ISOKET SPRAY

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ISOSORBIDE DINITRATE

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

C01DA08

Legemiddelform:

SPRAY

Sammensetning:

ISOSORBIDE DINITRATE 1.25 MG/DOSE

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

AESICA PHARMACEUTICALS GMBH, GERMANY

Terapeutisk gruppe:

ISOSORBIDE DINITRATE

Terapeutisk område:

ISOSORBIDE DINITRATE

Indikasjoner:

Angina pectoris, congestive heart failure.

Autorisasjon dato:

2014-02-28

Preparatomtale

THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS
CONTENT WAS CHECKED AND APPROVED BY IT.
PRESCRIBING INFORMATION
ISOKET
 SPRAY
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.7 g solution (= 15 ml) contains:
375 mg isosorbide dinitrate.
1 dose (= 0.05 ml) contains:
1.25 mg isosorbide dinitrate.
PHARMACEUTICAL FORM
Oromucosal spray
The solution is a clear, colourless liquid.
INDICATIONS

Angina pectoris

Congestive heart failure
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be adjusted to suit the patient’s needs.
1-3 squirts at about 30 seconds intervals are sprayed into the mouth
during an attack
or shortly before physical and/or mental stress that may trigger an
attack.
A single dose of 3 squirts applied to treat an acute angina attack
should only be
exceeded upon the physician’s express advice.
In acute myocardial infarction or acute heart failure one starts with
1-3 squirts. In the
event of non-response within 5 minutes, an additional squirt may be
given. In case
there is no improvement within the subsequent 10 minutes, spray
application may be
repeated under close blood pressure monitoring.
CONTRAINDICATIONS
Isoket

spray must not be used in:

Hypersensitivity to ISDN, other intro compounds or other ingredients

Acute circulatory failure (shock, collapse)

Cardiogenic shock (unless a sufficient end-diastolic pressure is
maintained by
appropriate measures).

Hypertrophic obstructive cardiomyopathy.

Constrictive pericarditis

Cardiac tamponade

Severe hypotension (systolic blood pressure less than 90 mmHg).

During nitrate therapy, phosphodiesterase inhibitors (e.g. sildenafil)
must not
be used (see section interations with other medicaments and other
forms of
interaction).
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Isoket

spray should be used only with particular caution and under medical
supervision in:

Low filling pressures e.g. in acute myocardial infarction, impaired
left
ventricular function (left ventricular failure)