Volulyte Solution for Infusion 6%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Magnesium Chloride Hexahydrate; Poly (O-2-hydroxyethyl) starch 130/0.4 Powder; Potassium Chloride; Sodium Acetate Trihydrate; Sodium Chloride

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

B05AA07, B05BB01

Dosage:

0.30g

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

Magnesium Chloride Hexahydrate 0.30g; Poly (O-2-hydroxyethyl) starch 130/0.4 Powder 60.00g; Potassium Chloride 0.30g; Sodium Acetate Trihydrate 4.63g; Sodium Chloride 6.02g

Administration route:

INTRAVENOUS

Prescription type:

General Sale List

Manufactured by:

Fresenius Kabi Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

2010-12-02

Patient Information leaflet

0XX XXX1/
00 Singapur
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Poly(O-2-hydroxyethyl)starch
…………………………………………………………………… 60.00 g
– Molar substitution 0.38 – 0.45
– Mean molecular weight = 130,000 Da
Sodium acetate trihydrate
………………………………………………………………………... 4.63 g
Sodium chloride
…………………………………………………………………………………… 6.02 g
Potassium chloride
………...……………………………………………………………………… 0.30 g
Magnesium chloride hexahydrate
………………………………………………………………... 0.30 g
Electrolytes:
Na
+
137.0 mmol/l
K
+
4.0 mmol/l
Mg
++
1.5 mmol/l
Cl
–
110.0 mmol/l
CH
3
COO
–
34.0 mmol/l
Theoretical osmolarity:
286.5 mosm/l
Titratable acidity:
< 2.5 mmol NaOH/l
pH:
5.7 – 6.5
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for infusion
A clear to slightly opalescent solution, colourless to slightly
yellow.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy and prophylaxis of hypovolaemia. Maintenance of adequate
circulating blood volume during
surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use as 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 depends on the patient’s blood
loss, on the maintenance or 
restoration of haemodynamics and on the haemodilution (dilution
effect). 
Maximum daily dose:
Up to 50 ml of Volulyte per kg of body weight (equivalent to 3.0 g
hydroxyethyl starch, 6.85 mmol


sodium and 0.2 mmol potassium per kg of body weight). This is
equivalent to 3,500 ml Volulyte for 
a 70 kg patient.



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1. NAME OF THE MEDICINAL P

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
VOLULYTE 6 %
Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml
solution for infusion contain:
Poly(O-2-hydroxyethyl)starch
……………………………………………………………………
60.00 g
–
Molar substitution 0.38 – 0.45
–
Mean molecular weight
= 130,000 Da
Sodium acetate trihydrate
………………………………………………………………………...
4.63 g
Sodium chloride
……………………………………………………………………………………
6.02 g
Potassium chloride
………...………………………………………………………………………
0.30 g
Magnesium chloride hexahydrate
………………………………………………………………...
0.30 g
Electrolytes:
Na
+
137.0 mmol/l
K
+
4.0 mmol/l
Mg
++
1.5 mmol/l
Cl –
110.0 mmol/l
CH3COO–
34.0 mmol/l
Theoretical osmolarity: 286.5 mosm/l
Titratable acidity: < 2.5 mmol NaOH/l
pH:
5.7 – 6.5
For a full
list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for infusion
A clear to slightly opalescent solution, colourless to slightly
yellow.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Volulyte 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
Volulyte is administered by intravenous infusion only.
The daily dose and rate of infusion depends on the patient’s blood
loss, on the maintenance or restoration of
haemodynamics and on the haemodilution (dilution effect). Volulyte 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:
Up to 50 ml of Volulyte per kg of body weight per day (equivalent to
3.0 g hydroxyethyl starch, 6.85 mEq sodium and 0.2
mEq potassium per kg of body weight). T