Piperacillin/tazobactam Kabi 2 g/0.25 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Piperacillin/Tazobactam Kabi is and what it is used for
2. What you need to know before using Piperacillin/Tazobactam Kabi
3. How to use Piperacillin/Tazobactam Kabi
4. Possible side effects
5. How to store Piperacillin/Tazobactam Kabi
6. Contents of the pack and other information

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

Piperacillin belongs to a group of medicines called broad-spectrum penicillin antibiotics, which can destroy many types of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. Thus, when piperacillin and tazobactam are administered together, a greater number of bacterial types are destroyed.

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 between 2 and 12 years of age to treat abdominal infections, such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and biliary tract infections. Piperacillin/tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain severe infections, your doctor may decide to use piperacillin/tazobactam in combination with other antibiotics.

2. What you need to know before using Piperacilina/Tazobactam Kabi

Do not use Piperacilina/Tazobactam Kabi

• if you are allergic to piperacillin or tazobactam, or to 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 also be allergic to Piperacilina/Tazobactam Kabi.

Warnings and precautions

Talk to your doctor or nurse before using Piperacilina/Tazobactam Kabi

• if you have allergies. If you have multiple allergies, make sure to inform your doctor or other healthcare professional before receiving this medicine.
• if you had diarrhea before treatment or if you develop diarrhea during or after treatment. In this case, inform your doctor or healthcare professional immediately. Do not take any anti-diarrheal medication without first consulting your doctor.
• if you have low levels of potassium in your blood. Your doctor may want to assess your kidney function before you receive this medicine and may perform periodic blood tests during treatment.
• if you have kidney or liver problems, or if you are undergoing hemodialysis. Your doctor may want to assess your kidney function before treatment and may perform periodic blood tests during treatment.
• if you are taking certain medications (called anticoagulants) to prevent excessive blood clotting (see also Use of Piperacilina/Tazobactam Kabi with other medicines in this leaflet), or if you experience unexpected bleeding during treatment. In this case, inform your doctor or healthcare professional immediately.
• if you are taking another antibiotic called vancomycin at the same time as Piperacilina/Tazobactam, as this may increase the risk of kidney damage (see also Use of Piperacilina/Tazobactam Fresenius Kabi with other medicines in this leaflet).
• if you experience seizures during treatment. In this case, inform your doctor or healthcare professional immediately.
• if you suspect you have developed a new infection or your existing infection has worsened. In this case, inform your doctor or healthcare professional immediately.
• if you develop severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP). Stop using Piperacilina/Tazobactam Fresenius Kabi and seek immediate medical attention if you notice any of the symptoms described in section 4.

Hemophagocytic lymphohistiocytosis

Cases of a condition in which the immune system produces excessive amounts of otherwise normal white blood cells called histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis), have been reported. This condition can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen lymph nodes, weakness, dizziness, difficulty breathing, bruising, or skin rash, contact your doctor immediately.

If you notice signs or symptoms of an allergic reaction accompanied by chest pain, inform your doctor immediately. This could be a sign of a condition called Kounis syndrome.

If you experience unexplained muscle pain, tenderness, weakness, and/or dark-colored urine, inform your doctor immediately. This could be a sign of muscle breakdown (called rhabdomyolysis), which may lead to kidney problems.

Children under 2 years of age

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

Use of Piperacilina/Tazobactam Kabi with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. Some medicines may interact with piperacillin or tazobactam.

These include:

• a medicine for gout (probenecid). This product may increase the time it takes for piperacillin and tazobactam to be eliminated from the body.
• medicines used to thin the blood or treat blood clots (e.g., heparin, warfarin, or acetylsalicylic acid).
• medicines used to relax muscles during surgery. Inform your doctor if you are undergoing general anesthesia.
• methotrexate (a medicine used to treat cancer, arthritis, or psoriasis). Piperacillin and tazobactam may increase the time it takes for methotrexate to be eliminated from the body.
• medicines that reduce potassium levels in the blood (e.g., diuretics or certain cancer medications).
• medicines containing other antibiotics such as tobramycin, gentamicin, or vancomycin. Inform your doctor if you have kidney problems. Taking Piperacilina/Tazobactam and vancomycin together may increase the risk of kidney damage, even if you do not have pre-existing kidney problems.

Effects on laboratory tests

If you are required to provide a blood or urine sample, inform your doctor or laboratory staff that you are using Piperacilina/Tazobactam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Piperacilina/Tazobactam Kabi is appropriate for you.

Piperacillin and tazobactam may pass to the unborn child through the placenta or to the infant through breast milk. If you are breastfeeding, your doctor will decide whether Piperacilina/Tazobactam Kabi is suitable for you.

Driving and using machines

Piperacilina/Tazobactam Kabi is not expected to affect your ability to drive or operate machinery.

Piperacilina/Tazobactam Kabi 2 g/0.25 g contains 112 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 5.6% of the maximum daily recommended sodium intake for an adult.

3. How to use Piperacilina/Tazobactam Kabi

Your doctor or another healthcare professional will administer this medicine by intravenous infusion (into a vein via an infusion drip over 30 minutes). The dose of medicine you will receive depends on your condition, 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 administered every 6–8 hours intravenously (directly into the bloodstream).

Children aged 2 to 12 years

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

Your doctor will calculate the dose based on the child's body weight, but each individual dose will not exceed 4 g/0.5 g of Piperacilina/Tazobactam Kabi.

