ADALUZIS 500 Milligram Pdr/Conc/Soln for Infus

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

CEFTOBIPROLE MEDOCARIL SODIUM

Commercializzato da:

Basilea Medical Ltd. c/o Cox Costello & Horne Limited

Codice ATC:

J01DI01

INN (Nome Internazionale):

CEFTOBIPROLE MEDOCARIL SODIUM

Dosaggio:

500 Milligram

Forma farmaceutica:

Pdr/Conc/Soln for Infus

Tipo di ricetta:

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

Area terapeutica:

Other cephalosporins

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2017-09-29

Foglio illustrativo

Package leaflet:
Information for the user
Adaluzis 500 mg powder
for concentrate for
solution for infusion
Ceftobiprole
䊲
This medicine is subject to additional
monitoring. This will allow quick identification
of new safety information. You can help
by reporting any side effects you may get.
See the end of section 4 for how to report
side effects
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
Adaluzis is an antibiotic medicine that contains
the active substance ceftobiprole medocaril
sodium. It belongs to a group of medicines
called ‘cephalosporin antibiotics’.
Adaluzis is used to treat adults with infections
of the lungs called ‘pneumonia’.
Adaluzis 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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
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 adverse reactions. See section 4.8 for how to
report adverse reactions.
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
Adaluzis is indicated for the treatment of the following infections in
adults (see sections 4.4, 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 dose of Adaluzis is 500 mg administered as a 2-hour
intravenous infusion every 8 hours. For CAP, a
switch to an appropriate oral antibiotic may be considered after
completion of at least 3 days of intravenous
ceftobiprole medocaril sodium treatment, depending on the patient’s
clinical response.
_Paediatric population_
The safety and efficacy of Adaluzis in children aged birth to < 18
years have not yet been established. Adaluzis is not
recommended for use in children or adolescents below 18 years of age.
_Elderly patients_
No dose adjustment is necessary in elderly patients, except in cases
of moderate to severe r