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OZURDEX™
OZURDEX™
HIGHLIGHTS OF PRESCRIBING INFORMATION
–––––– WARNINGS AND PRECAUTIONS –––––
2.2 Administration
These highlights do not include all the
• Intravitreal injections have been associated The intravitreal injection procedure should be carried out under controlled aseptic conditions which information needed to use OZURDEX™
include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate safely and effectively. See full prescribing
increased intraocular pressure, and retinal anesthesia and a broad-spectrum microbicide are recommended to be given prior to the injection. information.
detachments. Patients should be monitored Remove the foil pouch from the carton and examine for damage. Then, in a sterile field, open the foil OZURDEX™ (dexamethasone intravitreal
pouch and gently place the applicator on a sterile tray. Carefully remove the cap from the applicator. implant)
• Use of corticosteroids may produce posterior Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex
Initial U.S. Approval: 1958
subcapsular cataracts, increased intraocular the tab. The long axis of the applicator should be held parallel to the limbus, and the sclera should be
––––––––INDICATIONS AND USAGE ––––––––
engaged at an oblique angle with the bevel of the needle up (away from the sclera) to create a shelved OZURDEX™ contains a corticosteroid indicated
scleral path. The tip of the needle is advanced within the sclera for about 1 mm (parallel to the limbus), infections due to bacteria, fungi, or viruses. for the treatment of macular edema following then re-directed toward the center of the eye and advanced until penetration of the sclera is completed Corticosteroids should be used cautiously branch retinal vein occlusion (BRVO) or central and the vitreous cavity is entered. The needle should not be advanced past the point where the sleeve in patients with a history of ocular herpes –––––– DOSAGE AND ADMINISTRATION –––––
Slowly depress the actuator button until an audible click is noted. Before withdrawing the applicator –––––––––– ADVERSE REACTIONS –––––––––
from the eye, make sure that the actuator button is fully depressed and has locked flush with the • For ophthalmic intravitreal injection only. (2.1) The most common adverse reactions reported by applicator surface. Remove the needle in the same direction as used to enter the vitreous. • The intravitreal injection procedure should ≥20% of patients included increased intraocular pressure and conjunctival hemorrhage. (6.1) Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic injection, patients should be monitored for To report SUSPECTED ADVERSE REACTIONS,
nerve head immediately after the injection, tonometry within 30 minutes following the injection, and elevation in intraocular pressure and for contact Allergan at 1-800-433-8871 or
biomicroscopy between two and seven days following the injection. Patients should be instructed to www.allergan.com or FDA at 1-800-FDA-1088
report any symptoms suggestive of endophthalmitis without delay. or www.fda.gov/medwatch.
–––– DOSAGE FORMS AND STRENGTHS –––––
Each applicator can only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new applicator must be used, and the sterile field, syringe, gloves, drapes, and eyelid See 17 for PATIENT COUNSELING
speculum should be changed before OZURDEX™ is administered to the other eye.
dexamethasone 0.7 mg in the NOVADUR™
INFORMATION
DOSAGE FORMS AND STRENGTHS
–––––––––– CONTRAINDICATIONS –––––––––
Revised: June 2009
Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR™ solid polymer drug delivery
• Ocular or periocular infections. (4.1) CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
FULL PRESCRIBING INFORMATION:
OZURDEX™ (dexamethasone intravitreal implant) is contraindicated in patients with active or
CONTENTS*
suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, 1 INDICATIONS AND USAGE
including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial 2 DOSAGE AND ADMINISTRATION
11 DESCRIPTION
4.2 Advanced Glaucoma
12 CLINICAL PHARMACOLOGY
OZURDEX™ is contraindicated in patients with advanced glaucoma.
4.3 Hypersensitivity
3 DOSAGE FORMS AND STRENGTHS
OZURDEX™ is contraindicated in patients with known hypersensitivity to any components of this
4 CONTRAINDICATIONS
13 NONCLINICAL TOXICOLOGY
WARNINGS AND PRECAUTIONS
5.1 Intravitreal Injection-related Effects
14 CLINICAL STUDIES
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased 5 WARNINGS AND PRECAUTIONS
16 HOW SUPPLIED/STORAGE AND HANDLING
intraocular pressure, and retinal detachments.
5.1 Intravitreal Injection-related Effects 17 PATIENT COUNSELING INFORMATION
Patients should be monitored following the injection. (see PATIENT COUNSELING INFORMATION, 17)
5.2 Potential Steroid-related Effects
6 ADVERSE REACTIONS
*Sections or subsections omitted from the full prescribing information are not listed.
Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, 8 USE IN SPECIFIC POPULATIONS
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in active ocular herpes simplex.
FULL PRESCRIBING INFORMATION
ADVERSE REACTIONS
INDICATIONS AND USAGE
6.1 Clinical Studies Experience
OZURDEX™ (dexamethasone intravitreal implant) is indicated for the treatment of macular edema
Because clinical studies are conducted under widely varying conditions, adverse reaction rates following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of DOSAGE AND ADMINISTRATION
another drug and may not reflect the rates observed in practice.
