Vibativ
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-05-2018
Charakterystyka produktu
(SPC)
16-05-2018
Sprawozdanie z oceny publicznego
(PAR)
16-05-2018
Składnik aktywny:
telavancin
Dostępny od:
Theravance Biopharma Ireland Umited
Kod ATC:
J01XA03
INN (International Nazwa):
telavancin
Grupa terapeutyczna:
Antibacterials for systemic use,
Dziedzina terapeutyczna:
Pneumonia, Bacterial; Cross Infection
Wskazania:
Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-09-02
Ulotka dla pacjenta
25
B. PACKAGE LEAFLET
Medicinal product no longer authorised
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIBATIV 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
VIBATIV 750 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
telavancin
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 ARE GIVEN 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 pharmacist.
-
If you get any side effects, talk your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What VIBATIV is and what it is used for
2.
What you need to know before you use VIBATIV
3.
How to use VIBATIV
4.
Possible side effects
5.
How to store VIBATIV
6.
Contents of the pack and other information
1.
WHAT VIBATIV IS AND WHAT IT IS USED FOR
VIBATIV contains telavancin as active substance, which is an
antibiotic of the glycopeptide group.
VIBATIV is used to treat adult patients with infections of the lungs
that have developed in the
hospital, including patients on artificial ventilation, when these
infections are known or suspected to
be caused by bacteria called methicillin-resistant _Staphylococcus
aureus_ (MRSA).
It is only used when the bacteria that cause these infections can be
killed with telavancin. VIBATIV
can only be used when other antibiotics are not suitable.
If you also have other bacteria that cause your infection, your doctor
may prescribe other antibiotics in
addition to VIBATIV.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VIBATIV
DO NOT USE VIBATIV
-
if you are allergic (hypersensitive) to telavancin or any of the other
ingredients of VIBATIV
(listed in section 6)
-
If you suffer from severe kidney problems, or receive hae
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
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
VIBATIV 250 mg powder for concentrate for solution for infusion
VIBATIV 750 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VIBATIV 250 mg powder for concentrate for solution for infusion
Each vial contains 250 mg telavancin (as hydrochloride).
VIBATIV 750 mg powder for concentrate for solution for infusion
Each vial contains 750 mg telavancin (as hydrochloride).
After reconstitution, each ml contains 15 mg of telavancin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
A white to pale pink, whole or fragmented cake
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIBATIV is indicated for the treatment of adults with nosocomial
pneumonia (NP) including
ventilator associated pneumonia, known or suspected to be caused by
methicillin-resistant
_Staphylococcus aureus_ (MRSA).
VIBATIV should be used only in situations where it is known or
suspected that other alternatives are
not suitable (see sections 4.3, 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7
to 21 days.
Special populations
_ _
_Elderly patients _
Elderly patients should receive a telavancin dose in accordance with
their bodyweight and renal
function (see sections 4.3 and 5.2).
Medicinal product no longer authorised
3
_Renal impairment_
Patients with renal impairment should receive an initial dose
according to calculated or measured
creatinine clearance as presented in t
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