms of myocarditis and
signs and symptoms of myocarditis and
myocarditis and pericarditis after vaccination,
pericarditis. Vaccinees should be instructed to
pericarditis. Vaccinees should be instructed to
including for vaccination of individuals with a
seek immediate medical attention if they
seek immediate medical attention if they
history of myocarditis or pericarditis
develop symptoms indicative of myocarditis or develop symptoms indicative of myocarditis or
14