Adaluzis 500mg Powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CEFTOBIPROLE MEDOCARIL SODIUM

Available from:

Correvio

ATC code:

J01DI; J01DI01

INN (International Name):

CEFTOBIPROLE MEDOCARIL SODIUM

Dosage:

500 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other cephalosporins and penems; ceftobiprole medocaril

Authorization status:

Marketed

Authorization date:

2017-09-29

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADALUZIS 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Ceftobiprole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Adaluzis is and what it is used for
2.
What you need to know before you use Adaluzis
3.
How to use Adaluzis
4.
Possible side effects
5.
How to store Adaluzis
6.
Contents of the pack and other information
1.
WHAT ADALUZIS IS AND WHAT IT IS USED FOR
Zevtera is an antibiotic medicine that contains the active substance
ceftobiprole medocaril sodium. It
belongs to a group of medicines called ‘cephalosporin
antibiotics’.
Zevtera is used to treat term neonates, infants, children,
adolescents, and adults with infections of the
lungs called ‘pneumonia’.
Zevtera works by killing certain bacteria, which can cause serious
lung infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ADALUZIS
DO NOT USE ADALUZIS:
-
if you are allergic to ceftobiprole medocaril sodium or any of the
other ingredients of this
medicine (listed in section 6),
-
if you are allergic to other cephalosporin or beta-lactam antibiotics,
-
if you have had previous severe allergic reactions to other
antibiotics like penicillin or
carbapenem.
Do not use Adaluzis if any of the above applies to you. If you are not
sure, talk to your doctor or nurse
before being given Adaluzis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Adaluzis :
-
if you have kidney problems (your doctor may need to lower your dose
of this medicine),
-
if you have ever had any allergic reactions to other antibiotics like
penicillin or carbapenem,
-
if you have ever had fits (seizures or convulsions),
-
if you have diarrhoea before, during

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2023
CRN00DG2Q
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adaluzis 500mg Powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of ceftobiprole (as 666.6 mg of ceftobiprole
medocaril sodium). After reconstitution, each mL of
concentrate contains 50 mg of ceftobiprole (as 66.7 mg of ceftobiprole
medocaril sodium).
Excipient(s) with known effect:
Each vial contains approximately 1.3 mmol (29 mg) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White, yellowish to slightly brownish, cake to broken cake or powder.
The pH of the reconstituted solution is between 4.5 and 5.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zevtera is indicated for the treatment of the following infections in
adults, term neonates, infants, children and adolescents (see
sections 4.4 and 5.1):

Hospital-acquired pneumonia (HAP), excluding ventilator-associated
pneumonia (VAP)

Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended regimen for adult and paediatric patients with normal
renal function is shown in Table 1.
TABLE 1 DOSAGE IN ADULT AND PAEDIATRIC PATIENTS WITH NORMAL RENAL
FUNCTION OR MILD RENAL IMPAIRMENT (I.E., CREATININE
CLEARANCE [CL
CR
] ≥ 50 ML/MIN)
AGE GROUP
BODY WEIGHT (KG)
CEFTOBIPROLE DOSE
CONCENTRATION
OF INFUSION
SOLUTION
A
INFUSION
TIME/
FREQUENCY
Adults
-
500 mg
2 mg/mL
2 h
infusion /
every
8 hours
Adolescents
aged 12 to < 18 years
≥ 50 kg
500 mg
​
​
​
< 50 kg
10 mg/kg
​
​
Health Products Regulatory Authority
27 March 2023
CRN00DG2Q
Page 2 of 14
Infants aged ≥ 3 months and children < 12 years
≥ 33 kg
500 mg
4 mg/mL
2 h
infusion /
every
8 hours
​
< 33 kg
15 mg/kg
​
​
Term neonates and infants < 3 months
≥ 4 kg
15 mg