| Dossier: | Ctd |
|---|---|
| GMP: | Chinese GMP |
| Transport Package: | Free |
| Specification: | 2ml: 200mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Sugammadex Sodium Injection 2ml:200mg |
| Strength | 2ml:200mg |
| Packing | 5amps/box |
| Origin | China |
This product is colorless transparent liquid.
Antagonizing rocuronium or vecuronium induced neuromuscular block in adults.
Pediatric patients: In children and adolescents, this product is recommended only for routine antagonism of rocuronium induced block (2 to 17 years of age).
Usage and dosage:
Administration method
This product should be administered intravenously in a single dose, within 10 seconds into the existing venous access (see "Special Precautions for Handling and other operations" under [Precautions]). Only a single injection was used in clinical studies.
dosage
This product should be administered by a trained medical practitioner who is familiar with the administration, effects, characteristics, and complications of neuromuscular blocking drugs (NMBA) and neuromuscular blocking reversal drugs.
The dosage and duration of administration of this product should be based on the monitoring results of myokymia reaction and the degree of spontaneous recovery.
Patients should be monitored from the time of administration of this product until full recovery of neuromuscular function to ensure adequate ventilation and open airways. Satisfactory recovery should be determined by assessing skeletal muscle tone and respiratory measurements, as well as response to peripheral nerve stimulation.
The recommended dose of this product does not depend on the anesthesia regimen.
According to the results of hypersensitivity test abroad, FDA's review of hypersensitivity test data, and registration in the United States, it is recommended that the dose of 4mg/kg be selected for clinical application of this product in China.
This product can be used to antagonize different degrees of neuromuscular block induced by rocuronium or vecuronium:
Adult:
Conventional antagonism:
When rocuronium or vecuronium induced neuromuscular block spontaneously returns to at least until T2 reappears, antagonism at a dose of 2 mg/kg is recommended, and the median time for T4/T1 to return to 0.9 is about 2 minutes (see Clinical trials).
When rocuronium or vecuronium induced neuromuscular block returns to at least 1 to 2 post-tetanic stimulation counts (PTC), antagonism is recommended at a dose of 4 mg/kg, and the median time for T4/T1 to return to 0.9 is about 3 minutes
Matters needing attention:
Obese patients:
In obese patients, this product should be calculated based on actual body weight at the recommended dose for adults.
Patients with liver damage:
No clinical studies have been conducted in patients with liver impairment. Patients with severe liver function impairment or patients with liver function impairment combined with coagulation disorder should use this product with caution (see [Precautions]).
For patients with mild to moderate liver impairment: Since this product is excreted primarily through the kidneys, there is no need to adjust the dose.
Heart patient
A trial of 76 patients diagnosed with cardiac disease (e.g., ischaemic heart disease, chronic heart failure, or arrhythmia) or with a history of cardiac disease (primarily NYHA Class II) investigated the effects of 2 mg/kg or 4 mg/kg administration of this product on T2 recurrence. The time required to recover from rocuronium 0.6 mg/kg induced neuromuscular block. The median time required for the T4/T1 ratio to return to 0.9 in the 2 mg/kg and 4 mg/kg dose groups was 1.7 minutes and 1.3 minutes, respectively. This is similar to the median value observed in other trials; Therefore, no dose adjustment is required.
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