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STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V) BP

Active substance: POTASSIUM CHLORIDE

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329/13102982/1114

PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Sterile Potassium Chloride Concentrate
(15% w/v) BP
Potassium chloride
Read all of this leaflet carefully before you receive this medicine.
•  eep this leaflet. You may need to read it again.
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• f you have any further questions, ask your doctor.
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•  his medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
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• f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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In this leaflet:

schwarz

Dokument =  10 x 297mm
2
2 Seiten

1.  hat Sterile Potassium Chloride Concentrate (15% w/v) BP is and
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what it is used for
2. Before you use Sterile Potassium Chloride Concentrate (15% w/v) BP
3. How to use Sterile Potassium Chloride Concentrate (15% w/v) BP
4. Possible side effects
5. How to store Sterile Potassium Chloride Concentrate (15% w/v) BP
6. Further information

Additional precautions during treatment
•  disorder in your potassium balance (potassium blood levels too high
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or too low) can result in changes to the electrocardiogram (ECG).
Therefore your ECG will be monitored.
•  hile you are receiving this medicine your blood electrolyte levels
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and the acid-base balance will be monitored. This will be done to
ensure that these are normal.
• t will be made absolutely sure that the solution is administered into
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your vein in order to avoid tissue damage.

1. WHAT STERILE POTASSIUM CHLORIDE CONCENTRATE
(15% W/V) BP IS AND WHAT IT IS USED FOR

Taking or using other medicines

Sterile Potassium Chloride Concentrate (15% w/v) BP is a concentrated
solution of potassium chloride.
It is used to supply potassium to you
•  hen you are lacking this salt
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•  hen your deficit of potassium is accompanied by excess alkali or
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• f you have an abnormal low chloride level in your blood.
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2. BEFORE YOU USE STERILE POTASSIUM CHLORIDE
CONCENTRATE (15% W/V)
Do not use Sterile Potassium Chloride Concentrate (15% w/v)
BP if you have
•  n abnormally high potassium or chloride level in your blood (hypera
kalaemia, hyperchloraemia)
•  ny disease or disorder that is frequently associated with abnormally
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high blood potassium levels, such as:
–  bnormally low body water content (dehydration)
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– impaired kidney function
–  DDISON`S disease (a specific disease of the adrenal gland)
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–  eriodically appearing paralysis due to an inherited disorder of pop
tassium metabolism (GAMSTORP`S syndrome)
–  ickle cell anaemia (an inherited disease of the red blood cells)
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Take special care with Sterile Potassium Chloride Concentrate
(15% w/v) BP
• f you have severely impaired heart function (limitation of daily physi
ical activity)
• f you are taking or receiving medicines that reduce potassium excrei
tion in urine. For example if you are taking:
o certain medicines increasing urine flow (diuretics)
o compounds that block the effects of the adrenal hormones or
o certain blood pressure medications.
• f you are taking or receiving medicines that can affect kidney
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function(e.g. medicines suppressing inflammatory processes). Thus
the administration of Potassium Chloride will be stopped if your kidney function becomes worse during treatment.
Your doctor will take these points into consideration before and during your treatment with Sterile Potassium Chloride Concentrate (15%
w/v) BP.

Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
In particular, your doctor will have to pay attention to:
•  edicinal products for treatment of heart weakness (cardiac glycoM
sides, e.g. digoxin):
 he effects of these medicinal products will become weaker when the
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blood potassium level rises. They will become stronger (possibly with
irregular heartbeat) when your blood potassium level decreases.
•  edicinal products that lower the potassium excretion in urine:
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This group of medicinal products includes
– some medicines increasing the urine flow (certain diuretics),
–  ertain medicines for treatment of high blood pressure (anti-hyc
pertensives)
–  edicines that suppress your immune system (e.g. tacrolimus,
m
ciclosporin)
– medicines for the treatment of inflammations
– some painkillers.
– long-term use of blood thinning medicines (e.g. heparin)
Giving potassium together with these will lead to very high blood potassium levels. This may affect your heart rhythm.
• 
Suxamethomium (a muscle relaxing agent used in general anaesthesia):
 iving potassium together with this will also lead to very high blood
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potassium levels. This may affect your heart rhythm.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Up to now there are no reports about damaging effects or risks associated with the use of this medicine in pregnant women or breastfeeding mothers.
Pregnancy
Your doctor will administer potassium chloride to you only with caution
and when clearly needed.
Breast-feeding
Your doctor will administer potassium chloride to you only with caution.

