Piperacillin/Tazobactam 4 G/0.5 G Powder For Solution For Infusion

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Document: leaflet MAH GENERIC_PL 08828-0181 change

PACKAGE LEAFLET:

INFORMATION FOR THE USER_

Piperacillin/Tazobactam 2 g/0.25 g

powder for solution for infusion

Piperacillin/Tazobactam 4 g/0.5 g

powder for solution for infusion

Piperacillin and tazobactam

Read all of this leaflet carefully before you are given 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.

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

What is in this leaflet:

1. What Piperacillin/Tazobactam is and what it is used for

2. What you need to know before you are given Piperacillin/Tazobactam

3. How to use Piperacillin/Tazobactam

4. Possible side effects

5. How to store Piperacillin/Tazobactam

6. Contents of the pack and other information

1. What Piperacillin/Tazobactam is and what it is used for

Piperacillin belongs to the group of medicines known as "broad-spectrum penicillin antibiotics". It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.

Piperacillin/Tazobactam is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/ Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacillin/Tazobactam is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin/Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain serious infections, your doctor may consider using Piperacillin/Tazobactam in combination with other antibiotics.

2. What you need to know before you are given Piperacillin/Tazobactam

Do not use Piperacillin/Tazobactam

- if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam.

Warnings and Precautions

Talk to your doctor or nurse before using Piperacillin/Tazobactam:

• if you have allergies. If you have several

allergies, make sure you tell your doctor or other healthcare professional before receiving this product.

• if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor.

• if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.

• if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.

• if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Other medicines and Piperacillin/Tazobactam in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.

• if you develop convulsions during the treatment. In this case, you should inform your doctor or other healthcare professional.

• if you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.

Children below 2 years Piperacillin /Tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and efficacy.

Other medicines and

Piperacillin/Tazobactam

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines. Some medicines may

interact with piperacillin and tazobactam.

These include:

• medicine for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.

• medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).

• medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.

• methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.

• medicines that reduce the level of potassium in your blood (e.g. tablets enhancing urination or some medicines for cancer).

• medicines containing the other antibiotics tobramycin or gentamycin. Tell your doctor if you have kidney problems.

Effect on laboratory tests Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam if you have to provide a blood or urine sample.

Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor or other healthcare professional before receiving this product. Your doctor will decide if Piperacillin/ Tazobactam is right for you.

Piperacillin and tazobactam can pass to a

baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if Piperacillin/Tazobactam is right for you.

Driving and using machines The use of Piperacillin/Tazobactam is not expected to affect the ability to drive or use machines

Piperacillin/Tazobactam 2 g/0.25 g Contains 4.7 mmol (or 108 mg) sodium per vial of powder for solution for infusion. Piperacillin/Tazobactam 4 g/0.5 g Contains 9.4 mmol (or 216 mg) sodium per vial of powder for solution for infusion.

This should be taken into consideration if you are on a controlled-sodium diet.

3. Howto use Piperacillin/Tazobactam

Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 30 minutes) into one of your veins. The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.

Adults and adolescents aged 12 years or older

The recommended dose is 4 g / 0.5 g of Piperacillin / Tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).

Children aged 2 to 12 years The recommended dose for children with abdominal infections is 100 mg /12.5 mg / kg of body weight of Piperacillin / Tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg /10 mg / kg of body weight of Piperacillin / Tazobactam given every 6 hours into one of your veins (directly into the blood stream).

Your doctor will calculate the dose depending on your child's weight but the daily dose will not exceed 4 g / 0.5 g of Piperacillin/ Tazobactam.

You will be given Piperacillin/Tazobactam until the signs of infection have gone completely (5 to 14 days).

Patients with kidney problems

Your doctor may need to reduce the dose of Piperacillin/Tazobactam or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.

If you take more Piperacillin/Tazobactam than you should

As you will receive Piperacillin/Tazobactam from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions, or thinkyou have been given too much, tell your doctor immediately.

