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RHOPRESSA(netarsudil ophthalmic solution) 0.02%, for topical ophthalmic (五)
2018-06-21 08:19:51 来源: 作者: 【 】 浏览:3703次 评论:0
ge: Store at 2°C to 8°C (36°F to 46°F) until opened. After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.
 
17 PATIENT COUNSELING INFORMATION 
 
Handling the Container 
 
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.1)]. 
 
When to Seek Physician Advice 
 
Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of RHOPRESSA.
 
Use with Contact Lenses 
 
Advise patients that RHOPRESSA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of RHOPRESSA and may be reinserted 15 minutes following its administration.
 
Use with Other Ophthalmic Drugs 
 
Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.
 
Missed Dose 
 
Advise patients that if one dose is missed, treatment should continue with the next dose in the evening.
 
U.S. Patent Nos.: 8,450,344; 8,394,826; 9,096,569; 9,415,043
 
RHOPRESSA is a registered trademark of Aerie Pharmaceuticals, Inc.
 
Manufactured for: Aerie Pharmaceuticals, Inc., Irvine, CA 92614, U.S.A.
 
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 
 
RHOPRESSA (netarsudil ophthalmic solution) 0.02% label 
 
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 
 
RHOPRESSA (netarsudil ophthalmic solution) 0.02% sample label 
 
INGREDIENTS AND APPEARANCE 
 
 
RHOPRESSA   
netarsudil solution/ drops 
 
Product Information 
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70727-497 
Route of Administration OPHTHALMIC, TOPICAL 
 
Active Ingredient/Active Moiety 
 
Ingredient Name
 
Basis of Strength
 
Strength
 
NETARSUDIL MESYLATE (UNII: VL756B1K0U) (NETARSUDIL - UNII:W6I5QDT7QI) NETARSUDIL MESYLATE 0.285 mg  in 1 mL 
 
Inactive Ingredients 
 
Ingredient Name
 
Strength
 
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)   
MANNITOL (UNII: 3OWL53L36A)   
BORIC ACID (UNII: R57ZHV85D4)   
SODIUM HYDROXIDE (UNII: 55X04QC32I)   
WATER (UNII: 059QF0KO0R)   
 
Packaging 
 
#
 
It
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