Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for Infusion - BP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Potassium chloride; Sodium chloride

Available from:

Baxter Healthcare Limited

ATC code:

B05BB; B05BB01

INN (International Name):

Potassium chloride; Sodium chloride

Dosage:

0.15/0.9 percent weight/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:

2007-11-09

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for
Infusion - BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 1.50 g/l
Sodium Chloride 9.00 g/l
Each ml contains 1.50 mg Potassium Chloride and 9.00 mg Sodium
Chloride.
mmol/l: K
+
: 20 Na
+
: 154 C1
-
: 174
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity: 348 mOsm/L (approx.)
pH: 4.5 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Potassium Chloride 0.15 % w/v & Sodium Chloride 0.9% w/v Solution for
Infusion is indicated for the prevention and
treatment of potassium depletion and/or hypokalaemia, in sodium
chloride and water-losing conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the Elderly_,_ Adolescents and Children
Doses may be expressed in terms of mEq or mmol of each cation, mass of
each cation, or mass of each cation salt:
- for sodium
1 g NaCl = 394 mg of Na
+
or 17.1 mEq or 17.1 mmol of Na
+
and Cl
-
1 mmol Na
+
= 23mg Na
+
- for potassium
1 g KCl = 525 mg of K
+
or 13.4 mEq or 13.4 mmol of K
+
and Cl
-
1 mmol K
+
= 39.1 mg K
+
The dosage of this solution depends on the age,
weight,
clinical
and biological
(acidbase balance) conditions of the
patient, concomitant therapy and in particular the patient's hydration
state.
_Posology for prevention and treatment of potassium depletion_
- For Adults, the Elderly and Adolescents:
H
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A
L
T
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S
R
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A
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