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PIPERACILLIN/TAZOBACTAM 4 G/0.5 G POWDER FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

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Patient leaflet - PIPERACILLIN/TAZOBACTAM 4 G/0.5 G POWDER FOR SOLUTION FOR INFUSION

FRESENIUS

Anexo 6.00 do PT.G.087


CO DIGO: Code

DESIGNA?AO: ut.pjp/taz FKUK/IE

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ELABORADO POR: Jose Duarte

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°AJA: 20 Ago. 2019

Date *

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Technical Sheet FTP_LEA_MC_600X210

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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 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 nurse.

– 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 use 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 use 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 betalactamase 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 effectiveness.

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 or vancomycin. 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 4.9 mmol (or 112 mg) sodium per vial of powder for solution for infusion.

Piperacillin/Ta­zobactam 4 g/0.5 g

Contains 9.7 mmol (or 224 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

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 each individual 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.

See a doctor immediately if you experience any of these potentially serious side effects of Piperacillin/Ta­zobactam.

The serious side effects (with frequency in brackets) of Piperacillin/Ta­zobactam are:

– serious skin rashes [Stevens-Johnson syndrome, dermatitis bullous (Not known), dermatitis exfoliative (Not known), toxic epidermal necrolysis (Rare)] appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin and potentially may be life threatening

– severe potentially fatal allergic condition (drug reaction with eosinophilia and systemic symptoms) that can involve the skin and most importantly other organs under the skin such as the kidney and the liver (Not known)

– a skin condition (acute generalised exanthematous pustulosis) accompanied by fever, which consists of numerous tiny fluid filled blisters contained within large areas of swollen and reddened skin (Not known)

– swelling of the face, lips, tongue or other parts of the body (Not known)

– shortness of breath, wheezing or trouble breathing (Not known)

– severe rash or hives (Uncommon), itching or rash on the skin (Common)

– yellowing of the eyes or skin (Not known)

– damage to blood cells [the signs include: being breathless when you do not expect it, red or brown urine (Not known), nosebleeds (Rare) and small spot bruising (Not known), severe decrease in white blood cells (Rare)]

– severe or persistent diarrhoea accompanied by a fever or weakness (Rare)

If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other healthcare professional.

Very common side effects (may affect more than 1 in 10 people):

– diarrhoea

Common side effects (may affect up to 1 in 10 people):

– yeast infection

– decrease in platelets, decrease of red blood cells or blood pigment / haemoglobin, abnormal lab test (positive direct Coombs), prolonged blood clotting time (activated partial thromboplastin time prolonged)

– decrease in blood protein

– headache, sleeplessness

– abdominal pain, vomiting, nausea, constipation, upset stomach

– increase in blood liver enzymes

– abnormal kidney blood tests

– fever, injection site reaction

Uncommon side effects (may affect up to 1 in 100 people):

– decrease in white blood cells (leukopenia), prolonged blood clotting time (prothrombin time prolonged)

– decreased blood potassium, decreased blood sugar

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

– increase of a blood pigment breakdown product (bilirubin)

– joint and muscle pain

– chills

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

– serious infection of the colon, inflammation of the mucous lining of the mouth

Not known side effects (cannot be estimated from the available data):

– severe decrease of red blood cells, white blood cells and platelets (pancytopenia), decrease in white blood cells (neutropenia), bleeding time prolonged, increase of platelets increase of a specific type of white blood cells (eosinophilia)

– allergic reaction and severe allergic reaction

– inflammation of the liver.

– poor kidney functions and kidney problems

– a form of lung disease where eosinophils (a form of white blood cell) appear in the lung in increased numbers.

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:

For IE:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website:

e-mail:

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

For UK

Fresenius Kabi Limited

Cestrian Court,

Eastgate Way,

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

ForIRL

Fresenius Kabi Deutschland GmbH

Else-Kroener Strasse 1,

Bad Homburg v.d.H. 61352,

Germany

Manufacturer

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 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

flnnepaquriMH/Ta­aoSaKTaM Ka6n 2 g/0,25 g npax 3a MHtbyauoHeH pasiaop flnnepaquriMH/Ta­aobaKraM Ka6n 4 g/0,5 g npax 3a MHcbyauoHeH pa3TBop

Cyprus

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

Kovi? yia SiaAupa npo? eyxuaq

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

Kovi? yia SiaAupa npo? eyxuaq

Czech Republic

Piperacillin/Ta­zobactam Kabi 4 g/0,5 g

Denmark

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

Pulver til infusionsvaeske, oplesning

Piperacillin/Ta­zobactam Fresenius Kabi 4 g/0,5 g

Pulver til infusionsvaeske, oplesning

Finland

Piperacillin I Tazobactam Fresenius Kabi 2g / 0.25g infuusiokuiva-aine, liuosta varten

Piperacillin I Tazobactam Fresenius Kabi 4g / 0.5g infuusiokuiva-aine, liuosta varten voos/ts-new i™

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 biaAupa npog tyxuari Piperacillin/Ta­zobactam Kabi 4 g/0,5 g, Kovig yia biaAupa npog tyxuari

Hungary

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

Nonway

Piperacillin/Ta­zobactam Fresenius Kabi 2 g/0,25 g pulver til infusjonsvaeske, opplesning

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

Poland

Piperacillin/Ta­zobactam Kabi 2 g/0,25 g, proszek do sporzgdzenia 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 soluble perfuzabila

Piperacillin/Ta­zobactam Kabi 4 g/0,5 g,pulbere pentru solujie 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 solucidn para perfusidn Piperacillin/Ta­zobactam Kabi 4 g/0,5 g Polvo para solution 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

August 2019

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 OF THE AMINOGLYCOSIDE.

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 ADDEDTO BLOOD PRODUCTS ORALBUMIN 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. Shake until dissolved. When shaken constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).

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

* 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 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