部份中文聚维酮碘资料（仅供参考）
通用名称：聚维酮碘
商品名称：聚维酮碘（Betadine 5% ophthalmic solution）
有效成分：葡聚糖70.01％/羟丙甲纤维素29100.3％
剂型：滴眼液
适应症及用法：
BETADINE 5％无菌眼科准备解决方案眼睛的适应症为预备眼周区域（盖，眉头，和面颊）和眼表面的灌溉（角膜，结膜，眼睑和穹窿）的。
禁忌症：
对已知对碘，或该产品的其他成分敏感的人不要使用。
警告：
只能用于外部。不得用于眼内注射或灌溉。
剂量和给药：
当内表面与直接容器（即瓶）的内容是无菌的，瓶子的外表面不是无菌的。应避免在无菌领域使用的瓶子。
制造商：爱尔康

Betadine 5% ophthalmic solution
Betadine® 5% Sterile Ophthalmic Prep Solution(povidone-iodine ophthalmic solution)
(0.5% available iodine)
Description
AdvertisementPovidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:

BETADINE 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.
Clinical Pharmacology
A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log 10 reduction of 3.05 log 10 units in total aerobes at 10 minutes following prepping the skin with BETADINE 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log 10 units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log 10 reduction by the iodine complex compared with the control solution of 1.47 log 10 units at 10 minutes and 1.79 log 10 units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms per square cm.
Indications and Usage
BETADINE 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Contraindications
Do not use on individuals known to be sensitive to iodine, or other components of this product.
Warnings
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Precautions:
General:   No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.
Carcinogenesis, Mutagenesis, Impairment of Fertility:   No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.
Pregnancy Category C:   Animal reproduction studies have not been conducted with BETADINE 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.
Nursing Mothers:   Because of the potential for serious adverse reactions in nursing infants from BETADINE 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Adverse Reactions: Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Dosage and Administration
While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided.
BETADINE 5% Sterile Ophthalmic Prep Solution is used as follows:
1.Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze entire contents of bottle into a sterile prep cup.
2.Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.
3.Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.
4.While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe.
5.After the BETADINE 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.
How Supplied
BETADINE 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions and supplied in 1 fl.oz. (30 mL) form sealed blue HDPE bottles (NDC #0065 0411 30). Twenty-four (24) bottles are packed in each shipper.
-------------------------------------
产地国家： 美国
原产地英文商品名:
BETADINE drops 5% 30ml(1 oz)/bottle
原产地英文药品名:
povidone-iodine ophthalmic
中文参考商品译名:
BETADINE滴眼液 5% 30毫升(1盎司)/瓶
中文参考药品译名:
生产厂家中文参考译名:
爱尔康
生产厂家英文名:
Alcon