| Certification: | CE |
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| Disinfection: | Disinfection |
| Color: | Transparent |
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1. Careful Administration
LAENNEC should be administrated with care in patients predisposed to allergies.
2. Important Basic Cautions
This product is manufactured from the extract of human placenta delivered full-term in Japan. In order to screen each donor, a complete medical history, interviewing such as a history of travel and serologic testing for viruses, bacteria and infection are performed, after nucleic-acid testing (NAT) to meet with requirements for HBV-DNA, HCV-RNA and HIV-1-RNA is carried out. In addition, it has been confirmed that high-pressure steam sterilization for 20 minutes at 121 °C during the manufacturing process is effective in inactivating various viruses such as HIV etc. Furthermore, although in the product test, the nucleic-acid test meets with requirements for HBV-DNA, HCV-RNA, HIV-1-RNA, HTLV-DNA, and parvovirus B19-DNA, patients should be made aware of the following points during administration: To date, the transmission of infection, such as variant Creutzfeldt-Jakob disease (vCJD), by administration of this product in Japan or other countries has not been reported. However, although safety measures are taken to prevent infection during the manufacturing process, it is theoretically impossible to fully eliminate the risks of infection transmission originating in a human placenta used as raw material. While safety measures during the manufacturing process to prevent infection, as well as confirmation of the necessity of treatment for the disease before administration are carried out, doctors should explain to patients and try to have them understand that when human placenta is used as the raw material of a product, the risk of infection cannot be fully ruled out.
Product Description
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