Potassium Chloride 0.2% Sodium Chloride 0.18% Glucose 4% Intravenous Infusion Bp
In this leaflet the three solutions will collectively be referred to as Potassium
Chloride, Sodium Chloride and Glucose Infusion Solutions
PACKAGE LEAFLET: INFORMATION FOR THE USER
Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No. 14 or freeflex®
Potassium Chloride 0.2%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No. 30 or freeflex®
Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, as Steriflex® No. 17 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, Sodium Chloride and Glucose Infusion Solutions are and what they are used for
2. Before you are given Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions
3. How you are given Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions
4. Possible side effects
5. How Potassium Chloride, Sodium Chloride and Glucose Infusions are stored
6. Further information
1. WHAT POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS ARE AND WHAT THAY ARE USED FOR
Potassium chloride and sodium chloride help to maintain the body's store of essential potassium, sodium and chloride ions. Glucose is a simple sugar, which provides a source of energy.
These infusions are used to replace potassium in the body.
The names of these medicines are:
Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No.14 or freeflex®
Potassium Chloride 0.2%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, Steriflex® No.30 or freeflex®
Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, as Steriflex®No.17 or freeflex®
2. BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS
You should not receive Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions if you have:
• a known allergy (hypersensitivity) to Potassium Chloride, Sodium Chloride, and Glucose Infusion Solutions or to one or more of the ingredients of Potassium Chloride, Sodium Chloride, and Glucose 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 Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions:
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 Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions, 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.
Your blood potassium levels will be monitored and you may have your heart monitored by electrocardiogram (ECG).
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
• Digitalis (for heart disease)
• ACE-inhibitors (for high blood pressure or heart disease)
• Cyclosporine (a drug used after organ transplant)
• Amikacin (an antibiotic)
• Amphotericin (an antifungal treatment)
• Benzyl-penicillin (an antibiotic)
• Dobutamine (for heart disease)
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, Sodium Chloride and Glucose Infusion Solution.
Driving and using machines
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions may affect your ability to drive or operate machinery. Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions may cause listlessness, confusion, weakness and cardiac arrest. Ask you doctor when it would be safe to drive or operate machines.
3. HOW YOU ARE GIVEN POTASSIUM CHLORIDE. SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions 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 Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions 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, Sodium Chloride and Glucose Infusion Solutions 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, Sodium Chloride and Glucose Infusion Solutions can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. 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, Sodium Chloride and Glucose 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, Sodium Chloride and Glucose 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 POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS ARE STORED
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, Sodium Chloride and Glucose Infusion Solutions.
Potassium Chloride, Sodium Chloride and Glucose 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, Sodium Chloride and Glucose infusion Solutions contain:
The infusions contain potassium chloride, sodium chloride, glucose, water for injections, hydrochloric acid, and sodium hydroxide.
The three strengths are:
• Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex®No.14 orfreeflex®
• Potassium Chloride 0.2%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, Steriflex®No,30 orfreeflex®
• Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, as Steriflex®No.17 orfreeflex®
What Potassium Chloride, Sodium Chloride and Glucose infusion Solutions look like and contents of the pack.
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions are dear solution of potassium chloride, sodium chloride and glucose in water.
The solutions are contained in a sealed plastic container known as a Steriflex®bag orfreeflex® bag.
All three strengths of 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, WA71 NT. UK.
Manufacturer:
Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in February 2013.
V002/TM
FRESENIUS III KABI
PACKAGE LEAFLET: INFORMATION FOR THE USER
Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No. 14 or freeflex®
Potassium Chloride 0.2%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No.30 or freeflex®
Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, as Steriflex® No. 17 or freeflex®_
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. Vou 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, Sodium Chloride and Glucose Infusion Solutions are and what they are used for
2. Before you are given Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions
3. How you are given Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions
4. Possible side effects
5. How Potassium Chloride, Sodium Chloride and Glucose Infusions are stored
6. Further information
1. WHAT POTASSIUM CHLORIDE. SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS ARE AND WHAT THAY ARE USED FOR
Potassium chloride and sodium chloride help to maintain the body's store of essential potassium, sodium and chloride ions. Glucose is a simple sugar, which provides a source of energy.
These infusions are used to replace potassium in the body.
The names of these medicines are:
Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex® No.14 or freeflex®
Potassium Chloride 0.2%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, Steriflex® No.30 or freeflex®
Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, as Steriflex®No.l7 or freeflex®
2. BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS
You should not receive Potassium Chloride, Sodium Chloride and Glucose infusion solutions if you have:
• a known allergy (hypersensitivity) to Potassium Chloride, Sodium Chloride, and Glucose Infusion Solutions or to one or more of the ingredients of Potassium Chloride, Sodium Chloride, and Glucose 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 Potassium Chloride, Sodium Chloride and Glucose infusion Solutions:
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 Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions, 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.
Your blood potassium levels will be monitored and you may have your heart monitored by electrocardiogram (ECG).
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
• Digitalis (for heart disease)
• ACE-inhibitors (for high blood pressure or heart disease)
• Cyclosporine (a drug used after organ transplant)
• Amikacin (an antibiotic)
• Amphotericin (an antifungal treatment)
• Benzyl-penicillin (an antibiotic)
• Dobutamine (for heart disease)
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, Sodium Chloride and Glucose Infusion Solution.
Driving and using machines
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions may affect your ability to drive or operate machinery. Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions may cause listlessness, confusion, weakness and cardiac arrest. Ask you doctor when it would be safe to drive or operate machines.
3. HOW YOU ARE GIVEN POTASSIUM CHLORIDE. SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions 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 Potassium Chloride, Sodium Chloride and Glucose infusion Solutions 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, Sodium Chloride and Glucose Infusion Solutions 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, Sodium Chloride and Glucose Infusion Solutions can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare, 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, Sodium Chloride and Glucose 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, Sodium Chloride and Glucose 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 POTASSIUM CHLORIDE, SODIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS ARE STORED
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, Sodium Chloride and Glucose Infusion Solutions.
Potassium Chloride, Sodium Chloride and Glucose 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, Sodium Chloride and Glucose infusion Solutions contain:
The infusions contain potassium chloride, sodium chloride, glucose, water for injections, hydrochloric acid, and sodium hydroxide.
The three strengths are:
• Potassium Chloride 0.15%,Sodium Chloride 0.18%, Glucose 4% Intravenous Infusion BP, as Steriflex®No.l4 orfreeflex®
• Potassium Chloride 0.2%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, Steriflex®No.30orfreeflex®
• Potassium Chloride 0.3%,Sodium Chloride 0.18%,Glucose 4% Intravenous Infusion BP, asSteriflex®No.l7 orfreeflex®
What Potassium Chloride, Sodium Chloride and Glucose infusion Solutions look like and contents of the pack.
Potassium Chloride, Sodium Chloride and Glucose Infusion Solutions are clear solution of potassium chloride, sodium chloride and glucose in water.
The solutions are contained in a sealed plastic container known as a Steriflex® bag or freeflex® bag.
All three strengths of 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, WA71 NT. UK.
Manufacturer:
Fresenius Kabi,
6 Rue de Rempart,
Louvier, Cedex, France.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in October 2009.
V001/LV