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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 10 mg/ml solution for infusion

Paracetamol

The name of this medicine is Paracetamol 10mg/ml

solution for infusion, called Paracetamol Infusion in

the rest of the leaflet.

Read all of this leaflet carefully before you start

using 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Paracetamol Infusion is and what it is used for

2.    Before you use Paracetamol Infusion

3.    How to use Paracetamol Infusion

4.    Possible side effects

5.    How to store Paracetamol Infusion

6.    Further information

1. WHAT PARACETAMOL INFUSION IS AND WHAT IT IS USED FOR.

This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).

It is indicated

-    for the short-term treatment of moderate pain, especially following surgery,

and

-    for the short-term treatment of fever.

2. BEFORE YOU USE PARACETAMOL INFUSION

Do not use Paracetamol Infusion

-    if    you    are allergic (hypersensitive) to

paracetamol or any of the other ingredients of Paracetamol Infusion.

-    if    you    are allergic (hypersensitive) to

propacetamol (another pain killer and a precursor of paracetamol).

-    if you suffer from a severe liver disease.

Take special care with Paracetamol Infusion

-    if you suffer from a liver or kidney disease, or from alcohol abuse.

-    if you suffer from an inherited liver function disorder called Meulengracht Gilbert's syndrome.

-    if    you    suffer from glucose-6-phosphate

dehydrogenase deficiency.

-    if you are taking other medicines containing paracetamol.

-    if you suffer from a severe lack of nutrition

(malnutrition) or get parenteral nutrition.

Inform your doctor before treatment if any of the above mentioned conditions apply to you.

You should switch to taking pain killing tablets or syrup instead of Paracetamol Infusion as soon as possible.

Taking other medicines

You should not take other medicines containing

paracetamol if you are taking Paracetamol Infusion, in order not to exceed the recommended daily dose (see following section). Inform your doctor if you are taking other medicines containing paracetamol.

If you are using probenecid (a medicine used for the treatment of gout) your doctor should consider reducing the dose of paracetamol you need, as probenecid increases the levels of paracetamol in your blood.

Salicylamide (another pain killer) may increase the levels of paracetamol in your blood and may therefore increase the risk of its toxic effects.

Rifampicin (an antibiotic), barbiturates (sedatives), tricyclic antidepressants, and medicines to treat epileptic fits (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol. Taking these medicines or drinking alcohol whilst taking paracetamol may increase the liver toxic effects.

Taking paracetamol and chloramphenicol (an antibiotic) together may prolong the action of the antibiotic.

Please inform your doctor or pharmacist if you are taking oral contraceptives as these may shorten the action of paracetamol.

Taking paracetamol and zidovudine (a medicine used to treat HIV) together may lead to an increased risk of a reduction in the number of certain white blood cells (neutropenia). This increases your risk of getting infections.

Please inform your doctor or pharmacist if you are taking oral anticoagulants (substances that slow blood clotting). More check-ups to assess the effect of the anticoagulant might be needed.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Paracetamol Infusion may be used during pregnancy. However, in this case your doctor will carefully evaluate if the treatment is advisable.

Breast-feeding

Paracetamol Infusion may be used during breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol Infusion has no influence on the ability to drive or use machines.

3. HOW TO USE PARACETAMOL INFUSION

This product is for intravenous use.

Your doctor will administer Paracetamol Infusion to you. It is administered by drip (infusion).

The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old).

The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

Your doctor should closely monitor you before the end of the infusion, in order to avoid air entering your vein.

Dosage

Dosing based on patient weight (please see the dosing table here below):

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants

** Maximum daily dose: The maximum dailydose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

*** Patients weighing less will require smaller volumes

The    minimum    interval    between    each

administration must be at least 4 hours.

The    minimum    interval    between    each

administration in patients with severe renal insufficiency must be at least 6 hours.

The maximum daily dose must not exceed 3 g in adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration. No more than 4 doses to be given in 24 hours.

How Paracetamol Infusion is given

Paracetamol solution is administered as an infusion (via a drip) into your vein over 15 minutes.

