لوثيماكس

Country: Իսրայել

language: արաբերեն

source: Ministry of Health

active_ingredient:

LOTEPREDNOL ETABONATE 5 MG / 1 ML

MAH:

SALOMON,LEVIN & ELSTEIN LTD

ATC_code:

S01BA14

pharmaceutical_form:

OPHTHALMIC SUSPENSION

administration_route:

OCULAR

manufactured_by:

BAUSCH & LOMB INCORPORATED, USA

therapeutic_group:

LOTEPREDNOL

therapeutic_indication:

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

authorization_date:

2009-11-01

PIL

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,
/:




t
FAX: [phone]
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
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