UMAN ALBUMIN

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

ALBUMIN HUMAN

Dostupné z:

KAMADA LTD, ISRAEL

ATC kód:

B05AA01

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

ALBUMIN HUMAN 200 MG/ML

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

KEDRION S.P.A, ITALY

Terapeutické skupiny:

ALBUMIN

Terapeutické oblasti:

ALBUMIN

Terapeutické indikácie:

For restoration and maintenance of circulating blood volume where volume deficiency has been demontrated and use of a colloid such as albumin is appropriate. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient based on official recommendations.

Dátum Autorizácia:

2015-06-30

Príbalový leták

BEYOND PHARMA (2014) LTD.
Address: P.O.Box 119 Tel-Mond , Israel 40600 Tel: [phone] Fax:
972-153-77-9100550
ילוי
2019
,ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור :ןודנה
UMAN ALBUMIN 200G/I ינמוה ןימובלא
%
20
עידוהל םידבכתמ ונא
תאזב
ןוכדע לע
רישכתה לש אפורל ןולעה
Uman Albumin (Human Albumin 20%)
.
1
. : ןימובלא ןמוא רישכתה יטרפ

:םיליעפ םירמוח
HUMAN ALBUMIN 200 g/l
.

:ןתמו ןונימ תרוצ
solution for infusion
.
 :ןרצי
KEDRION SPA
 היוותה תרשואמ
:
For restoration and maintenance of circulating blood volume where
volume deficiency has
been demontrated and use of a colloid such as albumin is appropriate.
The choice of albumin rather than artificial colloid will depend on
the clinical situation of the
individual patient based on official recommendations.
.
2
.
: ןולעה ןוכדע
השענ םהב םיפיעס םיניוצמ וז העדוהב
הפסוה וניהש יוניש( הרמחה הווהמה יוניש
וא יתוהמ יוניש
וא הרמחה םיווהמ םניא רשא םיפסונ
םינוכדע .)יעצמא וקב תנמוסמ הקיחמ ,ןותחת
וקב ןמוסמ
.וז העדוהב םיללכנ םניא ,םייתוהמ םניאש
:םיאבה םיפיעסב ןכדוע אפורל ןולעה
4.
CLINICAL PARTICULARS
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Paediatric population _
The safety and efficacy of UMAN ALBUMIN in children, including
premature infants, have not
been established by controlled clinical trials and its use in
paediatric population is based only
on established medical practice. For this reason, UMAN ALBUMIN must be
used in children
and premature infants only if clearly necessary.
BEYOND PHARMA (2014) LTD.
Address: P.O.Box 119 Tel-Mond , Israel 40600 Tel: [phone] Fax:
972-153-77-9100550
Patients with renal impairment
UMAN ALBUMIN can be administered to dialysis patients as the aluminium
content of the
finished product is not mo

Súhrn charakteristických

_ _
_ _
_ _
PRESCRIBERS INFORMATION
1
NAME OF THE MEDICINAL PRODUCT :
UMAN ALBUMIN 200 g/l, solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
UMAN ALBUMIN
200 G/L
Solution containing total plasma proteins
to
20%
of which human albumin at least to
95%
a vial of 50 ml contains human albumin
equal to
10 g
a vial of 100 ml contains human albumin
equal to
20 g
The solution is
hyperoncotic
Excipient with known effect: This medicinal product contains up to 157
mg sodium per
vial of 50 ml and 314 mg per vial of 100 ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid; it is almost colourless, yellow,
amber or green.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For restoration and maintenance of circulating blood volume where
volume deficiency
has been demonstrated, and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on
the clinical situation
of the individual patient, based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The
concentration
of
the
albumin
preparation,
dosage
and
infusion-rate
must
be
adjusted to the patient’s individual requirements.
POSOLOGY
_ _
_ _
_ _
The dose required depends on the size of the patient, the severity of
trauma or illness
and on continuing fluid and protein losses. Measures of adequacy of
circulating volume
and not plasma albumin levels should be used to determine the dose
required.
If
human
albumin
is
to
be
administered,
haemodynamic
performance
should
be
monitored regularly. This may include:
-
arterial blood pressure and pulse rate
-
central venous pressure
-
pulmonary artery wedge pressure
-
urine output
-
electrolyte
-
haematocrit/haemoglobin.
_Paediatric population _
The safety and efficacy of UMAN ALBUMIN in children, including
premature infants,
have
not
been
established
by
controlled
clinical
trials
and
its
use
in
paediatric
population is based only on estabilished medical practice. For this
reason, UMAN
AL