If you forget to use Piperacillin/Tazobactam

If you thinkyou have not been given a dose of Piperacillin/Tazobactam, tell your doctor or other healthcare professional immediately.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

The serious side effects of Piperacillin/ Tazobactam are:

- swelling of the face, lips, tongue or other parts of the body

- shortness of breath, wheezing or trouble breathing

- severe rash, itching or hives on the skin

- yellowing of the eyes or skin

- damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)

If you notice any of the above, see a doctor straight away. For frequency of these reactions, refer to the information below.

Common side effects (may affect 1 to 10 users in 100):

- diarrhoea, vomiting, nausea

- skin rashes

Uncommon side effects (may affect 1 to 10 users in 1,000):

- thrush

- (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)

- allergic reaction

- headache, sleeplessness

- low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)

- jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset

- increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)

- itching, nettle rash

- increase of muscle metabolism product in the blood (blood creatinine increased)

- fever, injection site reaction

- yeast infection (candidal superinfection)

Rare side effects (may affect 1 to 10 users in 10,000):

- (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia)

- severe allergic reaction (anaphylactic/ anaphylactoid reaction, including shock)

- flushed red skin

- a certain form of infection of the colon (pseudomembranous colitis), abdominal pain

- inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gamma-glutamyltransferase increased)

- skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)

- joint and muscle pain

- poor kidney functions and kidney problems

- rigors chill / rigidity

Content of vial	Volume of solvent * to be added to vial
2g/0.25g (2g piperacillin & 0.25g tazobactam)	10 ml
4g/0.5g (4g piperacillin and 0.5g tazobactam)	20 ml

FRESENIUS

KABI

Very rare side effects (may affect less than 1 user in 10,000):

- severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)

- prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)

- decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein

- detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (Stevens-Johnson Syndrome)

- blood urea nitrogen increased

Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any 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 IE: Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:

FREEPOST, Pharmacovigilance Section, Irish Medicines Board

Kevin O'Malley Flouse, Earlsfort Centre, Earlsfort Terrace Dublin 2

Tel:+353 1 6764971 Fax:+353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

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

5. How to store Piperacillin/ Tazobactam

Keep this medicine out of the sight and reach of children. Keep the vials in the outer carton.

Do not use this medicine after the expiry date which is stated on the outer carton and the vials after "EXP". The expiry date refers to the last day of that month.

Unopened vials: Do not store above 25 °C.

For single use only. Discard any unused solution.

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 Piperacillin/Tazobactam contains

The active substances are piperacillin and tazobactam.

Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt).

Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).

There are no other ingredients.

What Piperacillin/Tazobactam looks like and contents of the pack Piperacillin/Tazobactam is a white to off-white lyophilised powder for solution for infusion. Piperacillin/Tazobactam 2 g/0.25 g is available in colourless glass vial (type II) of 15 ml and 50 ml sealed with a grey chlorobutyl rubber stopper. Piperacillin/Tazobactam 4 g/0.5 g is available in colourless glass vial (type II) of 50 ml sealed with a grey chlorobutyl rubber stopper. Pack sizes: 1, 5 and 10 vials Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way

Manor Park, Runcorn, Cheshire, WA7 1NT,

Manufacturer

Laboratorio Farmaceutico C.T.S.r.l.

Via Dante Alighieri 71 180 38 Sanremo -IM, Italy

and

LABESFAL - Laboratories Almiro S.A.

FRESENIUS KABI GROUP

3465-157 Santiago de Besteiros, PORTUGAL

and

For Piperacillin/Tazobactam 4g/0,5g MITIM S.r.l.

Via Cacciamali n°34-36-38

25125 Brescia

ITALY

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

Austria

Piperacillin/Tazobactam Kabi 2 g/0,25 g Pulver zur Herstellung einer Infusionslbsung Piperacillin/Tazobactam Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslbsung

Belgium

Piperacilline/Tazobactam Fresenius Kabi N.V. 2 g/0,25 g poeder voor oplossing voor infusie / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslbsung Piperacilline/Tazobactam Fresenius Kabi N.V. 4 g/0,5 g poeder voor oplossing voor infusie / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslbsung

Bulgaria

Piperacillin/Tazobactam Kabi 2 g/0,25 g npax aa nH({iy3noHeH pa3TBop Piperacillin/Tazobactam Kabi 4 g/0,5 g npax aa nH(f>y3MOHeH pa3TBop

