普絡易注射液 5 微克/毫升

Страна: Тайван

Език: китайски

Източник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Активна съставка:

ALPROSTADIL (PGE1)

Предлага се от:

台灣微脂體股份有限公司 台北市南港區園區街３號１１樓之１ (16176150)

АТС код:

C01EA01

Лекарствена форма:

注射劑

Композиция:

ALPROSTADIL (PGE1) (6832001600) ug

Броя в опаковка:

安瓿;;盒裝

Клас:

製　劑

Вид предписание :

限由醫師使用

Произведено от:

杏林新生製藥股份有限公司 桃園市龍潭區三和村店湖一路237號 TW

Терапевтична област:

alprostadil

Терапевтични показания:

週邊動脈阻塞疾病症狀改善。

Каталог на резюме:

註銷日期: 2023/07/27; 註銷理由: 未展延而逾期者; 有效日期: 2019/12/22; 英文品名: ProFlow Injection 5 μg/mL

Статус Оторизация:

已註銷

Дата Оторизация:

2010-12-22

Листовка

- 1 -
普絡易
®
注射液
5
微克
/
毫升
ProFlow® Injection 5μg/mL
As prescribed by physician
Storage
：
Between 2 and 8
℃
Expiry date: See the outer package
【
CONTRAINDICATIONS
】
PROFLOW® IS CONTRAINDICATED TO THE FOLLOWING PEOPLE:
1.
PATIENTS WITH SERIOUS HEART FAILURE. (THE EXACERBATION OF HEART
FAILURE HAS
BEEN REPORTED.)
2.
PATIENT
WITH
HEMORRHAGE
(INTRACRANIAL
HEMORRHAGE,
DIGESTIVE
TRACT
HEMORRHAGE, HEMOPTYSIS, ETC.) [HEMORRHAGE MAY BE PROMOTED.]
3.
PREGNANT WOMEN OR WOMEN WHO MAY POSSIBLE BE PREGNANT. (SEE “USE
DURING PREGNANT, PUERPERAL OR LACTATION SECTION”)
4.
PATIENTS WHO HAVE DEMONSTRATED OR HAVE KNOWN HYPERSENSITIVITY TO ANY
INGREDIENT OF PROFLOW® .
【
DESCRIPTION
】
ProFlow®
Injection
5μg/mL
is
a
white,
slightly
viscous
and
peculiar
odor
emulsion, having a pH of 4.5–6.0, the osmotic pressure ration (to
physiological
saline) is approximate 1.
ACTIVE SUBSTANCE:
Each 1mL ProFlow® contains Alprostadil 5μg
Each 2mL ProFlow® contains Alprostadil 10μg
EXCIPIENT:
Medium-chain triglycerides, purified yolk lecithin, polysorbate 80,
concentrated
glycerin, hydrochloric acid, sodium hydroxide, water for injection.
【
INDICATIONS
】
Improvement of peripheral arterial occlusion disease.
【
DOSAGE AND ADMINISTRATION
】
For adult patients, the recommended daily dose is 1mL to 2mL (5 to
10μg of
alprostadil) either without mixing or dilution, or as an admixture
with an infusion
solution, by intravenous infusion for at least 5 minutes.
PRECAUTION FOR ADMINISTRATION
Do not use this product in admixtures with drugs other than infusion
solutions.
Avoid diluting with plasma expanders (dextran, gelatin preparations,
etc.) When
ProFlow® is administered by intravenous infusion, make sure to use a
infusion
line separately to prevent aggregation within the line.
【
PRECAUTIONS
】
1.
PROFLOW® SHOULD BE ADMINISTERED IN THE FOLLOWING PATIENTS CAREFULLY:
(1)
PATIENTS WITH HEART FAILURE. (HEART FAILURE MAY BE AGGRAVATED.)
(2)
PATIENTS WITH HEMORRHAGE. (HEMORRHAGE MAY BE PROMOTED.)
(3)
PATIENTS