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

Active substance: POTASSIUM CHLORIDE

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329/12609091/0510

PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 150 mg/ml
concentrate for solution for infusion
Potassium chloride
Read all of this leaflet carefully before you receive this medicine.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor.
– This 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.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:
1. What Potassium Chloride 150 mg/ml is and what it is used for
2. Before you use Potassium Chloride 150 mg/ml
3. How to use Potassium Chloride 150 mg/ml
4. Possible side effects
5. How to store Potassium Chloride 150 mg/ml
6. Further information

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

1. WHAT POTASSIUM CHLORIDE 150 MG/ML IS AND
WHAT IT IS USED FOR

Taking or using other medicines

Potassium Chloride 150 mg/ml is a concentrated solution of potassium
chloride.
It is used to supply potassium to you
• when you are lacking this salt
• when your deficit of potassium is accompanied by excess alkali or
• if you have an abnormal low chloride level in your blood.

2. BEFORE YOU USE POTASSIUM CLORIDE
150 MG/ML
Do not use Potassium Chloride 150 mg/ml if you have
• an abnormally high potassium or chloride level in your blood
(hyperkalaemia, hyperchloraemia)
• any disease or disorder that is frequently associated with abnormally
high blood potassium levels, such as:
– abnormally low body water content (dehydration)
– impaired kidney function
– ADDISON`S disease (a specific disease of the adrenal gland)
– periodically appearing paralysis due to an inherited disorder of potassium metabolism (GAMSTORP`S syndrome)
– sickle cell anaemia (an inherited disease of the red blood cells)

Take special care with Potassium Chloride 150 mg/ml
• if you have severely impaired heart function (limitation of daily physical
activity)
• if you are taking or receiving medicines that reduce potassium excretion
in urine. For example if you are taking:
– certain medicines increasing urine flow (diuretics),
– compounds that block the effects of the adrenal hormones or
– certain blood pressure medications.
• if you are taking or receiving medicines that can affect kidney
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 Potassium Chloride 150 mg/ml.

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:
• Medicinal products for treatment of heart weakness (cardiac glycosides,
e.g. digoxin):
The effects of these medicinal products will become weaker when the
blood potassium level rises. They will become stronger (possibly with
irregular heartbeat) when your blood potassium level decreases.
• Medicinal products that lower the potassium excretion in urine:
This group of medicinal products includes:
– some medicines increasing the urine flow (certain diuretics),
– certain medicines for treatment of high blood pressure (anti-hypertensives)
– medicines that suppress your immune system (e.g. tacrolimus,
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):
Giving potassium together with this will also lead to very high blood
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 breast-feeding
mothers.
Pregnancy
Your doctor will administer this solution to you only with caution and
when clearly needed.
Breast-feeding
Your doctor will administer this solution 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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3. HOW TO USE POTASSIUM CHLORIDE 150 MG/ML
Administration
Potassium Chloride 150 mg/ml 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 this solution by an infusion pump.

The following side effects may be serious. If any of the
following side effects occur, stop using this medicine and
consult a doctor immediately.
• blood acidosis (accumulation of acidic substances in the blood),
• abnormal high chloride blood levels.
• irregular heart beat (the result of abnormal high administration rates)

Other side effects
Dosage
The amount you are to receive is calculated by your doctor, based on your
acid-base balance and blood electrolyte values.

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.

Adults and the elderly
You will not receive more than 1-1.5 ml solution per kg body weight a
day. Normally the infusion rate will not exceed 0.15 ml solution per kg
body weight per hour.

5. HOW TO STORE POTASSIUM CHLORIDE 150 MG/ML

Children
The dosage will depend on the requirements of the individual patient.
Care will be taken not to exceed a daily dose of 1-1.5 ml per kg body
weight.

Do not use Potassium Chloride 150 mg/ml after the expiry date which is
stated on the label and the carton. The expiry date refers to the last day
of that month.

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.

Do not use Potassium Chloride 150 mg/ml if you notice cloudiness or
particles in the solution, or if the container or its closure show visible
signs of damage.

If you use more Potassium Chloride 150 mg/ml than you
should

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

The product is supplied in single-use containers. Containers once opened
must be discarded after use.

It is unlikely that you will ever receive too much of the medicine. Your
doctor or healthcare professional will monitor the application.

6. FURTHER INFORMATION

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.

What Potassium Chloride 150 mg/ml contains

Heart and circulation:
• slow heartbeat or even heart stoppage,
• changes in the electrocardiogram,
• drop of blood pressure,
• re-distribution of circulating blood from limbs to head and trunk.
Muscles and nerve system:
• weakness,
• fatigue,
• states of confusion,
• heaviness of limbs,
• muscle twitching,
• loss of feeling,
• 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, Potassium Chloride 150 mg/ml 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 active substance is potassium chloride
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
One 20 ml ampoule contains 3.00 g potassium chloride
• The other ingredient is:
Water for injections

What Potassium Chloride 150 mg/ml looks like and contents
of the pack
Potassium Chloride 150 mg/ml 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.
Potassium Chloride 150 mg/ml is available in
• polyethylene ampoules, contents: 10 ml, 20 ml
in packs of 20 × 10 ml, 20 x 20 ml
Not all pack sizes may be marketed.

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

This leaflet was last approved in {04/2010}.

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Postal address:
34209 Melsungen, Germany

B. Braun Melsungen AG
34209 Melsungen, Germany

19.05.10 08:10

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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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