An interval of at least 4 hours must be left between administrations.

If you have the impression that the effect of Paracetamol Infusion is too strong or too weak, talk to your doctor.

If you use more Paracetamol Infusion than you should

If you have used more Paracetamol Infusion than you should, talk to your doctor or pharmacist immediately.

In overdose cases, symptoms generally appear within the first 24 hours and comprise of: nausea, vomiting, loss of appetite, paleness and belly ache. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you have any further questions on the use of this product ask your doctor or pharmacist.

The following information is intended for medical or healthcare professionals only:

Handling

For single use only. Any unused solution should be discarded.

Before administration, the product should be visually inspected for any particulate matter and/or discolouration.

The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.

The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of infusion route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

M088864/04 UK

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Infusion can cause side effects, although not everybody gets them.

Rare (affects 1 to 10 users in 10,000)

•    Changes in laboratory test results (abnormally high levels of liver enzymes found in blood tests). Should this occur, inform your doctor as regular blood tests may be required.

•    Low blood pressure (hypotension)

•    Feeling unwell (malaise)

Very rare (affects less than 1 user in 10,000)

•    Reduced number of certain blood cells (platelets, certain white blood cells), possibly leading to bleeding from the nose or gums and an increased risk of infections. Should these occur, inform your doctor, as regular blood tests may be required.

•    Allergic reactions ranging from simple skin rash or hives to severe allergic reactions (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other parts of the body and shortness of breath, wheezing or difficulty breathing, temporary narrowing of the airways into the lungs (bronchospasm).

If you think that Paracetamol Infusion is causing an allergic reaction, tell your doctor immediately.

Isolated reports (it is not known how common these are)

•    Fast heart beat (tachycardia)

•    Redness of the skin, flush, itching

Effects on laboratory tests

Treatment with Paracetamol Infusion may alter the results of some laboratory tests for uric acid, as well as the test for blood glucose.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL INFUSION

Keep out of the reach and sight of children.

Do not use Paracetamol Infusion after the expiry date which is stated on the label and carton after EXP The expiry date refers to the last day of the month.

Do not refrigerate or freeze.

Before administration, the product should be inspected visually.

Do not use Paracetamol Infusion if you notice any particles in the solution and discolouration other than slightly yellowish.

Your doctor or the hospital staff will normally store Paracetamol Infusion and they are responsible for the quality of the product when it has been opened and if it is not used immediately. However, if not used immediately it should normally not be stored longer than 24 hours. After dilution, the solution should be stored no longer than 6 hours (including the infusion time). They are also responsible for disposing of any unused Paracetamol Infusion correctly.

Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.

This medicinal product is authorised in the Member States of the EEA under the following names:

Paracetamol Kabi 10 mg/ml Infusionslosung

Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie napaqeTaMon Ka6u 10 mg/ml MH0y3MOHeH pa3TBop Paracetamol Kabi 10 mg/ml, roztok pro infuzi

Paracetamol “Fresenius Kabi”

Estonia    Paracetamol Kabi 10 mg/ml

Finland    Paracetamol Fresenius Kabi

Paracetamol Kabi 10 mg/ml Infusionslosung Paracetamol Kabi

Paracetamol Kabi 10 mg/ml Paracetamol 10 mg/ml solution for infusion

Paracetamolo Kabi 10 mg/ml Paracetamol Kabi 10 mg/ml skfdums infuzijam Paracetamol Kabi 10 mg/ml infuzinis tirpalas Paracetamol Kabi 10 mg/ml Infusionslosung

Paracetamol “Fresenius Kabi” 10 mg/ml infusjons-v^ske, oppl0sning Paracetamol Kabi

Paracetamol Kabi

Paracetamol Kabi 10 mg/ml, solute perfuzabila

Paracetamol Kabi 10 mg/ml Paracetamol Kabi 10 mg/ml raztopina za infundiranje Paracetamol Kabi 10 mg/ml solucion para perfusion Paracetamol Fresenius Kabi Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie Paracetamol 10 mg/ml solution for infusion

This leaflet was last revised in 02/2014.

