英文版
炖牛筋Restasis(Cyclosporine )药品使用说明书
环孢素0.05%眼用乳剂—用于干眼症
HAOEYOU ( 好医友)
伴娘事件
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
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16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
爱国主义征文
17.1 Handling the Container
17.2 U with Contact Lens
17.3 Administration
*FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
RESTASIS ophthalmic emulsion is indicated to increa tear production in patients who tear production is presumed to be suppresd due to ocular inflammation associated with
keratoconjunctivitis sicca. Incread tear production was not en in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
2 DOSAGE AND ADMINISTRATION
Invert the unit do vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart.RESTASIS can be ud concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after u.
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic emulsion containing cyclosporine 0.5 mg/mL
4 CONTRAINDICATIONS
RESTASIS is contraindicated in patients with known or suspected hypernsitivity to any of the ingredients in the formulation.
5 WARNINGS AND PRECAUTIONS
5.1 Potential for Eye Injury and Contamination
To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces.
5.2 U with Contact Lens
RESTASIS should not be administered while wearing contact lens. Patients with decread tear production typically should not wear contact lens. If contact lens are worn, they should be removed prior to the administration of the emulsion. Lens may be reinrted 15 minutes following
administration of RESTASIS ophthalmic emulsion.
波莱罗舞曲Sections or subctions omitted from the full prescribing information are not listed.
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6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Becau clinical trials are conducted under widely varying conditions, adver reaction rates obrved in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obrved in practice.
In clinical trials, the most common adver reaction following the u of RESTASIS was ocular burning (17%).
Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora,eye pain, foreign body nsation, pruritus, stinging, and visual disturbance (most often blurring).
6.2 Post-marketing Experience
The following adver reactions have been identified during post approval u of RESTASIS .Becau the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Reported reactions have included: hypernsitivity (including eye swelling, urticaria, rare c
as of vere angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C
Adver effects were en in reproduction studies in rats and rabbits only at do levels toxic to dams.At toxic dos (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoxic as indicated by incread pre- and postnatal mortality and reduced fetal weight together with related skeletal retardations. The dos are 5,000 and 32,000 times greater (normalized to body surface area), respectively, than the daily human do of one drop (approximately 28 mcL) of 0.05% RESTASIS twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire do is absorbed. No evidence of embryofetal toxicity was obrved in rats or rabbits receiving cyclosporine at oral dos up to 17 mg/kg/day or 30 mg/kg/day, respectively, during organogenesis.The dos in rats and rabbits are approximately 3,000 and 10,000 times greater (normalized to body surface area), respectively, than the daily human do.
Offspring of rats receiving a 45 mg/kg/day oral do of cyclosporine from Day 15 of pregnancy until Day 21 postpartum, a maternally toxic level, exhibited an increa in postnatal mortality; this do is 7,000 times greater than the daily human topical do (0.001 mg/kg/day) normalized to body surface area assuming that the entire do is absorbed. No adver events were obrved at oral dos up to 15mg/kg/day (2,000 times greater than the daily human do).
There are no adequate and well-controlled studies of RESTASIS in pregnant women. RESTASIS should be administered to a pregnant woman only if clearly needed.
8.3 Nursing Mothers
Cyclosporine is known to be excreted in human milk following systemic administration, but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ophthalmic emulsion, caution should be exercid when RESTASIS is administered to a nursing woman.
8.4 Pediatric U关于春天的诗词
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The safety and efficacy of RESTASIS ophthalmic emulsion have not been established in pediatric patients below the age of 16.
8.5 Geriatric U
No overall difference in safety or effectiveness has been obrved between elderly and younger patients.
11 DESCRIPTION
RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporine's chemical name is Cyclo[[(E )-(2S ,3R ,4R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N -methylglycyl-N -methyl-L-leucyl-L-valyl-N -methyl-L-leucyl-L-alanyl-D-alanyl-N -methyl-L-leucyl-N -methyl-L-leucyl-N -methyl-L-valyl] and it has the following structure:
Structural Formula
Formula: C H N O Mol. Wt.: 1202.6
Cyclosporine is a fine white powder. RESTASIS appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of RESTASIS ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Cyclosporine is an immunosuppressive agent when administered systemically.
苏菲的世界读书笔记
In patients who tear production is presumed to be suppresd due to ocular inflammation associat
ed with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator.The exact mechanism of action is not known.
12.3 Pharmacokinetics
Blood cyclosporine A concentrations were measured using a specific high pressure liquid
chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of RESTASIS 0.05%, twice daily, in humans for up to 12months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with RESTASIS ophthalmic emulsion.
鲁东大学简介
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis : Systemic carcinogenicity studies were carried out in male and female mice and rats. In ®®621111112®®®®
