Bleph 10

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Sulfacetamide sodium monohydrate 100 mg/mL

Fáanlegur frá:

Allergan New Zealand Ltd

INN (Alþjóðlegt nafn):

Sulfacetamide sodium monohydrate 100 mg/mL

Skammtar:

10 %

Lyfjaform:

Eye drops, solution

Samsetning:

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

Einingar í pakka:

Bottle, dropper, 15 mL

Tegund:

Restricted

Gerð lyfseðils:

Restricted

Framleitt af:

Katwijk Chemie BV

Vörulýsing:

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

Leyfisdagur:

1969-12-31

Vara einkenni

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