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POTASSIUM CHLORIDE 0.15% W/V AND SODIUM CHLORIDE 0.9 % W/V SOLUTION FOR INFUSION

Active substance(s): POTASSIUM CHLORIDE / SODIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE

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Package leaflet: Information for the user
B. Braun Melsungen AG · 34209 Melsungen, Germany

Potassium Chloride 0.15% w/v and
Sodium Chloride 0.9% w/v Solution for Infusion
Potassium chloride and sodium chloride

Read all of this leaflet carefully before you start using 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v is
and what it is used for
2. What you need to know before you use Potassium Chloride 0.15% w/v
and Sodium Chloride 0.9% w/v
3. How to use Potassium Chloride 0.15% w/v and Sodium Chloride
0.9% w/v
4. Possible side effects
5. How to store Potassium Chloride 0.15% w/v and Sodium Chloride
0.9% w/v
6. Contents of the pack and other information

3. How to use Potassium Chloride 0.15% w/v and
Sodium Chloride 0.9% w/v
Always use this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.

Dose
The recommended dose that you will be given will be determined by your
doctor . It will depend on your age, weight and condition, especially if your
heart or kidneys do not work properly.
While you receive this medicine your blood sodium chloride and electrolyte (salt) levels, water balance and heart will be checked regularly.
Your doctor will make sure that your urine flow is sufficient.
1. What Potassium Chloride 0.15% w/v and Sodium The recommended maximum dose for an adult is 40 ml/kg body
weight/day.
Chloride 0.9% w/v is and what it is used for
In cases where more potassium is needed, your doctor will think about
This medicine contains a solution of potassium chloride and sodium chlo- using other strengths as well.
ride. It is administered given to you through a tube placed into a vein This medicine may be given to you as long as you need salts and fluid via
(intravenous drip).
a drip into your vein.
You will receive it to maintain or restore your potassium, sodium, chloride
Elderly
and fluid levels when the levels are low.
In principle, the same dose as for adults can be used. However, if you are
2. What you need to know before you use this medicine elderly it might be necessary to adjust the dose stated to avoid heart or
kidney problems.

Do not use Potassium Chloride 0.15%w/v and Sodium Chloride
Use in children and adolescents
0.9% w/v
• if you have high levels of potassium (hyperkalaemia) or chloride (hyperchloraemia) or too high levels of sodium (severe hypernatraemia) in your
blood.
• if you have serious kidney disease
• if you have too much water in your body (hyperhydration)

In children and adolescents the dose will depend upon the individual
needs. Therefore, your child may receive a reduced dose.

Warnings and precautions

If you receive more Potassium Chloride 0.15% w/v and Sodium

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Talk to your doctor before you are given Potassium Chloride 0.15 % w/v Chloride 0.9% w/v than you should
and Sodium Chloride 0.9% w/v.
It is unlikely that this occurs because your doctor will determine your
Before or when giving you this medicine, your doctor will pay special daily doses.
attention to the following:
Signs of an overdose
• High levels of sodium in your blood (hypernatraemia)
If you have received too much of this medicine or you have kidney prob• Swelling of the lower limbs (oedematous states) or water on your lungs lems your salt levels and water and acid-base balance may be affected.
(pulmonary oedema):
You may also experience tissue fluid accumulation and potassium intoxiIf you have one of these conditions, you will be given large amounts of cation.
this medicine only carefully.
If your sodium level increases too rapidly your brain may become damaged
(osmotic demyelination syndrome).
• Kidney and liver function
You will receive this medicine as a slow intravenous drip after your doc- Potassium blood levels may especially be excessively increased. Signs of
tor has made sure that your kidneys and liver are working properly. If they such disorder may be:
don’t do so, your potassium blood levels and your heart will be monitored • Low blood pressure (hypotension)
while you receive this medicine. Your doctor will make sure to stop the • Irregular heart beats or your heart stops beating
infusion in case your condition worsens.
• General weakness and listlessness
• Heart disease:
• Muscle weakness, inability to move
If you suffer from a heart disease, this medicine will be given to you with • Very marked numbness, weakness or heaviness of your legs
caution.
• Confusion.
If you have high levels of acidic substances in your blood your doctor will If you have received too much chloride this may cause a loss of bicarbonate and consequently high levels of acidic substances in your blood.
take special care when giving you this solution.
Your doctor will take special care if you have Addison’s disease (a specif- Actions to be taken in case of an overdose
ic disease of the adrenal gland) as your potassium levels might become In such a case the infusion rate will be stopped immediately. You may also
too high.
be given medicines that increase your urine flow. Your heart rate will be
The rhythm of your heart, your fluid balance, the salts in your blood and monitored continuously. Your doctor will decide on further medication
your level of sodium chloride will be monitored while you are receiving such as insulin or other measures to bring your salt levels, water balance
this medicine.
and acid-base balance back to normal.
If you are elderly, you are more likely to suffer from heart and kidney prob- If you have any further questions on the use of this medicine, ask your
lems, will be closely monitored during treatment and the dosage will be doctor or pharmacist.
carefully adjusted.

