Covifor powder lyophilized for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

remdesivir

Available from:

M/s. Aspiro Pharma Limited

ATC code:

J05AB16

INN (International Name):

remdesivir

Dosage:

100mg

Pharmaceutical form:

powder lyophilized for solution for infusion

Units in package:

(6/6x1/) glass vials

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Patient Information leaflet

COVIFOR FOR INJECTION 100 MG/VIAL
PRODUCT INFORMATION LEAFLET OF COVIFOR
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,
ACTIVE INGREDIENTS: REMDESIVIR
DRUG CLASS: Antiviral
RX STATUS: Available by prescription only
GENERIC AVAILABLE: No
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU GIVES THIS MEDICINE TO
YOUR CHILD BECAUSE IT CONTAINS
IMPORTANT INFORMATION.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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.
WHAT IS IN THIS LEAFLET?
1. What COVIFOR is and what it is used for
2. What you need to know before you are given COVIFOR
3. How COVIFOR is given to you
4. Possible side effects
5. How to store COVIFOR
6. Contents of the pack and other information
WHAT COVIFOR IS AND WHAT IT IS USED FOR
The active substance in is Remdesivir. It is an antiviral medicine
used for treating COVID-19. COVID-19 is
caused by a virus called a coronavirus. COVIFOR 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.
COVIFOR will be given to people with COVID-19. It is suitable for
adults and adolescents (aged 12 and over
who weigh 40 kg or more). It will only be given to patients who have
pneumonia, and need extra oxygen to
help them breathe.
COVIFOR FOR INJECTION 100 MG/VIAL
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COVIFOR
YOU WILL NOT USUALLY BE GIVEN COVIFOR:
IF YOU ARE ALLERGIC to COVIFOR, or any of the other ingredients of
this medicine (listed in section 6)
TALK TO YOUR DOCTOR OR NURSE AS SOON AS POSSIBLE, if this applies to
you.
WARNINGS AND PRECAUTIONS talk to your doctor or nurse before sta

Summary of Product characteristics

COVIFOR FOR INJECTION 100 MG/VIAL
SUMMARY OF PRODUCT CHARACTERISTICS
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 MEDICAL PRODUCT
Covifor 100mg/Vial 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
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
• Covifor is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults and
adolescents (aged 12 years and older with body weight at least 40 kg)
with pneumonia requiring
supplemental oxygen. (low- or high-flow oxygen or other non-invasive
ventilation at start of
treatment) (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Use of Covifor is confined to healthcare facilities in which patients
can be monitored closely.
(see section4.4).Posology
The recommended dosage of Covifor in adults and adolescents (12 to
less than 18 years of age
and weighing at least 40 kg) is:
• Day 1 – single loading dose of Covifor200 mg given by
intravenous infusion
• Day 2 onwards – 100 mg given once daily by intravenous infusion.
The total duration of treatment should be at least 5 days and not more
than 10 days.
COVIFOR FOR INJECTION 100 MG/VIAL
SPECIAL POPULATIONS
_Elderly _
No dose adjustment of Covifor is required in patients over the age of
65 years. (see sections 5.1
and 5.2).
_Renal impairment _
The pharmacokinetics of Covifor have not been evaluated in patients
with renal impairment.
Patients with GFR ≥30 mL/min have received Covifor for treatment of
COV