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STERIFLEX NO 11 HARTMANNS SOLUTION FOR INJECTION

Active substance(s): CALCIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

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4741-1_4380-2 VOLUVEN - FR 23/06/14 10:22 Page1

kipdips142,406

1.0, CURRENT

5. HOW HARTMANN’S SOLUTION IS 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 Hartmann’s solution.
Hartmann’s solution should be stored between 2ºC and 25ºC.
The solution 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 Hartmann’s solution contains
Hartmann’s solution is a clear solution containing sodium lactate 0.317% w/v, sodium
chloride 0.6% w/v, potassium chloride 0.04% w/v, calcium chloride dihydrate 0.027% w/v.
The infusion also contains water for injections, and small amounts of hydrochloric acid and
sodium hydroxide.
What Hartmann’s solution looks like and contents of the pack
Hartmann’s solution is contained in a bag known either as a Steriflex® bag or a freeflex® bag.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hartmann’s Solution for Injection
BP as Steriflex® No. 11
and 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 Hartmann’s solution is and what it is used for
2. Before you receive Hartmann’s solution
3. How you are given Hartmann’s solution
4. Possible side effects
5. How Hartmann’s solution is stored
6. Further information

The solutions are available in 500 ml and 1000 ml bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.
Manufacturer:
Fresenius Kabi,
6 Rue de Rempart
Louviers, Cedex, France

4471-1 - V001/LV

This leaflet was last revised in June 2014.

1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR
Hartmann’s solution is a clear solution of sodium lactate, sodium chloride, potassium
chloride, calcium chloride and small amounts of hydrochloric acid and sodium hydroxide.
Hartmann’s solution is used for the treatment of increased acid in the body (metabolic
acidosis) and water loss (dehydration) with acidosis – this is a condition where the pH of
your blood is low. Your doctor will be able to explain this to you.
It may also be used to increase the amount of fluids outside your body cells or to restore
the amount of electrolytes (salts) outside the cells and in the treatment of diabetic coma
(unconsciousness caused by your blood sugar being too high or too low).
The full name of this medicine is Hartmann’s Solution for Injection BP as Steriflex®
No.11 or Freeflex®.
In this leaflet it is referred to as Hartmann’s solution.

4741-1_4380-2 VOLUVEN - FR 23/06/14 10:22 Page2

kipdips142,406
2. BEFORE YOU RECEIVE HARTMANN’S SOLUTION
You should not receive Hartmann’s solution if you have:
• a known allergy (hypersensitivity) to Hartmann’s Solution or any of the ingredients of
Hartmann’s Solution mentioned in Section 6. If you develop a rash or other allergic
reactions (like itching, swollen lips or face or shortness of breath), please inform
your doctor.
• very high sodium levels. This can happen with heart or kidney damage or during the first
five or six days after surgery or severe injury.
• heartbeat disorder (cardiac arrhythmia)
• liver disease
Your doctor will check these.
Care should be taken when being administered with Hartmann’s solution.
Tell your doctor if you have:
• severe potassium loss – you will need potassium supplements
• heart disease – you may need electrocardiogram (ECG) monitoring
• heart failure
• hypertension (high blood pressure)
• kidney disease
• Pulmonary oedema (fluid on the lungs)
• Peripheral oedema (fluid under the skin)
• complications in your pregnancy called eclampsia (symptoms include: convulsions,
increased blood pressure, circulatory problems, severe headaches, vision problems, pain
in the upper abdomen, vomiting, sudden swelling of your feet, ankles, face and hands
and excessive weight gain).
Your doctor or nurse will ensure the solution is clear and free from particles before use.
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:
• sulphadiazine sodium, benzylpenicillin, tetracyclines, amikacin (antibiotics)
• sodium bicarbonate (used to reduce acidity)
• amphotericin B (for fungal infections)
• sodium calcium edetate (a preservative)
• amiodarone (used for heartbeat disorders)
• dobutamine (used for heart disease)
• amsacrine (a cancer treatment)
• sodium nitroprusside (for the treatment of very high blood pressure)

