2.Important precautions
"Explanation to Patients"
It must be explained to patients that in addition to the necessity for medical treatment, safety measures are taken to prevent the spread of infectious diseases in the production of this substance. However, using human placenta as an important raw material cannot completely eliminate the risk of infectious diseases.
(1) This substance is manufactured using human placenta in Japan with prior consent. The medical history, travel history, serological examination, etc. of all donors were checked for viral or bacterial infections, etc., and a nucleic acid amplification test (NAT) was performed. grnjv9i;0skg=nhv HBV-DNA, HCV-RNA, and HIV-1RNA were also performed.
However, there is still a possibility that viruses may be contaminated that cannot be detected by the NAT testing process.
This substance is manufactured using the hydrochloric acid hydrolysis process. During the manufacturing process, hydrochloric acid is heated to more than 101 ° C for more than 1 hour and sterilized with high-pressure steam at 121 ° C for 60 minutes to inactivate the virus. However, since human placenta is used as a raw material, the risk of infection cannot be completely eliminated. Therefore, its use should be closely monitored
(2). Currently, there are no reports of infection with mutated Creutzfeldt-Jakob disease (vCJD) caused by exposure to this drug, both domestically and internationally.
However, in theory, the risk of vCJD infection cannot be completely eliminated. When receiving the drug, patients must be given thorough information, and receiving the drug should be accompanied by a thorough diagnosis of the need for treatment.
 
Precautions when using
(1) Method of administration: This product is for subcutaneous injection only.
(2) Opening the tube: This product uses the "one-time easy tube cutting" method. After wiping the part to be opened with an alcohol swab, turn the opening symbol on the tube in the opposite direction to open it without using a file.