Tetraspan 10% Solution for Infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Malic Acid; POTASSIUM CHLORIDE; Sodium Chloride; Magnesium chloride hexahydrate.; Calcium chloride dihydrate.; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.

Available from:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (International Name):

Malic Acid; POTASSIUM CHLORIDE; Sodium Chloride; Magnesium chloride hexahydrate.; Calcium chloride dihydrate.; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.

Units in package:

500ml mL; 250ml mL; 500ml mL; 1000ml mL

Manufactured by:

B.BRAUN MEDICAL SA

Patient Information leaflet

DIRECTIONS FOR USE
TETRASPAN 10 % SOLUTION FOR INFUSION
COMPOSITION
1000 ml contains
_Active substances: _
Poly(O-2-hydroxyethyl) starch (HES)
100.0 g
(Molar substitution: 0.42)
(Average molecular weight: 130,000 dalton)
Sodium chloride
6.25 g
Potassium chloride
0.30 g
Calcium chloride dihydrate
0.37 g
Magnesium chloride hexahydrate
0.20 g
Sodium acetate trihydrate
3.27 g
Malic acid
0.67 g
_Electrolyte concentration: _
Sodium
140 mmol/l
Potassium
4.0 mmol/l
Calcium
2.5 mmol/l
Magnesium
1.0 mmol/l
Chloride
118 mmol/l
Acetate
24 mmol/l
Malate
5.0 mmol/l
pH:
5.6
−
6.4
Theoretical osmolarity:
297 mOsmol/l
Acid titre:
< 2.0 mmol/l
_Excipients: _
Sodium hydroxide (for pH adjustment), Water for Injections
PHARMACEUTICAL FORM
Solution for infusion.
PHARMACO-THERAPEUTIC GROUP
Blood substitutes and plasma protein fractions, ATC code B05A A07
INDICATIONS
Treatment of imminent or manifest hypovolaemia and shock.
CONTRAINDICATIONS
–
Hyperhydration states including pulmonary edema.
–
Renal failure with oliguria or anuria.
–
Intracranial bleeding.
–
Hyperkalaemia.
–
Severe hypernatremia or severe hyperchloremia.
–
Hypersensitivity to hydroxyethyl starch or to any of the excipients.
–
Severely impaired hepatic function.
–
Congestive cardiac failure.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Volume overload from overdosage should always be avoided. Dosage
should be carefully adjusted, especially in
patients with cardiac insufficiency.
Particular caution should be exercised in patients with renal
impairment. The dose may need to be adjusted.
Elderly patients with hypervolaemia should be thoroughly monitored,
and the dosage should be adapted, in or-
der to avoid impairment of renal function.
Serum electrolytes, fluid balance, and kidney function should be
monitored. Adequate fluid intake must be en-
sured.
Patients with severe dehydration should first receive intravenous
electrolyte solutions.
Particular caution should be exercised in patients with hepatic
insufficiency and in those with blood coagulation
disorders

Summary of Product characteristics

1d0d0d1d1d0d1d0d0d1d1
1d0d0d1d1d0d1d0d0d1d1
1d0d0d1d1d0d1d0d0d1d1
1d0d0d1d1d0d1d0d0d1d1
535/NP53578/0920
COMPOSITION
1000 ml of solution contain:
Hydroxyethyl starch (HES)
100.0 g
(Molar substitution: 0.42)
(Average molecular weight: 130,000 Da)
Sodium chloride
6.25 g
Potassium chloride
0.30 g
Calcium chloride dihydrate
0.37 g
Magnesium chloride hexahydrate
0.20 g
Sodium acetate trihydrate
3.27 g
L-Malic acid
0.67 g
_Electrolyte concentrations:_
Sodium
140 mmol/l
Potassium
4.0 mmol/l
Calcium
2.5 mmol/l
Magnesium
1.0 mmol/l
Chloride
118 mmol/l
Acetate
24 mmol/l
L-Malate
5.0 mmol/l
Excipients:
Sodium hydroxide (for pH adjustment)
Water for injections
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless, aqueous solution.
pH:
5.6−6.4
Theoretical osmolarity:
297 mOsmol/l
Acidity (titration to pH 7.4):
<2.0 mmol/l
INDICATIONS
Treatment
of
hypovolaemia
due
to
acute
blood
loss.
(see
sections
“Dosage”, “Contraindications” and “Special warnings and
precautions for
use”)
DOSAGE
USE OF HYDROXYETHYL STARCH SHOULD BE RESTRICTED TO THE INITIAL PHASE
OF
VOLUME RESUSCITATION WITH A MAXIMUM TIME INTERVAL OF 24 H.
The daily volume and the infusion rate depend on the volume of blood
loss
and on how much fluid is required to restore haemodynamic parameters.
The first 10-20 ml should be infused slowly and under careful
monitoring
of the patient so that any anaphylactic/anaphylactoid reaction can be
detected as early as possible.
Prior to administration of HES, the indication of hypovolaemia should
be
confirmed, e.g. by assessing the positive fluid responsiveness of the
patient.
The volume limitations given by the degree of haemodilution should be
observed, see sections “Special warnings and precautions for use”
and
“Undesirable effects”.
_Adults_
Maximum daily volume:
If the patient is hypovolaemic, e.g. fluid responsive, up to 30 ml /
kg body
weight (BW) (equivalent to 3.0 g Hydroxyethyl starch per kg BW) can be
administered. This is equivalent to 2100 ml Tetraspan 10% for a
patient
weighing 70 kg.
If i