1.0, CURRENT
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or you are
planning to be pregnant or if you are breastfeeding. This is especially important if you
suffer from pre-eclampsia. Your doctor will decide whether you should receive Hartmann’s
solution.
Driving and using machines
Hartmann’s solution has no effect on driving or using machines.
3. HOW YOU ARE GIVEN HARTMANN’S SOLUTION
Hartmann’s solution must only be given to you in a hospital by healthcare professionals
You will receive your medicine by infusion (IV drip).
Dosage
The rate at which the infusion is given and the volume infused will depend on your own
specific requirements. Your doctor will decide on the correct dose for you to receive.
Elderly
If you have impaired heart or kidney function a reduced volume and rate of infusion may be
necessary in order to avoid fluid overload.
If you receive more Hartmann’s solution than you should
It is very unlikely that you will receive more infusion than you should. If you suspect an
overdosage with Hartmann’s solution you should immediately inform your doctor
describing the symptoms.
4. POSSIBLE SIDE EFFECTS
Like all medicines Hartmann’s solution can cause side effects, although not everybody gets
them.
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.

0730261_00_UK_Hartmanns:0730261_00_UK_Hartmanns

14.08.2013

10:48 Uhr

Seite 1

kipdips142,406

1.0, CURRENT

5. HOW HARTMANN’S SOLUTION IS STORED

PACKAGE LEAFLET: INFORMATION FOR THE USER

Keep out of the reach and sight of children.
Your doctor and hospital pharmacist are responsible for the correct
storage, use and disposal of Hartmann’s solution.
Hartmann’s solution should be stored between 2 °C and 25 °C.
The solution 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.

Hartmann’s Solution for Injection
BP as Steriflex® No. 11 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.

6. FURTHER INFORMATION
What Hartmann’s solution contains
Hartmann’s solution is a clear solution containing sodium lactate
0.317% w/v, sodium chloride 0.6% w/v, potassium chloride 0.04% w/v,
calcium chloride dihydrate 0.027% w/v.

In this leaflet:
1. What Hartmann’s solution is and what it is used for
2. Before you receive Hartmann’s solution
3. How you are given Hartmann’s solution
4. Possible side effects
5. How Hartmann’s solution is stored
6. Further information

The infusion also contains water for injections, and small amounts of
hydrochloric acid and sodium hydroxide.
What Hartmann’s solution looks like and contents of the pack
Hartmann’s solution is contained in a bag known either as a Steriflex® bag
or a freeflex® bag.
The solutions are available in 500 ml and 1000 ml bags.

1. WHAT HARTMANN’S SOLUTION IS AND
WHAT IT IS USED FOR

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.

Hartmann’s solution is a clear solution of sodium lactate, sodium
chloride, potassium chloride, calcium chloride and small amounts of
hydrochloric acid and sodium hydroxide.
Hartmann’s solution is used for the treatment of increased acid in the
body (metabolic acidosis) and water loss (dehydration) with acidosis
– this is a condition where the pH of your blood is low. Your doctor will
be able to explain this to you.

Manufacturer:
Fresenius Kabi Deutschland GmbH
Werk Friedberg
Freseniusstraße 1
61169 Friedberg
Germany

It may also be used to increase the amount of fluids outside your body
cells or to restore the amount of electrolytes (salts) outside the cells
and in the treatment of diabetic coma (unconsciousness caused by
your blood sugar being too high or too low).

This leaflet was last revised in July 2013.

V001/ FB

0730261/ 00 UK

The full name of this medicine is Hartmann’s Solution for Injection BP
as Steriflex® No.11 or freeflex®.
In this leaflet it is referred to as Hartmann’s solution.

