Zerbaxa

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Ceftolozane sulfate 1147mg equivalent to ceftolozane 1000 mg; Tazobactam sodium 537mg equivalent to tazobactam 500 mg

Fáanlegur frá:

Merck Sharp & Dohme (New Zealand) Limited

INN (Alþjóðlegt nafn):

Ceftolozane sulfate 1147 mg (equivalent to ceftolozane 1000 mg)

Skammtar:

1000mg/500mg

Lyfjaform:

Powder for injection

Samsetning:

Active: Ceftolozane sulfate 1147mg equivalent to ceftolozane 1000 mg Tazobactam sodium 537mg equivalent to tazobactam 500 mg Excipient: Arginine Citric acid Sodium chloride

Gerð lyfseðils:

Prescription

Framleitt af:

ACS Dobfar SpA

Ábendingar:

ZERBAXA (ceftolozane/tazobactam) is indicated for the treatment of the following infections in adults and paediatric (birth to less than 18 years of age) patients with the following infections caused by designated susceptible microorganisms: - Complicated intra-abdominal infections in combination with metronidazole. - Complicated urinary tract infections, including pyelonephritis. Consideration should be given to published therapeutic guidelines on the appropriate use of antibacterial agents.

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, Type 1, 20 mL equipped with 20 mm bromobutyl rubber stopper plus Al and plastic Flip-Off seal - 10 dose units - 36 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. (Only if appropriately diluted in an infusion bag)

Leyfisdagur:

2014-11-12

Upplýsingar fylgiseðill

1
ZERBAXA®
POWDER FOR INJECTION
Ceftolozane and tazobactam
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the more common questions about
ZERBAXA. It doe
s not contain all
of the available information.
It does not take
the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
having ZERBAXA
against the benefits
this medicine is expect
ed to have for you.
IF YOU HAVE ANY CONCERNS
OR QUESTIONS
ABOUT BEING GIVEN TH
IS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET
.
You may need to read it again.
WHAT ZERBAXA IS USED FOR
ZERBAXA contains two active substances:
•
Ceftolozane
, an antibiotic that
belongs
to the group of
“cephalosporins”.
Ceftolozane can kill
many kinds of bacteria
that can cause infection
.
•
Tazobactam belongs to the group of medi
cines known as “beta
-
lactamase inhibitors”.
Tazobactam can help ceftolozane work against some resistant types of
bacte
ria.
When ceftolozane and t
azobactam a
re given together, more types of bacteria are killed.
ZERBAXA
is used in adult
s and
children (birth to less than 18 years of age)
to treat:
•
Complicated abdominal
and urinary system infections, including a condition called
pyelonephritis
.
ZERBA
XA is an anti
biotic
prescribed to treat adults aged 18 years or older with
:
•
Noscomial pneumonia (an infection
of the lungs that can
occur while in the hospital or
in
recently hospitalised patients),
including a condition called
‘
ventilator-associated
pneumonia
”
(an infection
of the lungs that can occur while on a respirator.
Your doct
or may have prescribed ZERBA
XA for another reason. Ask your doctor if you have any
questions about why ZERBAXA has been prescribed for you.
ZERBAXA is
only available with a
doctor’s prescri
ption.
ZERBAXA is not addictive.
2
BEFORE YOU
ARE GIVEN ZERBAXA
W
HEN YOU MUST NOT B
E GIVEN IT
DO NOT HAVE ZERBAXA
:
•
if you are allergic to ceftoloz
ane, tazobactam or any of the other ingredients
in
th

Vara einkenni

NEW ZEALAND DATA SHEET
Page
1
of 40
1.
PRODUCT
NAME
ZERBAXA
®
(ceftolozane/tazobactam) Powder for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg of ceftolozane (as ceftolozane sulfate) and
500 mg tazobactam (as
tazobactam sodium).
For the full list of excipients, see
Section 6.1
List of excipients
.
3.
PHARMACEUTICAL FORM
Powder for injection
Ceftolozane sulfate/tazobactam sodium (
ZERBAXA
) is a white to yellow powder for solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ZERBAXA
(ceftolozane/tazobactam) is indicated for the treatment of the
following infections
in adults
and paediatric (birth to less than 18 years of age) patients with the
following infections
caused by designated susceptible microo
rganisms:
-
Complicated intra
-
abdominal infections in combination with metronidazole
-
Complicated urinary tract infections, including pyelonephritis
ZERBAXA
(ceftolozane/tazobactam)
is also indicated for the treatment of the following
infection in adults (18
years or older):
-
Nosocomial pneumonia, including ventilator
-
associated pneumonia (VAP)
Consideration
should be given to published therapeutic guidelines on the appropriate
use of
antibacterial agents.
4.2
DOSE AND METHOD OF A
DMINISTRATION
Dosage Regimen
The
recommended
intravenous dose regimen for ZERBAXA
(ceftolozane/tazobactam)
in
patients 18 years or older and with creatinine clearance (CrCL)
greater than 50 mL/min is
shown
by infection type
in Table 1.
NEW ZEALAND DATA SHEET
Page
2
of 40
TABLE 1: DOSE OF ZERBAXA (
CEFTOLOZANE/TAZOBACTAM)
BY TYPE OF INFECTION IN ADULT
PATIENTS
(18 YEARS OR OLDER)
WITH A CREATININE CLEARANCE (CRCL)
GREATER THAN 50 ML/MIN
TYPE OF INFECTION
DOSE
FREQUENCY
INFUSION
TIME
DURATION
OF
TREATMENT
Complicated intra
-abdominal
infections*
1000 mg
ceftolozane
/ 500 mg
tazobactam
Every
8 hours
1 hour
4-14 days
Complicated urinary tract
infections, including
pyelonephritis
1000 mg
ceftolozane
/ 500 mg
tazobactam
Every
8 hours
1 hour
7 days
Nosocomial Pneumonia,
including Ventilat
or-ass