6. FURTHER INFORMATION

What Paracetamol Infusion contains

-    The active substance is paracetamol. 1 ml contains 10 mg paracetamol.

-    Each 50 ml vial contains 500 mg paracetamol.

-    Each 100 ml vial contains 1,000 mg paracetamol.

-    The other ingredients are cysteine, mannitol (E421), water for injections.

What Paracetamol Infusion looks like and contents of the pack

Paracetamol 10 mg/ml solution for infusion is a clear and slightly yellowish solution for infusion.

Paracetamol 10 mg/ml solution for infusion is available in 50 ml or 100 ml glass vials closed with stoppers and aluminium/plastic flip-off caps.

Pack sizes:

1 vial 10 vials 12 vials 20 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Ltd,

Cestrian Court, Eastgate Way, Manor Park,

Runcorn, Cheshire, WA7 1NT

Manufacturer

Fresenius Kabi Austria GmbH,

HafnerstraUe 36, 8055 Graz Austria

Compatibility

Paracetamol 10 mg/ml solution for infusion can be diluted in sodium chloride 9 mg/ml (0.9%) solution or 50 mg/ml glucose (5%) solution up to one tenth (one volume Paracetamol 10 mg/ml solution for infusion into nine volumes diluent). In this case, the diluted solution should be used within 6 hours following its preparation (infusion time included).

The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particulate matter or precipitate.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

Effects on laboratory tests

Treatment with Paracetamol Infusion may alter the results of some laboratory tests for uric acid, as well as the test for blood glucose.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

5.    HOW TO STORE PARACETAMOL INFUSION

Keep out of the reach and sight of children.

Do not use Paracetamol Infusion after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of the month.

Do not refrigerate or freeze.

Before administration, the product should be inspected visually.

Do not use Paracetamol Infusion if you notice any particles in the solution or discolouration other than slightly yellowish.

Your doctor or the hospital staff will normally store Paracetamol Infusion and they are responsible for the quality of the product when it has been opened and if it is not used immediately. However, if not used immediately it should normally not be stored longer than 24 hours. After dilution, the solution should be stored no longer than 6 hours (including the infusion time). They are also responsible for disposing of any unused Paracetamol Infusion correctly.

Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Paracetamol Infusion contains

-    The active substance is paracetamol. 1 ml contains 10 mg paracetamol.

Each 50 ml vial contains 500 mg paracetamol.

Each 100 ml vial contains 1,000 mg paracetamol.

-    The other ingredients are cysteine, mannitol (E421), water for injections.

What Paracetamol Infusion looks like and contents of the pack

Paracetamol 10 mg/ml solution for Infusion is a clear and slightly yellowish solution for Infusion.

Paracetamol 10 mg/ml solution for Infusion is available in 50 ml or 100 ml glass vials closed with stoppers and aluminium/plastic flip-off caps.

Pack sizes:

1 vial 10 vials 12 vials 20 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Ltd, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1 NT.

Manufacturer

Fresenius Kabi Deutschland GmbH, FreseniusstraBe 1,61169 Friedberg, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Paracetamol Kabi 10 mg/ml Infusionslosung Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie riapaueTaMon Ka6n 10 mg/ml MHcjDy3MOHeH pa3TBop Paracetamol Kabi 10 mg/ml, roztok pro infuzi Paracetamol “Fresenius Kabi”

Paracetamol Kabi 10 mg/ml

Paracetamol Fresenius Kabi

Paracetamol Kabi 10 mg/ml Infusionslosung

Paracetamol Kabi

Paracetamol Kabi 10 mg/ml

Paracetamol 10 mg/ml solution for Infusion

Paracetamolo Kabi 10 mg/ml

Paracetamol Kabi 10 mg/ml skldums infuzijam

Paracetamol Kabi 10 mg/ml infuzinis tirpalas

Paracetamol Kabi 10 mg/ml Infusionslosung

Paracetamol “Fresenius Kabi” 10 mg/ml infusjons-vaeske,

opplosning

Paracetamol Kabi

Paracetamol Kabi

Paracetamol Kabi 10 mg/ml, solutie perfuzabila Paracetamol Kabi 10 mg/ml Paracetamol Kabi 10 mg/ml raztopina za infundiranje Paracetamol Kabi 10 mg/ml solucion para perfusion Paracetamol Fresenius Kabi

Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie Paracetamol 10 mg/ml solution for Infusion

This leaflet was last approved in 09/2012.

