樂酸克凍晶注射劑４０公絲

Χώρα: Ταϊβάν

Γλώσσα: Κινεζικά

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

Δραστική ουσία:

OMEPRAZOLE

Διαθέσιμο από:

臺灣阿斯特捷利康股份有限公司 台北市大安區敦化南路二段207號21樓 (16440975)

Φαρμακολογική κατηγορία (ATC):

A02BC01

Φαρμακοτεχνική μορφή:

凍晶注射劑

Σύνθεση:

OMEPRAZOLE (5640002300) MG

Μονάδες σε πακέτο:

小瓶;;安瓿

Kατηγορία:

製　劑

Τρόπος διάθεσης:

限由醫師使用

Κατασκευάζεται από:

ASTRAZENECA AB S-151 85 SODERTALJE SWEDEN SE

Θεραπευτική περιοχή:

omeprazole

Θεραπευτικές ενδείξεις:

下列病症無法幾口服藥物有效治療時之取代療法：十二指腸潰瘍、胃潰瘍、逆流性食導炎及ＺＯＬＬＩＮＧＥＲ－ＥＬＬＩＳＯＮ症。

Περίληψη προϊόντος:

註銷日期: 2016/08/19; 註銷理由: 自請註銷; 有效日期: 2018/05/04; 英文品名: LOSEC 40MG I.V. INJECTION

Καθεστώς αδειοδότησης:

已註銷

Ημερομηνία της άδειας:

1993-05-04

Φύλλο οδηγιών χρήσης

1
LOSEC 40 MG
_omeprazole _
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION
1 vial containing dry substance and 1 ampoule containing solvent. The
substance for
injection contains: Omeprazole sodium equivalent to omeprazole 40 mg.
For excipients see “List of excipients”.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
THERAPEUTIC INDICATIONS
Duodenal ulcer, gastric ulcer and reflux oesophagitis.
Zollinger-Ellison syndrome.
POSOLOGY AND METHOD OF ADMINISTRATION
_Duodenal ulcer, gastric ulcer and reflux oesophagitis:_ Patients who
cannot be given
oral medication can be treated parenterally with 40 mg once daily. The
usual
treatment period before transfer to oral treatment is 2-3 days.
In _Zollinger-Ellison syndrome_ the dose should be adjusted
individually. Higher doses
and/or several doses daily may be required.
Intravenous treatment can be given as _injection_, whereby the
solution for injection
must be given slowly over a period of at least 2½ minutes and with a
rate of
maximum 4 ml per minute.
_Impaired renal function _
A dose adjustment is not necessary for patients with impaired renal
function.
_Impaired liver function _
In patients with impaired liver function clearance is greatly reduced.
_Elderly patients _
A dose adjustment is not necessary in elderly patients.
_Children _
There is only limited experience of treatment in children.
CONTRAINDICATIONS
Known hypersensitivity to omeprazole, substituted benzimidazoles or
any of the
excipients.
Omeprazole like other PPIs must not be used concomitantly with
nelfinavir (see
Interactions with other medicinal products and other forms of
interaction).
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In the presence of any alarm symptoms (eg, significant unintentional
weight loss,
recurrent vomiting, dysphagia, haematemesis or melena) and when
gastric ulcer is
2
suspected or present, malignancy should be excluded, as treatment may
alleviate
symptoms and delay diagnosis.
Co-administration of atazanavir with proton pump inhibitors is not