Veklury

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

remdesivir

Fáanlegur frá:

Gilead Sciences Ireland UC

INN (Alþjóðlegt nafn):

remdesivir

Lækningarsvæði:

COVID-19 virus infection

Ábendingar:

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19

Vörulýsing:

Revision: 22

Leyfisstaða:

Authorised

Leyfisdagur:

2020-07-03

Upplýsingar fylgiseðill

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VEKLURY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
remdesivir
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE,
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
IF VEKLURY HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
THE INFORMATION IN THIS LEAFLET
IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
WHAT IS IN THIS LEAFLET
1.
What Veklury is and what it is used for
2.
What you need to know before you are given Veklury
3.
How Veklury is given to you
4.
Possible side effects
5.
How to store Veklury
6.
Contents of the pack and other information
1.
WHAT VEKLURY IS AND WHAT IT IS USED FOR
The active substance in Veklury is remdesivir. It is an antiviral
medicine used for treating COVID-19.
COVID-19 is caused by a virus called a coronavirus. Veklury stops the
virus multiplying in cells and
this stops the virus multiplying in the body. This can help your body
to overcome the virus infection,
and may help you get better faster.
Veklury will be given to treat COVID-19 in:
•
adults and children (at least 4 weeks old and weighing at least 3 kg)
who have
pneumonia, and need extra oxygen to help them breathe, but who are not
on artificial
ventilation (where mechanical means are used to assist or replace
spontaneous breathing
at start of treatment).
•
adults and children (weighing at least 40 kg) who do not need extra
oxygen to help them
breathe and are at increased risk for progress

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Veklury 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of remdesivir. After reconstitution, each
vial contains 5 mg/mL of
remdesivir solution.
Excipients with known effect
Each vial contains 3 g betadex sulfobutyl ether sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white to yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Veklury is indicated for the treatment of coronavirus disease 2019
(COVID-19) in:
•
adults and paediatric patients (at least 4 weeks of age and weighing
at least 3 kg) with
pneumonia requiring supplemental oxygen (low- or high-flow oxygen or
other non-
invasive ventilation at start of treatment)
•
adults and paediatric patients (weighing at least 40 kg) who do not
require supplemental
oxygen and who are at increased risk of progressing to severe COVID-19
(see section 5.1)
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.
3
Posology
TABLE 1:
RECOMMENDED DOSE IN ADULTS AND PAEDIATRIC PATIENTS
GIVEN BY INTRAVENOUS INFUSION
ADULTS
PAEDIATRIC PATIENTS
(WEIGHING AT LEAST
40 KG)
PAEDIATRIC PATIENTS AT LEAST
4 WEEKS OLD (WEIGHING AT
LEAST 3 KG BUT LESS THAN
40 KG)
DAY 1
(SINGLE LOADING DOSE)
200 mg
200 mg
5 mg/kg
DAY 2 AND ONWARDS
(ONCE DAILY)
100 mg
100 mg
2.5 mg/kg
TABL