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for medical or healthcare professionals only: Handling

For single use only. Any unused solution should be discarded.

Before administration, the product should be visually inspected for any particulate matter and/or discolouration.

The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.

The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of infusion route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

Compatibility

Paracetamol 10 mg/ml solution for infusion can be diluted in sodium chloride 9 mg/ml (0.9%) solution or 50 mg/ml glucose (5%) solution up to one tenth (one volume Paracetamol 10 mg/ml solution for infusion into nine volumes diluent). In this case, the diluted solution should be used within 6 hours following its preparation (infusion time included).

The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particulate matter or precipitate.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

Uft FRESENIUS III KABI

Paracetamol 10 mg/ml solution for infusion

Paracetamol

The name of this medicine is Paracetamol 10mg/ml solution for infusion, called Paracetamol Infusion in the rest of the leaflet.

Read all of this leaflet carefully before you start using 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Paracetamol Infusion is and what it is used for

2.    Before you use Paracetamol Infusion

3.    How to use Paracetamol Infusion

4.    Possible side effects

5.    How to store Paracetamol Infusion

6.    Further information

1.    WHAT PARACETAMOL INFUSION IS AND WHAT IT IS USED FOR

This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). It is indicated

-    for the short-term treatment of moderate pain, especially following surgery, and

-    for the short-term treatment of fever.

2.    BEFORE YOU USE PARACETAMOL INFUSION Do not use Paracetamol Infusion

if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol Infusion.

-    if you are allergic (hypersensitive) to propacetamol (another pain killer and a precursor of paracetamol).

-    if you suffer from a severe liver disease.

068 8221/03 UK V003/FB

Take special care with Paracetamol Infusion

-    if you suffer from a liver or kidney disease, or from alcohol abuse.

if you suffer from an inherited liver function disorder called Meulengracht Gilbert's syndrome.

-    if you suffer from glucose-6-phosphate dehydrogenase deficiency.

-    if you are taking other medicines containing paracetamol.

if you suffer from a severe lack of nutrition (malnutrition) or get parenteral nutrition,

Inform your doctor before treatment if any of the above mentioned conditions apply to you.

You should switch to taking pain killing tablets or syrup instead of Paracetamol Infusion as soon as possible.

Taking other medicines

You should not take other medicines containing paracetamol if you are taking Paracetamol Infusion, in order not to exceed the recommended daily dose (see following section). Inform your doctor if you are taking other medicines containing paracetamol.

If you are using probenecid (a medicine used for the treatment of gout) your doctor should consider reducing the dose of paracetamol you need, as probenecid increases the levels of paracetamol in your blood.

Salicylamide (another pain killer) may increase the levels of paracetamol in your blood and may therefore increase the risk of its toxic effects.

Rifampicin (an antibiotic), barbiturates (sedatives), tricyclic antidepressants, and some medicines to treat epileptic fits (antiepiieptics such as carbarnazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol. Taking these medicines or drinking alcohol whilst taking paracetamol may increase the liver toxic effects.

Taking paracetamol and chloramphenicol (an antibiotic) together may prolong the action of the antibiotic.

Please inform your doctor or pharmacist if you are taking oral contraceptives as these may shorten the action of paracetamol.

Taking paracetamol and zidovudine (a medicine used to treat HIV) together may lead to an increased risk of a reduction in the number of certain white blood cells (neutropenia). This increases your risk of getting infections.

Please inform your doctor or pharmacist if you are taking oral anticoagulants (substances that slow blood clotting). More check-ups to assess the effect of the anticoagulant might be needed.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Paracetamol Infusion may be used during pregnancy. However, in this case your doctor will carefully evaluate if the treatment is advisable.

