Hartmann’s Solution for Infusion, PPC PSEB bag

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Fresenius Kabi Limited

ATC code:

B05BB; B05BB01

INN (International Name):

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

Dosage:

percent volume/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes

Authorization status:

Not marketed

Authorization date:

2005-05-20

Patient Information leaflet

6
5
The following information is intended for medical or healthcare
professionals only:
Warnings
This solution must not be given by intramuscular injection.
Keep to a slow infusion rate.
The infusion must be stopped if any abnormal sign develops.
Risk of complications related to volume and amount of electrolytes
administered.
Risk of overload of cardiovascular system with pulmonary oedema,
especially in
predisposed individuals.
Infusion of Hartmann's Solution may cause metabolic alkalosis because
of the
presence of lactate ions.
Hartmann’s Solution may not produce its alkalinizing action in
patients with
hepatocellular insufficiency since lactate metabolism may be impaired.
In case of concomitant blood transfusion and because of the presence
of calcium, Hartmann's Solution must not be administered via the same
infusion system because of the risk of coagulation.
Precautions for use
The patient's clinical status and laboratory parameters (blood and
urine
electrolytes) must be monitored during use of this solution,
especially
in the following situations:
• congestive cardiac failure,
• severely impaired renal function,
• oedema with sodium retention.
Precautions for using bag
• do not use an air entry
• flush the infusion system in order to avoid any passage of air
• do not connect in series since the residual of the first container
might be carried on by the solution coming from the second
container, with the risk of air embolism.
• for single use only; do not reconnect partially used container.
Physico-chemical incompatibilities:
It is up to the physician to determine the incompatibility of an added
medicine
regarding Hartmann's Solution, by checking for any possible colour
change
and/or possible formation of precipitate, insoluble complex or
crystals.
There is physical-chemical incompatibility with certain antibiotics
when they
are given intravenously: chlortetracycline, amphotericin B,
oxytetracycline.
Before adding any medicine, check that the pH zone in which it is
effective
corresponds to that

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hartmann’s Solution for Infusion, PPC 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.
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)
0.02
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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