"愛力根" 露明目點眼液劑 0.03%

Quốc gia: Đài Loan

Ngôn ngữ: Tiếng Trung

Nguồn: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Thành phần hoạt chất:

BIMATOPROST

Sẵn có từ:

台灣愛力根藥品股份有限公司 台北市中正區羅斯福路2段102號9樓 (53529261)

Mã ATC:

S01EE03

Dạng dược phẩm:

點眼液劑

Thành phần:

BIMATOPROST (7600001600) MG

Các đơn vị trong gói:

塑膠瓶裝

Lớp học:

製　劑

Loại thuốc theo toa:

須由醫師處方使用

Sản xuất bởi:

ALLERGAN SALES,LLC 8301 MARS DRIVE, WACO, TEXAS 76712, U.S.A. US

Khu trị liệu:

bimatoprost

Chỉ dẫn điều trị:

隅角開放性青光眼及高眼壓症。

Tóm tắt sản phẩm:

註銷日期: 2019/03/15; 註銷理由: 屆期未申請展延; 有效日期: 2017/07/15; 英文品名: LUMIGAN OPHTHALMIC SOLUTION 0.03%

Tình trạng ủy quyền:

已註銷

Ngày ủy quyền:

2002-07-15

Tờ rơi thông tin

LUMIGAN
® 0.01% AND 0.03%
(BIMATOPROST OPHTHALMIC SOLUTION)
_HIGHLIGHTS OF PRESCRIBING INFORMATION_
These highlights do not include all the information needed to use
LUMIGAN
®
0.01% and
0.03% (bimatoprost ophthalmic solution) safely and effectively. See
full prescribing
information for LUMIGAN
®
.
LUMIGAN
® 0.01% AND 0.03% (BIMATOPROST OPHTHALMIC SOLUTION) INITIAL U.S.
APPROVAL:
2001
_________INDICATIONS AND USAGE _________
LUMIGAN
® is a prostaglandin analog indicated for the reduction of elevated
intraocular
pressure in patients with open angle glaucoma or ocular hypertension.
(1)
_______DOSAGE AND ADMINISTRATION_______
One drop in the affected eye(s) once daily in the evening. (2)
_____DOSAGE FORMS AND STRENGTHS _____
Solution containing 0.1 mg/mL bimatoprost (LUMIGAN® 0.01%) or
containing 0.3 mg/mL
bimatoprost (LUMIGAN
®
0.03%). (3)
_______WARNINGS AND PRECAUTIONS _______
• Pigmentation.
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes
can occur
(5.1). Iris pigmentation likely to be permanent.
• Eyelash Changes.
Gradual change to eyelashes including increased length, thickness and
number
of lashes. Usually reversible. (5.2)
___________ADVERSE REACTIONS ___________
Most common adverse reaction (range 25% - 45%) is conjunctival
hyperemia. (6.1)
_______USE IN SPECIFIC POPULATIONS _______
Use in pediatric patients below the age of 16 years is not recommended
because of
potential safety concerns related to increased pigmentation following
long-term chronic
use. (7.3)
SEE 14 FOR PATIENT COUNSELING INFORMATION REVISED: DECEMBER 2013
FULL PRESCRIBING INFORMATION:
CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Angle-closure, Inflammatory, or Neovascular Glaucoma
5.6 Bacterial Keratitis
5.7 Use with Contact Lenses
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Events
7 USE IN SPECIFIC POPULA