Cyprus

Piperacillin/Tazobactam Kabi 2 g/0,25 g, Kovig yia biaAupa upog eyxuan Piperacillin/Tazobactam Kabi 4 g/0,5 g, Kovig yia biaAupa upog eyxuan

Czech Republic

Piperacillin/Tazobactam Kabi 2 g/0,25 g Piperacillin/Tazobactam Kabi 4 g/0,5 g

Denmark

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g

Pulver til infusionsvaeske, oplosning Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g

Pulver til infusionsvaeske, oplosning Finland

Piperacillin / Tazobactam Fresenius Kabi 2g/0.25g

infuusiokuiva-aine, liuosta varten Piperacillin / Tazobactam Fresenius Kabi 4g / 0.5g

infuusiokuiva-aine, liuosta varten France

Piperacilline/Tazobactam Kabi 2 g/0,25 g, poudre pour solution pour perfusion Piperacilline/Tazobactam Kabi 4 g/0,5 g, poudre pour solution pour perfusion

Germany

Piperacillin/Tazobacatm Kabi 2 g/0,25 g Pulver zur Herstellung einer Infusionslbsung Piperacillin/Tazobacatm Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslbsung

Greece

Piperacillin/Tazobactam Kabi 2 g/0,25 g, Kovig yia biaAupa npog eyxuan Piperacillin/Tazobactam Kabi 4 g/0,5 g, Kovig yia biaAupa npog Eyxuan

Hungary

Piperacillin/Tazobactam Kabi 2 g/0,25 g por oldatos infuziohoz Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infuziohoz

Ireland

Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion

The Netherlands

Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie

Norway

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g

pulver til infusjonsvaeske, opplosning Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g

pulver til infusjonsvaeske, opplosning Poland

Piperacillin/Tazobactam Kabi 2 g/0,25 g, proszek do spoizndzenia roztworu do infuzji. Piperacillin/Tazobactam Kabi 4 g/0,5 g, proszek do spoizndzenia roztworu do infuzji.

Portugal

Piperacillin/Tazobactam Kabi 2g/0,25g Piperacillin/Tazobactam Kabi 4g/0,5g

Romania

Piperacillin/Tazobactam Kabi 2 g/0,25 g, pulbere pentru solutie perfuzabila Piperacillin/Tazobactam Kabi 4g/0,5 g,pulbere pentru solutie perfuzabila

Slovakia

Piperacillin/Tazobactam Kabi 2 g/0,25 g Piperacillin/Tazobactam Kabi 4 g/0,5 g

Spain

Piperacillin/Tazobactam Kabi 2 g/0,25 g Polvo para solucion para perfusion Piperacillin/Tazobactam Kabi 4 g/0,5 g Polvo para solucion para perfusion

Sweden

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g Powder for solution for infusion Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g Powder for solution for infusion

United Kingdom

Piperacillin/ Tazobactam 2g/0.25g powder for solution for infusion Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion

This leaflet was last revised in 01/2014

The following information is intended for healthcare professionals only:

This is an extract from the Summary of Product Characteristics to assist in the administration of Piperacillin/Tazobactam. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SmPC.

Incompatibilities with diluents and other medicinal products

LACTATED RINGER'S (HARTMANN'S) SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN/TAZOBACTAM.

WHEN USED CONCURRENTLY WITH ANOTHER ANTIBIOTIC (E.G. AMINOGLYCOSIDES), PIPERACILLIN/TAZOBACTAM MUST BE ADMINISTERED SEPARATELY. MIXING OF PIPERACILLIN/TAZOBACTAM WITH AN AMINOGLYCOSIDE IN VITRO CAN CAUSE INACTIVATION OFTHEAMINOGLYCOSIDE.

PIPERACILLIN/TAZOBACTAM SHOULD NOT BE MIXED WITH OTHER DRUGS IN A SYRINGE OR INFUSION BOTTLE SINCE COMPATIBILITY HAS NOT BEEN ESTABLISHED.

DUE TO CHEMICAL INSTABILITY, PIPERACILLIN/TAZOBACTAM SHOULD NOT BE USED IN SOLUTIONS THAT CONTAIN SODIUM BICARBONATE.

