Posology : מינונים

4.2    Posology and method of administration

Patients should be monitored when receiving remdesivir (see section 4.4).
Patients receiving remdesivir in an outpatient setting should be monitored according to local medical practice.
Use under conditions where treatment of severe hypersensitivity reactions, including anaphylaxis, is possible.


Posology

Table 1:      Recommended dose in adults and paediatric patients
Given by intravenous infusion
Adults           Paediatric patients    Paediatric patients at least
(weighing at least      4 weeks old (weighing at
40 kg)             least 3 kg but less than
40 kg)
Day 1                            200 mg                 200 mg                      5 mg/kg (single loading dose)
Day 2 and onwards                100 mg                 100 mg                     2.5 mg/kg (once daily)


Table 2:     Treatment duration
Adults            Paediatric patients       Paediatric patients at least (weighing at least         4 weeks old (weighing at
40 kg)                least 3 kg but less than
40 kg)
Patients with pneumonia            The            The recommended           Daily for up to a total of and requiring               recommended         duration of treatment is             10 days supplemental oxygen            duration of              5 days treatment is 5 days
Patients who do not       The total duration        Not applicable.              Not applicable.
require supplemental          of treatment oxygen and are at         should be 3 days,
increased risk for        starting as soon as progressing to severe        possible after
COVID-19                      diagnosis of
COVID-19 and within 7 days of the onset of symptoms.

Special populations

Elderly
No dose adjustment of remdesivir is required in patients over the age of 65 years (see sections 5.1 and 5.2).
Renal impairment
The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment. Patients with eGFR ≥ 30 mL/min have received remdesivir for treatment of COVID-19 with no dose adjustment.
Remdesivir should not be used in patients with eGFR < 30 mL/min (see sections 4.4 and 5.2).

Hepatic impairment
The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment. It is not known if dosage adjustment is appropriate in patients with hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of remdesivir in children less than 4 weeks of age and weighing less than 3 kg have not yet been established. No data are available.

Immunocompromised population
The safety and efficacy of remdesivir in immunocompromised patients have not yet been established. Only limited data are available (see section 4.4).

Method of administration

For intravenous use.
Remdesivir is for administration by intravenous infusion after reconstitution and further dilution.

It must not be given as an intramuscular (IM) injection.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

Table 3:     Recommended rate of infusion – for reconstituted and diluted remdesivir powder for concentrate for solution for infusion in adults and paediatric patients weighing at least 40 kg
Infusion Bag Volume                          Infusion Time                Rate of Infusion 30 min                    8.33 mL/min
250 mL                                    60 min                    4.17 mL/min
120 min                    2.08 mL/min
30 min                    3.33 mL/min
100 mL                                    60 min                    1.67 mL/min 120 min                    0.83 mL/min

Table 4:     Recommended rate of infusion – for reconstituted and diluted remdesivir powder for concentrate for solution for infusion in paediatric patients at least 4 weeks of age and weighing at least 3 kg but less than 40 kg
Infusion Bag Volume                          Infusion Time                Rate of Infusiona 30 min                     3.33 mL/min
100 mL                                    60 min                     1.67 mL/min 120 min                     0.83 mL/min
30 min                     1.67 mL/min
50 mL                                    60 min                     0.83 mL/min 120 min                     0.42 mL/min
30 min                     0.83 mL/min
25 mL                                    60 min                     0.42 mL/min
120 min                     0.21 mL/min a     Rate of infusion may be adjusted based on total volume to be infused.