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Safety
首页 - Gendicine - SafetyIntroduction
The main side effect is self-limiting fever of 37.5℃ to 39.5℃ occurring usually 2 to 4 hrs after administration and lasting for approximately 2 to 6 hrs. The fever tends to relieve spontaneously without intervention. Fever may reflect a mobilized immune system and is probably beneficial to the patientGenerally, fever occurs at the beginning of the treatment regimen, and then decreases gradually in severity and incidence. Other rare side effects include chill, pain at the injection site, fatigue, nausea, and diarrhea. Usually, no special management is needed as the symptoms relieve with time. However symptomatic treatment may be employed according to clinical situation. There is no increase in the side effect that are commonly encountered in radiotherapy or chemotherapy, such as bone marrow inhibition, injury to liver, kidney and heart were observed when used in combination with Gendicine®. On the other hand, positive clinical improvement such as apetiteand activity were observed. No allergic reaction has been reported.
Contraindications:
1. Women at pregnant or during breast-feeding period.
2. Patients with generalized infection and fever of inflammation or unknown etiology.
Drug Interactions:
Gendicine® is originated from recombinant virus by molecular genetic engineering technology. It must not be administrated with virus-inactivating drugs within the effective therapeutic period.
Overdose:
Maximum tolerated dose has not been precisely determined from clinical trials data both at home and abroad. Overdose may cause mild to moderate fever or allergic reaction.
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