2.1 General Dosing Information
The following information is based on the combined clinical trial results from the initial 6 month masked period of two randomized, sham-controlled, parallel studies.
For ophthalmic intravitreal injection only.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting
multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
12.3 Pharmacokinetics
Plasma concentrations were obtained from 21 patients in the two, 6-month Phase 3 efficacy studies
prior to dosing and on Days 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of quantitation (LLOQ= 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 Adverse reactions reported by greater than 2% of patients in the first six months
pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did OZURDEX™
not appear to be related to age, body weight, or sex of patients. In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies in animals have been conducted to determine whether OZURDEX™
(dexamethasone intravitreal implant) has the potential for carcinogenesis.
Although no adequate studies have been conducted to determine the mutagenic potential of OZURDEX™, dexamethasone has been shown to have no mutagenic effects in bacterial and
mammalian cells in vitro or in the in vivo mouse micronucleus test. Increased IOP with OZURDEX™ peaked at day 60 and returned to baseline levels by day 180. During
the initial treatment period, 0.7% (3/421) of the patients who received OZURDEX™ required laser or
14 CLINICAL STUDIES
surgical procedures for management of elevated IOP.
The efficacy of OZURDEX™ was assessed in two, multicenter, double-masked, randomized, parallel
Following a second injection of OZURDEX™ in cases where a second injection was indicated, the
overall incidence of cataracts was higher after 1 year.
Following a single injection, OZURDEX™ for the treatment of macular edema following branch retinal
USE IN SPECIFIC POPULATIONS
vein occlusion (BRVO) or central retinal vein occlusion (CRVO) demonstrated the following clinical results for the percent of patients with ≥15 letters of improvement from baseline in best-corrected 8.1 Pregnancy
Topical dexamethasone has been shown to be teratogenic in mice producing fetal resorptions and cleft Number (Percent) of Patients with 15 Letters Improvement from Baseline in BCVA
palate. In the rabbit, dexamethasone produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. Pregnant rhesus monkeys treated with dexamethasone sodium phosphate intramuscularly at 1 mg/kg/day every other day for 28 days or at 10 mg/kg/day once or every other day on 3 or 5 days between gestation days 23 and 49 had fetuses with minor cranial Study Day
abnormalities. A 1 mg/kg/dose in pregnant rhesus monkeys would be approximately 85 times higher than an OZURDEX™ injection in humans (assuming 60 kg body weight).
There are no adequate and well-controlled studies in pregnant women. OZURDEX™ (dexamethasone
intravitreal implant) should be used during pregnancy only if the potential benefit justifies the potential 8.3 Nursing Mothers
It is not known whether ocular administration of corticosteroids could result in sufficient systemic * P-values were based on the Pearson’s Chi-square test. absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid In each individual study and in a pooled analysis, time to achieve ≥ 15 letters (3-line) improvement in production, or cause other untoward effects. Caution should be exercised when corticosteroids are BCVA cumulative response rate curves were significantly faster with OZURDEX™ compared to sham
(p < 0.01), with OZURDEX™-treated patients achieving a 3-line improvement in BCVA earlier than
8.4 Pediatric Use
The onset of a ≥15 letter (3 line) improvement in BCVA with OZURDEX™ occurs within the first
Safety and effectiveness of OZURDEX™ in pediatric patients has not been established.
two months after implantation in approximately 20-30% of subjects. The duration of effect persists 8.5 Geriatric Use
approximately one to three months after onset of this effect.
No overall differences in safety or effectiveness have been observed between elderly and younger 16 HOW SUPPLIED/STORAGE AND HANDLING
OZURDEX™ (dexamethasone intravitreal implant) 0.7 mg is supplied in a foil pouch with 1 single-use
11 DESCRIPTION
plastic applicator, NDC 0023-3348-07.
OZURDEX™ is an intravitreal implant containing 0.7 mg (700 μg) dexamethasone in the NOVADUR™
Storage: Store at 15° - 30° C (59° - 86° F).
solid polymer drug delivery system. OZURDEX™ is preloaded into a single-use, specially designed
17 PATIENT COUNSELING INFORMATION
DDS® applicator to facilitate injection of the rod-shaped implant directly into the vitreous. The
NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix.
In the days following intravitreal injection of OZURDEX™, patients are at risk for potential
OZURDEX™ is preservative-free. The chemical name for dexamethasone is pregna-1,4-diene-3,20-
complications including in particular, but not limited to, the development of endophthalmitis or dione, 9-fluoro-11,17,21-trihydoxy-16-methyl-,(11b,16a). Its structural formula is: elevated intraocular pressure. If the eye becomes red, sensitive to light, painful, or develops a change in vision, the patients should seek immediate care from an ophthalmologist. Patients may experience temporary visual blurring after receiving an intravitreal injection. They should not drive or use machines until this has resolved.
2009 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® and ™ marks owned by Allergan, Inc. Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.
The PLGA matrix slowly degrades to lactic acid and glycolic acid.

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