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Method of administration
The medicine will be administered to you through a tube placed into a
vein (intravenous drip).

Children
4. Possible side effects
This medicine will be given to your child only with special caution. Their
Like all medicines, this medicine cause side effects, although not everydoctor will closely monitor their salt and fluid balance.
body gets them. When this medicine is used according to the directions,
Other medicines and Potassium Chloride 0.15% w/v and Sodi- it is very unlikely that side effects occur. Tell your doctor if you notice pain
or tenderness or inflammation or blood clots at the site of injection.
um Chloride 0.9% w/v
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
If you are taking digoxin or similar medicines that help your heart to work
better, tell your doctor as it may change how they work. The amount of
Potassium Chloride 0.15 % w/v and Sodium Chloride 0.9 % w/v may have
to be adjusted, especially at the end of therapy.
Also tell your doctor if you are taking medicines that contain potassium
or may lead to high potassium levels, such as
• potassium-sparing medicines e.g. spironolactone or triamterene (medicines that increase urine flow)
• ACE inhibitors (medicines to treat high blood pressure or heart failure)
• Angiotensin II receptor antagonists (a type of blood pressure medicine)
• non-steroidal anti-inflammatory agents (for sudden or long lasting pain
and inflammation)
• ciclosporin, tacrolimus (medicines that are used after an organ transplant)
• suxamethonium (a medicine that is used during operations to put you
to sleep).
They will take special care of you if you receive/take medicines that make
you hold on to potassium as these may lead to heart problems (cardiac
arrhythmia).
Also, you doctor will take care if you use medicines that make you hold on
to sodium because these may lead to swelling due to a build up of water
(oedema).
If you are taking certain medicines, namely corticosteroids, (used to treat
a wide range of diseases such as asthma, hayfever, hives, eczema, painful
joints or muscles, pain caused by a trapped nerve, inflammatory bowel
disease, lupus, multiple sclerosis), ACTH (used to treat a wide variety of
diseases such as spasms in infants and children, multiple sclerosis, arthritis, lupus, Stevens-Johnson syndrome) and loop diuretics (for high blood
pressure), the amount of potassium lost through your kidneys can be
increased.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel:
+353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail:
medsafety@hpra.ie

5. How to store Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v

Keep this medicine out of the sight and reach of children.
Do not use Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v
after the expiry date which is stated on the labels of the bottles and the
carton. The expiry date refers to the last day of that month.
Do not use the product if the solution appears cloudy or discoloured, if you
find particles in the solution or if the bottle and its closure are damaged.
This container is for single use only. After use discard container and any
remaining contents.
Do not reconnect partially used containers.
The equipment to be primed with the solution in order to prevent air
entering the system.
In case of an adverse reaction, infusion must be stopped immediately.
The product should be used immediately. If not used immediately, in-use
storage times and conditions are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are Do not store above 25°C.
planning to have a baby, ask you doctor or pharmacist for advice before
taking/using this medicine.
6. Contents of the pack and other information
This medicine can be given while you are pregnant or breast-feeding if
What Potassium Chloride 0.15% w/v and Sodium Chloride
your doctor thinks it is necessary.

