炎即爽眼藥水

국가: 대만

언어: 중국어

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

유효 성분:

PEMIROLAST POTASSIUM

제공처:

台灣參天製藥股份有限公司 台北市中山區松江路126號9樓之1 (86383884)

ATC 코드:

S01GX

약제 형태:

點眼液劑

구성:

主成分 () ; PEMIROLAST POTASSIUM (9200042710) MG

패키지 단위:

塑膠瓶裝

수업:

製　劑

처방전 유형:

須由醫師處方使用

Manufactured by:

SANTEN PHARMACEUTICAL CO. LTD.(NOTO PLANT) 2-14, SHIKINAMI, HODATSUSHIMIZU-CHO, HAKUI-GUN, ISHIKAWA,JAPAN JP

치료 영역:

Other antiallergics

치료 징후:

過敏性結膜炎。

제품 요약:

有效日期: 2027/08/19; 英文品名: ALEGYSAL OPHTHALMIC SOLUTION

승인 날짜:

2002-08-19

환자 정보 전단

参天製薬　アレギサール点眼液（台湾）ロール添付文書〈09〉1ページ（16/08/09）209.55×297　2°
コン　キンアカ　大光印刷株式会社
752401
参天製薬　アレギサール点眼液（台湾）ロール添付文書〈09〉2ページ（16/08/09）209.55×297　1°
コン　大光印刷株式会社
752401
1
Anti-allergy Eye Drops
Alegysal
®
ophthalmic solution
Pemirolast potassium ophthalmic solution
DOH Import No. 023521
DESCRIPTION
Product Name
Alegysal ophthalmic solution
Active Ingredient
Pemirolast potassium
Content (per 1 mL)
1mg
Additives
Benzalkonium chloride, concentrated glycerin, dibasic
sodium phosphate hydrate, and sodium dihydrogen
phosphate dihydrate, purified water
pH
7.5~8.5
Osmolar ratio
0.7~0.9
Description
Clear, colorless, sterile, aqueous ophthalmic solution
INDICATION
ALLERGIC CONJUNCTIVITIS
CATEGORY
This drug must be prescribed by a physician
ADMINISTRATION AND DOSAGE
Usually 1 drop a time, twice a day (in the morning and evening)
PRECAUTIONS
1.
ADVERSE REACTIONS
UPON APPROVAL
Adverse drug reactions were reported in 16 (2.50%) of 639 patients in
clinical studies in Japan. The major adverse drug
reactions were blepharitis in 4 patients (0.63%), eye irritation in 4
patients (0.63%), and conjunctival hyperaemia in 3
patients (0.47%).
POST MARKETING STUDY (AT THE END OF REEXAMINATION)
Adverse drug reactions were reported in 43 (1.01%) of 4255 patients in
post marketing studies in Japan. The major adverse
drug reactions were eye irritation in 16 patients (0.38%), blepharitis
in 9 patients (0.21%), eyelid itching in 5 patients
(0.12%), eye discharge in 5 patients (0.12%), and conjunctival
hyperaemia in 5 patients (0.12%).
If an adverse reaction is observed, appropriate measures including
discontinuing administration should be taken.
Incidence
Type
5% >

0.1%
<0.1%
Hypersensitivity
Blepharitis
Eyelid dermatitis
Ophthalmic
Conjunctival hyperaemia,
irritation, eye discharge,
itching
Conjunctivitis
2.
USE DURING PREGNANCY, DELIVERY OR LACTATION
This product