ISOKET 0.1 % AMPOULES

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ISOSORBIDE DINITRATE

Disponibbli minn:

GLAXO SMITH KLINE (ISRAEL) LTD

Kodiċi ATC:

C01DA08

Għamla farmaċewtika:

SOLUTION FOR INFUSION

Kompożizzjoni:

ISOSORBIDE DINITRATE 1 MG/ML

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

AESICA PHARMACEUTICALS GMBH ( FORMERLY SCHWARZ PHARMA AG)

Grupp terapewtiku:

ISOSORBIDE DINITRATE

Żona terapewtika:

ISOSORBIDE DINITRATE

Indikazzjonijiet terapewtiċi:

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.

Data ta 'l-awtorizzazzjoni:

2012-12-31

Karatteristiċi tal-prodott

_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