玻璃安瓿裝的葡萄糖酸鈣10%注射劑中存在金屬鋁 Presence of aluminium in calcium gluconate injection 10% in glass ampoules

 



  •        英國藥物管理局(MHRA)與加拿大衛生部分別發出安全性通告, 指葡萄糖酸鈣溶液與玻璃接觸後, 有可能使金屬鋁析出, 對病人造成鋁過量的風險。所有裝量的葡萄糖酸鈣10%注射劑, 其玻璃容器可能含有鋁, 當長期用於腎功能受損的病人時, 可能會達致中毒的水平。為了避免病人吸收過量的鋁, 引起中樞神經系統和骨髓毒性, 衛生專業人士處方葡萄糖酸鈣注射劑作腸外營養或靜脈輸液時, 對下列風險較高的人士應注意上述事項：
  1. 早產兒, 因其腎功能未完全發育, 以及需要大量含鈣和鏻的補充液。
  2. 腎功能受損的病人。

    為了減低上述病人吸收鋁的風險, 建議醫生﹑藥劑師及其他衛生專業人士：

  1. 對於18歲以下的小孩或腎功能受損的病人, 不要重複或長期使用小容積(10mL)﹑玻璃安瓿裝的葡萄糖酸鈣注射劑。
  2. 不要使用小容積(10mL)﹑玻璃安瓿裝的葡萄糖酸鈣注射劑製備全腸外營養(TPN)輸液。
  3. 對於上述風險較高的人士, 可使用塑料容器裝的葡萄糖酸鈣注射劑, 以減少病人吸收鋁的機會。

 

        Both British Medicines and Health Products Regulatory Agency (MHRA) and Health Canada at different occasions announced about the safety concerns over the presence of aluninium that can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to excessive aluminium to patients. All package sizes of calcium gluconate injection 10% in glass container may contain aluminium which might reach toxic levels with prolonged administration if patient’s kidney function is impaired.  Healthcare practitioners should consider this information when prescribing calcium gluconate injection for parenteral nutrition or intravenous infusion in the following vulnerable populations to prevent aluminium accumulation reaching level associated with central nervous system and bone toxicity:

  1. premature neonates, because of their kidneys are immature, and because they require large amounts of calcium and phosphate solutions.
  2. patients with impaired kidney function.

In an effort to minimize the exposure of aluminium to these patients, it is advised physicians, pharmacists and other health professionals that:

  1. do not use calcium gluconate injection packed in small-volume (10 mL) glass containers for repeated or prolonged treatment, in children aged younger than 18 years, or in patients with renal impairment.
  2. do not use calcium gluconate injection in small-volume glass containers in the preparation of TPN solutions.
  3. use calcium gluconate injection packed in plastic containers to reduce the aluminium burden in vulnerable patients.

 

參考資料/References and websites：                                                         

https://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/calcium_gluconate_hpc-cps-eng.php