Hartmann’s Solution for Infusion, PSEB bag

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
07-09-2017

Aktiivinen ainesosa:

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

Saatavilla:

Fresenius Kabi Limited

ATC-koodi:

B05BB; B05BB01

INN (Kansainvälinen yleisnimi):

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

Annos:

%v/v

Lääkemuoto:

Solution for infusion

Prescription tyyppi:

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

Terapeuttinen alue:

Solutions affecting the electrolyte balance; electrolytes

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2005-05-20

Valmisteyhteenveto

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann’s Solution for Infusion, PSEB 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 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.
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
0.04
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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