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資料３－２ ヒドロキシエチルデンプン調査結果報告書 (21 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_29975.html |
| 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安全対策調査会（令和4年度第22回 12／27）《厚生労働省》 |
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効能・効果
用法・用量
カナダ
HES130（VOLUVEN）
VOLUVEN is indicated for the treatment of hypovolemia due to
acute blood loss when crystalloids alone are not considered sufficient.
VOLUVEN is not a substitute for red blood cells or coagulation
factors in plasma.
VOLUVEN (6% HES 130/0.4 in 0.9% sodium chloride injection) is
administered by intravenous infusion only.
Total volume and rate of infusion are dependent on the clinical
situation and the individual patient.
As with any intravenous fluid, VOLUVEN should be administered in
accordance with accepted clinical practices for fluid and electrolyte
management.
In clinical trials, infusions up to 33 mL/kg/day were most commonly
used. There is limited experience with infusions between 33
mL/kg/day and 50 mL/kg/day.
The initial 10-20 mL is to be infused slowly, keeping the patient
under close observation for possible anaphylactic/anaphylactoid
reactions.
VOLUVEN can be administered repetitively over several days
according to the patient’s needs.
The dosage and duration of treatment depends on the duration and
extent of hypovolemia, the hemodynamics and on the hemodilution.
Children:
Data are limited in children, therefore it is not recommended to use
HES products in this population
21
オーストラリア
HES130（VOLUVEN）
Treatment of hypovolaemia due to acute blood loss when crystalloids
alone are not considered sufficient.
The use of Voluven is not a substitute for the appropriate use of packed red
blood cells or fresh frozen plasma.
For intravenous infusion.
Use of Voluven should be restricted to the initial phase of volume
resuscitation with a maximum duration of use of 24 hours.
Administration of Voluven may cause anaphylactic reactions that may
manifest as acute hypotension. In all patients, the initial 10-20 mL of
Voluven should be infused slowly, keeping the patient under close
observation for anaphylactic/anaphylactoid reactions manifesting as
unexpected hypotension, or the development of
wheeze or rash.
The daily dose and rate of infusion depend on the patient’s blood loss, on
the maintenance or restoration of haemodynamics and on the
haemodilution (dilution effect).
用法・用量
カナダ
HES130（VOLUVEN）
VOLUVEN is indicated for the treatment of hypovolemia due to
acute blood loss when crystalloids alone are not considered sufficient.
VOLUVEN is not a substitute for red blood cells or coagulation
factors in plasma.
VOLUVEN (6% HES 130/0.4 in 0.9% sodium chloride injection) is
administered by intravenous infusion only.
Total volume and rate of infusion are dependent on the clinical
situation and the individual patient.
As with any intravenous fluid, VOLUVEN should be administered in
accordance with accepted clinical practices for fluid and electrolyte
management.
In clinical trials, infusions up to 33 mL/kg/day were most commonly
used. There is limited experience with infusions between 33
mL/kg/day and 50 mL/kg/day.
The initial 10-20 mL is to be infused slowly, keeping the patient
under close observation for possible anaphylactic/anaphylactoid
reactions.
VOLUVEN can be administered repetitively over several days
according to the patient’s needs.
The dosage and duration of treatment depends on the duration and
extent of hypovolemia, the hemodynamics and on the hemodilution.
Children:
Data are limited in children, therefore it is not recommended to use
HES products in this population
21
オーストラリア
HES130（VOLUVEN）
Treatment of hypovolaemia due to acute blood loss when crystalloids
alone are not considered sufficient.
The use of Voluven is not a substitute for the appropriate use of packed red
blood cells or fresh frozen plasma.
For intravenous infusion.
Use of Voluven should be restricted to the initial phase of volume
resuscitation with a maximum duration of use of 24 hours.
Administration of Voluven may cause anaphylactic reactions that may
manifest as acute hypotension. In all patients, the initial 10-20 mL of
Voluven should be infused slowly, keeping the patient under close
observation for anaphylactic/anaphylactoid reactions manifesting as
unexpected hypotension, or the development of
wheeze or rash.
The daily dose and rate of infusion depend on the patient’s blood loss, on
the maintenance or restoration of haemodynamics and on the
haemodilution (dilution effect).