Doribax
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-10-2014
Charakterystyka produktu
(SPC)
17-10-2014
Sprawozdanie z oceny publicznego
(PAR)
17-10-2014
Składnik aktywny:
doripenem
Dostępny od:
Janssen-Cilag International NV
Kod ATC:
J01DH04
INN (International Nazwa):
doripenem
Grupa terapeutyczna:
Antibacterials for systemic use,
Dziedzina terapeutyczna:
Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Urinary Tract Infections; Bacterial Infections; Cross Infection
Wskazania:
Doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Withdrawn
Data autoryzacji:
2008-07-25
Ulotka dla pacjenta
38
B. PACKAGE LEAFLET
Medicinal product no longer authorised
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
DORIBAX 250 MG POWDER FOR SOLUTION FOR INFUSION
doripenem
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Doribax is and what it is used for
2.
What you need to know before you use Doribax
3.
How to use Doribax
4.
Possible side effects
5.
How to store Doribax
6.
Contents of the pack and other information
1.
WHAT DORIBAX IS AND WHAT IT IS USED FOR
Doribax contains the active substance doripenem. This medicine is an
antibiotic which works by
killing different types of bacteria (germs) that cause infections in
various parts of the body.
Doribax is used to treat adults for the following infections:
-
Pneumonia (a serious type of chest or lung infection) that you catch
in a hospital or similar
setting. This includes pneumonia that you catch when on a machine that
helps you breathe.
-
Complicated infections of the area around your stomach (abdominal
infections).
-
Complicated urinary tract infections, including kidney infections and
cases that have spread to
the bloodstream.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DORIBAX
DO NOT USE DORIBAX:
-
If you are allergic to doripenem.
-
If you are allergic to other antibiotics such as penicillins,
cephalosporins or carbapenems (which
are used to treat various infections) as you may also be allergic to
Doribax.
Do not use this medicine if any of the above applies to you. If you
are not sure, talk to your doctor,
pharmacist or nurse before being given Doribax.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before being given Doribax,
and if you have:
-
Kidney problems. Your doctor may nee
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Doribax 250 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains doripenem monohydrate equivalent to 250 mg
doripenem.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion)
White to slightly yellowish off-white crystalline powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doribax is indicated for the treatment of the following infections in
adults (see sections 4.4 and 5.1):
●
Nosocomial pneumonia (including ventilator–associated pneumonia)
●
Complicated intra-abdominal infections
●
Complicated urinary tract infections
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 and administration by infection is shown in the
following table:
Infection
Dose
Frequency
Infusion time
Nosocomial pneumonia including
ventilator–associated pneumonia
500 mg or 1 g*
every 8 hours
1 or 4 hours**
Complicated intra-abdominal infection
500 mg
every 8 hours
1 hour
Complicated UTI, including pyelonephritis
500 mg
every 8 hours
1 hour
*
1 g every 8 hours as a 4-hour infusion may be considered in patients
with augmented renal clearance (particularly
those with creatinine clearance (CrCl) ≥ 150 ml/min) and/or in
infections due to non-fermenting gram-negative
pathogens (such as _Pseudomonas_ spp. and _Acinetobacter_ spp.). This
dose regimen is based on PK/PD data (see
sections 4.4, 4.8 and 5.1).
** Based mainly on PK/PD considerations, a 4-hour infusion time may be
more suitable for infection with less
susceptible pathogens (see section 5.1). This dosing regimen should
also be considered in particularly severe
infections.
_Duration of treatment_
The usual treatment duration of doripenem therapy ranges from 5-14
days and should be guided by the
severity, site of the infection, infecting pathogen and the
patient’s cli
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