Bleph 10

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

即購入

製品の特徴 製品の特徴 (SPC)
10-06-2009

有効成分:

Sulfacetamide sodium monohydrate 100 mg/mL

から入手可能:

Allergan New Zealand Ltd

INN(国際名):

Sulfacetamide sodium monohydrate 100 mg/mL

投薬量:

10 %

医薬品形態:

Eye drops, solution

構図:

Active: Sulfacetamide sodium monohydrate 100 mg/mL Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Hydrochloric acid Monobasic sodium phosphate monohydrate Polysorbate 80 Polyvinyl alcohol Purified water Sodium edetate Sodium hydroxide Sodium thiosulfate pentahydrate

パッケージ内のユニット:

Bottle, dropper, 15 mL

クラス:

Restricted

処方タイプ:

Restricted

製:

Katwijk Chemie BV

製品概要:

Package - Contents - Shelf Life: Bottle, dropper, - 15 mL - 18 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light

承認日:

1969-12-31

製品の特徴

                                 
 
BLEPH-10
® 
sulfacetamide sodium Datasheet Version 2.0   
 
 
 
 
 
 
 
 
DATA SHEET 
 
NAME OF MEDICINE 
 
 
 
 
BLEPH
®
-10 EYE DROPS 
Sulfacetamide sodium 100mg/mL ophthalmic solution 
 
 
PRESENTATION 
 
Eyedrops: 10% with 1.4% polyvinyl alcohol (LIQUIFILM
®
), 0.005% benzalkonium chloride, 
polysorbate 80, sodium thiosulfate disodium edetate, dibasic sodium
phosphate anhydrous, 
monobasic sodium phosphate heptahydrate,
hydrochloric acid or sodium hydroxide to pH 7.4 and 
purified water. 
 
 
USES 
 
ACTIONS: The sulfonamides are bacteriostatic agents and
the spectrum of activity is similar for all. 
Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by
preventing the condensation of the 
pteridine with aminobenzoic acid through competitive inhibition of
the enzyme dihydropteroate 
synthetase. Resistant strains have altered dihydropteroate
synthetase with reduced affinity for 
sulfonamides or produce increased quantities of aminobenzoic acid. 
 
Topically applied sulfonamides are considered active against
susceptible strains of the following 
common bacterial eye pathogens: _Escherichia coli,
Staphylococcus aureus, Streptococcus _
_pneumoniae, Streptococcus _(viridans group), _Haemophilus
influenzae_,  _Klebsiella  _species and 
_Enterobacter_ species. 
 
Topically applied sulfonamides do not provide adequate
coverage against _Neisseria_ species, 
_Serratia marcescens_ and _Pseudomonas aeruginosa. _A
significant percentage of staphylococcal 
isolates are completely resistant to sulfa drugs.  
 
INDICATIONS 
 
Treatment of conjunctivitis, corneal ulcer, and other
superficial ocular infections from susceptible 
micro-organisms and as an adjunct to systemic sulphonamide therapy
of trachoma. 
 
 
DOSAGE AND ADMINISTRATION 
 
CONJUNCTIVITIS, CORNEAL ULCER AND SUPERFICIAL OCULAR INFECTIONS: 
One or two drops into lower conjunctival sac of the affected
eye(s) every 2 or 3 h
                                
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