巧特欣注射劑

Country: Тајван

Језик: Кинески

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

Активни састојак:

CARBETOCIN (ANHYDROUS ACETIC ACID FREE DEFINITION)

Доступно од:

輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)

АТЦ код:

H01BB03

Фармацеутски облик:

注射液劑

Састав:

CARBETOCIN (ANHYDROUS ACETIC ACID FREE DEFINITION) (7600001910) ug

Јединице у пакету:

瓶裝

Класа:

製　劑

Тип рецептора:

限由醫師使用

Произведен од:

ZUELLIG PHARMA SPECIALTY SOLUTIONS GROUP PTE. LTD. 15 CHANGI NORTH WAY #01-02, #02-02, #02-10, SINGAPORE 498770 SG

Терапеутска област:

carbetocin

Терапеутске индикације:

預防子宮收縮乏力造成的產後出血。

Резиме производа:

有效日期: 2027/08/17; 英文品名: Duratocin Injection 100mcg/ml

Датум одобрења:

2012-08-17

Информативни летак

DURATOCIN
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbetocin 100 micrograms/ml.
For a full list of excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL DOSAGE FORM
Solution for injection.
A clear colourless solution.
CLINICAL PARTICULARS
Therapeutic indications
Prevention of postpartum haemorrhage due to uterine atony.
Posology and method of administration
Posology
Caesarean section under epidural or spinal anaesthesia:
Withdraw 1 ml of DURATOCIN
®
containing 100 micrograms carbetocin
and administer only by intravenous injection, under adequate medical
supervision in a hospital.
Vaginal delivery:
Withdraw 1 ml of DURATOCIN
®
containing 100 micrograms carbetocin
and administer by intravenous injection or intramuscular injection,
under
adequate medical supervision in a hospital.
Paediatric population
There is no relevant use of carbetocin in children below 12 years of
age.
The safety and efficacy of carbetocin in adolescents has not yet been
established.
Currently available data are described in section 5.1 but no
recommendation on a
posology can be made.
Method of administration
Carbetocin must only be administered after delivery of the infant, and
as soon as possible after delivery, preferably before the delivery of
the
placenta.
For intravenous administration carbetocin must be administered slowly,
over 1 minute.
DURATOCIN
®
is intended for single use only. No further doses of
carbetocin should be administered.
Contraindications
- Pregnancy and labour before delivery of the infant.
- Induction of labour.
- Serious cardiovascular disorders.
- Hypersensitivity to carbetocin, oxytocin or to any of the excipients
listed
in “LIST OF EXCIPIENTS”.
- Hepatic or renal disease.
- Epilepsy
Special warnings and precautions for use
Carbetocin is intended for use only at well equipped specialist
obstetrics
units with experienced and qualified staff available at all times.
The use of carbetocin at any stage before delivery of the infant is
not
appropriate because its uterotonic activity persists for several
ho