0.9% w/v Solution for Infusion contains

Driving and using machines

B|BRAUN

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• The active substances are potassium chloride and sodium chloride.
Potassium Chloride 0.15 % w/v and Sodium Chloride 0.9 % w/v has no
1 ml of solution for infusion contains:
influence on the ability to drive or use machines.
Potassium chloride
1.5 mg
Sodium chloride
9.0 mg

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1 litre of solution for infusion contains 20 mmol potassium, 154 mmol
sodium and 174 mmol chloride.
• The other ingredient is water for injections.
• Theoretical osmolarity
340 mOsmol/l
pH approximately
4.5- 7.0

Paediatric population
Generally a substitution rate of 0.5 mmol/kg potassium BW per hour
should not be exceeded. Continuous ECG monitoring should be applied
during infusion.

Maximum daily dose
The maximum recommended dose of potassium is 3 mmol/kg BW per
What Potassium Chloride 0.15% w/v and Sodium Chloride
24 hours. In any case the limits for daily fluid intake must not be exceed0.9% w/v Solution for Infusion looks like and contents of the
ed.

pack

Solution for infusion
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution
for Infusion, is a clear, colourless solution of potassium chloride and
sodium chloride in water.
It comes in plastic (polyethylene) bottles containing 500 ml or 1000 ml
supplied in packs of 10 x 500 ml and 10 x 1000 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address
34209 Melsungen
Phone: +49/5661/71-0
Fax: +49/5661/714567

Manufacturers
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
B. Braun Medical S.A.
Carretera de Terrassa 121
08191 Rubi, Barcelona, Spain

This leaflet was last revised in 03/2017

Infusion rate
The infusion rate will depend on the conditions of the individual patient
(see section 4.4).
In patients with chronic hyponatraemia the rate of infusion should be
slow, so that the resulting increase of the serum sodium level is limited to
a maximum of 0.35 mmol/l/h.
Method of administration
The maximum rate of Potassium Chloride 0.15% w/v and Sodium Chloride
0.9% w/v Solution for Infusion administration via peripheral lines is
10 mmol potassium per hour. For greater infusion rates, the solutions
should be infused via a central line.
As a matter of principle, infusion pumps should be used for the infusion
of potassium in the setting of correction therapy.
Contraindications
− Hyperkalaemia,
− Severe renal impairment with oliguria, anuria or azotaemia
− Hyperchloraemia and severe hypernatraemia,
− Hyperhydration.
Special warnings and precautions
Disorders where restriction of sodium intake is indicated, such as cardiac
insufficiency, generalized oedema, pulmonary oedema, hypertension, preeclampsia, severe renal insufficiency. liver cirrhosis.
Sodium chloride supplementation must be exercised slowly in patients
with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects.
Paediatric population:

The following information is intended for healthcare profesPremature or term infants may retain an excess of sodium due to immasionals only:

ture renal function. In premature or term infants, repeated infusion of
Posology
sodium chloride should therefore only be given after determination of the
Adults:
serum sodium level.
The following recommendations are general guidelines on potassium,
Incompatibilities
however prescribing should follow local guidelines.
In the absence of compatibility studies, this medicinal product must not
Potassium
be mixed with other medicinal products.
The amount required for correction of moderate potassium deficiency and
Shelf life after first opening the container
in maintenance may be calculated according to the following formula:
From a microbiological point of view, unless the method of opening premmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** cludes the risk of microbial contamination, the product should be used
– serum-K+actual [mmol/l])
immediately. If not used immediately, in-use storage times and conditions

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are the responsibility of the user.
*Term represents the extracellular fluid volume
** should be 4.5 mmol/l
The maximum recommended dose of potassium is 2 – 3 mmol/kg body
weight (b.w.)/24 h.

Schwarz
210x594 mm
272/436489/0417
Lätus: 2191
Großbritannien/Irland
Font size 9

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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