ISOKET AMPOULE 10MG10ML

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

ISOSORBIDE DINITRATE

Beszerezhető a:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (nemzetközi neve):

ISOSORBIDE DINITRATE

db csomag:

10ml mL

Gyártó:

EVER Pharma Jena GmbH

Betegtájékoztató

Not Applicable

Termékjellemzők

ISOKET AMPOULE 10MG/10ML
ISOSORBIDE DINITRATE (SOLUTION FOR INFUSION OR INJECTION)
NAME OF THE MEDICINAL PRODUCT
Isosorbide dinitrate, 1mg/ml, solution for infusion or injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoket is a concentrated solution of Isosorbide dinitrate 1mg/1ml
(0.1%) in sterile isotonic
saline. It is supplied in 10 ml ampoules. The solution contains no
alcohol or potassium.
EXCIPIENTS
Sodium chloride, water for injections, sodium hydroxide (for
pH-adjustment), hydrochloric
acid (for pH-adjustment).
PHARMACEUTICAL FORM
The solution is clear, colourless liquid.
CLINICAL INFORMATION
INDICATIONS
Isoket is indicated in the treatment of unresponsive left ventricular
failure secondary to acute
myocardial infarction, unresponsive left ventricular failure of
various aetiology and severe or
unstable angina pectoris.
DOSAGE AND ADMINISTRATION
This medicinal product is a concentrated solution and must be diluted
prior use. The diluted
solution should never be injected directly in the form of a bolus.
Isosorbide dinitrate solution for infusion or injection, can be
administered as an intravenous
admixture with a suitable vehicle (
_see Section Use and Handling_
).
Prepared isosorbide dinitrate admixtures should be given by
intravenous infusion or with the
aid of a syringe pump incorporating a glass or rigid plastic syringe.
During administration, the
patient’s blood pressure and pulse should be closely monitored and
dose adjusted according to
the patient’s response.
ROUTE OF ADMINISTRATION
For intravenous use.
ADULTS
A dose of between 2 mg and 12 mg per hour is usually satisfactory.
However, dosages up to 20 mg per hour administered should be adjusted
to the patient
response.
CHILDREN
The safety and efficacy of isosorbide dinitrate solution for infusion
or injection has not yet
been established in children.
ELDERLY
No dose adjustment is necessary.
RENAL AND HEPATIC IMPAIRMENT
Isosorbide dinitrate should be used with caution in patients with
severely impaired renal or
hepatic function
_(see Section W