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POTASSIUM CHLORIDE 0.3% W/V & SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INFUSION

Active substance(s): POTASSIUM CHLORIDE / SODIUM CHLORIDE

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0xxxxx1_00_Potassium_Eng_03_PB 17.07.2014 08:59 Seite 1

Package leaflet: Information for the user
Sodium salts should be administered with caution to patients
with hypertension, heart failure, peripheral or pulmonary oedema,
impaired renal function, preeclampsia, or other conditions
associated with sodium retention

5. How to store Potassium Chloride 0.3% w/v & Sodium
Chloride 0.9% w/v
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated
on the bottle. The expiry date refers to the last day of that month.
Do not use this medicine if the solution is not clear or has visible
particles. Do not use this medicine if the bottle is damaged in
any way.

In-use shelf life (Additives)
Chemical and physical stability of any additive medicinal product
at the pH of the Potassium Chloride 0.3% w/v & Sodium
Chloride 0.9% w/v should be established prior to use.
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products.
It is the responsibility of the doctor to judge the incompatibility
of an additive medication towards the solution of Potassium
Chloride 0.3 %w/v & Sodium Chloride 0.9 % w/v, by checking a
possible change of colour and/or a possible formation of
precipitate, insoluble complex or crystals. Refer also to the
Summary of Product Characteristics accompanying the additive
medicine. Incompatibility of the medicinal product to be added
to Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v
must be assessed before addition.

From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v contains
- The active substances are potassium chloride and sodium
chloride. Each ml of solution contains 3 mg potassium
chloride and 9 mg sodium chloride.
- Each 500 ml bottle contains 1.50 g potassium chloride and
4.5 g sodium chloride.
- Each 1000 ml bottle contains 3.00 g potassium chloride
and 9.00 g sodium chloride.
- The other ingredients are water for injections and sodium
hydroxide and hydrochloric acid for pH adjustment.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Limited,
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT, UK
Manufacturer
Fresenius Kabi Deutschland GmbH
Freseniusstraße 1, D-61169 Friedberg, Germany

This medicinal product is authorised in the Member States of
the EEA under the following names:

Potassium Chloride 0.3% w/v &
Sodium Chloride 0.9% w/v Solution for Infusion

Name of the
Name of the medicinal product
Member State
Belgium
KCl 0.3% & NaCl 0.9% Fresenius Kabi, oplossing
voor infusie
Estonia
Potassium Chloride/ Sodium Chloride Fresenius
3 mg/9 mg/ml infusioonilahus
France
Chlorure de potassium 0,3% et chlorure de sodium
0,9% Kabi, solution pour perfusion
Ireland
Potassium Chloride 0.3% w/v & Sodium chloride
0.9% w/v Solution for Infusion
Italy
Sodio Cloruro e Potassio Cloruro Kabi
Latvia
Potassium Chloride/ Sodium Chloride Fresenius
3 mg/9 mg/ml šķīdums infūzijām
Lithuania
Potassium Chloride/ Sodium Chloride Fresenius
3 mg/9 mg/ml infuzinis tirpalas
Poland
Kalium Chloratum 0,3% + Natrium Chloratum 0,9%
Kabi
Portugal
Cloreto de Potássio 0,3% p/v e Cloreto de Sódio
0,9% p/v Kabi
Slovenia
Kalijev klorid/natrijev klorid Kabi 3 mg/9 mg v 1 ml
raztopina za infundiranje
Spain
Cloruro de potasio Kabi 0,04 mEq/ml/ en Cloruro
de sodio 0,9% solución para perfusion EFG
The Netherlands KCl 0.3% & NaCl 0.9% Fresenius Kabi, oplossing
voor infusie
United
Potassium Chloride 0.3% w/v & Sodium chloride
Kingdom
0.9% w/v Solution for Infusion

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 nurse.
- If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v is and what it is used for
2. What you need to know before you are given Potassium
Chloride 0.3% w/v & Sodium Chloride 0.9% w/v
3. How Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v is given
4. Possible side effects
5. How to store Potassium Chloride 0.3% w/v & Sodium
Chloride 0.9% w/v
6. Contents of the pack and other information
1. What Potassium Chloride 0.3% w/v & Sodium
Chloride 0.9% w/v is and what it is used for
Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v
is a solution of potassium chloride and sodium chloride in
water. Potassium chloride and sodium chloride are chemicals
(often called ‘salts’) that occur naturally in the blood.

This leaflet was last revised in 07/2014.

