PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v

Solution for Infusion BP

Active substances: potassium chloride and sodium chloride

Read all of this leaflet carefully before you start using this medicine.

•    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.

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 or pharmacist.

This medicine is called Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Solution for Infusion BP, but will be referred to as Potassium 0.3 & Sodium 0.9 Infusion throughout the remainder of this leaflet.

1. What Potassium 0.3 & Sodium

0.9 Infusion is and what it is used for

Potassium 0.3 & Sodium 0.9 Infusion is a solution of potassium chloride and sodium chloride in water. Potassium chloride and sodium chloride are chemical substances (often called “salts”) found in the blood.

Potassium 0.3 & Sodium 0.9 Infusion is used to prevent and treat:

•    a loss of potassium from the body (potassium depletion, e.g. after treatment with certain diuretics [water tablets])

•    a low level of potassium in the blood (hypokalaemia).

in situations that may cause sodium chloride and water loss including:

•    when you cannot eat or drink, due to illness or after surgery

•    pronounced sweating due to high fever

•    extensive skin loss, as can occur in severe burns.

2. Before you use Potassium 0.3 & Sodium 0.9 Infusion

You must NOT receive Potassium 0.3 & Sodium 0.9 Infusion if you are suffering from any of the following conditions

•    higher levels of potassium in the blood than normal (hyperkalaemia)

•    higher levels of chloride in the blood than normal (hyperchloraemia)

•    higher levels of sodium in the blood than normal (hypernatraemia)

•    severe kidney failure (when your kidneys do not work well and you require dialysis)

•    uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:

-    shortness of breath

-    swelling of the ankles

•    Addison's disease (poor function of the adrenal gland. The adrenal gland produces hormones that help to control the concentrations of the chemicals in the body).

Take special care with Potassium 0.3 & Sodium 0.9 Infusion

Potassium 0.3 & Sodium 0.9 Infusion is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating how much solution to give you.

Please tell your doctor if you have or have had any of the following medical conditions.

•    any type of heart disease or poor heart function

•    poor kidney function

•    adrenocortical insufficiency (this disease of the adrenal gland affects hormones that control the concentration of chemicals in the body)

•    a loss of water from the body (acute dehydration, e.g. from vomiting or diarrhoea)

•    extensive tissue damage (as can occur in severe burns)

•    if you are on treatment with cardiac glycosides (also called cardiotonics), such as digitalis or digoxin. These medicines are used to treat heart disease. Regular monitoring of the level of potassium in the blood must be performed

•    high blood pressure (hypertension)

•    build up of fluid under the skin, particularly around the ankles (peripheral oedema)

•    build up of fluid in the lungs (pulmonary oedema)

•    high blood pressure during pregnancy (pre-eclampsia)

•    any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (See also below “Taking other medicines”).

When you are given this infusion, your doctor will take blood and urine samples to monitor:

•    the amount of fluid in your body

•    your vital signs

•    the amount of chemicals such as sodium and potassium in your blood (your plasma electrolytes)

•    the blood concentration of a substance called creatinine (your plasma creatinine)

•    the blood concentration of a substance called urea (your BUN levels)

•    the acidity of your blood and urine (your acid-base balance)

•    your heart tracing (ECG).

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). During long term treatment with Potassium 0.3 & Sodium 0.9 Infusion you may need to be given extra nutrition.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important that you inform your doctor if you are taking:

•    cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin

•    medicines that increase the concentration of potassium in the blood, such as:

-    potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterene)

-    angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)

-    angiotensin II receptor antagonists (used to treat high blood pressure)

-    cyclosporin (used to prevent rejection of a transplant)

-    tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases)

-    medicines that contain potassium (e.g. potassium supplements, salt substitutes containing potassium)

•    corticosteroids (anti-inflammatory medicines).

Using Potassium 0.3 & Sodium 0.9 Infusion with food and drink

You should ask your doctor about what you can eat or drink.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor if you are pregnant or breast-feeding.

