Zerbaxa

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

ceftolozane sulfate, tazobactam sodium

Διαθέσιμο από:

Merck Sharp & Dohme B.V. 

Φαρμακολογική κατηγορία (ATC):

J01

INN (Διεθνής Όνομα):

ceftolozane, tazobactam

Θεραπευτική ομάδα:

Antibacterials for systemic use,

Θεραπευτική περιοχή:

Bacterial Infections

Θεραπευτικές ενδείξεις:

Zerbaxa is indicated for the treatment of the following infections in adults:Complicated intra abdominal infections;Acute pyelonephritis;Complicated urinary tract infections;Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Περίληψη προϊόντος:

Revision: 15

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-09-18

Φύλλο οδηγιών χρήσης

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZERBAXA 1 G / 0.5 G
POWDER FOR
CONCENTRATE FOR
SOLUTION FOR INFUSION
ceftolozane /
tazobactam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
If y
ou get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. Se
e section 4.
WHAT IS IN THIS LEAFLET
1.
What Zerbaxa is and what it is used for
2.
What you need to know before you take
Zerbaxa
3.
How to take Zerbaxa
4.
Possible side effects
5.
How to store Zerbaxa
6.
Contents of the pack and other information
1.
WHAT ZERBAXA IS AND WHAT IT IS USED FOR
Zerbaxa is a medicine used to treat a range of bacterial infections.
It contains
two active substances:
-
ceftolozane, an antibiotic that belongs to the group of
“cephalosporins” and which can kill
certain bacteria that can cause infection;
-
tazobactam, which blocks the action of certain enzymes called beta
-
lactamases. These enzymes
make
bacteria resistant to ceftolozane by breaking down the antibiotic
before it can act. By
blocking their action, tazobactam makes ceftolozane more effective at
killing bacteria.
Zerbaxa is used in
all age groups
to treat complicated infections within the a
bdomen, and
kidney and
urinary system
.
Zerbaxa is also used in adults to treat
an infection of the lungs called “pneumonia”
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZERBAXA
DO NOT TAKE ZERBAXA
-
if you are allergic to ceftolozane, tazobactam or any of
the other ingredients of this medicine
(listed in section
6).
-
if you are allergic to
medicines known as “
cephalosporin
s”
.
-
if you have had a severe
allergic reaction
(e.g.,
severe skin peeling; swelling of the face, hands,
feet, lips, tongue or throat; or
diffi
culty swallowing or breathing) to certain other antibiotics
(e.g., penicillins

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zerbaxa 1 g/0.5
g powder for
concentrate for
solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains
ceftolozane
sulfate
equivalent to 1
g ceftolozane and
tazobactam
sodium equivalent
to 0.5 g tazobactam.
After reconstitution with 10
mL diluent, the total volume of the solution in the vial is
11.4
mL, which
contains 88
mg/mL of ceftolozane and 44
mg/mL of
tazobactam.
Excipient with known effect
E
ach vial contains 10
mmol (230
mg) of sodium.
When the powder is reconstituted with 10
mL of sodium chloride 9
mg/mL (0.9%) solution for
injection,
the vial contains 11.5
mmol (265
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).
White to yellow
ish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zerbaxa is indicated for the treatment of the following infections
in adult and
paediatric patients
(see
sections 4.2 and 5.1):
-
Complicated intra
-
abdominal infections (see section
4.4);
-
Acute pyelonephritis;
-
Complicated
urinary tract infections (see section
4.4).
Zerbaxa is also indicated for the treatment of the following infection
in adult
patients (18 years or
older) (see section 5.1):
-
Hospital-
acquired pneumonia
(HAP),
including ventilator
-
associated pneumonia
(VAP).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended
intravenous
dose regimen
for adult
patients with creatinine clearance >
50 mL/min
is shown by infection type
in Table 1.
3
TABLE 1: INTRAVENOUS DOSE OF ZERBAXA BY TYPE OF INFECTION IN ADULT PATIENTS (18
YEARS OR OLDER)
WITH CREATININE CLEARANCE
* > 50 ML/MIN
TYPE OF INFECTION
DOSE
FREQUENCY
INFUSION
TIME
DURATION OF
TREATMENT
Complicated intra
-abdominal
infection**
1
g ceftolozane /
0.5
g tazobactam
Every
8 hours
1 hour
4-14 days
Complicated
urinary tract