Breast-feeding

Paracetamol Infusion may be used during breast-feeding,

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol Infusion has no influence on the ability to drive or use machines,

3. HOW TO USE PARACETAMOL INFUSION

This product is for intravenous use.

Your doctor will administer Paracetamol Infusion to you. It is administered by drip (infusion).

The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old).

The 50 ml vial is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

Your doctor should closely monitor you before the end of the infusion, in order to avoid air entering your vein.

How Paracetamol Infusion is given

RISK OF MEDICATION ERRORS

Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml_), which could result in accidental overdose and death.

Paracetamol Infusion solution is administered as an infusion (via a drip) into your vein over 15 minutes.

An interval of at least 4 hours must be left between administrations,

If you have the impression that the effect of Paracetamol Infusion is too strong or too weak, talk to your doctor.

If you use more Paracetamol Infusion than you should

If you have used more Paracetamol Infusion than you should, talk to your doctor or pharmacist immediately.

In overdose cases, symptoms generally appear within the first 24 hours and comprise of: nausea, vomiting, loss of appetite, paleness and belly ache. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Infusion can cause side effects, although not everybody gets them.

Rare (affects 1 to 10 users in 10,0001

•    Changes in laboratory test results (abnormally high levels of liver enzymes found in blood tests). Should this occur, inform your doctor as regular blood tests may be required.

•    Low blood pressure (hypotension)

•    Feeling unwell (malaise)

Very rare (affects less than 1 user in 10.0001

•    Reduced number of certain blood cells (platelets, certain white blood cells), possibly leading to bleeding from the nose or gums and an increased risk of infections. Should these occur, inform your doctor, as regular blood tests may be required.

•    Allergic reactions ranging from simple skin rash or hives to severe allergic reactions (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other parts of the body and shortness of breath, wheezing or difficulty breathing, temporary narrowing of the airways into the lungs (bronchospasm).

If you think that Paracetamol Infusion is causing an allergic reaction, tell your doctor immediately.

Isolated reports fit is not known how common these arel

•    Fast heart beat (tachycardia)

•    Redness of the skin, flush, itching

Isolated reports fit is not known how common these are)

•    Fast heart beat (tachycardia)

•    Redness of the skin, flush, itching Effects on laboratory tests

Treatment with Paracetamol Infusion may alter the results of some laboratory tests for uric acid, as well as of the test for blood glucose.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

5.    HOW TO STORE PARACETAMOL INFUSION

Keep out of the reach and sight of children.

Do not use Paracetamol Infusion after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of the month.

Do not refrigerate or freeze.

Before administration, the product should be inspected visually.

Do not use Paracetamol Infusion if you notice any particles in the solution or discolouration other than slightly yellowish.

Your doctor or the hospital staff will normally store Paracetamol Infusion and they are responsible for the quality of the product when it has been opened and if it is not used immediately. Plowever, if not used immediately it should normally not be stored longer than 24 hours. After dilution, the solution should be stored no longer than 6 hours (including the infusion time). They are also responsible for disposing of any unused Paracetamol Infusion correctly.

Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Paracetamol Infusion contains

-    The active substance is paracetamol. 1 ml contains 10 mg paracetamol.

-    Each 50 ml bag contains 500 mg paracetamol.

-    Each 100 ml bag contains 1,000 mg paracetamol.

-    The other ingredients are cysteine, mannitol (E421), water for injections.

What Paracetamol Infusion looks like and contents of the pack

Paracetamol 10 mg/ml solution for infusion is a clear and slightly yellowish solution for

infusion.

Paracetamol 10 mg/ml solution for infusion is available in 50 ml or 100 ml bags closed with stoppers and plastic tamper-evident covers.