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The Instructions for Use of the medicinal product to be added
must be consulted. Before adding a medicinal product, verify it
is soluble and/or stable in water at the pH of Potassium Chloride
0.3% w/v & Sodium Chloride 0.9% w/v (pH: 4.5 to 7.0).
Those additives known to be incompatible should not be used.
From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user.

What Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v looks like and contents of the pack
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v
Solution for Infusion is a clear and colourless solution, free
from visible particles. It is available in 500 ml and 1000 ml
polyethylene bottles (KabiPac) closed with a polyolefin cap
containing a polyisoprene rubber stopper. It is supplied in
packs of 10 bottles.
Not all pack sizes may be marketed.

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This medicine is used to prevent and treat:
- loss of potassium from the body (e.g. after treatment with
certain diuretics [water tablets])
- low level of potassium in the blood (hypokalaemia) in situations
that may cause potassium chloride and water loss including
- when you cannot eat or drink, due to illness or after surgery
- pronounced sweating due to high fever
- sodium chloride and water-losing conditions
2. What you need to know before you are given
Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v
You will not be given Potassium Chloride 0.3% w/v &
Sodium Chloride 0.9% w/v:
- if the level of potassium in your blood is higher than normal
(hyperkalaemia)
- if the level of chloride in your blood is higher than normal
(hyperchloraemia)
- if the level of sodium in your blood is higher than normal
(hypernatraemia)
- if you have severe problems with the way your kidneys
work (you may produce little or no urine)
- if you have heart failure that is not properly treated
(uncompensated cardiac failure) and causes symptoms
such as:
- shortness of breath
- swelling of ankles
- if you have a condition where the adrenal glands do not
function properly (Addison’s disease)

Other medicines and Potassium Chloride 0.3% w/v &
Sodium Chloride 0.9% w/v
Tell your doctor if you are taking, have recently taken or might
take any other medicines. In particiular, tell your doctor if you
are taking:
- cardiac glycosides used in the treatment of heart failure
(such as digoxin)
- antiarrhythmic medicines used to suppress abnormal rhythm
of the heart (such as quinidine, hydroquinidine, procainamide)
- medicines that increase the concentration of potassium in
the blood such as:
o potassium-sparing diuretics, known as ‘water tablets’
(such as amiloride, spironolactone, triamterene)
o ACE inhibitors (mainly used to treat high blood pressure)

o Angiotensin II receptors antagonists (used to treat high
blood pressure)
o ciclosporin (used to prevent rejection of a transplant)
o tacrolimus (used to prevent rejection of transplantation
and treatment of some skin diseases)
o medicines that contain potassium
- corticosteroids (anti-inflammatory medicines)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice
before you are given this medicine.
This medicine can be used during pregnancy and breast-feeding.
The amount of medicine you receive will be carefully monitored by
your doctor. Your doctor will also conduct blood tests to monitor
the levels of chemicals that are in your blood. This is because
changes in the levels of potassium in your blood can affect how
your heart and the heart of your unborn baby works.
Your doctor will carefully monitor your blood pressure as sodium
chloride can increase it (risk of preeclampsia).
Driving and using machines
This medicine will not affect your ability to drive or operate
machinery.
3. How Potassium Chloride 0.3% w/v & Sodium Chloride
0.9% w/v is given
This medicine will be given to you by a doctor or nurse.
Your doctor will decide how much medicine you need and
when it will be given. This depends on your age, weight,
clinical and biological conditions and how hydrated you are
(the amount of water in your body). The amount of medicine
you receive may also be affected by other treatments you are
receiving.

Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v
is given slowly into a vein as an infusion. How quickly you are
given the infusion will be determined by your doctor. If you
need a large volume or rapid infusion of medicine, your doctor
will monitor your ECG (heart activity).
When you are given Potassium Chloride 0.3% w/v & Sodium
Chloride 0.9% w/v your doctor will do blood tests to monitor
your blood levels of potassium and other electrolytes (such as
sodium and chloride) that are normally in the blood. Your doctor
will also check that you are urinating normally (adequate urine
production).
If you are given more Potassium Chloride 0.3% w/v &
Sodium Chloride 0.9% w/v than you should
If you are given too much medicine you may experience: tingling
and burning of the arms and legs (paresthesia), muscle
weakness, inability to move (paralysis), irregular heartbeat
(arrhythmia), heart block (very slow heartbeat), cardiac
arrest (the heart stops beating), mental confusion, fluid
accumulation in the lungs making breathing difficult (pulmonary
oedema), fluid accumulation under the skin especially around
the ankles (peripheral oedema), acidification of the blood
(acidosis) leading to fatigue, confusion, lethargy and increased
respiratory rate.
Tell your doctor immediately if you develop any of these
symptoms. Your infusion will be stopped and you will be
given treatment depending on your symptoms.
If you have any further questions on the use of this medicine,
ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

The following side effects have been reported during postmarketing use of the medicine. The frequency of occurance
cannot be estimated from the available data. Side effects may
occur due to the technique of administration.

