Sterile Potassium Chloride Concentrate (15% W/V) Bp
329/1 3102982/V2
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG ■ 34209 Melsungen, Germany
M Sterile Potassium Chloride Concentrate s (15% w/v) BP
Potassium chloride
Read all of this leaflet carefully before you receive this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor. 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.
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Dokument = 210 x 297mm 2 Seiten
In this leaflet:
1. What Sterile Potassium Chloride Concentrate (15% w/v) BP is and what it is used for
2. Before you use Sterile Potassium Chloride Concentrate (15% w/v) BP
3. How to use Sterile Potassium Chloride Concentrate (15% w/v) BP
4. Possible side effects
5. How to store Sterile Potassium Chloride Concentrate (15% w/v) BP
6. Further information
1. WHAT STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V) BP IS AND WHAT IT IS USED FOR
Sterile Potassium Chloride Concentrate (15% w/v) BP is a concentrated solution of potassium chloride.
It is used to supply potassium to you
• when you are lacking this salt
• when your deficit of potassium is accompanied by excess alkali or
• if you have an abnormal low chloride level in your blood.
• as part of parenteral nutrition, when you are unable to eat food normally.
2. BEFORE YOU USE STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V)
Do not use Sterile Potassium Chloride Concentrate (15% w/v) BP if you have
• an abnormally high potassium or chloride level in your blood (hyperka-laemia, hyperchloraemia)
• any disease or disorder that is frequently associated with abnormally high blood potassium levels, such as:
- abnormally low body water content (dehydration)
- impaired kidney function
- ADDISON'S disease (a specific disease of the adrenal gland)
- periodically appearing paralysis due to an inherited disorder of potassium metabolism (GAMSTORP'S syndrome)
- sickle cell anaemia (an inherited disease of the red blood cells)
Take special care with Sterile Potassium Chloride Concentrate (15% w/v) BP
• if you have severely impaired heart function (limitation of daily physical activity)
• if you are taking or receiving medicines that reduce potassium excretion in urine. For example if you are taking: certain blood pressure medications
Thus the administration of Potassium Chloride will be stopped if your kidneyfunction becomes worse during treatment.
Your doctor will take these points into consideration before and during your treatment with Sterile Potassium Chloride Concentrate (15% w/v) BP.
Additional precautions during treatment
• A disorder in your potassium balance (potassium blood levels too high or too low) can result in changes to the electrocardiogram (ECG).
Therefore your ECG will be monitored.
• While you are receiving this medicine your blood electrolyte levels and the acid-base balance will be monitored. This will be done to ensure that these are normal.
• It will be made absolutely sure that the solution is administered into your vein in order to avoid tissue damage.
Taking or using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, your doctor will have to pay attention to:
• Medicinal products for treatment of heart weakness (cardiac glycosides, e.g. digoxin):
The effects of these medicinal products will become weaker when the blood potassium level rises. They will become stronger (possibly with irregular heartbeat) when your blood potassium level decreases.
• Medicinal products that lower the potassium excretion in urine:
This group of medicinal products includes
- some medicines increasing the urine flow (certain diuretics),
- certain medicines for treatment of high blood pressure (anti-hypertensives)
- medicines that suppress your immune system (e.g. tacrolimus, ciclosporin)
- medicines for the treatment of inflammations
- some painkillers.
- long-term use of blood thinning medicines (e.g. heparin)
Giving potassium together with these will lead to very high blood potassium levels. This may affect your heart rhythm.
• Suxamethomium (a muscle relaxing agent used in general anaesthesia): Giving potassium together with this will also lead to very high blood potassium levels. This may affect your heart rhythm.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Up to now there are no reports about damaging effects or risks associated with the use of this medicine in pregnant women or breastfeeding mothers.
Pregnancy
Your doctor will administer potassium chloride to you only with caution and when clearly needed.
Breast-feeding
Your doctor will administer potassium chloride to you only with caution. Driving and using machines
This medicine has no influence on the ability to drive and use machines
Latus
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GB_329
Sterile Potassium Chloride Concentrate (15% w/v) BP 329/13102982/V2 MPc, MPw - GIF Standort Berlin
Font size: 9 pt.
G 080940
3. HOW TO USE STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V) BP
Administration
Sterile Potassium Chloride Concentrate (15% w/v) BP is administered to you after dilution in a suitable solution. It is given through a cannula or small tube into a vein (intravenous infusion).
