Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
ISOSORBIDE DINITRATE
GLAXO SMITH KLINE (ISRAEL) LTD
C01DA08
SOLUTION FOR INFUSION
ISOSORBIDE DINITRATE 1 MG/ML
I.V
Required
AESICA PHARMACEUTICALS GMBH ( FORMERLY SCHWARZ PHARMA AG)
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE
Isoket 0.1% 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.
2012-12-31
_The format of this leaflet was determined _ _by the Ministry of Health and its content _ _was checked and approved in August _ _2011_ PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT ISOKET 0.1% AMPOULES ISOKET 0.1% BOTTLE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ampoule isosorbide dinitrate (ISDN) i.v. 0.1 % contains 10 mg isosorbide dinitrate in 10 ml sterile isotonic sodium chloride solution. 1 bottle isosorbide dinitrate (ISDN) i.v. 0.1 % (50 ml) contains 50 mg isosorbide dinitrate in 50 ml sterile isotonic sodium chloride solution. Each ml contains 3.54 mg (0.154 mmol) sodium (as sodium chloride). For list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is a clear, colourless and odourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isoket 0.1% 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The posology must be adjusted to suit the patient’s needs and the response of the clinical and haemodynamic variables must be monitored. Initially treatment is started with a dose of 1–2 mg/h; then the dose can be adjusted to the individual requirements. The maximum dose does not normally exceed 8 (-10) mg/h. Higher doses of 10 mg/h - and up to 50 mg/h in individual cases - may be necessary in patients suffering from heart failure. MODE OF ADMINISTRATION Isoket 0.1 % solution can be used either diluted in a continuous intravenous infusion by means of automated equipment, or undiluted using a syringe pump, in a hospital setting; the cardiac and circulatory parameters must constantly be monitored. Isoket 0.1 % solution is compatible with the infusion solutions common in clinical practice such as physiological saline, 5 - 30 % glucose solution, Ringer’s solution, protein-containing solutions. When combining Isoket 0.1 % solution with infusion s সম্পূর্ণ নথি পড়ুন