VOLUVEN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE; STARCH ETHERIFIED

Available from:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

B05AA

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

STARCH ETHERIFIED 60 G/L; SODIUM CHLORIDE 9 G/L

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

BLOOD SUBSTITUTES AND PLASMA PROTEIN FRACTIONS

Therapeutic indications:

Therapy and prophylaxis of hypovolemia, acute normovolaemic haemodilution technique.

Authorization date:

2021-01-31

Patient Information leaflet

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה :ךיראת
4
.
.
2014
( :םושירה רפסמו תילגנאב רישכת םש
121
60
30105
00 )
VOLUVEN 6% :םושירה לעב םש
CURE MEDICAL & TECHNICAL SUPPLY
! דבלב תורמחהה טורפל דעוימ הז ספוט
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.3
CONTRAINDICA-TIONS
Contraindications

Fluid overload (hyperhydration)

Starch
allergy

Renal failure with oliguria or
anuria

Patients receiving dialysis treatment

Intracranial bleeding

Hypervolaemia

Severe
hypernatremia
or
severe
hyperchloremia

Known hypersensitivity to
hydroxyethyl starches
Contraindications
Because of the risk of kidney injury and mortality, HES solutions
must no longer be used in patients with sepsis, burn injuries or
critically ill patients.-prac 2013
HES solutions are now contraindicated in patients with renal
impairment or renal replacement therapy. The use of HES must
be discontinued at the first sign of renal injury. An increased
need for renal replacement therapy has been reported up to 90
days after HES administration. Patients’ kidney function should
be monitored after HES administration.-prac 2013
HES solutions are contraindicated in severe coagulopathy. HES
solutions should be discontinued at the first sign of coagulopathy.
Blood coagulation parameters should be monitored carefully in
case of repeated administration
- patients with severe liver disease
- patients with known hypersensitivity to hydroxyethyl starch
-
clinical conditions where volume overload is a potential
problem, especially in cases of pulmonary oedema and
congestive cardiac failure
- patients with pre-existing coagulation or bleeding disorders
- patients with renal failure with oliguria or anuria not related to
hypovolaemia
- patients receiving dialysis treatment
- patients with severe hypernatraemia or severe hyperchloraemia
- patients with intracranial bleeding
-
Known hypersen

Summary of Product characteristics

1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
VOLUVEN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mL solution for infusion contains 6 g hydroxyethyl starch
130/0.4 in 0.9% sodium
chloride injection.
PHARMACEUTICAL FORM
Solution for infusion
WARNING: MORTALITY RENAL REPLACEMENT THERAPY
•
IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SEPSIS, USE
OF HYDROXYETHYL STARCH
(HES) PRODUCTS, INCLUDING VOLUVEN, INCREASES RISK OF
- MORTALITY
- RENAL REPLACEMENT THERAPY
• DO NOT USE HES PRODUCTS, INCLUDING VOLUVEN, IN CRITICALLY ILL
ADULT PATIENTS, INCLUDING
PATIENTS WITH SEPSIS.
_ _
_ _
1
INDICATIONS AND USAGE
Therapy and prophylaxis of hypovolaemia, acute normovolaemic
haemodilution technique
(ANH).
2
DOSAGE AND ADMINISTRATION
For continuous intravenous infusion.
HES solutions should be used at the lowest effective dose for the
shortest period of time.
Treatment should be guided by continuous haemodynamic monitoring so
that the infusion is
stopped as soon as appropriate haemodynamic goals have been achieved.
2
The initial 10-20 ml is 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 33 ml / kg b.w. / day.
The duration of treatment depends on the duration and extent of
hypovolaemia, the
haemodynamics and on the haemodilution.
There is currently no clinical experience for application lasting
several days.
Paediatric dose:
The dosage in children should be adapted to the individual patient
colloid needs, taking into
account the disease state, as well as the haemodynamic and hydration
status (see section
5.1).
In 41 newborns to infants (< 2 years), a mean dose of 16 ± 9 ml/kg
was administered. In 31
children from 2 – 12 years of age a mean dose of 36 ± 11 ml/kg was
administered. The dose
in adolescents > 12 is the same as the adult dose.
3