PIPERACILLIN/TAZOBACTAM SHOULD NOT BE ADDED TO BLOOD PRODUCTS OR ALBUMIN HYDROLYSATES.

Instructions for use

Piperacillin/Tazobactam will be given by intravenous infusion (a drip for 30 minutes).

Intravenous use

Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved. When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).

* Compatible solvents for reconstitution:

- 0.9% (9 mg/ml) sodium chloride solution for injection

- Sterile water for injections(1)

(1) Maximum recommended volume of sterile water for injection per dose is 50 ml.

The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.

The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:

- 0.9% (9 mg/ml) sodium chloride solution for injection

- Glucose 5%

- Dextran 6% in 0.9% sodium chloride

V003/MI

L00076/00

FI43001.00

Piperacillin/Tazobactam 2 g/0.25 g

powder for solution for infusion

Piperacillin/Tazobactam 4 g/0.5 g

powder for solution for infusion

Piperacillin and tazobactam

Read all of this leaflet carefully before you are given 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.

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

What is in this leaflet:

1. What Piperacillin/Tazobactam is and what it is used for

2. What you need to know before you are given Piperacillin/Tazobactam

3. How to use Piperacillin/Tazobactam

4. Possible side effects

5. How to store Piperacillin/Tazobactam

6. Contents of the pack and other information

1. What Piperacillin/Tazobactam is and what it is used for

Piperacillin/Tazobactam is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain serious infections, your doctor may consider using Piperacillin/Tazobactam in combination with other antibiotics.

2. What you need to know before you are given Piperacillin/Tazobactam

Do not use Piperacillin/Tazobactam

- if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam.

Warnings and Precautions

Talk to your doctor or nurse before using Piperacillin/Tazobactam:

• if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.

• if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.

• if you develop convulsions during the treatment. In this case, you should inform your doctor or other healthcare professional.

• if you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.

Children below 2 years

Piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and efficacy.

Other medicines and Piperacillin/Tazobactam Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may interact with piperacillin and tazobactam.

These include:

• medicine for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.

• medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).

• medicines used to relax your muscles during surgeiy. Tell your doctor if you are going to have a general anaesthetic.

• methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.

• medicines that reduce the level of potassium in your blood (e.g. tablets enhancing urination or some medicines for cancer).

• medicines containing the other antibiotics tobramycin or gentamycin. Tell your doctor if you have kidney problems.

Effect on laboratory tests Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam if you have to provide a blood or urine sample.

Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breastfeeding, your doctor will decide if Piperacillin/ Tazobactam is right for you.

Driving and using machines

The use of Piperacillin/Tazobactam is not expected to affect the ability to drive or use machines

Piperacillin/Tazobactam 2 g/0.25 g

Contains 4.7 mmol (or 108 mg) sodium per vial of

powder for solution for infusion.

Piperacillin/Tazobactam 4 g/0.5 g

Contains 9.4 mmol (or 216 mg) sodium per vial of

powder for solution for infusion.

This should be taken into consideration if you are on a controlled-sodium diet.

3. How to use Piperacillin/Tazobactam

Adults and adolescents aged 12 years or older The recommended dose is 4 g / 0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).

Children aged 2 to 12 years

The recommended dose for children with abdominal infections is 100 mg /12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg /10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).

Your doctor will calculate the dose depending on your child's weight but the daily dose will not exceed 4 g / 0.5 g of Piperacillin/Tazobactam.

You will be given Piperacillin/Tazobactam until the sign of infection has gone completely (5 to 14 days).

Patients with kidney problems Your doctor may need to reduce the dose of Piperacillin/Tazobactam or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.

If you take more Piperacillin/Tazobactam than you should

As you will receive Piperacillin/Tazobactam from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions, or think you have been given too much, tell your doctor immediately.

If you forget to use Piperacillin/Tazobactam

If you think you have not been given a dose of Piperacillin/Tazobactam, tell your doctor or other healthcare professional immediately.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

The serious side effects of Piperacillin/ Tazobactam are:

- swelling of the face, lips, tongue or other parts of the body

- shortness of breath, wheezing or trouble breathing

- severe rash, itching or hives on the skin

- yellowing of the eyes or skin

- damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)

If you notice any of the above, see a doctor straight away. For frequency of these reactions, refer to the information below.

