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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

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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, 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.

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

• 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)
1. What Potassium Chloride 0.15% w/v and Sodium • salt-retaining medicines, e.g. corticosteroids such as hydrocortisone or
prednisone
Chloride 0.9% w/v is and what it is used for
• potassium-sparing water tablets, e.g. those containing spironolactone
This medicine is a solution for infusion, i.e. it is administered to you
or triamterene or other substances that may lead to high potassium levthrough thin tube placed into a vein.
els, such as certain medicines used to treat high blood pressure (socalled
It will be given to you to maintain or restore your potassium, sodium,
ACE inhibitors) cyclosporine or suxamethonium.
chloride and fluid levels.

Pregnancy and breast-feeding

you are pregnant or breast-feeding, think you may be pregnant or are
2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTAS- Ifplanning
to have a baby, ask you doctor or pharmacist for advice before
SIUM CHLORIDE 0.15% W/V AND SODIUM CHLORIDE taking/using this medicine.
0.9% W/V
Pregnancy

Do not use Potassium Chloride 0.15%w/v and Sodium Chloride If you think you are likely to be pregnant, tell your doctor immediately.
0.9% w/v
This medicine can be given while you are pregnant if your doctor consid-

• if you have abnormally high levels of potassium or chloride in your blood
ers it necessary.
• if you have severe kidney disease
• if you have swelling of the lower limbs, too much water in your body tis- Breast-feeding
If you are breast-feeding, tell your doctor immediately. This medicine can
sues (hyperhydration)
be given while you are breast feeding if your doctor considers it necessary.

Warnings and precautions

3. How to use Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v
Method of administration
The medicine will be administered to you by infusion through a vein.
The container of this medicine contains a significant volume of air. To
avoid risk of air entering your blood circulation this product must not be
administered by pressure infusion.

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• 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

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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

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

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
6. Contents of the pack and other information
also need dialysis.
If you have any further questions on the use of this medicine, ask your What Potassium Chloride 0.15% w/v and Sodium Chloride
0.9% w/v contains
doctor or pharmacist.
• The active substances are Potassium Chloride and Sodium Chloride.

4. Possible side effects

1,000 ml solution for infusion contain:
Like all medicines, this medicine cause side effects, although not every- Potassium chloride
Sodium chloride
body gets them.
• The other ingredient is:
If any of the following happen, tell your doctor immediately or
Water for injections

1.5 g
9.0 g

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

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.

Tell your doctor if you notice any of the following side effects Marketing Authorisation Holder and Manufacturer
• 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

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
If you get any side effects, talk to your doctor or pharmacist. This includes
Carl-Braun-Straße 1
any possible side effects not listed in this leaflet. You can also report side
34212 Melsungen, Germany
effects directly (see details below). By reporting side effects you can help
B. Braun Medical S.A.
provide more information on the safety of this medicine.
Carretera de Terrassa 121
United Kingdom:
08191 Rubi, Barcelona, Spain
Yellow Card Scheme
This leaflet was last revised in 06.2015
Website: www.mhra.gov.uk/yellowcard

B|BRAUN

Schwarz
210x297 mm
272/436489/0615
Lätus: 2191
Großbritannien/Irland
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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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

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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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