Uman Albumin Solution for Infusion 200 gl

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Human Albumin (Human Plasma Protein containing at least 95% Albumin)

Fáanlegur frá:

DUO MEDICAL PTE. LTD.

ATC númer:

B05AA01

Skammtar:

200 g/l

Lyfjaform:

INFUSION, SOLUTION

Samsetning:

Human Albumin (Human Plasma Protein containing at least 95% Albumin) 200 g/l

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

Kedrion S.p.A.

Leyfisstaða:

ACTIVE

Leyfisdagur:

2011-11-03

Upplýsingar fylgiseðill

 
_ _
_UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _
_ _
_Page 1 of 7 _
_SUMMARY OF PRODUCT CHARACTERISTICS _
_(CPMP/PhVWP/BPWG/2231/99 rev.2) _

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 
For excipients, see 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 
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  should  be 
adjusted to the patient’s individual requirements. 

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_UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _
_ _
_Page 2 of 7 _

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 pre

Vara einkenni

_ _
_UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _
_ _
_Page 1 of 7 _
_SUMMARY OF PRODUCT CHARACTERISTICS _
_(CPMP/PhVWP/BPWG/2231/99 rev.2) _
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
For excipients, see 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
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
should be
adjusted to the patient’s individual requirements.
_ _
_UMAN ALBUMIN_SPC_SG_K08=K09_Rev00 _
_ _
_Page 2 of 7 _
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.
UMAN ALBUMIN can be administered to premature infants and dialysis
patients as
the aluminium content of the finished product is not more than 200

g/l.
METHOD OF ADMINISTRATION
Human albumin can be directly administered by the intravenous route,
or it can also be
diluted in an isoton