Hartmann’s Solution for Infusion, PVC bag

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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产品特点 产品特点 (SPC)
07-09-2017

有效成分:

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

可用日期:

Fresenius Kabi Limited

ATC代码:

B05BB; B05BB01

INN(国际名称):

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

剂量:

%v/v

药物剂型:

Solution for infusion

处方类型:

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

治疗领域:

Solutions affecting the electrolyte balance; electrolytes

授权状态:

Not marketed

授权日期:

2005-05-20

产品特点

                                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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