Lotemax 0.5%

Nazione: Giordania

Lingua: inglese

Fonte: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Scarica Foglio illustrativo (PIL)
07-03-2024

Principio attivo:

Loteprednol Etabonate 0.5 %

Commercializzato da:

مستودع البتراء للمواد الطبية - Petra Drug Store

Codice ATC:

S01BA14

INN (Nome Internazionale):

Loteprednol Etabonate 0.5 %

Dosaggio:

0.5%

Confezione:

5 ml

Prodotto da:

BAUSCH & LOMB INCORPORATED/USA (امريكا)

Dettagli prodotto:

9.81 :سعر الجمهور + الضريبة

Foglio illustrativo

                                PART #
/ SPEC # 9731500 L-500346 (11"x5" Fold) / 9731600 L-500347 (0.9375"x5" Fold)
COLOR(S): Black DESCRIPTION: Lotemax Insert, Middle East (UAE, Kuwait,
Lebanon, Jordan)
SPECIAL INSTRUCTIONS:
☐
DIELINE DOES NOT PRINT
☐
PRINT PER SPECIFICATION
☐
BARCODES VERIFIED
PRINTED BARCODES MUST BE VERIFIED READABLE AND ACCURATE BY
VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK.
BAUSCH+LOMB, 8500 HIDDEN RIVER PARKWAY, TAMPA, FL 33638 - 813-866-2485
STERILE OPHTHALMIC SUSPENSION
RX ONLY
DESCRIPTION :
LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a
sterile, topical anti-inflammatry corticosteroid for
ophthalmic use. Loteprednol etabonate is a white to off-white powder.
Loteprednol etabonate is represented by the following structural
formula:
Mol.Wt. 466.96
Chemical Name: chloromethyl 17
α
-[(ethoxycarbonyl)oxy]-11
β
-hydroxy-3-oxoandrostra-1,4diene-17
β
-carboxylate
EACH ML CONTAINS:
ACTIVE: Loteprednol Etabonate (0.5%);
INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and
Tyloxapol; Hydrochloric Acid and/or Sodium Hy-
droxide may be added to adjust the pH to 5.5-5.6. The suspension is
essentially isotonic with a tonicity of 250 to 310
mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and probably delay or slow healing. They
inhibit the edema, fibrin deposition, capillary dilation, leukocyte
migration, capillary proliferation, fibroblast proliferation,
deposition of collagen, and scar formation associated with
inflammation. There is no generally accepted explanation for the
mechanism of action of ocular corticosteroids. However,
corticosteroids are thought to act by the induction of phospho-
lipase A, inhibitory proteins, collectively called lipocortins. It is
postulated that these proteins control the biosynthesis of
potent mediators of inflammation such as prostaglandins and
leukotrienes by inhibiting the release of their common pre-
cursor arachidonic acid. Arachido
                                
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