Recarbrio

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

imipenem monohydrate, cilastatin sodium, relebactam monohydrate

Fáanlegur frá:

Merck Sharp & Dohme B.V. 

ATC númer:

J01DH56

INN (Alþjóðlegt nafn):

imipenem, cilastatin, relebactam

Meðferðarhópur:

Carbapenems, Antibacterials for systemic use,

Lækningarsvæði:

Gram-Negative Bacterial Infections

Ábendingar:

Recarbrio is indicated for:- Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).- Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.- Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Vörulýsing:

Revision: 5

Leyfisstaða:

Authorised

Leyfisdagur:

2020-02-13

Upplýsingar fylgiseðill

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFOR
MATION FOR THE USER
RECARBRIO 500 MG/500 MG/250
MG POWDER FOR SOLUTION FOR INFUSION
imipenem/cilastatin/relebactam
This medicine
is subjec
t to additiona
l moni
toring. This will allo
w quick identification of new
sa
fety information. You can he
lp by reporting any side effects you may get. See the end of section 4
for how to repor
t side effects.
READ AL
L OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MED
ICINE
BECAUSE IT CONTAINS IM
PORTANT
INFORMATION FOR YOU.

Kee
p 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, t
alk to your doctor or nurse.
This includes
any possible s
ide effects
not listed in th
is leaflet. See section
4.
WHAT
IS IN THIS LEAFLET
1.
What Recarbrio is and what it is used for
2.
What
you need to k
now before you are given
Recarbrio
3.
How you are given Recarbrio
4.
Possible side effec
ts
5.
How to store Recarbrio
6.
Contents of th
e pa
ck and other information
1.
WHAT RECARBRIO
IS AND WHAT IT IS US
ED FOR
Recarbrio is an antibiotic. It
contains the a
ctive substances imipenem, ci
last
atin, and rele
bactam.
Recarbrio is used in adults to treat:

certain bacterial infections of
the lungs (p
neumonia)

inf
ections of the bloo
d associated with
the infection
s of the lung mentioned above

infections
caused by bact
eria that other antibiotics m
ay
not be able to
kill
Recarbrio is used in patients 18 years or older.
2.
WHAT YOU NEE
D TO KNOW
BEFORE YOU ARE GIVEN RECARBRIO
YOU SHOULD N
OT BE GIVEN
RECARBRIO IF:

you are allergic t
o imipenem, cilastatin, relebactam or any of t
he other ingredients of this medicine
(listed in section 6)

you are allergic to carbapenem antibiotics

you ever had a severe allergic reaction to penicillin antibiotics or
cephalospor
in antibiotics
You s
hould not be given
Recarbrio
if any of the above apply to you. If you are not sure, talk to your
doctor or
nurse before being given
Recarbrio.
WARNINGS

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 adve
rse reactions.
See section
4.8 for how to
report adverse reactions
.
1.
NAME OF
THE
MEDICINAL PROD
UCT
Recarbrio 500 mg/500 mg/250
mg powder for
solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains
imipenem monohydrate eq
uivalent to 500
mg imipenem,
cilastatin sodium
equivalent to 500
mg cilastatin, and
relebactam mon
ohydrate equivalent to 250
mg relebactam.
Excipient(s)
with known effect
The total amount of sodium in each vial is
37.5 mg (1.6 mmol).
For the full
list of excipients, see section 6.1.
3.
PHARMAC
EUTICAL
FORM
Powder for solution for infusion.
A white to
light yellow
powder.
4.
CLINIC
AL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Re
carbrio is indicated for
:

T
reatment of
hospital-acquired
pneumonia (HAP)
, including ventilator
associated pneumonia
(VAP), in adult
s (see sections
4.4 and 5.1).

Treatment of
bacteraemia that occurs
in associatio
n with, or
is suspected to be associated with
HAP or VAP, in adults.

T
reatment of
infections due to aerobic Gram-negative organisms in adults
with limited
treatment options
(see sections
4.2, 4.4, and 5.1).
Considerat
ion should be given to official guidance on the appropriate
us
e of antibacterial agents.
4.2
POSOLOGY AND
METHOD OF ADMINISTR
ATION
It is recommended th
at Recarbrio sho
uld be used to treat
infections due to aerobic Gram-negative
organisms in adult patient
s with limited treatment options only after consultation wit
h
a physician with
appropriate experien
ce in t
he management of inf
ectious diseases
.
Posology
Table 1 shows the recommend
ed intravenous dos
e for
patients with a
cre
atinine clearance
(CrCl)
≥
90 mL/min (see sections 4.4 and 5.1).
3
TABLE
1: RECOMMENDED
I
NTRAVENOUS
DOSE FOR P
ATIENTS WITH A
CREATININE CLEARANCE
(CRCL) ≥ 90 ML/MIN
1,2
TYPE OF INFECTIO