Country: Iżrael
Lingwa: Ebrajk
Sors: Ministry of Health
LOTEPREDNOL ETABONATE
ABIC MARKETING LTD, ISRAEL
S01BA14
תרחיף לעין
LOTEPREDNOL ETABONATE 5 MG / 1 ML
עיני
מרשם נדרש
BAUSCH & LOMB INCORPORATED, USA
LOTEPREDNOL
LOTEPREDNOL
Lotemax is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to otain an advisable diminution in edema and inflammation. Lotemax is less effective than prednisolone acetate 1 % in two 28 day controlled clinical studies in acute anterior uveitis, where 72 % of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87 % of patients treated with prednisolone acetate 1 % . The incidence of patients with clinically significant increases in IOP (> or = 10 mmHg) was 1 % with Lotemax adn 6 % with prednisolone acetate 1 %. Lotemax should not be used in patients who require a more potent corticosteroid for this indication. Lotemax is also indicated for the treatment of po
2014-10-31
Part # / SPEC#: 9633701 (L-500346) / 9632901 (L-500347) DESCRIPTION: Lotemax Israel Insert - COLORS: Black SPECIAL INSTRUCTIONS: Q SCANNER BAR LOCATION:NA QDIELINE DOES NOT PRINT QCOATING PER SPECIFICATION PRINTED BARCODES MUST BE VERIFIED READABLE AND ACCURATE BY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK. BAUSCH & LOMB, 1400 N. GOODMAN ST. ROCHESTER,/:tFAX: 585-338-8959 7/7/2022 BLACK BLACK C Y AN MAGEN T A YELLOW APPROVAL SIGNATURE ACCURATE AND MEETS COUNTRY REQUIREMENTS. SPECIAL INSTRUCTIONS: Q DIELINE DOES NOT PRINT Q PRINT PER SPECIFICATION PRINTED BARCODES MUST BE VERIFIED READABLE AND ACCURATE BY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK. B AUS C H & L OMB , 8500 HIDDE N R IVE R PAR K WAY, TAMPA, FL 33637 - 813- 866-2485 DATE FORMAT: _________________________________ (For example MM/YYY Y; MM/YY; MM/DD/Y Y; etc.) BARCODE INFORMATION: Is Barcode required : UPC/EAN Barcode # : _____________________________ Barcode Format: ________________________________ Does Barcode need to contain variable inform ation REGULATORY MUST ANSWER QUESTIONS BELOW BEFORE A RTWORK CAN BE FINALIZED: DO PROPOSED CHANGES REQUIRE HEALTH AUTHORITY APPROVAL PRIOR TO IMPLEMEN TATION WITH COMMERCIAL PRODUCT? IF YES, PROVIDE TYPE OF FILING/ VARIATION REQUIRED, S TATUS OF FILING AND OTHER DETAILS IN THE COMMENT BOX BELOW. YES NO YES NO YES NO COMMENTS: FOR COLOR MATCH DURING INCOMING INSPECTION ON LY: םיחקורה תונקת יפל ןכרצל ןולע 1986 - ו"משתה )םירישכת( דבלב אפור םשרמ יפ לע תקוושמ הפורתה ףיחרת סקמטול םייניעל ילירטס ףיחרת בכרה :ליכמ ל"מ 1 לכ Loteprednol Etabonate 5 mg (0.5%) )0.5%( ג"מ 5 טאנובטא לונדרפטול ףיעס האר םיינגרלאו םיליעפ יתלב םיביכרמ לע עדימל ףיעסו "הפורתה לש םיביכרמהמ קלח לע בושח עדימ" 2 ."ףסונ עדימ" 6 .הפורתב שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק ת Aqra d-dokument sħiħ