Pack sizes:

Bags: 20 bags, 50 bags' 60 bags Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Fresenius Kabi Ltd,

Cestrian Court, Eastgate Way, Manor Park,

Runcorn, Cheshire, WA7 1 NT, UK

Manufacturer

Fresenius Kabi France

6 rue du Rempart - 27400 Louviers - France

Fresenius Kabi Norge AS

Svinesundveien 80 - NO-1753 Halden, Norway

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Paracetamol	Kabi 10 mg/ml Infusionslosung
Belgium	Paracetamol	Fresenius Kabi 10 mg/ml oplossing voor infusie
Bulgaria	napau.eTaMO/1 Ka5n 10 mg/ml nHcf)y3MOHeH pa3TBOp
Czech Republic	Paracetamol	Kabi 10 mg/ml, roztok pro infuzi
Denmark	Paracetamol	“Fresenius Kabi”
Estonia	Paracetamol	Kabi 10 mg/ml
Finland	Paracetamol	Fresenius Kabi
Germany	Paracetamol	Kabi 10 mg/ml Infusionslosung
Greece	Paracetamol	Kabi
Flungary	Paracetamol	Kabi 10 mg/ml
Ireland	Paracetamol	10 mg/ml solution for infusion
Italy	Paracetamol	o Kabi 1 0 mg/ml
Latvia	Paracetamol	Kabi 10 mg/ml skldums infuzijam
Lithuania	Paracetamol	Kabi 10 mg/ml infuzinis tirpalas
Luxembourg	Paracetamol	Kabi 10 mg/ml Infusionslosung
Norway	Paracetamol	“Fresenius Kabi” 10 mg/ml infusjons-vseske, opplosning
Poland	Paracetamol	Kabi
Portugal	Paracetamol	Kabi
Romania	Paracetamol	Kabi 10 mg/ml, solute perfuzabila
Slovakia	Paracetamol	Kabi 10 mg/ml
Slovenia	Paracetamol	Kabi 10 mg/ml raztopina za infundiranje
Spain	Paracetamol	Kabi 10 mg/ml solucion para perfusion
Sweden	Paracetamol	Fresenius Kabi
The Netherlands	Paracetamol	Fresenius Kabi 10 mg/ml oplossing voor infusie
UK	Paracetamol	10 mg/ml solution for infusion

This leaflet was last revised in Jan 2013.

FRESENIUS

KABI

PACKAGE LEAFLET INFORMATION FOR THE USER

Paracetamol 10 mg/ml solution for infusion

Paracetamol

The name of this medicine is Paracetamol 10mg/ml solution for infusion, called Paracetamol Infusion in the rest of the leaflet.

Read all of this leaflet carefully before you start using 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 Paracetamol Infusion is and what it is used for

2.    Before you use Paracetamol Infusion

3.    Flow to use Paracetamol Infusion

4.    Possible side effects

5.    Flow to store Paracetamol Infusion

6.    Further information

1.    WHAT PARACETAMOL INFUSION IS AND WHAT IT IS USED FOR

This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever).

It is indicated

-    for the short-term treatment of moderate pain, especially following surgery, and

-    for the short-term treatment of fever.

2.    BEFORE YOU USE PARACETAMOL INFUSION

Do not use Paracetamol Infusion

-    if you are allergic (hypersensitive) to paracetamol or any of the other ingredients of Paracetamol Infusion.

-    if you are allergic (hypersensitive) to propacetamol (another pain killer and a precursor of paracetamol).

-    if you suffer from a severe liver disease.

Take special care with Paracetamol Infusion

-    if you suffer from a liver or kidney disease, or from alcohol abuse.

-    if you suffer from an inherited liver function disorder called Meulengracht Gilbert's syndrome.

-    if you suffer from glucose-6-phosphate dehydrogenase deficiency.

-    if you are taking other medicines containing paracetamol.

-    if you suffer from a severe lack of nutrition (malnutrition) or get parenteral nutrition. Inform your doctor before treatment if any of the above mentioned conditions apply to you.

You should switch to taking pain killing tablets or syrup instead of Paracetamol Infusion as soon as is possible.

Taking other medicines

You should not take other medicines containing paracetamol if you are taking Paracetamol Infusion, in order not to exceed the recommended daily dose (see following section). Inform your doctor if you are taking other medicines containing paracetamol. If you are using probenecid (a medicine used for the treatment of gout) your doctor should consider reducing the dose of paracetamol you need, as probenecid increases the levels of paracetamol in your blood.

