ARIKAYCE LIPOSOMAL 590 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

AMIKACIN AS SULFATE

Beschikbaar vanaf:

TRUEMED LTD, ISRAEL

ATC-code:

J01GB06

farmaceutische vorm:

SUSPENSION FOR INHALATION

Samenstelling:

AMIKACIN AS SULFATE 70 MG/ML

Toedieningsweg:

INHALATION

Prescription-type:

Required

Geproduceerd door:

INSMED NETHERLANDS BV.,THE NETHERLANDS

Therapeutisch gebied:

AMIKACIN

therapeutische indicaties:

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. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Autorisatie datum:

2022-05-02

Bijsluiter

PATIENT SAFETY INFORMATION CARD
IMPORTANT SAFETY INFORMATION
ARIKAYCE LIPOSOMAL 590 MG
(ACTIVE INGREDIENT: AMIKACIN)
PATIENT NAME: ____________________________________________
CONTACT DETAILS OF THE ATTENDING DOCTOR: ______________________
ARIKAYCE LIPOSOMAL 590 MG START DATE: ________________________
REGISTRATION HOLDER: TrueMed Ltd., 10 Beni Gaon St., Netanya.
MANUFACTURER: Insmed Netherlands B.V., Netherlands.
Side effects can be reported to the Ministry of Health by clicking the
link “Report
Side Effects of Drug Treatment” found on the Ministry of Health
homepage
(www.health.gov.il) or by entering the link:
https://sideeffects.health.gov.il
Read the patient leaflet before start using the medicine.
This card was approved by the Ministry of
Health in April 2022.
לפוטמל יתוחיטב עדימ סיטרכ
בושח יתוחיטב עדימ
ג״מ 590 למוזופיל סייקירא
)ןיצקימא :ליעפ ביכרמ(
____________________________________________________ :לפוטמה
םש
_______________________________________ :לפטמה אפורה לש
רשק יטרפ
____________________ :ג״מ 590 למוזופיל סייקיראב
לופיטה תלחתה ךיראת
.הינתנ ,10 ןואג ינב בוחר ,מ״עב דמורת
:םושירה לעב
.דנלוה ,Insmed Netherlands B.V. :ןרציה
לע חווידל ןווקמה ספוטה תועצמאב
תואירבה דרשמל יאוול תועפות לע חוודל
ןתינ
www.health.gov.il :תואירבה דרשמ רתא לש תיבה ףדב
אצמנש יאוול תועפות
https://sideeffects.health.gov.il :רושיקל הסינכ ידי לע
וא
.הפורתב שומישה תליחת םרטב ןכרצל ןולעב
ןייעל שי
.2022 לירפאב תואירבה דרשמ ידי לע רשוא הז
סיטרכ
جلاعتملل ناملأا لوح تامولعم ةقاطب
ناملأا لوح ةماه تامولعم
غلم 590 لاموزوپيل سييكيرا
(نيساكيمأ :لا
ّ
عفلا بكر
ُ
ملا)
________________________________

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
ARIKAYCE
®
liposomal 590 mg
PATIENT SAFETY INFORMATION CARD
The marketing of ARIKAYCE liposomal 590 mg is subject to a risk
management plan (RMP)
including a `Patient safety information card`. The `Patient safety
information card`, emphasizes
important safety information that the patient should be aware of
before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
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
Suspension for inhalation
White, milky, aqueous, Suspension for inhalation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARIKAYCE liposomal 590 mg 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 590 mg treatment should be initiated and managed by
physicians
experienced in the treatment of non-tuberculous lung disease due to
_Mycobacterium avium _
Complex.
ARIKAYCE liposomal 590 mg 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 m