Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
MYCOPHENOLIC ACID
NOVARTIS ISRAEL LTD
L04AA06
GASTRO RESISTANT TABLETS
MYCOPHENOLIC ACID 180 MG
PER OS
Required
NOVARTIS PHARMA PRODUKTIONS GMBH
MYCOPHENOLIC ACID
Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
2023-05-31
Novartis Israel Ltd. 6 Tozeret Haaretz street, P.O.Box 7126, Tel Aviv Tel: 03-9201111, Fax: 03-9229230 עב לארשי סיטרבונ " מ . ץראה תרצות 6 .ד.ת , 7126 ביבא לת , :לט 03-9201111 :סקפ , 03-9229230 םוי ינש 27 ץרמ 2023 אפור / ה , חקור / ת דבכנ / ה , ןודנה : תופוצמ תוילבט קיטרופימ mg mg, 360 coated Tablets 180 - ilm F ® Myfortic [128-30-30715, 128-33-30716] ונא םישקבמ ךעידוהל יכ ןכרצלו אפורל םינולעה רובע רישכתה ןודנב ב ונכדוע סראמ 2023 . רישכתה לארשיב הוותמ ל היוותה :ןמקלדכ Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. ביכרמ ליעפ : mycophenolate sodium :ןונימ תרוצ Film-coated Tablets דומעב בקועה ןייעל שי ,ףסונ עדימל .יתועמשמ יוניש וא הרמחה הווהמ רשא יוניש השענ םהב םיפיעס םינייוצמ םיפרוצמה אפורלו ןכרצל םינולעב יפכ ורשואש לע ידי דרשמ תואירבה . ןולעה חלשנ ןכדועמה םוסרפל רגאמב תופורתה רתאבש דרשמ :תואירבה https://data.health.gov.il/drugs/index.html#!/byDrug ןתינ ולבקל ספדומ לע ידי הינפ תרבחל ,מ"עב לארשי סיטרבונ ץראה תרצות 6 .ד.ת , 7126 ביבא לת , :לט 03-9201111 :סקפ , 03-9229230 הכרבב , ילאירבג ךורב הנוממ חקור מ"עב לארשי סיטרבונ ןלהל טוריפ םייונישה םיירקיעה ) טסקט ףסונש ןמוסמ לוחכב , טסקט טמשוהש ןמוסמ טסקטכ םודא םע וק הצוח ( : ןולעב אפורל : 4.4 Special warnings and precautions for use ... Patients treated with immunosuppressants, including Myfortic, are at increased risk for opportunistic infections (bacterial, fungal, viral and proto Baca dokumen lengkap
MYF API Dec23 V4 1. NAME OF THE MEDICINAL PRODUCT Myfortic ® 180 mg gastro-resistant tablets Myfortic ® 360 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 192.4 and 384.8 mycophenolate sodium equivalent to 180 mg or 360 mg mycophenolic acid. Excipients: Each Myfortic 180 mg tablet contains 45 mg lactose anhydrous and 13 mg sodium. Each Myfortic 360 mg tablet contains 90 mg lactose anhydrous and 26 mg sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant Tablets Myfortic 180mg is a lime green, gastro-resistant film-coated round tablet, with bevelled edges and the imprint (debossing) “C” on one side. Myfortic 360mg is a pale orange-red, gastro-resistant film-coated, ovaloid tablet with imprint (debossing) “CT” on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. 4.2 Posology and method of administration Posology Treatment with Myfortic should be initiated and maintained by appropriately qualified transplant specialists. The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic gastro-resistant tablets) administered twice daily (1,440 mg daily dose). In patients receiving mycophenolate mofetil (MMF) 2 g, treatment can be replaced by 720 mg administered twice daily (1,440 mg daily dose) of Myfortic. For additional information about the corresponding therapeutic doses of mycophenolate sodium and mycophenolate mofetil, see sections 4.4 and 5.2. In _de novo_ patients, Myfortic should be initiated within 48 hours following transplantation. 2 MYF API Dec23 V4 Special population _Paediatric population_ Insufficient data are available to support the efficacy and safety of Myfortic in children and adolescents. _ _ Limited pharmacokinetic data are available for paediatric renal transplant patients (see section 5.2 Baca dokumen lengkap