Hartmann’s Solution for Infusion, PVC bag

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

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Herunterladen Fachinformation (SPC)
07-09-2017

Wirkstoff:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate ; Sodium lactate solution 50%

Verfügbar ab:

Fresenius Kabi Limited

ATC-Code:

B05BB; B05BB01

INN (Internationale Bezeichnung):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate ; Sodium lactate solution 50%

Dosierung:

%v/v

Darreichungsform:

Solution for infusion

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Solutions affecting the electrolyte balance; electrolytes

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2005-05-20

Fachinformation

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann’s Solution for Infusion, PVC bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For full list of excipients, see section 6.1.
Molar formula
3 PHARMACEUTICAL FORM
Solution for infusion.
Osmolarity: 279 mOsm/l
Osmolarity: 255 mOsm/kg
pH: 5.5 to 6.3
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Predominantly extracellular dehydration, regardless of cause
(vomiting, diarrhea, fistulas, etc.).
-
Hypovolemia regardless of cause: hemorrhagic shock, burns,
peri-operative water and electrolyte loss.
-
Mild metabolic acidosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY :
This is determined by the physician according to clinical
status,
age and weight
of
the patient
and according to
laboratory findings.
METHOD OF ADMINISTRATION :
This solution must be given by slow intravenous infusion under
strictly aseptic conditions.
Bag :
50 ml
100 ml
250 ml
500 ml
1000 ml
Sodium chloride (g)
0.30
0.60
1.50
3.00
6.00
Potassium chloride (g)
0.020
0.040
0.10
0.20
0.40
Dihydrated calcium chloride (g)
0.01
0.03
0.07
0.14
0.27
50% sodium lactate solution (g)
0.32
0.63
1.59
3.17
6.34
Bag :
50 ml
100 ml
250 ml
500 ml
1000 ml
Sodium (mmol)
6.55
13.09
32.73
65.45
130.90
Potassium (mmol)
0.27
0.54
1.35
2.70
5.40
Calcium (mmol)
0.09
0.18
0.46
0.92
1.84
Chloride (mmol)
5.59
11.17
27.93
55.85
111.70
Lactate (mmol)
1.42
2.83
7.08
14.15
28.30
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