Quofenix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

delafloxacin meglumine

Available from:

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

ATC code:

J01MA23

INN (International Name):

delafloxacin

Therapeutic group:

Antibacterials for systemic use,

Therapeutic area:

Community-Acquired Infections

Therapeutic indications:

Quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (ABSSSI),community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2019-12-16

Patient Information leaflet

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUOFENIX 300 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
delafloxacin
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 pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Quofenix is and what it is used for
2.
What you need to know before you are given Quofenix
3.
How to use Quofenix
4.
Possible side effects
5.
How to store Quofenix
6.
Contents of the pack and other information
1.
WHAT QUOFENIX IS AND WHAT IT IS USED FOR
Quofenix is an antibiotic that contains the active substance
delafloxacin. It belongs to a group of
medicines called fluoroquinolones.
It is used to treat adults with serious short-term infections caused
by certain bacteria when usual
antibiotics cannot be used or have not worked:
•
infections of the skin and tissue under the skin
•
infection of the lungs called ‘pneumonia’.
It works by blocking bacteria enzymes needed to copy and to repair
their DNA. By blocking these
enzymes, Quofenix kills bacteria that cause the infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN QUOFENIX
_ _
YOU MUST NOT BE GIVEN QUOFENIX:
•
If you are allergic to delafloxacin or any of the other ingredients of
this medicine (listed in
section 6).
•
If you are allergic to any other fluoroquinolone or quinolone
antibacterial medic

Summary of Product characteristics

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
Quofenix 300 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains delafloxacin meglumine equivalent to 300 mg
delafloxacin.
After reconstitution each ml contains 25 mg of delafloxacin.
Excipient(s) with known effect:
Each vial contains 2480 mg of sulfobutylbetadex sodium.
Each vial contains 175 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
Light yellow to tan cake, which may exhibit cracking and shrinkage and
slight variation in texture and
colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quofenix is indicated for the treatment of the following infections in
adults:
•
acute bacterial skin and skin structure infections (ABSSSI)
•
community-acquired pneumonia (CAP)
when it is considered inappropriate to use other antibacterial agents
that are commonly recommended
for the initial treatment of these infections (see sections 4.4 and
5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 300 mg delafloxacin every 12 hours
administered over 60 minutes by
intravenous infusion. Switch to delafloxacin 450 mg tablet orally
every 12 hours is possible at the
discretion of the physician. The total duration of treatment is 5 to
14 days for ABSSSI and 5 to 10
days for CAP.
Special population
_Elderly_
3
No dose adjustment is required. As per fluoroquinolone class patients
aged over 60 years are at
increased risk for developing severe tendon disorders including tendon
rupture (see sections