Land: Singapore
Sprog: engelsk
Kilde: HSA (Health Sciences Authority)
CEFTIBUTEN
MSD PHARMA (SINGAPORE) PTE. LTD.
J01DD14
400 mg
CAPSULE
ORAL
Prescription Only
Merck Sharp & Dohme Corp.
1994-12-09
CCDS-MK3972-MTL-062014 CEDAX® Capsules/Powder for Oral Suspension Brand of Ceftibuten MSD This insert contains basic prescribing information only. For more comprehensive information, a Professional Brochure is available to physicians on request. FOR ORAL ADMINISTRATION DESCRIPTION: Ceftibuten dihydrate is a semisynthetic, third generation cephalosporin antibiotic for oral administration. Its chemical formula is: (+)-(6R, 7R)-7-[(z)-2-(2-amino-4- thiazolyl)-4-carboxycrotonamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, dihydrate. It occurs as both the cis- and trans-forms. Molecular weight = 446.43. Each CEDAX® Capsule contains 400 mg ceftibuten. The inactive ingredients in CEDAX® Capsules are microcrystalline cellulose, sodium starch glycolate and magnesium stearate. The gelatin capsule contains sodium lauryl sulfate, purified water and titanium dioxide as a coloring agent. The capsule banding solution contains polysorbate 80, gelatin and purified water. The capsules are branded with black ink comprised of: shellac, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide. The alternate black ink is comprised of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide. Each bottle of CEDAX® Powder for Oral Suspension contains sufficient powder to deliver 180 mg per 5 ml dose following reconstitution. CEDAX® Powder for Oral Suspension is cherry flavored and contains xanthan gum, sucrose, simethicone, silicon dioxide, titanium dioxide, polysorbate 80 a Læs hele dokumentet