País: Israel
Idioma: anglès
Font: Ministry of Health
ABATACEPT
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
L04AA24
SOLUTION FOR INJECTION
ABATACEPT 125 MG/ML
S.C
Required
BRISTOL-MYERS SQUIBB HOLDINGS PHARMA, LTD. LIABILITY COMPANY, PUERTO RICO
ABATACEPT
ABATACEPT
ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).
2018-03-31
February 2023 BMS ISRAEL 18 Aharon Bart St, PO BOX 3661, Kiryat Arie Petach-Tikva 4951448 Tel: +972-3-5231021; Fax: 972-3-9229869 2200001 - IL - 427 nternal reference: I DIRECT HEALTHCARE PROFESSIONAL COMMUNICATION To: Physicians/Prescribers in transplant centers in Israel who may perform HSCT From: BMS Israel Medical director Subject: PTLD or CMV reactivation in Patients Undergoing Unrelated-Donor Hematopoietic Stem Cell Transplantation (HSCT) with Intravenous ORENCIA in Israel :ריצקת לש תוצרפתהל תורשפאה יבגל עדימ ליכמ יאופרה תווצל הז בתכמ EBV וא CMV היסנרואב שומיש ןמזב ) abatacept ( םילפוטמב לש עזג יאת תלתשה םירבועה םדה תכרעמ ) HSCT .( בתכמה ץפוי לארשיב הלתשה יזכרמב םיאפורל . ב שומישב abatacept םע בולישב methotrexate (MTX) יבכעמו calcineurin ) CNI ( לחמ תעינמל ת דגנ לתש הפירח ןסכאמ (aGVHD) , לש תוצרפתה ןכתת CMV וא EBV םג ומכ םוהיז ,םיוולינ םיכוביס CMV וא ינשלופ Post-transplant lymphoproliferative disease (PTLD) . תוצרפתה יוהיזל רוטינ לוקשל שי CMV וא EBV ענומ לופיט ןתמ םג ומכ . הזאפ רקחמ II לש שומישה תא ססיבש abatacept תעינמב aGVHD בקע תוצרפתה רחא EBV ו CMV םאתהב םילפוטמב זכרמב תוגוהנה תוילופיט תוקיטקרפל יאופרה . תליחת ינפל ה תוצרפתה תעינמל ילאריו יטנא לופיט לש ןתמ ץלמומ היסנרואב לופיט EBV ךשמל 6 עינמל הלתשהה ןמזמ םישדוח ת EBV-associated PTLD . ךשמל םילפוטמ רחא בוקעל ץלמומ ןכ ומכ 6 ןמזמ םישדוח לש תוצרפתה וא םוהיז יוהיז ךרוצל הלתשהה CMV , וקידבה תואצותב תולת אלל תויגולורסה ת ה ףיגנ יוליגל - CMV םרט ועצובש הלתשהה , לש ןה םרותה םרת Llegiu el document complet
ORENCIA_SPI_MoH_Jun2022 1 FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT ORENCIA 125 MG SC AND ORENCIA 250 MG QUALITATIVE AND QUANTITATIVE COMPOSITION For Orencia 250 mg IV: 250 mg white to off-white lyophilized powder in a single-dose vial (one may use less than the full contents of the vial or use more than one vial) _[see Dosage and _ _Administration (2.1, 2.2, 2.3)]. _ For Orencia 125 mg SC: 125 mg/mL of a clear to slightly opalescent, colorless to pale-yellow solution in a single-dose prefilled glass syringe PHARMACEUTICAL FORM Orencia 250 mg IV- Powder (lyophilized) for concentrate for solution for IV infusion. Orencia 125 mg SC- Solution for Subcutaneous Injection 1. THERAPEUTIC INDICATIONS 1.1 ORENCIA 125 MG: ADULT RHEUMATOID ARTHRITIS (RA) ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. ADULT PSORIATIC ARTHRITIS (PSA) ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA). ORENCIA_SPI_MoH_Jun2022 2 1.2 ORENCIA 250 MG: ADULT RHEUMATOID ARTHRITIS (RA) ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS: ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients 6 years of age and older who have had an insufficient Llegiu el document complet