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

—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 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:

Fresenius Kabi,

6 Rue de Rempart Louviers, Cedex, France

This leaflet was last revised in June 2014.

FRESENIUS

KABI

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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.

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)

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.

I 0730261 _00_UK_Hartmanns : 073026 l_00_UK_Hartmanns 14.08.2013    10 :48 Uhr Seite 1

kipdi|j)S 142.406

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

0.517% 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 f reef lex® 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:

Fresenius Kabi Deutschland GmbH Werk Friedberg FreseniusstraBe 1 61169 Friedberg Germany

This leaflet was last revised in July 2013.

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.

I 0730261 _00_UK_Hartmanns : 073026 l_00_UK_Hartmanns 14.08.2013    10 :48 Uhr Seite 3

kipdi|j)S 142.406

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 (ECO 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)

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.

Hartmann's Solution for Injection BP as Steriflex® No. 11 or f reef lex®

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.

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.    m

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)

pfegnaricy 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.

% FRESENIUS Ml KABI