4

1

0730261_00_UK_Hartmanns:0730261_00_UK_Hartmanns

14.08.2013

10:48 Uhr

Seite 3

kipdips142,406

1.0, CURRENT

2. BEFORE YOU RECEIVE HARTMANN’S SOLUTION
You should not receive Hartmann’s solution if you have:
• a known allergy (hypersensitivity) to Hartmann's Solution or any of the
ingredients of Hartmann's Solution mentioned in Section 6. If you
develop a rash or other allergic reactions (like itching, swollen
lips or face or shortness of breath), please inform your doctor.
• very high sodium levels. This can happen with heart or kidney
damage or during the first five or six days after surgery or severe injury.
• heartbeat disorder (cardiac arrhythmia)
• liver disease
Your doctor will check these.
Care should be taken when being administered with Hartmann’s
solution.
Tell your doctor if you have:
• severe potassium loss – you will need potassium supplements
• heart disease – you may need electrocardiogram (ECG) monitoring
• heart failure
• hypertension (high blood pressure)
• kidney disease
• peripheral oedema (fluid under the skin)
• pulmonary oedema (fluid on the lungs)
• complications in your pregnancy called eclampsia (symptoms include:
convulsions, increased blood pressure, circulatory problems, severe
headaches, vision problems, pain in the upper abdomen, vomiting,
sudden swelling of your feet, ankles, face and hands and excessive
weight gain).
Your doctor or nurse will ensure the solution is clear and free from
particles before use.
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:
• sulphadiazine sodium, benzylpenicillin, tetracyclines, amikacin (antibiotics)
• sodium bicarbonate (used to reduce acidity)
• amphotericin B (for fungal infections)
• sodium calcium edetate (a preservative)
• amiodarone (used for heartbeat disorders)
• dobutamine (used for heart disease)
• amsacrine (a cancer treatment)
• sodium nitroprusside (for the treatment of very high blood pressure)

2

Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you
are pregnant or you are planning to be pregnant or if you are
breastfeeding. This is especially important if you suffer from
pre-eclampsia. You doctor will decide whether you should receive
Hartmann’s solution.
Driving and using machines
Hartmann’s solution has no effect on driving or using machines.

3. HOW YOU ARE GIVEN HARTMANN’S SOLUTION
Hartmann’s solution must only be given to you in a hospital by
healthcare professionals
You will receive your medicine by infusion (IV drip).
Dosage
The rate at which the infusion is given and the volume infused will
depend on your own specific requirements. Your doctor will decide on
the correct dose for you to receive.
Elderly
If you have impaired heart or kidney function a reduced volume and
rate of infusion may be necessary in order to avoid fluid overload.
If you receive more Hartmann’s solution than you should
It is very unlikely that you will receive more infusion than you should.
If you suspect an overdosage with Hartmann’s solution you should
immediately inform your doctor describing the symptoms.

4. POSSIBLE SIDE EFFECTS
Like all medicines Hartmann’s solution can cause side effects, although
not everybody gets them.
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 which 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 your doctor or
pharmacist.

3

kipdips142,406
PACKAGE LEAFLET: INFORMATION FOR THE USER

Hartmann's Solution for Injection
BP as Steriflex® No. 11 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 Hartmann’s solution is and what it is used for
2. Before you receive Hartmann’s solution
3. How you are given Hartmann’s solution
4. Possible side effects
5. How Hartmann’s solution is stored
6. Further information

1. WHAT HARTMANN’S SOLUTION IS AND
WHAT IT IS USED FOR
Hartmann’s solution is a clear solution of sodium lactate, sodium
chloride, potassium chloride, calcium chloride and small amounts of
hydrochloric acid and sodium hydroxide.
Hartmann’s solution is used for the treatment of increased acid in the
body (metabolic acidosis) and water loss (dehydration) with acidosis this is a condition where the pH of your blood is low. Your doctor will
be able to explain this to you.
It may also be used to increase the amount of fluids outside your body
cells or to restore the amount of electrolytes (salts) outside the cells
and in the treatment of diabetic coma (unconsciousness caused by
your blood sugar being too high or too low).
The full name of this medicine is Hartmann’s Solution for Injection BP
as Steriflex®No.11 or freeflex®.
In this leaflet it is referred to as Hartmann’s solution.