Changes in the potassium levels in your blood can affect how well your heart and your unborn baby's heart work. Your doctor will therefore carefully monitor the levels of the chemicals in your blood.

Potassium 0.3 & Sodium 0.9 Infusion can be given during pregnancy. The amount you are given must be carefully controlled by your doctor.

However, if another medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should:

•    consult your doctor

•    read the Patient Information Leaflet of the medicine that is to be added.

Driving and using machines

Potassium 0.3 & Sodium 0.9 Infusion does not affect your ability to drive or use machines.

3. How to use Potassium 0.3 & Sodium 0.9 Infusion

Potassium 0.3 & Sodium 0.9 Infusion will be given to you by a doctor or nurse. Your doctor will decide on how much you need and when it is to be given. This will depend on your age, weight, clinical and biological conditions and state of hydration (the amount of water in your body). The amount you are given may also be affected by other treatments you are receiving.

You should NOT be given Potassium 0.3 & Sodium 0.9 Infusion if there are particles floating in the solution or if the pack is damaged in any way.

The speed of infusion will be decided by your doctor.

If you require a large volume or rapid infusion of Potassium 0.3 & Sodium 0.9 Infusion, your doctor may monitor your ECG (heart tracing).

Potassium 0.3 & Sodium 0.9 Infusion will usually be given to you through a plastic tube attached to a needle in a vein. Usually a vein in your arm is used to give you the infusion. However, your doctor may use another method to give you the medicine.

When you are given Potassium 0.3 & Sodium 0.9 Infusion, your doctor will perform blood tests to monitor your blood levels of:

•    potassium

•    other electrolytes (such as sodium and chloride) and other chemical substances that are normally in your blood like creatinine (a breakdown product from the muscles).

If you suffer from poor kidney function, you may receive a lower dose.

Any unused solution should be thrown away. You should NOT be given an infusion of Potassium 0.3 & Sodium 0.9 Infusion from a bag that has been partly used.

If you receive more Potassium 0.3 & Sodium 0.9 Infusion than you should

If you are given too much Potassium 0.3 & Sodium 0.9 Infusion (over-infusion), this may lead to the following symptoms:

•    pins and needles in the arms and legs (paresthesia)

•    muscle weakness

•    an inability to move (paralysis)

•    an irregular heartbeat (cardiac arrhythmias)

•    heart block (a very slow heartbeat)

•    cardiac arrest (the heart stops beating; a life-threatening situation)

•    confusion

•    fluid collection in the lungs making it difficult to breathe (pulmonary oedema)

•    fluid collection under the skin, particularly around the ankles (peripheral oedema)

•    acidification of the blood (acidosis) leading to tiredness, confusion, lethargy and increased breathing rate.

If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.

If a medicine has been added to your Potassium 0.3 & Sodium 0.9 Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Patient Information Leaflet of the added medicine for a list of possible symptoms.

Stopping your Potassium 0.3 & Sodium 0.9 Infusion

Your doctor will decide when to stop giving you this infusion.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, Potassium 0.3 & Sodium 0.9 Infusion can cause side effects, although not everybody gets them.

The side effects that may occur due to the administration technique include:

•    fever (febrile response)

•    infection at the site of infusion

•    local pain or reaction (redness or swelling at the site of infusion)

•    irritation and inflammation of the vein into which the solution is infused (phlebitis).

This can cause redness, pain or burning and swelling along the path of the vein into which the solution is infused

•    the formation of a blood clot (venous thrombosis) at the site of infusion, which causes pain, swelling or redness in the area of the clot

•    escape of the infusion solution into the tissues around the vein (extravasation). This can damage the tissues and cause scarring

•    an excess of fluid in the blood vessels (hypervolaemia).

If a medicine has been added to the solution for infusion, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. You should read the Patient Information Leaflet of the added medicine for a list of possible symptoms.

