VOLUVEN SOLUTION FOR INFUSION 6%

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

POLY (O-2-HYDROXYETHYL) STARCH; SODIUM CHLORIDE

Inapatikana kutoka:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC kanuni:

B05AA07, B05AA07

Kipimo:

60 g/l

Dawa fomu:

INJECTION

Tungo:

POLY (O-2-HYDROXYETHYL) STARCH 60 g/l; SODIUM CHLORIDE 9 g/l

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

General Sale List

Viwandani na:

FRESENIUS KABI DEUTSCHLAND GMBH

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2003-05-16

Taarifa za kipeperushi

0XX XXX1/
00 SGP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml contain:
Poly(O-2-hydroxyethyl)starch
…………………………………………………………………… 60.00
g
(Molar substitution 0.38 - 0.45)
(Mean molecular weight : 130,000)
Sodium chloride
…………………………………………………………………………………… 9.00
g
Na
+
154 mmol
Cl
–
154 mmol
Theoretical osmolarity
308 mosm/l
pH
4,0 – 5,5
Titratable acidity
< 1,0 mmol NaOH/l
3. PHARMACEUTICAL FORM
Solution for infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy and prophylaxis of hypovolaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For continuous intravenous infusion
The initial 10 – 20 ml are to be infused slowly, keeping the patient
under close observation (due to
possible anaphylactoid reactions).
The daily dose and rate of infusion depend on the patient’s blood
loss, on the maintenance or 
restoration of haemodynamics and on the haemodilution (dilution
effect). 
The maximum daily dose is 45 ml/kg b.w./day.
There is currently limited experience with repetitive dosing up to 4
days. The duration of treatment
depends on the duration and extent
of  hypovolaemia,  the  haemodynamics  and  on  the  haemodi-
lution.
There is currently no clinical experience with this maximum daily dose
 of 45 ml/kg bw/day given for
prolonged periods.
Treatment of children
Limited clinical data on the use of Voluven
®
in children is available. In 41 children including newborns
to infants (< 2 years), a mean dose of 16 ± 9 ml/kg was
administered safely and well tolerated for 
stabilisation of haemodynamics (see section 4.4). 
The dosage in children should be adapted to the individual patient
colloid needs, taking into account
basic disease, haemodynamics, and hydration status.
1
1. NAME OF THE MEDICINAL PRODUCT
VOLUVEN
®
6% Solution for Infusion
'PS
UIF
EPTBHF
JO
DSJUJDBMMZ
JMM
QBUJFOUT
QMFBTF
SFGFS
UP
TFDUJPO

4.3 CONTRA-INDICATIONS
– Fluid overload (hyperhy

Tabia za bidhaa

1.
NAME OF THE MEDICINAL PRODUCT
VOLUVEN
®
6% Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml contain:
In cases of severe dehydration a crystalloid solution should be given
first. Generally, sufficient
fluid should be administered in order to avoid dehydration.
Particular care must be taken in patients with electrolyte
abnormalities.
Clinical evaluation and periodic laboratory determinations are
necessary to monitor fluid
balance, serum electrolyte concentrations, kidney function, acid-base
balance, and coagulation
parameters during prolonged parenteral therapy or whenever the
patient’s condition warrants
such evaluation.
Monitor liver function in patients receiving HES products, including
Voluven.
Poly(O-2-hydroxyethyl)starch
………………………………………………………..........……………
60.00 g (Molar substitution 0.38 - 0.45)
(Meanmolecular weight : 130,000)
Sodium chloride
…………………………………………….........………………………………………
9.00 g
Na
+
154 mmol
Cl
–
154 mmol
Theoretical osmolarity
308 mosm/l
pH
4,0 – 5,5
Titratable acidity
< 1,0 mmol NaOH/l
3. PHARMACEUTICAL FORM
Solution for infusion
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voluven 6% is indicated for the treatment and prophylaxis of
hypovolaemia in adults and
children. It is not a substitute for red blood cells or coagulation
factors in plasma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Voluven is administered by intravenous infusion only.
The daily dose and rate of infusion depend on the patient’s blood
loss, on the maintenance
or restoration of haemodynamics and on the haemodilution (dilution
effect). Voluven can be
administered repetitively over several days.
The initial 10 to 20 ml should be infused slowly, keeping the patient
under close observation
due to possible anaphylactic/anaphylactoid reactions.
ADULT DOSE:
The maximum daily dose is 45 ml/kg b.w./day.
There is currently limited experience with repetitive dosing up to 4
day