The following information is intended for healthcare professionals
only:
Handling & Preparation
This product is for single use only. Any unused solution should
be discarded.
Use only if the solution is clear, without visible particles and if
the container is undamaged.

Tell your doctor or nurse if any of the following side
effects occur:
- Infection at the injection site
- Abnormal increase in blood volume (hypervolemia)
- Administration of solution into the surrounding tissue
(extravasation). This can damage tissue and cause scarring.
- Irritation or pain at the injection site
- Inflammation of the vein in which the solution is infused
(phlebitis). This can cause redness, swelling and pain or
burning along the vein into which the solution is administered.
- Blood clot at injection site which causes pain, swelling or
redness in the area of the clot
- Fever

Route of administration
The administration is performed by intravenous route using
sterile and non - pyrogenic equipment.
Intravenous potassium should be administered in a large
peripheral or central vein to diminish the risk of causing sclerosis.
If infused through central vein, be sure the catheter is not in
the atrium or ventricle to avoid localized hyperkalaemia.
Solutions containing potassium should be administered slowly.

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 this
leaflet.

Rate of administration
As administered intravenously, potassium should not be given
faster than 15 to 20 mmol/h to avoid a dangerous hyperkalaemia.
In any case, the dosage given under “General Posology”
should not be exceeded.

For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For Ireland - Via;
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

General posology
The recommended dosage for treatment of isotonic fluid
depletion (extracellular dehydration) by means of any
intravenous solution is:
- for adults: 500 ml to 3 litres/24 h
- for babies and children: 20 to 100 ml per 24 h and per kg
of body weight, depending of the age and the total body
mass.

By reporting side effects you can help provide more information
on the safety of this medicine.

Posology
- Adults, Older people and Adolescents:
Typical dose of potassium for the prevention of hypokalaemia
may be up to 50 mmol daily and similar doses may be adequate
in mild potassium deficiency. When used for treatment of
hypokalaemia, the recommended dosage is 20 mmol of
potassium over 2 to 3 hours (i. e. 7-10 mmol/h) under ECG
control.
- Paediatric population:
When used in the treatment of hypokalaemia the recommended
dosage is 0.5 mmol/kg b.w./h over 1-2 hours.
The maximal recommended dose of potassium is
2 to 3 mmol/kg b.w./day.
- Patients with renal impairment
Patients with renal impairment should receive lower doses.
Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v is
a hypertonic solution, with an approximate osmolarity of
388 mOsm/l.
Administration should be carried out under regular and careful
surveillance. Regular monitoring of clinical status, plasma
electrolyte concentrations, plasma creatinine levels, BUN level,
acid-base balance and ECG is essential in patients receiving
potassium therapy, particularly those with cardiac or renal
impairment.
Adequate urine flow should be ensured and fluid balance
should be monitored.
Potassium salts should be administered with considerable care
to patients with cardiac disease or conditions predisposing to
hyperkalaemia such as renal or adrenocortical insufficiency,
acute dehydration, or extensive tissue destruction as occurs
with severe burns. In patients under digitalis therapy, regular
monitoring of the plasma potassium level is mandatory.

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Warnings and precautions
This medicine has a higher concentration (hypertonic solution)
than the blood. Your doctor will take this into consideration
when calculating your dose.

Talk to your doctor or nurse before receiving Potassium
Chloride 0.3% w/v & Sodium Chloride 0.9% w/v if you:
- have any type of heart disease or heart failure
- have reduced kidney function
- have a disease of the adrenal gland that affects the amount
of steroid hormones in the body (adrenocortical insufficiency)
- are very dehydrated (loss of water from the body, e.g. from
vomiting or diarrhoea)
- have a severe injury involving a large area of skin, such
as a burn
- have high blood pressure
- have swelling under the skin, especially around the ankles
(peripheral oedema) or in the lungs (pulmonary oedema)
- have high blood pressure during pregnancy (preeclampsia)
- have any other condition when the body retains too much
sodium (sodium retention)
You will be closely monitored while being given this medicine.
Your doctor will take blood and urine samples to monitor your
condition. Special care will be taken if you have heart or
kidney problems.

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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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