EMBESIN

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ARGIPRESSIN

Inapatikana kutoka:

AOP ORPHAN PHARMACEUTICALS ISRAEL LTD, ISRAEL

ATC kanuni:

H01BA06

Dawa fomu:

CONCENTRATE FOR SOLUTION FOR INFUSION

Tungo:

ARGIPRESSIN 40 IU / 2 ML

Njia ya uendeshaji:

I.V

Dawa ya aina:

Required

Viwandani na:

AMOMED PHARMA GMBH, AUSTRIA

Eneo la matibabu:

ARGIPRESSIN

Matibabu dalili:

Embesin is indicated for the treatment of catecholamine-refractory hypotension following septic shock in patients older than 18 years. A catecholamine-refractory hypotension is present if the mean arterial blood pressure cannot be stabilized to 65 – 75 mmHg despite adequate volume substitution and application of catecholamines.

Idhini ya tarehe:

2020-03-11

Tabia za bidhaa

Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Embesin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule with 2 ml concentrate for solution for infusion contains
40 I.U. argipressin (equating 133
microgram).
1 ml concentrate for solution for infusion contains 20 I.U.
argipressin (equating 66.5 microgram).
Excipients with known effect: Each ml contains less than 23 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion. The solution is clear,
colourless and free from visible particles with a
pH between 2.5 - 4.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Embesin is indicated for the treatment of catecholamine refractory
hypotension following septic shock in
patients older than 18 years. A catecholamine refractory hypotension
is present if the mean arterial blood
pressure cannot be stabilised to
65 – 75 mmHg
despite adequate volume substitution and application of
catecholamines (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy with argipressin in patients with catecholamine refractory
hypotension is slowly started by a
continuous intravenous infusion of 0.01 I.U. per minute using a
perfusor / motor pump.
Dependent on the clinical response, the dose may be increased every 15
– 20 minutes up to 0.03 I.U. per
minute. For intensive care patients, the usual target blood pressure
is 65 – 75 mmHg. Argipressin should
only be used in addition to conventional vasopressor therapy with
catecholamines. Doses above 0.03 I.U. per
minute should only be applied as emergency treatment, as this may
cause gut and skin necrosis (see section
4.4).
Dose reductions of Embesin should be done in accordance with the
clinical course. The treatment
duration should also be chosen according to the individual clinical
picture.
The solution for infusion is prepared by diluting 40 I.U. Embesin with
NaCl 9 mg/ml (0.9%) solution. The
total volume after dilution should be 50 ml (equivalent to 0.8 I.U.
argipressin per ml).
Infusion rates acc