Common side effects (may affect 1 to 10 users in 100):

- diarrhoea, vomiting, nausea

- skin rashes

Uncommon side effects (may affect 1 to 10 users in 1,000):

- thrush

- (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)

- allergic reaction

- headache, sleeplessness

- low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)

- jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset

- increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)

- itching, nettle rash

- increase of muscle metabolism product in the blood (blood creatinine increased)

- fever, injection site reaction

- yeast infection (candidal superinfection)

Rare side effects (may affect 1 to 10 users in 10,000):

- severe allergic reaction (anaphylactic/ anaphylactoid reaction, including shock)

- flushed red skin

- a certain form of infection of the colon (pseudomembranous colitis), abdominal pain

- skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)

- joint and muscle pain

- poor kidney functions and kidney problems

- rigors chill / rigidity

Very rare side effects (may affect less than 1 user in 10,000):

- severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)

- prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)

- decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein

- blood urea nitrogen increased

Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. Ibis includes any 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

FREEPOST, Pharmacovigilance Section, Irish Medicines Board

Kevin O'Malley House, Earlsfort Centre, Earlsfort

Terrace

Dublin 2

Tel:+353 1 6764971 Fax:+353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

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

5. How to store Piperacillin/Tazobactam

Keep this medicine out of the sight and reach of children. Keep the vials in the outer carton.

Do not use this medicine after the expiry date which is stated on the outer carton and the vials after "EXP". The expiry date refers to the last day of that month.

Unopened vials: Do not store above 25 °C.

For single use only. Discard any unused solution.

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 Piperacillin/Tazobactam contains The active substances are piperacillin and tazobactam. Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt).

Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).

There are no other ingredients.

What Piperacillin/Tazobactam looks like and contents of the pack

Piperacillin/Tazobactam is a white to off-white lyophilised powder for solution for infusion. Piperacillin/Tazobactam 2 g/0.25 g is available in colourless glass vial (type II) of 15 ml and 50 ml sealed with a grey chlorobutyl rubber stopper. Piperacillin/Tazobactam 4 g/0.5 g is available in colourless glass vial (type II) of 50 ml sealed with a grey chlorobutyl rubber stopper.

Pack sizes: 1, 5 and 10 vials Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way

Manor Park, Runcorn, Cheshire, WA7 1NT, UK

Manufacturer

Laboratorio Farmaceutico C.T.S.r.l.

Via Dante Alighieri 71

180 38 Sanremo -IM, Italy and

LABESFAL - Laboratories Almira S.A.

FRESENIUS KABI GROUP

3465-157 Santiago de Besteiros, PORTUGAL

and

For Piperacillin/Tazobactam 4g/0,5g MITIM S.r.l.

Via Cacciamali n°34-36-38

25125 Brescia

ITALY

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

Austria

Piperacillin/Tazobactam Kabi 2 g/0,25 g Pulver zur Herstellung einer Infusionslosung Piperacillin/Tazobactam Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslosung

Belgium

Piperacilline/Tazobactam Fresenius Kabi N.V.

2 g/0,25 g poeder voor oplossing voor infusie / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslosung

Piperacilline/Tazobactam Fresenius Kabi N.V. 4 g/0,5 g poeder voor oplossing voor infusie / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslosung

Bulgaria

Piperacillin/Tazobactam Kabi 2 g/0,25 g npax 3a nHtpy3H0HeH paarBop

Piperacillin/Tazobactam Kabi 4 g/0,5 g npax 3a nHtpy3H0HeH paarBop

Cyprus

Piperacillin/Tazobactam Kabi 2 g/0,25 g,

Kovig yio SiciAupa Trpog Eyxuari Piperacillin/Tazobactam Kabi 4 g/0,5 g,

Kovig yio SidAupd Trpog Eyxuari

Czech Republic

Piperacillin/Tazobactam Kabi 2 g/0,25 g Piperacillin/Tazobactam Kabi 4 g/0,5 g

Denmark

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g Pulver til infusionsvaeske, oplosning Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g Pulver til infusionsvaeske, oplosning

