Vaborem
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
26-07-2023
Karatteristiċi tal-prodott
(SPC)
26-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-12-2018
Ingredjent attiv:
meropenem trihydrate, vaborbactam
Disponibbli minn:
Menarini International Operations Luxembourg S.A.
Kodiċi ATC:
J01DH
INN (Isem Internazzjonali):
meropenem, vaborbactam
Grupp terapewtiku:
Antibacterials for systemic use,
Żona terapewtika:
Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated
Indikazzjonijiet terapewtiċi:
Vaborem is indicated for the treatment of the following infections in adults:Complicated urinary tract infection (cUTI), including pyelonephritisComplicated intra-abdominal infection (cIAI)Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Sommarju tal-prodott:
Revision: 7
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-11-20
Fuljett ta 'informazzjoni
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VABOREM 1 G/1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
meropenem/vaborbactam
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 Vaborem is and what it is used for
2.
What you need to know before you are given Vaborem
3.
How you will be given Vaborem
4.
Possible side effects
5.
How to store Vaborem
6.
Contents of the pack and other information
1.
WHAT VABOREM IS AND WHAT IT IS USED FOR
WHAT VABOREM IS
Vaborem is an antibiotic medicine that contains two active substances:
meropenem and vaborbactam.
•
Meropenem belongs to group of antibiotics called “carbapenems”. It
can kill many types of bacteria
by preventing them from building the protective walls that surround
their cells.
•
Vaborbactam is a “beta lactamase inhibitor”. It blocks the action
of an enzyme that allows some
bacteria to resist the action of meropenem. This helps meropenem kill
some bacteria that it cannot
kill on its own.
WHAT VABOREM IS USED FOR
Vaborem is used in adults to treat certain serious bacterial
infections:
•
of the bladder or kidneys (urinary tract infections)
•
of the stomach and gut (intra-abdominal infections)
•
of the lungs (pneumonia)
It is also used to treat infections
•
of the blood associated with any of the infections mentioned above
•
caused by bacteria that other antibiotics may not be able to kill
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VABOREM
YOU MUST NOT BE GIVEN VABOREM
IF
•
you are allergic to meropenem, vaborbactam or the other ingredients of
this medicine (listed in
section 6).
•
you are allergic to other carbapenem antibiotics (the group to which
merope
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vaborem 1 g/1 g powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g meropenem,
and 1 g vaborbactam.
After reconstitution, 1 ml of the solution contains 50 mg meropenem
and 50 mg vaborbactam (see section
6.6).
Excipient with known effect:
Each vial contains 10.9 mmol of sodium (approximately 250 mg).
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 light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vaborem is indicated for the treatment of the following infections in
adults (see sections 4.4 and 5.1):
•
Complicated urinary tract infection (cUTI), including pyelonephritis
•
Complicated intra-abdominal infection (cIAI)
•
Hospital-acquired pneumonia (HAP), including ventilator associated
pneumonia (VAP).
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated
with, any of the infections listed above.
Vaborem is also indicated for the treatment of infections due to
aerobic Gram-negative organisms in
adults with limited treatment options (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vaborem should be used to treat infections due to aerobic
Gram-negative organisms in adult patients with
limited treatment options only after consultation with a physician
with appropriate experience in the
management of infectious diseases (see sections 4.4 and 5.1).
Posology
3
Table 1 shows the recommended intravenous dose for patients with a
creatinine clearance
(CrCl) ≥40 ml/min (see sections 4.4 and 5.1).
TABLE 1:
RECOMMENDED INTRAVENOUS DOSE FOR PATIENTS WITH A CREATININE CLEARANCE
(CRCL) ≥40 ML/MIN
1
Type of infection
Dose of Vaborem
(meropenem/
v
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