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• leaflet MAH GENERIC_PL 20117-0204

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 10 mg/ml solution for infusion

Paracetamol

Read all of this leaflet carefully before you

start using this medicine because it contains

important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you use Paracetamol Infusion

3.    How to use Paracetamol Infusion

4.    Possible side effects

5.    How to store Paracetamol Infusion

6.    Contents of the pack and other 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. What you need to know 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 (listed in section 6)

-    if    you    are    allergic    (hypersensitive)    to

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

-    if you suffer from a severe liver disease.

Warning and precautions

Talk to your doctor before using Paracetamol Infusion

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.

Other medicines and Paracetamol Infusion 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 and may increase as well as alcohol its liver toxic effects.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

Paracetamol infusion can be used during pregnancy. However, the lowest possible dose that reduces your pain and/or your fever should be given to you and the medicine should be administered for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to receive the medicine more often.

Breast-feeding

Paracetamol infusion may be used during breastfeeding.

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 overdosage, because of the risk of irreversible 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 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.

M088864/05 UK

4. Possible side effects

6. Contents of the pack and other information

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

Rare (may affect up to 1 in 1,000 people)

•    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 (may affect up to 1 in 10,000 people)

•    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.

•    very rare cases of serious skin reactions have been reported

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

For the UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland: Reports may be made by following the links to the online reporting option accessible from the HPRA homepage, or by completing the downloadable report form also accessible from the HPRA website, which may be completed manually and submitted to the HPRA via freepost, to the following address:

Pharmacovigilance Section

Health Products Regulatory Authority

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracetamol infusion

Keep out of the sight and reach 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.

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

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” 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 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

Before administration, the product should be This leaflet was last revised in Aug 2015. 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.

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.

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. Contents of the pack and other 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 Infusionslbsung Paracetamol Fresenius Kabi 10 mg/ml oplossing voor infusie riapapeTaMOJi Ka6i/i 10 mg/ml i/ihc|oy3i/ioheh 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 Infusionslbsung

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 infGzijam

Paracetamol Kabi 10 mg/ml infuzinis tirpalas

Paracetamol Kabi 10 mg/ml Infusionslbsung

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

ning

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 revised in Aug 2015.

PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for 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.

Paracetamol 10 mg/ml solution for infusion

Paracetamol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you use Paracetamol Infusion

3.    How to use Paracetamol Infusion

4.    Possible side effects

5.    How to store Paracetamol Infusion

6.    Contents of the pack and other 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. What you need to know 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 (listed in section 6).

if you are allergic (hypersensitive) to propacetamol (another pain killer and a

precursor of paracetamol).

if you suffer from a severe liver disease.

068 8221/04 UKV004/FB

Warnings and precautions

Talk to your doctor before using Paracetamol Infusion

Take special care with Paracetamol Infusion

if you suffer from a live' 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.

Other medicines and Paracetamol Infusion

You should not take other mediches contahing paracetamol if you are taking Paracetamol Infusion, in order not to exceed the recommended daily close (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 and may increase as well as alcohol its liver toxic effects.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

Paracetamol Infusion can be used during pregnancy. However, the lowest possible dose that reduces your pain and/or your fever should be given to you and the medicine should be administered for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to receive the medicine more often.

Breast-feeding

Paracetamol Infusion may be used during breast-feeding.

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.

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 3g 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 Infusion solution is administered as an infusion (via a drip) into your vein over 15 minutes.

An internal 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 overdosage, because of the risk of irreversible 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 (may affect up to 1 in 1,000 people)

•    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 (mav affect up to 1 in 10,000 people)

•    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.

•    Very rare cases of serious skin reactions have been reported.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

For the UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland: Reports may be made by following the links to the online reporting option accessible from the HPRA homepage, or by completing the downloadable report form also accessible from the HPRA website, which may be completed manually and submitted to the HPRA via freepost, to the following address:

Pharmacovigilance Section

Health Products Regulatory Authority

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet,

You can also report side effects directly:

For UK - via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - Reports may be made by following the links to the online reporting option accessible from the FHPRA homepage, or by completing the downloadable report form also accessible from the FHPRA website, which may be completed manually and submitted to the FHPRA via freepost, to the following address:

FREEPOST

Pharmacovigilance Section Health Products Regulatory Authority Kevin O’Malley Flouse

Earlsfort Centre - Earlsfort Terrace - Dublin 2 Tel: +353 1 6764971 - Fax: +353 1 6762517 Website: www.hpra.ie - e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Paracetamol Infusion

Keep out of the sight and reach of children.

Do not use Paracetamol Infusion after the expiry date which is stated on the label and carton after EXR 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. Flowever, 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.    Contents of the pack and other 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.

Paracetamol 10 mg/ml solution for infusion

Paracetamol

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,eiaMO/i Ka6n 10 mg/ml MH(J)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    I nfusionslosung

Greece    Paracetamol Kabi

Hungary    Paracetamol Kabi    10 mg/ml

Ireland    Paracetamol 10 mg/ml solution for infusion

Italy    Paracetamolo Kabi 10 mg/ml

Latvia    Paracetamol Kabi 10 mg/ml skTdums infOzijam

Lithuania    Paracetamol Kabi    10 mg/ml    infuzinis    tirpalas

Luxembourg    Paracetamol Kabi    10 mg/ml    I nfusionslosung

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 Aug 2015

FRESENIUS

KABI

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4,

What is in this leaflet:

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

2.    What you need to know before you use Paracetamol Infusion

3.    How to use Paracetamol Infusion

4.    Possible side effects

5.    How to store Paracetamol Infusion

6.    Contents of the pack and other 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.    What you need to know 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 (listed in Section 6).

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

-    if you suffer from a severe liver disease.

Warnings and precautions

Talk to your doctor before using Paracetamol Infusion.

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.

Other medicines and Paracetamol Infusion

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 and may increase as well as alcohol its liver toxic effects.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

Paracetamol Infusion can be used during pregnancy. However, the lowest possible dose that reduces your pain and/or your fever should be given to you and the medicine should be administered for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to receive the medicine more often,

Breast-feeding

Paracetamol Infusion may be used during breast-feeding.

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 overdosage, because of the risk of irreversible 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 fmav affect up to 1 in 1,000 people)

•    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 fmav affect up to 1 in 10.000 people)

•    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,

•    Very rare cases of serious skin reactions have been reported.

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 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.

The following information is intended for 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/mi 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.