Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
octreotide acetate (UNII: 75R0U2568I) (octreotide - UNII:RWM8CCW8GP)
Sagent Pharmaceuticals
octreotide acetate
octreotide 50 ug in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Octreotide acetate injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of GH and IGF-1 (somatomedin C) levels (see DOSAGE AND ADMINISTRATION ). In patients with acromegaly, octreotide acetate injection reduces GH to within normal ranges in 50% of patients and reduces IGF-1 (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of GH and IGF-1 (somatomedin C) offers potential benefit before the effects of irradiation are manifested. Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials p
Octreotide Acetate Injection is available as follows: Store refrigerated between 2° and 8°C (36° and 46°F). At room temperature (20° to 30°C or 70° to 86°F), Octreotide Acetate Injection is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. Single-Dose Vials —should be opened just prior to administration and the unused portion discarded. Multi-Dose Vials —should be discarded within 14 days after initial use. Protect from light. Retain in carton until time of use. Dispose of unused product or waste properly. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2020 Sagent Pharmaceuticals, Inc. Revised: October 2020 SAGENT Pharmaceuticals®
Abbreviated New Drug Application
OCTREOTIDE ACETATE- OCTREOTIDE ACETATE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- OCTREOTIDE ACETATE INJECTION (FOR SUBCUTANEOUS OR INTRAVENOUS USE) SAGENT Rx only DESCRIPTION Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution with a pH range 3.9 to 4.5 for administration by deep subcutaneous (intrafat) or intravenous (IV) injection. Octreotide acetate, 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*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1 mL single-dose vials in 3 strengths, containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP, and sterile 5 mL multi-dose vials in 2 strengths, containing 200 mcg and 1,000 mcg per mL of octreotide acetate, USP. Each mL of the single-dose vial also contains: Each mL of the multi-dose vial also contains: The molecular weight of octreotide acetate is 1,019.3 g/mol (free peptide, C H N O S ) and its amino acid sequence is: CLINICAL PHARMACOLOGY ® sodium chloride, USP ....................................................................................7 mg glacial acetic acid, USP................................................................................. 2 mg sodium acetate trihydrate, USP .................................................................... 2 mg water for injection, USP .............................................quantity sufficient to 1 mL sodium chloride, USP................................................................................... 7 mg glacial acetic acid, USP................................................................................. 2 mg sodium acetate trihydrate, USP .................................................................... 2 mg phenol, US Lesen Sie das vollständige Dokument