Arikayce liposomal

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

Amikacin sulfate

Disponibil de la:

Insmed Netherlands B.V.

Codul ATC:

J01GB06

INN (nume internaţional):

amikacin

Grupul Terapeutică:

Antibacterials for systemic use,

Zonă Terapeutică:

Respiratory Tract Infections

Indicații terapeutice:

Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

Rezumat produs:

Revision: 2

Statutul autorizaţiei:

Authorised

Data de autorizare:

2020-10-27

Prospect

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIKAYCE LIPOSOMAL 590 MG NEBULISER DISPERSION
amikacin
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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to 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 ARIKAYCE liposomal is and what it is used for
2.
What you need to know before you use ARIKAYCE liposomal
3.
How to use ARIKAYCE liposomal
4.
Possible side effects
5.
How to store ARIKAYCE liposomal
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT ARIKAYCE LIPOSOMAL IS AND WHAT IT IS USED FOR
ARIKAYCE liposomal is an
ANTIBIOTIC
that contains the active ingredient amikacin. Amikacin
belongs to a group of antibiotics called aminoglycosides which stop
the growth of certain bacteria that
cause infections.
ARIKAYCE liposomal is used by inhalation to treat
LUNG INFECTION
caused by
_Mycobacterium avium_
Complex in adults with limited treatment options who do not have
cystic fibrosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARIKAYCE
LIPOSOMAL
DO NOT USE ARIKAYCE
LIPOSOMAL
-
if you are allergic to
AMIKACIN
or other
AMINOGLYCOSIDES
,
SOYA
or
ANY OF THE OTHER INGREDIENTS
of this medicine (listed in section 6)
-
if you are taking any other aminoglycosides (oral or for injection)
-
if you have very poor kidney function
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using ARIKAYCE liposomal if:
-
you use a bronchodilator (“reliever”) for breathing problems, as
you will be asked to use that
first, before using ARIKAYCE liposomal;
-
you have
KIDNEY PROBLEMS
; you may need to have a kidney te

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ARIKAYCE liposomal 590 mg nebuliser dispersion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains amikacin sulfate equivalent to 590 mg amikacin in a
liposomal formulation. The
mean delivered dose per vial is approximately 312 mg of amikacin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser dispersion
White, milky, aqueous, nebuliser dispersion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARIKAYCE liposomal is indicated for the treatment of non-tuberculous
mycobacterial (NTM) lung
infections caused by
_Mycobacterium avium_
Complex (MAC) in adults with limited treatment options
who do not have cystic fibrosis (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
ARIKAYCE liposomal treatment should be initiated and managed by
physicians experienced in the
treatment of non-tuberculous lung disease due to
_Mycobacterium avium _
Complex.
ARIKAYCE liposomal should be used in conjunction with other
antibacterial agents active against
_Mycobacterium avium _
Complex lung infections.
Posology
The recommended dose is one vial (590 mg) administered once daily, by
oral inhalation.
_Duration of treatment _
Treatment with inhaled liposomal amikacin, as part of a combination
antibacterial regimen, should be
continued for 12 months after sputum culture conversion.
Treatment with inhaled liposomal amikacin should not continue beyond a
maximum of 6 months if
sputum culture conversion (SCC) has not been confirmed by then.
The maximum duration of treatment with inhaled liposomal amikacin
should not exceed 18 months.
_Missed doses _
If a daily dose of amikacin is missed, the next dose should be
administered the next day. A double
dose should not be given to make up for the missed dose.
_Elderly _
No dose adjustment is required.
3
_Hepatic impairment _
Inhaled liposomal amikacin has not