Please tell your doctor or nurse if you notice any listed or unlisted side effects. If any side effects occur, the infusion must be stopped.

5. How to store Potassium 0.3 & Sodium 0.9 Infusion

Keep out of the reach and sight of children.

Potassium 0.3 & Sodium 0.9 Infusion does not require special storage conditions.

Potassium 0.3 & Sodium 0.9 Infusion should NOT be given to you after the expiry date which figures on the bag. The expiry date refers to the last day of that month.

You should not be given Potassium 0.3 & Sodium 0.9 Infusion, if there are particles floating in the solution or if the unit is damaged in any way.

6. Further information

What Potassium 0.3 & Sodium 0.9 Infusion contains

The active substances are:

•    potassium chloride: 3 g per litre

•    sodium chloride: 9 g per litre

The only other ingredient is water for injections.

What Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion looks like and contents of the pack

Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (VIAFLO). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

•    500 ml

•    1000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

•    20 bags of 500 ml

•    10 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturers

Marketing Authorisation Holder:

Send all enquiries to this address Baxter Healthcare Ltd.

Caxton Way

Thetford Norfolk IP24 3SE United Kingdom

Manufacturers:

Baxter SA

Boulevard Rene Branquart, 80

7860 Lessines

Belgium

Baxter Healthcare Ltd.

Caxton Way

Thetford Norfolk IP24 3SE United Kingdom

Bieffe Medital Sabinanigo

Ctra de Biescas, Senegue 22666 Sabinanigo (Huesca)

Spain

This leaflet was approved in 10/2012

For information about Potassium 0.3 & Sodium 0.9 Infusion or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:

Tel: 01635 206345.

Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v

Solution for Infusion BP

The following information is intended for medical or healthcare professionals only:

Handling and Preparation

Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set.

Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the product. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

Additives may be introduced before infusion or during infusion through the re-sealable medication port. When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Adding medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must be stopped immediately. Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

1.    Opening

a.    Remove the VIAFLO container from the overpouch just before use.

b.    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.

c.    Check the solution for limpidity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

2.    Preparation for administration

Use sterile material for preparation and administration.

a.    Suspend container from eyelet support.

b.    Remove plastic protector from outlet port at bottom of container:

-    grip the small wing on the neck of the port with one hand,

-    grip the large wing on the cap with the other hand and twist,

-    the cap will pop off.

c.    Use an aseptic method to set up the infusion.

d.    Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

3. Techniques for injection of additive medications

The solution should not be administered in the atrium or ventricle to avoid localised hyperkalaemia, but in large peripheral or central vein to diminish the risk of causing sclerosis.

Warning: Additives may be incompatible (see Paragraph 5 “Incompatibilities of additive medications” below).

To add medication before administration

a.    Disinfect medication port.

b.    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

c.    Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration

a.    Close clamp on the set.

b.    Disinfect medication port.

c.    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

d.    Remove container from IV pole and/or turn to an upright position.

e.    Evacuate both ports by tapping gently while the container is in an upright position.

f.    Mix solution and medication thoroughly.

g.    Return container to in use position, re-open the clamp and continue administration.

4.    In-use shelf-life: (Additives)

Chemical and physical stability of any additive medication at the pH of the Potassium Chloride 0.3% and Sodium Chloride 0.9% solution in the VIAFLO container should be established prior to use. From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

5.    Incompatibilities of additive medications

As with all parenteral solutions, incompatibility of the additive medications with the solution must be assessed before addition.

In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

It is the responsibility of the physician to judge the incompatibility of an additive medication with the Potassium Chloride 0.3% & Sodium Chloride 0.9% solution, by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals apparition. The Instructions for Use of the medication to be added must be consulted.

Before adding a drug, verify it is soluble and/or stable in water at the pH of the Potassium Chloride 0.3% & Sodium Chloride 0.9% solution (pH: 4.5 to 7.0).

Those additives known to be incompatible should not be used.

Baxter and Viaflo are trademarks of Baxter International lnc.

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