VASOPRESSIN FARMAK

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ARGIPRESSIN ACETATE

متاح من:

A.L. MEDI-MARKET LTD.

ATC رمز:

H01BA06

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

ARGIPRESSIN ACETATE 20 IU / 1 ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JSC "FARMAK", UKRAINE

المجال العلاجي:

ARGIPRESSIN

الخصائص العلاجية:

Vasopressin Farmak 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.

تاريخ الترخيص:

2023-01-03

خصائص المنتج

Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Vasopressin Farmak
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate for solution for infusion contains 20 I.U.
(international units) argipressin (in the form
of acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid, free from visible particles.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vasopressin Farmak 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 Vasopressin Farmak 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. Vasopressin
Farmak
with NaCl 9 mg/ml (0.9%) or 5% glucose solution. The total volume
after dilution should be 50 ml
(equivalent to 0.8 I.U. argipressin per ml).
Infusion rates according to the recommended doses:
Dose Vasopressin Farmak
/ min
Dose Vasopressin Farmak
/ hour
Infusion rate
Page 2 of 7
0.01 I.U.
0.6 I.U.
0