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SEMPREX-D DESCRIPTION SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are a fixed combination product formulated for oral administration. Acrivastine is an antihistamine and pseudoephedrine is a decongestant. Each capsule contains 8 mg acrivastine and 60 mg pseudoephedrine hydrochloride and the inactive ingredients: lactose, magnesium stearate and sodium starch glycolate. The green and white capsule shell consists of gelatin, D&C Yellow No. 10, FD&C Green No. 3, and titanium dioxide. The yellow…

SANGCYA ORAL SOLUTION (SANGSTAT) WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe SangCya® (Cyclosporine Oral Solution, USP [ MODIFIED ]). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe SangCya®. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The…

SAGRAMOSTIM (LEUKINE®) DESCRIPTION LEUKINE® (sargramostim) is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. LEUKINE is a glycoprotein of 127 amino acids characterized by 3 primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of…

SANDOGLOBULIN IV DESCRIPTION Immune Globulin Intravenous (Human), (IGIV) Sandoglobulin®, is a sterile, highly purified polyvalent antibody product containing in concentrated form all the IgG antibodies which regularly occur in the donor population (1). This immunoglobulin preparation is produced by cold alcohol fractionation from the plasma of volunteer US donors. Part of the fractionation may be performed by another US-licensed manufacturer. The fractionation process by which Sandoglobulin® is prepared from plasma…

SANDOSTATIN LAR DEPOT DESCRIPTION Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-, cyclic (2->7)-disulfide; [R-(R*,R*)]. Sandostatin LAR® Depot (octreotide acetate for injectable suspension) is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a…

SALAZOPYRIN® SALAZOPYRIN EN-TABS® Pharmacia & Upjohn Sulfasalazine Anti-inflammatory Action And Clinical Pharmacology: About 20% of sulfasalazine is absorbed in the small intestine after oral administration. A small percentage of the absorbed sulfasalazine is excreted in the urine and the rest via the bile into the small intestine (enterohepatic circulation). This portion together with the unabsorbed sulfasalazine enters the colon where it is split by bacteria into 2 main metabolites, sulfapyridine…

SALAGEN DESCRIPTION SALAGEN® Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in most non-polar solvents. Pilocarpine hydrochloride, with a chemical name of (3 S-cis )-2(3 H )-Furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)methyl] monohydrochloride, has a molecular weight of 244.72. Each SALAGEN® Tablet for oral administration contains 5 mg…

SANDIMMUNE (CYCLOSPORINE) DESCRIPTION Cyclosporine, the active principle in Sandimmune® (cyclosporine) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine is designated as [ R -[ R*,R*-(E )]]-cyclic (L-alanyl – D – alanyl- N -methyl – L – leucyl- N -methyl-L-leucyl- N -methyl – L – valyl-3-hydroxy- N , 4-dimethyl-L-2-amino – 6 – octenoyl-L-(alpha)-amino-butyryl –…

SAIZEN DESCRIPTION Saizen® [somatropin (rDNA origin) for injection] is a human growth hormone produced by recombinant DNA technology. Saizen® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Saizen® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone…

SYNFLEX® DS AltiMed Naproxen Sodium Analgesic-Anti-inflammatory Availability And Storage: Synflex: Each oval-shaped, blue, film-coated tablet, with SYNFLEX engraved on one side, contains: naproxen sodium 275 mg. Nonmedicinal ingredients: FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Bisulfite-, erythrosine-, gluten-, lactose-, sorbitol-, tartrazine- and xylitol-free. Bottles of 100 and 500. Synflex DS: Each oblong, dark blue, film-coated tablet, with SYNFLEX DS…