Freeflex
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Potassium Chloride 0.15% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.12 or freeflex®
Potassium Chloride 0.2% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No. 28 or freeflex®
Potassium Chloride 0.3% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.15 or freeflex®
Read all of this leaflet carefully before you start taking 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.
In this leaflet:
1. What Potassium Chloride and Sodium Chloride Infusion Solutions are and what they are used for
2. Before you receive a Potassium Chloride and Sodium Chloride Infusion Solution
3. How you are given a Potassium Chloride and Sodium Chloride Infusion Solution
4. Possible side effects
5. How to store Potassium Chloride and Sodium Chloride Infusion Solutions
6. Further information
1. WHAT POTASSIUM CHLORIDE AND SODIUM CHLORIDE INFUSION SOLUTIONS ARE AND WHAT THEY ARE USED FOR
Potassium chloride and sodium chloride help to maintain the body's store of essential potassium, sodium and chloride ions.
Potassium Chloride and Sodium Chloride infusion Solutions are used to replace potassium in the body.
The names of these medicines are:
Potassium Chloride 0.15% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.12 or freeflex®
Potassium Chloride 0.2% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No. 28 or freeflex®
Potassium Chloride 0.3% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.15 or freeflex®
In this leaflet the three solutions are collectively referred to as Potassium Chloride and Sodium Chloride Infusion Solutions.
2. BEFORE YOU ARE GIVEN A POTASSIUM CHLORIDE AND SODIUM CHLORIDE INFUSION SOLUTION
You should not receive a Potassium Chloride and Sodium Chloride Infusion Solution if you have:
• a known allergy (hypersensitivity) to any of the ingredients of Potassium Chloride and Sodium Chloride Infusion Solutions mentioned in Section 6 (for symptoms of an allergic reaction please refer to Section 4).
• Addison's disease
• Adrenal insufficiency (where the adrenal glands do not produce enough hormones)
• Kidney disease
• Oliguria or anuria (decreased or no urine production)
• Hyperkalaemia (high potassium levels)
• Liver disorder
Your doctor will check these.
Care should be taken when being administered with a Potassium Chloride and Sodium Chloride Infusion Solution:
Tell your doctor if you:
• have heart disease
• are dehydrated or have heat cramp
• have sickle cell disease (a condition affecting the red blood cells)
Before you receive a Potassium Chloride and Sodium Chloride Infusion Solution, your doctor will give you a non-potassium containing solution to prevent kidney damage.
Your doctor will make sure that the intravenous infusion is carried out slowly.
Your doctor or nurse will ensure the solution is clear and free from particles before use.
In addition to the information above your doctor may monitor your blood potassium levels and you may have your heart monitored by electrocardiogram (ECG) if you are being administered Potassium Chloride 0.2% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No. 28 or freeflex®.
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.
Inform your doctor if you take or have recently taken any of the medicines below:
• Potassium sparing diuretics (water tablets that preserve potassium)
• Potassium containing intravenous solutions
• Amikacin (an antibiotic)
• Amphotericin (an antifungal treatment)
• Benzyl-penicillin (an antibiotic)
• Dobutamine (for heart disease)
In addition to the previous medicines
Potassium Chloride 0.15% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.12 or freeflex® and
Potassium Chloride 0.2% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No. 28 freeflex® should not be used with the following medicines:
• Digitalis (for heart disease)
• ACE-inhibitors (for high blood pressure or heart disease)
• Cyclosporine (a drug used after organ transplant)
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or you are planning to become pregnant or if you are breastfeeding. Your doctor will decide whether you should receive a Potassium Chloride and Sodium Chloride Infusion Solution.
Driving and using machines
Potassium Chloride and Sodium Chloride InfusionSolutions may result in lack of energy, confusion, weakness, hypotension and sometimes cardiac arrest. These side effects will effect your ability to drive or use machinery. Ask your doctor when it would be safe to drive or operate machines.
3. HOW YOU ARE GIVEN A POTASSIUM CHLORIDE AND SODIUM CHLORIDE INFUSION SOLUTION
A Potassium Chloride and Sodium Chloride Infusion Solution will be given to you in hospital by healthcare professionals.
You will receive your medicine by infusion (IV drip).
Dosage
The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive.
Elderly
A reduced volume and rate of infusion may be necessary, particularly if you suffer from heart and/or kidney damage.
If you receive more of a Potassium Chloride and Sodium Chloride Infusion Solution than you should
It is very unlikely that you will receive more infusion than you should. If you suspect an overdosage with a Potassium Chloride and Sodium Chloride Infusion Solution you should look for the symptoms/side effects described below in this leaflet. You should immediately inform your doctor describing the symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Potassium Chloride and Sodium Chloride Infusion Solutions can cause side effects, although not everybody gets them.
Potassium Chloride and Sodium Chloride Infusion Solutions may cause severe allergic reactions. If you get any of the following symptoms after receiving this medicine, you should contact your doctor immediately:
- Skin rash
- Difficulty breathing
- Swelling of your face, lips, tongue or throat.
It is unlikely that you will receive more of a Potassium Chloride and Sodium Chloride Infusion Solution than you should. In the case of an overdose you may experience:
- low blood pressure (hypotension)
- Irregular heart beat
- Sudden stop of heart beat (cardiac arrest)
As a Potassium Chloride and Sodium Chloride Infusion Solution will be given to you in hospital by healthcare Professionals you will be monitored closely.
The following side effects have also been reported:
• listlessness (having no energy)
• low blood pressure (hypotension)
• confusion
• 'pins and needles'
• weakness
• high blood pressure
• irregular heart beats and very rarely heart attack
• thrombosis (the formation of a clot) may occur in the vein where the infusion is given
The symptoms of thrombosis include:
- pain, swelling and redness at the blood clot site.
- an itchy rash at the clot site
- warm skin around the clot
- a mild fever
- major veins that stand out from your skin.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.
5. HOW TO STORE POTASSIUM CHLORIDE AND SODIUM CHLORIDE INFUSION SOLUTIONS
Keep out of the reach and sight of children.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Potassium Chloride and Sodium Chloride Infusion Solutions. Potassium Chloride and Sodium Chloride Infusion Solutions should be stored between 2°C and 25°C.
The solutions must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of using the approved hospital procedures.
6. FURTHER INFORMATION
What Potassium Chloride and Sodium Chloride Infusion Solutions contain:
The infusions contain potassium chloride, sodium chloride, glucose, water for injections, and traces of hydrochloric acid and sodium hydroxide.
The three strengths are:
• Potassium Chloride 0.15% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.12 or freeflex®
• Potassium Chloride 0.2% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No. 28 or freeflex®
• Potassium Chloride 0.3% and Sodium Chloride 0.9% Intravenous Infusion BP Steriflex® No.15 or freeflex®
What Potassium Chloride and Sodium Chloride Infusion Solutions look like and the contents of the pack.
Potassium Chloride and Sodium Chloride Infusion Solutions are clear Solutions. The solution is contained in a sealed plastic container known as a Steriflex® bag or freeflex® bag.
Solutions are available in 500 ml and 1000 ml bags.
Not all sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.
Manufacturer:
Ivex Pharmaceuticals Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. or
Fresenius Kabi,
6 Rue de Rempart,
Louvier, Cedex, France
This leaflet was last approved in October 2009