Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Galcanezumab
DKSH SINGAPORE PTE. LTD.
N02CD02
INJECTION, SOLUTION
Galcanezumab 100 mg/ml
SUBCUTANEOUS
Prescription Only
Eli Lilly and Company
ACTIVE
2020-12-18
Page 1 of 24 EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120 MG/ML EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120 MG/ML EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML 1 PRODUCT NAME Emgality Solution for Injection in Pre-filled Pen 120 mg/ml Emgality Solution for Injection in Pre-filled Syringe 100 mg/ml 2 INDICATIONS AND USAGE 2.1 MIGRAINE Emgality Solution for Injection in Pre-filled Pen 120 mg/ml is indicated for the preventive treatment of migraine in adults. 2.2 EPISODIC CLUSTER HEADACHE Emgality Solution for Injection in Pre-filled Syringe 100mg/ml is indicated for the reduction in the frequency of attacks in adults with episodic cluster headache. 3 DOSAGE AND ADMINISTRATION 3.1 RECOMMENDED DOSING FOR MIGRAINE The recommended dosage of Emgality is 240mg (two consecutive subcutaneous injections of 120mg each) once as a loading dose, followed by monthly doses of 120mg injected subcutaneously. If a dose of Emgality is missed, administer as soon as possible. Thereafter, Emgality can be scheduled monthly from the date of the last dose. 3.2 RECOMMENDED DOSING FOR EPISODIC CLUSTER HEADACHE The recommended dosage of Emgality is 300 mg galcanezumab injected once monthly subcutaneously (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period. Page 2 of 24 The treatment benefit should be assessed after the first dose of treatment. Any further decision to continue once monthly treatment during the current cluster period or to initiate treatment for subsequent cluster periods should be based on individual patient basis and clinical judgement _[see 13.2 Clinical Studies]_ . If further dosing is warranted, galcanezumab should be administered no more than once monthly during a cluster period, and should not be used after the end of a cluster period. Page 3 of 24 Patients should be instructed to inject a missed dose as soon as possible and inject the next dose, if required, a month from the date Прочетете целия документ