국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Alprostadil 6.15ug equivalent to 5 µg/ml after reconstitution.
Pharmacia Limited Company trading as Pharmacia
Alprostadil 6.15 µg (=5 µg/ml after reconstitution.)
5 mcg
Powder for injection
Active: Alprostadil 6.15ug equivalent to 5 µg/ml after reconstitution. Excipient: Hydrochloric acid Lactose monohydrate Sodium citrate dihydrate Sodium hydroxide Benzyl alcohol Water for injection
Combination pack, 6x(vial+ diluent syringe),
Prescription
Prescription
Pharmacia & Upjohn Company LLC
Package - Contents - Shelf Life: Combination pack, 6x(vial+ diluent syringe) - - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 48 hours reconstituted stored at or below 25°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted (not refrigerated) stored at or below 25°C - Combination pack, 1x(vial+ diluent syringe) - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 48 hours reconstituted stored at or below 25°C 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted (not refrigerated) stored at or below 25°C - Syringe, glass, 1x1ml - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 1x5?g - 5 ?g - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1993-02-16
DATA SHEET CAVERJECT ® ALPROSTADIL 10 MICROGRAMS AND 20 MICROGRAMS POWDER FOR INJECTION PRESENTATION Caverject is a white crystalline powder containing 10 micrograms or 20 micrograms alprostadil in a 5 mL clear glass vial. USES ACTIONS Alprostadil is the naturally occurring form of prostaglandin E 1 (PGE 1 ). Alprostadil has a wide variety of pharmacological actions; vasodilation and inhibition of platelet aggregation are among the most notable of these effects. In most animal species tested, alprostadil relaxed retractor penis and corpus cavernosum urethrae _in vitro_ . Alprostadil also relaxed isolated preparations of human corpus cavernosum and spongiosum as well as cavernous arterial segments contracted by either noradrenaline or PGF 2 α _in vitro_ . In pigtail monkeys ( _Macaca nemestrina_ ), alprostadil increased cavernous arterial blood flow _in vivo_. The degree and duration of cavernous smooth muscle relaxation in this animal model was dose- dependent. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism. PHARMACOKINETICS _ABSORPTION _ For the treatment of erectile dysfunction, alprostadil is administered by injection into the corpora cavernosa. The absolute bioavailability of alprostadil has not been determined. _DISTRIBUTION _ Following intracavernosal injection of 20 micrograms alprostadil, mean peripheral plasma concentrations of alprostadil at 30 and 60 minutes after injection (89 and 102 picograms/mL, respectively) were not significantly greater than baseline levels of endogenous alprostadil (96 picograms/mL). Alprostadil is bound in plasma primarily to albumin (81% bound) and to a lesser extent α -globulin IV-4 fraction (55% bound). No significant binding to erythrocytes or white blood cells was observed. _BIOTRANSFORMATION OR METABOLISM _ Alprostadil is 전체 문서 읽기