POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE BP 0.15/0.18/ %w/v Intravenous Inf Solution

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

POTASSIUM CHLORIDE SODIUM CHLORIDE GLUCOSE MONOHYDRATE

Fáanlegur frá:

Baxter Healthcare Limited

INN (Alþjóðlegt nafn):

POTASSIUM CHLORIDE SODIUM CHLORIDE GLUCOSE MONOHYDRATE

Skammtar:

0.15/0.18/ %w/v

Lyfjaform:

Intravenous Inf Solution

Gerð lyfseðils:

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

Leyfisstaða:

Withdrawn

Leyfisdagur:

2012-10-18

Vara einkenni

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.15% w/v Potassium Chloride, 0.18% w/v Sodium Chloride and 4% w/v Glucose Intravenous Infusion BP, Viaflex
Container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
Potassium Chloride
0.15 % w/v
Sodium Chloride
0.18 % w/v
Anhydrous Glucose
4.0 % w/v
(as Glucose Monohydrate)
4.4 % w/v
Equivalent to:
mmol/L
Potassium
20
Sodium
30
Chloride
50
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution, free from visible particles.
pH: 3.5 - 5.5
Osmolarity: 322 mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the restoration and maintenance of fluid, calorie and sodium, potassium and chloride balance where the oral route
of administration is not feasible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Dosage of product is dependent upon the age, weight, clinical state and degree of deficiency of the patient and must be
determined on an individual basis.
ADMINISTRATION
Intravenous.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/06/2009_
_CRN 2067156_
_page number: 1_
4.3 CONTRAINDICATIONS
o
Use of a solution which is cloudy, contains sediment or is in any way unusual.
o
Use in patients with fluid and sodium retention, congestive heart failure, or severe impairment of renal function.
o
Use in the presence of dehydration without fluid replacement.
o
Use in hyperkalaemia such as is associated with adrenal insufficiency or severe renal insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
o
Plasma electrolyte levels should be carefully monitored during use, especially in patients with pre-existing
imbalances, in renal failure or in hepatic disease.
o