Usually your doctor will give you potassium chloride by an infusion pump. Dosage
The amount you are to receive is calculated by your doctor, based on your acid-base balance and blood electrolyte values.
Adults and the elderly
You will not receive more than 1 - 1.5 ml solution per kg body weight. Normally the infusion rate will not exceed 0.3 mmol potassium per kg body weight per hour.
Children
For children the maximum daily amount of this medicine will be determined according to the age and the body weight:
Term and preterm neonates
|
Period |
Terms neonates |
Preterm neonates | |
|
> 1500g |
< 1500 g | ||
|
1st week |
2 | ||
|
1st month prior to stable growth |
3 |
2 | |
|
1st month with stable growth |
3 |
5 | |
Infants after the first month of life and children: 3 mmol/kg BW
Patients in a special condition
Your doctor will determine your dosage in cases of changes in the acid-base balance of your blood. For example when you have diabetes and you have a disturbed glucose metabolism or if you receive glucose/insulin.
If you use more Sterile Potassium Chloride Concentrate (15% w/v) BP than you should
It is unlikely that you will ever receive too much of the medicine. Your doctor or healthcare professional will monitor the application.
Symptoms
Overdose may lead to abnormally high potassium levels with the adverse effects listed below. Adverse effects are more likely to occur when you suffer from a shift of your blood to the acidic side (acidosis) or disorders of your kidneys.
Heart and circulation:
• slow heartbeat or even heart stoppage
• changes in the electrocardiogram
• drop of blood pressure
• re-distribution of circulating blood from limbs to head and trunk. Muscles and nerve system:
Weakness, fatigue, states of confusion, heaviness of limbs, muscle twitching, loss of feeling, and paralysis.
Treatment
If an overdose occurs the infusion will be stopped immediately and your doctor will give you any necessary treatment.
If you have any further questions on the use of this product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sterile Potassium Chloride Concentrate (15% w/v) BP can cause side effects, although not everybody gets them.
Side effects, however, are only to be expected as a result of overdose and/ or an abnormally high rate of administration. These correspond to the symptoms of an abnormally high blood potassium level. Their frequencies are dose-dependent.
The following side effects may be serious. If any of the following side effects occur, stop using this medicine and consult a doctor immediately.
• blood acidosis (accumulation of acidic substances in the blood)
• abnormal high chloride blood levels
• irregular heart beat (the result of abnormally high administrationrates).
Other side effects
Feeling sick (nausea)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW To STORE STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V) BP
Keep out of the reach and sight of children.
Do not use Sterile Potassium Chloride Concentrate (15% w/v) BP after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.
Do not store above 25 °C.
No special requirements for disposal.
Containers are for single-use only. Containers once opened must be discarded after use.
Do not use if solution is not clear or the container or closure show visible signs of damage.
The product is supplied in single-use containers. Containers once opened must be discarded after use.
After dilution
From a microbiological point of view, dilutions should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
6. FURTHER INFORMATION
What Sterile Potassium Chloride Concentrate (15% w/v) BP contains
• The active substance is potassium chloride 1 ml of solution contains
150 mg of potassium chloride.
corresponding to 2 mmol potassium and 2 mmol chloride One 10 ml ampoule contains 1.50 g potassium chloride
• The other ingredient is:
Water for injections
What Sterile Potassium Chloride Concentrate (15% w/v) BP looks like and contents of the pack
Sterile Potassium Chloride Concentrate (15% w/v) BP is a concentrate for the production of a solution for infusion. It must be diluted before use and is administered by an intravenous drip.
It is a clear, colourless aqueous solution.
Sterile Potassium Chloride Concentrate (15% w/v) BP is available in
• polyethylene ampoules, contents: 10 ml in packs of 20 x 10 ml
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG Carl-Braun-StraBe 1,
34212 Melsungen, Germany Postal address:
34209 Melsungen, Germany Phone: +49-5661-71-0 Fax.: +49-5661-71-4567
This leaflet was last approved in January 2015
BlBRAUN
B. Braun Melsungen AG
34209 Melsungen, Germany
13102982_Sterile Potas_Chlor_MP-GIFA4__GB_329 V2.indd 2 30.01.15 10:09