K218302/02218302

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Package leaflet: Information for the user

AUGMENTIN'® Intravenous

j    co-amoxidav (amoxicillin and davulanic add)

3

How Augmentin is given

You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.

The recommended doses are:

Adults, and children weighing 40 kg and over

Information for the Healthcare Professional

AUGMENTIN® Intravenous

co-amoxiclav (amoxicillin and davulanic acid)

Please refer to the Summary of Product Characteristics for further information

Administration

Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Augmentin is not suitable for intramuscular administration.

Reconstitution

For single use only. Discard any unused solution.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

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

Children weighing less than 40 kg

All doses are worked out depending on the child's bodyweight in kilograms.

Patients with kidney and liver problems

•    If you have kidney problems you may be given a different dose. A different strength or a different medicine may be chosen by your doctor.

•    If you have liver problems your doctor will keep a close check on you and you may have more regular liver function tests.

How Augmentin will be given to you

•    Augmentin will be given as an injection into a vein or by intravenous infusion.

•    Make sure you drink plenty of fluids while having Augmentin.

•    You will not normally be given Augmentin for longer than 2 weeks without the doctor reviewing your treatment.

If more Augmentin is given to you than recommended

It is unlikely you will be given too much, but if you think you have been given too much Augmentin, tell your doctor, pharmacist or nurse immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.

If you have any further questions about how this medicine is given, ask your doctor, pharmacist or nurse.

Preparation of solutions for intravenous injection

500 mg/100 mg powder for solution for injection or infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin 500 mg/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin should be administered within 20 min of reconstitution.

1000 ma/200 ma powder for solution for injection or infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion Augmentin vials are not suitable for multi-dose use.

500 mg/100 mg powder for solution for injection or infusion

Augmentin should be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.

1000 ma/200 ma powder for solution for injection or infusion

Augmentin should be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or before dilution for infusion)

500 ma/100 ma powder for solution for injection or infusion

The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

1000 ma/200 ma powder for solution for injection or infusion

The reconstituted solution (1 vial with 20 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

Diluted for intravenous infusion

500 ma/100 ma powder for solution for injection or infusion

Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately.

1000 ma/200 ma powder for solution for injection or infusion

Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 100 ml of infusion fluid) should be used immediately.

:    Intravenous infusions of amoxicillin/clavulanic acid may be given in a range of different

:    intravenous fluids. Satisfactory antibiotic concentrations are retained at 5°C and at room

:    temperature (25°C) in the recommended volumes of the following infusion fluids. If

:    reconstituted and maintained at room temperature (25°C), infusions should be completed

i: j within the times stated in the table below.

dL

4 Possible side effects

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room temperature.

The stability of Augmentin IV solutions is concentration dependent. In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly.

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of amoxicillin/clavulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

This leaflet was last revised in October 2015.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

•    skin rash

•    inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body

•    fever, joint pain, swollen glands in the neck, armpit or groin

•    swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing

•    collapse.

^ Contact a doctor immediately if you get

any of these symptoms. Stop taking Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

^ Contact your doctor as soon as possible

for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people

•    thrush (candida - a yeast infection of the vagina, mouth or skin folds)

•    diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people

•    skin rash, itching

•    raised itchy rash (hives)

•    feeling sick (nausea), especially when taking high doses

•    vomiting

•    indigestion

•    dizziness

•    headache.

Uncommon side effects that may show up in

your blood tests:

•    increase in some substances (enzymes) produced by the liver.

Rare side effects

These may affect up to 1 in 1,000 people

•    skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

if you notice any of these symptoms contact a doctor urgently.

•    swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your

blood tests:

•    low number of cells involved in blood clotting

•    low number of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

•    Allergic reactions (see above)

•    Inflammation of the large intestine (see above)

•    Inflammation of the protective membrane surrounding the brain (aseptic meningitis)

•    Serious skin reactions:

-    a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)

-    widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

-    a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).

Contact a doctor immediately if you get any of these symptoms.

•    inflammation of the liver (hepatitis)

•    jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow

•    inflammation of tubes in the kidney

•    blood takes longer to clot

•    convulsions (in people taking high doses of Augmentin or who have kidney problems).

Side effects that may show up in your blood or urine tests:

•    severe reduction in the number of white blood cells

•    low number of red blood cells (haemolytic anaemia)

•    crystals in urine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine

6 Contents of the pack and other information

5 How to store Augmentin

Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's information. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Augmentin contains:

500 mg/100 mg powder for injection or infusion

•    The active substances are amoxicillin and clavulanic acid.

Each vial or bottle contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mg/200 mg powder for injection or infusion

•    The active substances are amoxicillin and clavulanic acid.

Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

There are no other ingredients.

However, please see section 2 for further important information about sodium and potassium in Augmentin.

The doctor, nurse or pharmacist will make up the injection before use using an appropriate fluid (such as Water for Injections or an injection/infusion fluid).

What Augmentin looks like and contents of the pack

Augmentin IV 500 mg/100 mg powder for solution for injection or infusion is supplied as clear glass vials of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5 or 10.

Augmentin IV 1000 mg/200 mg powder for solution for injection is supplied as clear glass vials or bottles of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5, 10, 25 or 100. The bottles are supplied in packs of 5.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Beecham Group Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer: Biopharma S.r.l., Via delle Gerbere 22/30, 00134 Santa Palomba,

Roma - Italy

Other formats

To listen or to request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name    Augmentin Intravenous

Reference number 00038/0320

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in October 2015.

Augmentin is a registered trade mark of the GSK group of companies.

© 2015 GSK group of companies. All rights reserved.

