歐芙必妥眼藥水

国家: 台湾

语言: 中文

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

资料单张 资料单张 (PIL)
26-03-2020
公众评估报告 公众评估报告 (PAR)
26-03-2020

有效成分:

OFLOXACIN

可用日期:

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代码:

S01AE01

药物剂型:

點眼液劑

组成:

主成分 (OFLOXACIN) ; OFLOXACIN (0836002000) 3MG/ML

每包单位数:

塑膠瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

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

治疗领域:

ofloxacin

疗效迹象:

外眼部細菌性感染症

產品總結:

有效日期: 2026/09/02; 英文品名: OFLOVID OPHTHALMIC SOLUTION

授权日期:

2021-04-14

资料单张

                                *Revised: December 2006 (6th version)
Standard Commodity Classification No. of Japan
871319
- BROAD-SPECTRUM ANTIBACTERIAL OPHTHALMIC PREPARATION -
TARIVID

OPHTHALMIC SOLUTION 0.3%
< Ofloxacin >
DESIGNATED DRUG
and
PRESCRIPTION-ONLY DRUG
CONTRAINDICATIONS (TARIVID OPHTHALMIC SOLUTION IS
CONTRAINDICATED IN THE FOLLOWING PATIENTS.)
Patients with a history of hypersensitivity to the ingredient of
this product or any quinolone antibiotics.
DESCRIPTION
Brand name
Tarivid ophthalmic solution 0.3%
Active ingredient
Ofloxacin
Content per mL
3mg
Inactive ingredient
Sodium chloride, Dilute hydrochloric
acid, Sodium hydroxide, Purified water
pH
6.0
−
7.0
Osmolar ratio
0.95
−
1.15
Description
Clear, pale to light yellow sterile
aqueous ophthalmic solution
INDICATIONS

Susceptible
strains
of
_Staphylococcus_
sp.,
_Streptococcus_
sp.,
_Streptococcus pneumoniae, Enterococcus _
sp.
_, Micrococcus_
sp.,
_Moraxella_
sp.,
_Corynebacterium_
sp.,
_ Klebsiella_
sp.,
_Serratia _
sp.,
_Proteus_
sp.,
_Morganella morganii, Providencia_
sp.,
_Haemophilus _
_influenzae, _
_Haemophilus _
_aegyptius _
[Koch-Weeks
bacillus],
_Pseudomonas_
sp.,
_Pseudomonas _
_aeruginosa, _
_Burkholderia _
_cepacia, _
_Stenotrophomonas _
_(Xanthomonas) _
_maltophilia, _
_Acinetobacter_
sp., and
_Propionibacterium acnes._

Blepharitis, dacryocystitis, hordeolum, conjunctivitis, tarsadenitis,
keratitis (including corneal ulcer).
DOSAGE AND ADMINISTRATION
Usually, instill 1 drop a time 3 times daily.
The
dosage
may
be
adjusted
according
to
the
patient’s
symptoms.
< PRECAUTIONS >
1. In order to avoid the emergence of resistant bacteria, bacterial
susceptibility should be confirmed and treatment with this
drug should be limited to the minimum period required for the
eradication of the infection.
2. Avoid long-term use.
PRECAUTIONS
1.
ADVERSE REACTIONS
Adverse reactions to this drug were reported in 44 of 13,329
patients evaluated before and after approval (0.33%). The
major adverse reactions were eye irritation in 11 patien
                                
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