Potassium Chloride 0.15 % w/v and Glucose 5% w/v Solution for Infusion BP

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

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Δραστική ουσία:

Glucose monohydrate; Potassium chloride

Διαθέσιμο από:

Baxter Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

B05XA; B05XA01

INN (Διεθνής Όνομα):

Glucose monohydrate; Potassium chloride

Δοσολογία:

0.15/5.0 percent volume/volume

Φαρμακοτεχνική μορφή:

Solution for infusion

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Electrolyte solutions; potassium chloride

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2003-04-17

Φύλλο οδηγιών χρήσης

                                1a
-
pronounced sweating due to high fever
-
extensive skin loss, as can occur in severe burns
2. What you need to know before
you are given Potassium 0.15 &
Glucose Infusion
Do NOT receive Potassium 0.15 & Glucose
Infusion if you are suffering from any of the
following conditions
•
higher levels of potassium in the blood than normal
(hyperkalaemia)
•
higher levels of chloride in the blood than normal
(hyperchloraemia)
•
severe kidney failure (when your kidneys do not work
well and you require dialysis)
•
uncompensated heart failure. This is heart failure that is
not adequately treated and causes symptoms such as:
− shortness of breath
− swelling of the ankles
•
Addison’s disease (poor function of the adrenal gland.
The adrenal gland produces hormones that help to
control the concentrations of the chemicals in the body).
•
diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
•
states of glucose intolerance, for example:
-
metabolic stress (when the body’s metabolism does
not function correctly, e.g. due to severe illness)
-
hyperosmolar coma (unconsciousness). This is a
type of coma that can occur if you have diabetes
and do not receive enough medicine.
-
a higher amount of sugar in the blood than normal
(hyperglycaemia)
-
a higher amount of lactate in the blood than normal
(hyperlactataemia)
•
if you are allergic to potassium chloride and glucose
monohydrate or any other ingredients of this medicine
(listed in Section 6).
Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
nurse.
•
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet:
1. What Potassium 0.15 & Glucose Infusion is and
what it is used for
2. What you need to know before you are given

                                
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Αρχείο Π.Χ.Π.

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15 % w/v and Glucose 5% w/v Solution for Infusion
BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride :
1.5 g/L
Glucose ( as monohydrate) :
50.0 g/L
mmol/l: K
+
: 20 Cl
-
: 20
For the full list of excipients : see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of potassium depletion and/or hypokalemia in
cases where supply of water and carbohydrates
is required due to restriction of the intake of fluids and
electrolytes by normal routes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the Elderly and Children_
Doses may be expressed in terms of mEq or mmol of potassium, mass of
potassium or mass of potassium salt:
1g 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 (acid-base balance) conditions of the
patient, concomitant therapy and in particular the patient’s
hydration state.
_General posology_
The recommended dosage for the treatment of carbohydrates and fluid
depletion is :
-
for adults : 500 ml to 3 Litres/24h
-
for babies and children :
- 0-10 kg body weight : 100 ml/kg/24h
- 10-20 kg body weight : 1000 ml + ( 50 ml /kg over 10 kg) /24h
- > 20 kg body weight : 1500 ml + ( 20 ml/kg over 20 kg)/24h
The infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid hyperglycaemia.
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