Driving and using machines
This medicine has no influence on the ability to drive and use machines

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Lätus

GB___329
Sterile Potassium Chloride
Concentrate (15% w/v) BP
329/13102982/1114
MP-GIF
Standort Berlin
Font size: 9,25 pt.
G 080940

329/13102982/1114

3. HOW TO USE STERILE POTASSIUM CHLORIDE
C
­ ONCENTRATE (15% W/V) BP
Administration
Sterile Potassium Chloride Concentrate (15% w/v) BP is administered to
you after dilution in a suitable solution. It is given through a cannula or
small tube into a vein (intravenous infusion).
Usually your doctor will give you potassium chloride by an infusion pump.

Dosage
The amount you are to receive is calculated by your doctor, based on
your acid-base balance and blood electrolyte values.
Adults and the elderly
You will not receive more than 1 – 1.5 ml solution per kg body weight.
Normally the infusion rate will not exceed 0.3 mmol potassium per kg
body weight per hour.
Children
For children the maximum daily amount of this medicine will be determined according to the age and the body weight:
Term and preterm neonates
Period
1st week
1st month
prior to stable
growth
1st month with
stable growth

Term neonates

3
3

Preterm neonates
>1500 g
<1500 g
2
2
5


Infants after the first month of life and children: 3 mmol/kg BW
Patients in a special condition
Your doctor will determine your dosage in cases of changes in the acidbase balance of your blood. For example when you have diabetes and you
have a disturbed glucose metabolism or if you receive glucose/insulin.

If you use more Sterile Potassium Chloride Concentrate
(15% w/v) BP than you should
It is unlikely that you will ever receive too much of the medicine. Your
doctor or healthcare professional will monitor the application.
Symptoms
Overdose may lead to abnormally high potassium levels with the adverse effects listed below. Adverse effects are more likely to occur
when you suffer from a shift of your blood to the acidic side (acidosis)
or disorders of your kidneys.
Heart and circulation:
•  low heartbeat or even heart stoppage
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•  hanges in the electrocardiogram
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•  rop of blood pressure
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•  e-distribution of circulating blood from limbs to head and trunk.
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Muscles and nerve system:
Weakness, fatigue, states of confusion, heaviness of limbs, muscle
twitching, loss of feeling, and paralysis.
Treatment
If an overdose occurs the infusion will be stopped immediately and your
doctor will give you any necessary treatment.
If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sterile Potassium Chloride Concentrate (15% w/v) BP
can cause side effects, although not everybody gets them.
Side effects, however, are only to be expected as a result of overdose
and/or an abnormally high rate of administration. These correspond to
the symptoms of an abnormally high blood potassium level. Their frequencies are dose-dependent.

The following side effects may be serious. If any of the
f
­ ollowing side effects occur, stop using this medicine and
consult a doctor immediately.
•  lood acidosis (accumulation of acidic substances in the blood)
b
•  bnormal high chloride blood levels
a
• rregular heart beat (the result of abnormally high administration rates).
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Other side effects
Feeling sick (nausea)
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in the package leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE STERILE POTASSIUM CHLORIDE
CONCENTRATE (15% W/V) BP
Keep out of the reach and sight of children.
Do not use Sterile Potassium Chloride Concentrate (15% w/v) BP after
the expiry date which is stated on the label and the carton. The expiry
date refers to the last day of that month.
Do not store above 25 °C.
No special requirements for disposal.
Containers are for single-use only. Containers once opened must be
discarded after use.
Do not use if solution is not clear or the container or closure show visible signs of damage
The product is supplied in single-use containers. Containers once
opened must be discarded after use.
After dilution
From a microbiological point of view, dilutions should be used immediately. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not
be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in
controlled and validated aseptic conditions.

6. FURTHER INFORMATION
What Sterile Potassium Chloride Concentrate (15% w/v) BP
contains
•  he active substance is potassium chloride
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1 ml of solution contains
150 mg of potassium chloride.
corresponding to 2 mmol potassium and 2 mmol chloride
One 10 ml ampoule contains 1.50 g potassium chloride
•  he other ingredient is:
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Water for injections

What Sterile Potassium Chloride Concentrate (15% w/v) BP
looks like and contents of the pack
Sterile Potassium Chloride Concentrate (15% w/v) BP is a concentrate
for the production of a solution for infusion. It must be diluted before
use and is administered by an intravenous drip.
It is a clear, colourless aqueous solution.
Sterile Potassium Chloride Concentrate (15% w/v) BP is available in
•  olyethylene ampoules, contents: 10 ml in packs of 20 × 10 ml
p

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1, 34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Phone: +49-5661-71-0
Fax.: +49-5661-71-4567

This leaflet was last approved in June 2014.

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B. Braun Melsungen AG
34209 Melsungen, Germany

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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