NGENLA® Contraindications

(somatrogon-ghla)

4 CONTRAINDICATIONS

•
Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1)].
•
Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2)].
•
Closed epiphyses.
•
Active malignancy due to the risk of malignancy progression [see Warnings and Precautions (5.3)].
•
Active proliferative or severe non-proliferative diabetic retinopathy [see Warnings and Precautions (5.4)].
•
Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.13)].

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Contraindications

4 CONTRAINDICATIONS

•
Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1)].
•
Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2)].
•
Closed epiphyses.
•
Active malignancy due to the risk of malignancy progression [see Warnings and Precautions (5.3)].
•
Active proliferative or severe non-proliferative diabetic retinopathy [see Warnings and Precautions (5.4)].
•
Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.13)].
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