Finland

Piperacillin /Tazobactam Fresenius Kabi 2g / 0.25g

Content of vial	Volume of solvent * to be added to vial
2g/0.25g (2g piperacillin & 0.25g tazobactam)	10 ml
4g/0.5g (4g piperacillin and 0.5g tazobactam)	20 ml

infuusiokuiva-aine, liuosta varten Piperacillin /Tazobactam Fresenius Kabi 4g / 0.5g infuusiokuiva-aine, liuosta varten

France

Piperacilline/Tazobactam Kabi 2 g/0,25 g, poudre pour solution pour perfusion

Piperacilline/Tazobactam Kabi 4 g/0,5 g, poudre pour solution pour perfusion

Germany

Piperacillin/Tazobacatm Kabi 2 g/0,25 g Pulver zur Herstellung einer Infusionslosung Piperacillin/Tazobacatm Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslosung

Greece

Piperacillin/Tazobactam Kabi 2 g/0,25 g,

Kovig yia SiaAupa npog cyxuon Piperacillin/Tazobactam Kabi 4 g/0,5 g,

Kovig yia SiaAupa npog eyxuan

Hungary

Piperacillin/Tazobactam Kabi 2 g/0,25 g por oldatos infuziohoz Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infuziohoz

Ireland

Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion

The Netherlands

Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie

Norway

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g pulver til infusjonsvaeske, opplosning Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g pulver til infusjonsvaeske, opplosning

Poland

Piperacillin/Tazobactam Kabi 2 g/0,25 g, proszekdo sporzqdzenia roztworu do infuzji. Piperacillin/Tazobactam Kabi 4 g/0,5 g, proszek do sporzqdzenia roztworu do infuzji.

Portugal

Piperacillin/Tazobactam Kabi 2g/0,25g Piperacillin/Tazobactam Kabi 4g/0,5g

Romania

Piperacillin/Tazobactam Kabi 2 g/0,25 g, pulbere pentru solujie perfuzabila

Piperacillin/Tazobactam Kabi 4 g/0,5 g,pulbere pentru solute perfuzabila

Slovakia

Piperacillin/Tazobactam Kabi 2 g/0,25 g Piperacillin/Tazobactam Kabi 4 g/0,5 g

Spain

Piperacillin/Tazobactam Kabi 2 g/0,25 g Polvo para solucion para perfusion

Piperacillin/Tazobactam Kabi 4 g/0,5 g Polvo para solucion para perfusion

Sweden

Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g Powder for solution for infusion Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g Powder for solution for infusion

United Kingdom

Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion

Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion

This leaflet was last revised in

01/2014

The following information is intended for healthcare professionals only:

Incompatibilities with diluents and other medicinal products

LACTATED RINGER'S (HARTMANN'S) SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN/ TAZOBACTAM.

PIPERACILLIN/TAZOBACTAM SHOULD NOT BE MIXED WITH OTHER DRUGS IN A SYRINGE OR INFUSION BOTTLE SINCE COMPATIBILITY HAS NOT

BEEN ESTABLISHED.

DUE TO CHEMICAL INSTABILITY, PIPERACILLIN/ TAZOBACTAM SHOULD NOT BE USED IN SOLUTIONS THAT CONTAIN SODIUM BICARBONATE.

PIPERACILLIN/TAZOBACTAM SHOULD NOT BE ADDED TO BLOOD PRODUCTS OR ALBUMIN HYDROLYSATES.

Instructions for use

Piperacillin/Tazobactam will be given by intravenous infusion (a drip for 30 minutes).

Intravenous use

* Compatible solvents for reconstitution:

- 0.9% (9 mg/ml) sodium chloride solution for injection

- Sterile water for injections(l)

(1) Maximum recommended volume of sterile water for injection per dose is 50 ml.

The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:

- 0.9% (9 mg/ml) sodium chloride solution for injection

- Glucose 5%

- Dextran 6% in 0.9% sodium chloride

FRESENIUS voos

KABI 796727/03