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1. Potassium Chloride 0.15% W/V And Sodium Chloride 0.9 % W/V Solution For Infusion
2. Potassium Chloride 0.15% W/V And Sodium Chloride 0.9 % W/V Solution For Infusion

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272/436489/0514

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, Sodium Chloride

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

1. What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v is and what it is used for

This medicine is a solution for infusion, i.e. it is administered to you through thin tube placed into a vein.

It will be given to you to maintain or restore your potassium, sodium, chloride and fluid levels.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTASSIUM CHLORIDE 0.15% W/V AND SODIUM CHLORIDE 0.9% W/V

Do not use Potassium Chloride 0.15%w/v and Sodium Chloride 0.9% w/v

•    if you have abnormally high levels of potassium or chloride in your blood

•    if you have severe kidney disease

•    if you have swelling of the lower limbs, too much water in your body tissues (hyperhydration)

Warnings and precautions

•    if you have kidney problems

•    if you have liver disease

•    if you have abnormally high levels of acid in your body fluids and tissues (acidosis)

•    if you have lung disease or congestion of or water on the lungs (pulmonary oedema)

•    if you have abnormally high levels of electrolytes (salts) in your body fluids and tissues.

•    if you have cardiac disease

•    if your adrenal glands are not working properly

Special caution and careful monitoring of salt and fluid levels is required when this medicine is to be administered to children.

Other medicines and Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines.

In particular tell your doctor, if you are taking any of the following medicines, so that the amount of Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v can be adjusted accordingly:

•    digoxin (a medicine used to treat heart weakness)

•    salt-retaining medicines, e.g. corticosteroids such as hydrocortisone or prednisone

•    potassium-sparing water tablets, e.g. those containing spironolactone or triamterene or other substances that may lead to high potassium levels, such as certain medicines used to treat high blood pressure (socalled ACE inhibitors) cyclosporine or suxamethonium.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking/using this medicine.

Pregnancy

If you think you are likely to be pregnant, tell your doctor immediately. This medicine can be given while you are pregnant if your doctor considers it necessary.

Breast-feeding

If you are breast-feeding, tell your doctor immediately. This medicine can be given while you are breast feeding if your doctor considers it necessary.

BIBRAUN

Schwarz 210x297 mm 272/436489/0514 Latus: 2191 GroBbritannien/Irland Font size 9

272/436489/0514

Dosage

The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight and clinical condition.

- While you receive this medicine your electrolyte (salt) levels and water

balance will be monitored routinely.

The normal maximum dosage for an adult is 40 ml/kg body weight/day. Children will receive a reduced dosage dependent upon their age.

If you use more Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v than you should

It is unlikely that this happens as your infusion will be controlled by a doctor or nurse.

Yet if overdose occurs, you may experience disorders of fluid balance and serum electrolytes, swelling and heart and circulation disorders. Further symptoms are described below (see section 4).

The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion and administration of suitable medicines to treat the symptoms observed. In extreme situations you may also need dialysis.

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

4. Possible side effects

Like all medicines, this medicine cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately or go to the emergency department at your nearest hospital:

•    difficulty in breathing

•    sudden severe chest pain

•    slowing or quickening of your heart beat

•    high or low blood pressure (hypertension or hypotension)

•    bad fainting attacks, or collapse

•    weakness, disturbances of muscle movement

•    very marked numbness, swelling or heaviness of your limbs

•    cold skin or grey pallor

•    confusion

Tell your doctor if you notice any of the following side effects

•    headaches, dizziness

•    restlessness

•    nausea (feeling sick) or vomiting (being sick)

•    diarrhoea or pain in your abdomen

•    pain or tenderness at the site of injection

•    dry mouth or feeling thirsty

•    sweating or feeling feverish

Tell your doctor if you notice pain or tenderness at the site of injection.

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

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 this medicine after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month. Do not store above 25°C.

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

This medicine is for single use only.

This medicine should be clear in appearance. Do not use Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v if it is cloudy or if the container has been damaged.

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

6. Contents of the pack and other information

What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v contains

•    The active substances are Potassium Chloride and Sodium Chloride. 1,000 ml solution for infusion contain:

Potassium chloride    1.5 g

Sodium chloride    9.0 g

•    The other ingredient is:

Water for injections

What Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v looks like and contents of the pack

Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v is a solution for infusion, i.e. a solution to be administered by a vein drip.

It is a sterile, clear, colourless solution of aforementioned substances in water.

It comes in colourless polyethylene bottles of 500 ml or 1,000 ml, each available in packs of 10 bottles.

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: +49-5661-4567

Manufacturers

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany B. Braun Medical S.A.

Carretera de Terrassa 121 08191 Rubi, Barcelona, Spain

This leaflet was last revised in 06/2014

Ireland:

IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

BBRAUN

B. Braun Melsungen AG

34209 Melsungen Germany

Schwarz 210x297 mm 272/436489/0514 Latus: 2191 GroRbritannien/Irland Font size 9