Ülke: Tayvan
Dil: Çince
Kaynak: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
BIMATOPROST
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)
S01EE03
點眼液劑
BIMATOPROST (7600001600) MG
塑膠瓶裝
製 劑
須由醫師處方使用
ALLERGAN SALES,LLC 8301 MARS DRIVE, WACO, TEXAS 76712, U.S.A. US
bimatoprost
隅角開放性青光眼及高眼壓症。
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%
已註銷
2002-07-15
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 Belgenin tamamını okuyun