Diagnogreen Special Precautions

Indocyanine green should be administered with care in the patients with any allergic predisposition.
Clinically Significant Adverse Reactions: Shock or anaphylactoid symptoms may occur with the use of indocyanine green. Therefore, patients should be carefully monitored during treatment and the following actions should be taken as needed if any abnormality is noted: In case of prodromal for shock or anaphylactoid symptoms eg, oral numbness, nausea, chest distress, bulbar conjunctival congestion and edema of the eyelids develop during injection of indocyanine green, the injection should be immediately discontinued. In the event of shock or anaphylactoid symptoms, according to the condition, appropriate first-aid measures should be immediately provided, including fluid infusion, vasopressor use, cardiotonic therapy, corticosteroid treatment, airway control, artificial ventilation, oxygen inhalation, cardiac massage and appropriate postural regulation.
Physicians should carefully determine for which conditions Diagnogreen is indicated, and caution must be exercised in terms of the following points if the use of Diagnogreen is necessary based on a clinical diagnosis: Sufficient history should be obtained to predict any adverse reactions including shock; indocyanine green should be dissolved thoroughly in the attached solvent. Other solvents (eg, physiological saline) should not be used for this purpose. (Injection of a solution containing undissolved indocyanine green may be associated with nausea, fever and shock-like symptoms. In the process of dissolution, the vial should be turned upside down several times and shaken gently so that the drug attaching to the internal side of the rubber stopper can be thoroughly dissolved. Then, the vial should be rotated horizontally on a flat surface. The wall of vial should be attentively observed to ensure that no undissolved drug remains. Complete dissolution of the drug attaching to the rubber stopper or the cap should also be confirmed); first-aid drugs and devices should be prepared in advance; patients should be kept calm and thoroughly observed during the whole process of test. (The patients should lie on their back for liver function tests.)
Effects on the Ability to Drive or Operate Machinery: Attention is drawn, especially drivers and machine operators, about the risk of blurred vision associated with the use of indocyanine green.
Use in Pregnancy: Category C: Indocyanine green should not be administered to pregnant women or women who may possibly be pregnant unless the benefits outweigh the potential risks based on the diagnosis, since the safety of the drug used during pregnancy has not been established.
Use in Lactation: It is not known whether or not indocyanine green is secreted in human breast milk. Use of indocyanine green in nursing mothers is not recommended. If use of indocyanine green is judged to be essential, breastfeeding must be discontinued during treatment. The safety of indocyanine green in nursing mothers has not been established.
Use in Children: In the clinical study of chorioretinal angiography diagnostics, the safety of indocyanine green in low-birth-weight infants, newborns, nursing infants, infants or children has not been established. (There is no clinical experience.)
Use in the Elderly: Since elderly patients generally have reduced physiological functions, indocyanine green should be used with caution in such patients while monitoring the condition during treatment.