Tetraspan 6% 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

Summary of Product characteristics

1d0d0d1d1d1d0d0d0d0d1
1d0d0d1d1d1d0d0d0d0d1
1d0d0d1d1d1d0d0d0d0d1
1d0d0d1d1d1d0d0d0d0d1
534/NP53478/0920
COMPOSITION
1000 ml of solution contain:
Hydroxyethyl starch (HES)
60.0 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:
296 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 50 ml/kg
body
weight (BW) (equivalent to 3.0 g hydroxyethyl starch per kg BW) can be
administered. This is equivalent to 3500 ml Tetraspan 6% for a patient
weighing 70 kg.
If it i