Duosol with 2mmolL Potassium solution for haemofiltration

Country: Malaysia

Language: English

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

Active ingredient:

Sodium Chloride; Calcium chloride dihydrate.; Sodium Hydrogen Carbonate.; Glucose monohydrate; Magnesium chloride hexahydrate.; Sodium Chloride; POTASSIUM CHLORIDE

Available from:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (International Name):

Sodium Chloride; Calcium chloride dihydrate.; Sodium Hydrogen Carbonate.; Glucose monohydrate; Magnesium chloride hexahydrate.; Sodium Chloride; POTASSIUM CHLORIDE

Units in package:

2 X 5000 ml

Manufactured by:

B.Braun Avitum AG

Patient Information leaflet

Not applicable

Summary of Product characteristics

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION OF THE READY-TO-USE SOLUTION FOR
HAEMOFILTRATION AFTER MIXING:
1000 ml ready-to-use solution for haemofiltration
contain [mmol/l]:
Na
+
140
K
+
2.0
Ca
++
1.5
Mg
++
0.5
Cl
–
111
HCO
3
–
35.0
Glucose anhydrous
5.6 (equiv. to 1.0 g)
Theoretical osmolarity [mOsm/l]
296
pH
7.0–8.0
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for haemofiltration
Clear and colourless solution, free from visible particles
The solution is free from bacterial endotoxins.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The ready-to-use solution is indicated for use in patients with
acute renal failure of any cause requiring continuous
haemofiltration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of solutions for haemofiltration in patients with acute
renal failure should be under the direction of a physician with
experience in using such treatment.
Posology
The filtration rate prescribed is dependent on the clinical status
and the body weight of the patient. Unless otherwise
prescribed, a filtration rate of 20-25 ml/kg body weight per hour
is recommended for the removal of metabolic waste products
normally excreted in the urine, depending on the metabolic
condition of the patient.
The dose-volume is at the discretion of the physician because
the volume of substitution solution depends on the intensity of
treatment performed and on the amount of fluid to be replaced
in order to achieve fluid balance.
_Paediatric population_
The dosage recommendations mentioned above are also
applicable for the paediatric population.
Method of administration
Intravenous use.
The ready-to-use solution for haemofiltration has to be
prepared by opening the peel seam. The mixing is performed by
twisting the bag five times. For further instructions, see section
6.6.
The ready-to-use solution for haemofiltration is infused into the
extracorporeal circulation by means of an infusion pump.
During haemofiltration the solution for haemofiltration replaces
the ult