ZERBAXA 1 G0.5 G

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

CEFTOLOZANE AS SULFATE; TAZOBACTAM AS SODIUM

Saatavilla:

MERCK SHARP & DOHME ISRAEL LTD

ATC-koodi:

J01DI54

Lääkemuoto:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Koostumus:

TAZOBACTAM AS SODIUM 0.5 G; CEFTOLOZANE AS SULFATE 1 G

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

MERCK SHARP & DOHME CORP., USA

Terapeuttinen alue:

CEFTOLOZANE AND ENZYME INHIBITOR

Käyttöaiheet:

Zerbaxa is indicated for the treatment of the following infections in adults:-Complicated intra abdominal infections;-Acute pyelonephritis caused by pathogens resistant to other treatments as confirmed by urine culture-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

Valtuutus päivämäärä:

2018-02-07

Pakkausseloste

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is to be supplied upon physician’s prescription only
ZERBAXA
® 1 G/0.5 G
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Each vial contains:
Ceftolozane (as sulfate) 1 g
Tazobactam (as sodium) 0.5 g
For a list of inactive ingredients see section 6. “FURTHER
INFORMATION”. See also section 2.7 “Important
information about some of the ingredients of ZERBAXA”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

This leaflet contains concise information about the medicine. If you
have any further questions, refer to
the doctor or the pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
1. WHAT ZERBAXA IS INTENDED FOR?
ZERBAXA is used in adults to treat complicated infections within the
abdomen, and kidney and urinary
system infections.
ZERBAXA 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.
THERAPEUTIC GROUP: Antibacterials for systemic use, other
cephalosporins and penems.
2. BEFORE USING ZERBAXA
2.1
DO NOT USE ZERBAXA IF:
-
you are allergic to ceftolozane, tazobactam or any of the other
ingredients of this medicine (listed in
section 6).
-
you are allergic to medicines known as “cephalosporins”.
-
you have had a severe allergic reaction (e.g., severe skin peeling;
swelling of the face, hands, feet,
lips, tongue or throat; or difficulty swallowing or breathing) to
certain other antibiotics (e.g., penicillins
or carbapenems).
2.2 SPECIAL WARNINGS REGARDING USE OF ZERBAXA

Valmisteyhteenveto

1
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
Each 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 yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zerbaxa is indicated for the treatment of the following infections in
adults (see section 5.1):
-
Complicated intra-abdominal infections (see section 4.4);
-
Acute pyelonephritis caused by pathogens resistant to other treatments
as confirmed by urine culture;
-
Complicated urinary tract infections (see section 4.4).
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 patients with creatinine
clearance > 50 mL/min is shown by
infection type in Table 1.
2
TABLE 1: INTRAVENOUS DOSE OF ZERBAXA BY TYPE OF INFECTION IN PATIENTS
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 infection
Acute pyelonephritis
1 g ceftolozane /
0.5 g tazobactam
Every 8 hours
1 hour
7 days
*To be used in combination with metronidazole when anaerobic pathogens
are suspected.
Special populations
_ _
_Elderly (≥ 65 years of age)_
No dose adjustmen