<218302/02218302

Package leaflet: Information for the user

' Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

Children weighing less than 40 kg

All doses are worked out depending on the child's bodyweight in kilograms.

1000000

0130906

Information for the Healthcare Professional

Intravenous

co-amoxiclav (amoxicillin and clavulanic acid)

Please refer to the Summary of Product Characteristics for further information

Administration

Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Augmentin is not suitable for intramuscular administration.

Reconstitution

For single use only. Discard any unused solution.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration.

The solution should only be used if the solution is clear and free from particles.

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

Preparation of solutions for intravenous injection

500 mg/100 mg powder for solution for injection or infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin 500 mg/100 mg should be dissolved in 10 ml of solvent. This yields approximately 10.5 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin should be administered within 20 min of reconstitution.

1000 mg/200 mg powder for solution for injection or infusion

Water for Injections Ph.Eur. is the normal solvent. Augmentin 1000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless to yellow in colour.

Augmentin should be administered within 20 min of reconstitution.

Preparation of solutions for intravenous infusion Augmentin vials are not suitable for multi-dose use.

500 mg/100 mg powder for solution for injection or infusion

Augmentin should be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.

1000 mg/200 mg powder for solution for injection or infusion

Augmentin should be reconstituted as described above for injection. Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or before dilution for infusion)

500 mg/100 mg powder for solution for injection or infusion

The reconstituted solution (1 vial with 10 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

1000 mg/200 mg powder for solution for injection or infusion

The reconstituted solution (1 vial with 20 ml of Water for Injections Ph.Eur.) should be used or diluted immediately, within 20 minutes.

Diluted for intravenous infusion

500 mg/100 mg powder for solution for injection or infusion

Chemical and physical in-use stability has been demonstrated for 2-3 hours at 25°C, or 8 hours at 5°C. From a microbiological point of view, the reconstituted and diluted solution (1 reconstituted vial in a minimum volume of 50 ml of infusion fluid) should be used immediately.

4 Possible side effects

For storage at 5°C, reconstituted solutions of Augmentin IV may be added to pre-refrigerated infusion bags containing either Water for Injections Ph.Eur. or sodium chloride BP (0.9% w/v), which may be stored for up to 8 hours. Thereafter, the infusion should be administered immediately after reaching room temperature.

The stability of Augmentin IV solutions is concentration dependent. In the event that the use of more concentrated solutions is required, the stability period should be adjusted accordingly.

Augmentin IV is less stable in infusions containing glucose, dextran or bicarbonate. Reconstituted solutions of amoxicillin/clavulanic acid may be injected into the drip tubing over a period of 3 to 4 min.

Any residual antibiotic solution should be discarded.

This leaflet was last revised in October 2015.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

•    skin rash

•    inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body

•    fever, joint pain, swollen glands in the neck, armpit or groin

•    swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing

•    collapse.

^ Contact a doctor immediately if you get

any of these symptoms. Stop taking Augmentin.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

^ Contact your doctor as soon as possible

for advice if you get these symptoms.

Common side effects

These may affect up to 1 in 10 people

•    thrush (candida - a yeast infection of the vagina, mouth or skin folds)

•    diarrhoea

Uncommon side effects

These may affect up to 1 in 100 people

•    skin rash, itching

•    raised itchy rash (hives)

•    feeling sick (nausea), especially when taking high doses

•    vomiting

•    indigestion

•    dizziness

•    headache.

Uncommon side effects that may show up in

your blood tests:

•    increase in some substances (enzymes) produced by the liver.

Rare side effects

These may affect up to 1 in 1,000 people

•    skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

if you notice any of these symptoms contact a doctor urgently.

•    swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your

blood tests:

•    low number of cells involved in blood clotting

•    low number of white blood cells.

Frequency not known

Frequency cannot be estimated from the available data.

•    Allergic reactions (see above)

•    Inflammation of the large intestine (see above)

•    Inflammation of the protective membrane surrounding the brain (aseptic meningitis)

•    Serious skin reactions:

-    a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)

-    widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis)

-    a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).

Contact a doctor immediately if you get any of these symptoms.

•    inflammation of the liver (hepatitis)

•    jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow

•    inflammation of tubes in the kidney

•    blood takes longer to clot

•    convulsions (in people taking high doses of Augmentin or who have kidney problems).

Side effects that may show up in your blood or urine tests:

•    severe reduction in the number of white blood cells

•    low number of red blood cells (haemolytic anaemia)

•    crystals in urine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

5 How to store Augmentin

Augmentin Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's information. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Augmentin contains:

500 mg/100 mg powder for injection or infusion

•    The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid.

1000 mg/200 mg powder for injection or infusion

•    The active substances are amoxicillin and clavulanic acid. Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

There are no other ingredients. However, please see section 2 for further important information about sodium and potassium in Augmentin.

The doctor, nurse or pharmacist will make up the injection before use using an appropriate fluid (such as Water for Injections or an injection/infusion fluid).

What Augmentin looks like and contents of the pack

Augmentin IV 500 mg/100 mg powder for solution for injection or infusion is supplied as clear glass vials of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5 or 10.

Augmentin IV 1000 mg/200 mg powder for solution for injection is supplied as clear glass vials or bottles of sterile powder for making up as an injection or infusion. The vials are supplied in packs of 1, 5, 10, 25 or 100. The bottles are supplied in packs of 5.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Beecham Group Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufacturer: SmithKline Beecham, Worthing, West Sussex BN14 8QH

Other formats

To listen or to request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name    Augmentin Intravenous

Reference number 00038/0320

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in October 2015.

Augmentin is a registered trade mark of the GSK group of companies.

© 2015 GSK group of companies. All rights reserved.

1000000

0130906

1000000

0130906