1.0, CURRENT

2. BEFORE YOU RECEIVE HARTMANN’S SOLUTION
You should not receive Hartmann’s solution if you have:
• a known allergy (hypersensitivity) to Hartmann's Solution or any of the
ingredients of Hartmann's Solution mentioned in Section 6. If you
develop a rash or other allergic reactions (like itching, swollen
lips or face or shortness of breath), please inform your doctor.
• very high sodium levels. This can happen with heart or kidney
damage or during the first five or six days after surgery or severe injury.
• heartbeat disorder (cardiac arrhythmia)
• liver disease
Your doctor will check these.
Care should be taken when being administered with Hartmann’s
solution.
Tell your doctor if you have:
• severe potassium loss – you will need potassium supplements
• heart disease – you may need electrocardiogram (ECG) monitoring
• heart failure
• hypertension (high blood pressure)
• kidney disease
• peripheral oedema (fluid under the skin)
• pulmonary oedema (fluid on the lungs)
• complications in your pregnancy called eclampsia (symptoms include:
convulsions, increased blood pressure, circulatory problems, severe
headaches, vision problems, pain in the upper abdomen, vomiting,
sudden swelling of your feet, ankles, face and hands and excessive
weight gain).
Your doctor or nurse will ensure the solution is clear and free from
particles before use.
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:
• sulphadiazine sodium, benzylpenicillin, tetracyclines, amikacin (antibiotics)
• sodium bicarbonate (used to reduce acidity)
• amphotericin B (for fungal infections)
• sodium calcium edetate (a preservative)
• amiodarone (used for heartbeat disorders)
• dobutamine (used for heart disease)
• amsacrine (a cancer treatment)
• sodium nitroprusside (for the treatment of very high blood pressure)

kipdips142,406

Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you
are pregnant or you are planning to be pregnant or if you are
breastfeeding. This is especially important if you suffer from
pre-eclampsia. You doctor will decide whether you should receive
Hartmann’s solution.
Driving and using machines
Hartmann’s solution has no effect on driving or using machines.

3. HOW YOU ARE GIVEN HARTMANN’S SOLUTION
Hartmann’s solution must only be given to you in a hospital by
healthcare professionals
You will receive your medicine by infusion (IV drip).
Dosage
The rate at which the infusion is given and the volume infused will
depend on your own specific requirements. Your doctor will decide on
the correct dose for you to receive.
Elderly
If you have impaired heart or kidney function a reduced volume and
rate of infusion may be necessary in order to avoid fluid overload.
If you receive more Hartmann’s solution than you should
It is very unlikely that you will receive more infusion than you should.
If you suspect an overdosage with Hartmann’s solution you should
immediately inform your doctor describing the symptoms.

4. POSSIBLE SIDE EFFECTS
Like all medicines Hartmann’s solution can cause side effects, although
not everybody gets them.
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 which 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 your doctor or
pharmacist.

1.0, CURRENT

5. HOW HARTMANN’S SOLUTION IS 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 Hartmann’s solution.
Hartmann’s solution should be stored between 2°C and 25°C.
The solution 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 Hartmann’s solution contains
Hartmann’s solution is a clear solution containing sodium lactate
0.317% w/v, sodium chloride 0.6% w/v, potassium chloride 0.04% w/v,
calcium chloride dihydrate 0.027% w/v.
The infusion also contains water for injections, and small amounts of
hydrochloric acid and sodium hydroxide.
What Hartmann’s solution looks like and contents of the pack
Hartmann’s solution is contained in a bag known either as a Steriflex® bag
or a freeflex® bag.
The solutions are available in 500 ml and 1000 ml bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1NT. UK.
Manufacturer:
Terumo BCT Limited
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in February 2014.

V001/TM

Expand view ⇕

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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