Salicylamide (another pain killer) may increase the levels of paracetamol in your blood and may therefore increase the risk of its toxic effects.

Rifampicin (an antibiotic), barbiturates (sedatives), tricyclic antidepressants and medicines to treat epileptic fits (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol. Taking these medicines or drinking alcohol whilst taking paracetamol may increase the liver toxic effects.

Taking paracetamol and chloramphenicol (an antibiotic) together may prolong the action of the antibiotic.

Please inform your doctor or pharmacist if you are taking oral contraceptives as these may shorten the action of paracetamol.

Taking paracetamol and zidovudine (a medicine used to treat HIV) together may lead to an increased risk of a reduction in the number of certain white blood cells (neutropenia). This increases your risk of getting infections.

Please inform your doctor or pharmacist if you are taking oral anticoagulants (substances that slow blood clotting). More check-ups to assess the effect of the anticoagulant might be needed.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Pregnancy

Inform your doctor if you are pregnant or plan to become pregnant. Paracetamol Infusion may be used during pregnancy. However, in this case your doctor will carefully evaluate if the treatment is advisable.

Breast-feeding

Paracetamol Infusion may be used during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol Infusion has no influence on the ability to drive or use machines.

3. HOW TO USE PARACETAMOL INFUSION

This product is for intravenous use.

Your doctor will administer Paracetamol Infusion to you. It is administered by drip (infusion).

The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years old).

The 50 ml bag is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

Your doctor should closely monitor you before the end of the infusion, in order to avoid air entering your vein.

Dosage

Dosing based on patient weight (please see the dosing table here below):

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants.

** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

***Patients weighing less will require smaller volumes.

The minimum interval between each administration must be at least 4 hours. The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

The maximum daily dose must not exceed 3 g in adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration.

No more than 4 doses to be given in 24 hours.

How Paracetamol Infusion is given RISK OF MEDICATION ERRORS

Take care to avoid dosing errors due to confusion between milligram (mg) and

millilitre (mL), which could result in accidental overdose and death._

Paracetamol solution is administered as an infusion (via a drip) into your vein over 15 minutes.

An interval of at least 4 hours must be left between administrations.

If you have the impression that the effect of Paracetamol Infusion is too strong or too weak, talk to your doctor.

If you use more Paracetamol Infusion than you should

If you have used more Paracetamol Infusion than you should talk to your doctor or pharmacist immediately.

In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, loss of appetite, paleness and belly ache. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Infusion can cause side effects, although not everybody gets them.

Rare (affects 1 to 10 users in 10.0001

•    Changes in laboratory test results (abnormally high levels of liver enzymes found in blood tests). Should this occur, inform your doctor as regular blood tests may be required.

•    Low blood pressure (hypotension)

•    Feeling unwell (malaise)

Very rare (affects less than 1 user in 10.0001

•    Reduced number of certain blood cells (platelets, certain white blood cells), possibly leading to bleeding from the nose or gums and an increased risk of infections. Should these occur, inform your doctor, as regular blood tests may be required.

•    Allergic reactions ranging from simple skin rash or hives to severe allergic reactions (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other parts of the body and shortness of breath, wheezing or difficulty breathing, temporary narrowing of the airways into the lungs (bronchospasm).

If you think that Paracetamol Infusion is causing an allergic reaction, tell your doctor immediately.

The following information is intended for medical or healthcare professionals only:

Handling

For single use only. Any unused solution should be discarded.

Before administration, the product should be visually inspected for any particulate matter and/or discolouration.

The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg.

The 50 ml bag is restricted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

As for all solutions for infusion presented in bags, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of infusion route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

Compatibility

Paracetamol 10 mg/ml solution for infusion can be diluted in sodium chloride 9 mg/ml (0.9%) solution or 50 mg/ml glucose (5%) solution up to one tenth (one volume Paracetamol 10 mg/ml solution for infusion into nine volumes diluent). In this case, the diluted solution should be used within 6 hours following its preparation (infusion time included).

The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particulate matter or precipitate.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.