Potassium Chloride 15% w/v Concentrate for Solution for Infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Potassium chloride

Inapatikana kutoka:

B. Braun Medical Limited

ATC kanuni:

B05XA; B05XA01

INN (Jina la Kimataifa):

Potassium chloride

Kipimo:

15 percent weight/volume

Dawa fomu:

Concentrate for solution for infusion

Dawa ya aina:

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

Eneo la matibabu:

Electrolyte solutions; potassium chloride

Idhini hali ya:

Marketed

Idhini ya tarehe:

1991-11-26

Taarifa za kipeperushi

329/13600397/0318
Font size: PIL 8, SPC 7,5
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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.
• If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Potassium Chloride 15% w/v is and what it is used for
2. What you need to know before you use Potassium Chloride 15% w/v
3. How to use Potassium Chloride 15% w/v
4. Possible side effects
5. How to store Potassium Chloride 15% w/v
6. Contents of the pack and other information
1. WHAT POTASSIUM CHLORIDE 15% W/V IS AND WHAT IT IS USED FOR
Potassium Chloride 15% w/v is a concentrated solution of potassium
chloride. It is
used to supply potassium to you
• when you are lacking this salt
• when you have a deficit of potassium, especially if it is
accompanied by excess
alkali and abnormally low chloride levels in your blood
(hypochloraemic alkalosis)
• as part of parenteral nutrition, when you are unable to eat food
normally.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTASSIUM CLORIDE
15% W/V
DO NOT USE POTASSIUM CHLORIDE 15% W/V
• if you have an abnormally high potassium or chloride level in your
blood (hyper-
kalaemia, hyperchloraemia)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Potassium Chloride 15% w/v.
SPECIAL CARE WITH POTASSIUM CHLORIDE 15% W/V IS NECESSARY
• if you have heart problems
• if you have a disease where the potassium excretion in the urine
is often reduced,
such as impaired kidney function, Addison’s disease (a specific
disease of the
adrenal gland), or sickle cell anaemia (an inherited disease of the
red blood cells).
If your kidney function is severely impaired or if you are on
dialysis, your doctor
will consult a kidney specialist before giv

Tabia za bidhaa

Health Products Regulatory Authority
14 November 2019
CRN009G74
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 15% w/v Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains
Potassium Chloride
150 mg
1 dosage unit of solution contains
Potassium Chloride
● per 10 ml ampoule
1.50 g
_Electrolyte concentrations _
[mmol/ml]
Potassium
Chloride
2
2
_Excipients_
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear solution, free from visible particles. pH in the range 5.0- 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of potassium deficiency, in particular if accompanied by
hypochloraemic alkalosis.

Supplementation of potassium as a part of parenteral nutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adjusted according to the actual serum
electrolyte concentrations and the acid base status and the
individual requirements of the patient. Potassium concentrates for
infusion must be diluted with a compatible i.v. solution prior
to administration.
Health Products Regulatory Authority
14 November 2019
CRN009G74
Page 2 of 8
_Adults and elderly patients:_
Treatment of moderate, asymptomatic potassium deficiency:
The amount required for correction of moderate potassium deficiency
and in maintenance may be calculated according to the
following formula:
mmol K
+
required = (BW*[kg] × 0.2)** × 2 × (serum-K
+
target*** – serum-K
+
actual [mmol/l])
*BW = body weight
**Term represents the extracellular fluid volume
***K
+
target should be 4.5 mmol/ per litre
Maximum infusion rate:
Up to 10 mmol potassium per hour (corresponding to 0.15 mmol
potassium/kg body weight per hour).
Treatment of severe symptomatic potassium deficiency (serum potassium
level below 2.5 mmol/ per litre):
Maximum daily dose:
Up to 2 – 3 mmol/kg body weight/day
Maximum infusion rate:
Up to 20 mmol potassium per hour (corresponding to