Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
AMIKACIN AS SULFATE
TRUEMED LTD, ISRAEL
J01GB06
SUSPENSION FOR INHALATION
AMIKACIN AS SULFATE 70 MG/ML
INHALATION
Required
INSMED NETHERLANDS BV.,THE NETHERLANDS
AMIKACIN
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.
2022-05-02
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) ________________________________ সম্পূর্ণ নথি পড়ুন
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 সম্পূর্ণ নথি পড়ুন