You will be administered Piperacilina/Tazobactam Kabi until all signs of infection have completely disappeared (from 5 to 14 days).

Patients with kidney problems

Your doctor may need to reduce your dose of Piperacilina/Tazobactam Kabi or adjust the frequency of administration. Your doctor may also wish to perform blood tests to ensure you are receiving the appropriate dose, especially if you need to use this medicine for a prolonged period.

If you use more Piperacilina/Tazobactam Kabi than you should

Since a doctor or another healthcare professional will administer Piperacilina/Tazobactam Kabi, it is unlikely that you will receive an incorrect dose. However, if you experience adverse effects such as seizures, or if you think you have been given too much medicine, inform your doctor immediately.

If you forget to use Piperacilina/Tazobactam Kabi

If you think a dose of Piperacilina/Tazobactam Kabi has not been administered, inform your doctor or healthcare professional immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of these potentially serious adverse effects of Piperacillin/Tazobactam.

Serious adverse effects (with frequency in parentheses) of Piperacillin/Tazobactam Kabi are:

• severe skin rashes initially appearing as reddish spots or circular lesions with central blisters on the trunk. Other signs include ulcers in the mouth, throat, nose, limbs, genitals, and red, swollen eyes (conjunctivitis). The rash may progress to widespread blistering or peeling of the skin and, potentially, can be fatal. These may be signs of Stevens-Johnson syndrome (not known), bullous dermatitis (not known), exfoliative dermatitis (not known), toxic epidermal necrolysis (rare), or a skin disease accompanied by fever, characterized by numerous small fluid-filled pustules appearing on large areas of swollen and reddened skin, known as acute generalized exanthematous pustulosis (not known)
• potentially severe allergic reaction (drug reaction with eosinophilia and systemic symptoms) that may affect the skin and other vital organs such as the kidneys or liver (not known)
• swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing (allergic reactions, including anaphylactic shock, not known) – sudden chest pain that may occur during an allergic reaction known as Kounis syndrome (not known)
• severe rash or hives (uncommon), itching or skin rash (common)
• inflammation of the liver (hepatitis, not known), yellowing of the skin or whites of the eyes (jaundice, not known)
• low levels of red blood cells (anemia, common), excessive breakdown of red blood cells leading to unexpected shortness of breath, red or brown urine (hemolytic anemia, not known)
• low platelet counts, which may cause bleeding and bruising (thrombocytopenia, common)
• low levels of white blood cells, which fight infections (leukopenia, uncommon, or neutropenia, not known)
• very low levels of a type of white blood cells called granulocytes (agranulocytosis, rare)
• elevated platelet counts (thrombocytosis, not known)
• elevated levels of a type of white blood cells called eosinophils (eosinophilia, not known)
  • low levels of all types of blood cells, including platelets (pancytopenia, not known), persistent or severe diarrhea accompanied by fever or weakness (pseudomembranous colitis, rare)
  • decreased potassium levels in blood (uncommon)
  • seizures, observed in patients receiving high doses or with kidney problems (uncommon)
  • severe muscle pain, tenderness, or weakness (rhabdomyolysis, not known)

If any of the following adverse effects are severe, or if you experience any adverse effect not listed in this leaflet, inform your doctor or another healthcare professional.

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

• diarrhea

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

• yeast infection
• antibodies in the blood that attack red blood cells (positive direct Coombs test), prolonged blood clotting time (prolonged activated partial thromboplastin time), decreased blood proteins
• headache, insomnia
• abdominal pain, vomiting, nausea, constipation, stomach discomfort
• increased liver enzymes in blood
• abnormal kidney blood tests
• fever, injection site reaction

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

• prolonged blood clotting time (prolonged prothrombin time), decreased blood sugar levels
• low blood pressure, inflammation of veins (pain upon touch or redness in the affected area), skin redness
• increased levels of a breakdown product of blood pigment (bilirubin)
• skin reactions with redness, formation of skin lesions
• muscle and joint pain
• chills

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

• nosebleeds, inflammation of the mucous membrane in the mouth

Adverse effects with unknown frequency (cannot be estimated from available data):

• small bruises, prolonged bleeding time
• blistering disease in which blisters form on the skin and mucous membranes (linear IgA disease)
• impaired kidney function and kidney problems
• a type of lung disease in which eosinophils (a type of white blood cells) appear in increased numbers in the lungs
• acute disorientation and confusion (delirium)

In patients with cystic fibrosis, treatment with piperacillin has been associated with an increased incidence of fever and skin rashes.

Beta-lactam antibiotics, including piperacillin/tazobactam, may lead to manifestations of encephalopathy and seizures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Piperacillin/Tazobactam Kabi

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Unopened vials: Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Piperacillin/Tazobactam Kabi

The active substances are piperacillin and tazobactam.

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

There are no other components.

Appearance of the product and contents of the pack

Piperacillin/Tazobactam Kabi 2 g/0.25 g is a sterile, white or almost white, lyophilized powder for solution for infusion.

Piperacillin/Tazobactam Kabi 2 g/0.25 g is available in colorless glass vials (type II) of 10 ml and 50 ml, closed with a halobutyl rubber stopper.

Pack sizes: 1, 5 and 10 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España S.A.U
C/ Marina 16-18,
08005 - Barcelona
Spain

Manufacturer:

LABESFAL - Laboratórios Almiro S.A.
FRESENIUS KABI GROUP
3465-157 Santiago de Besteiros
PORTUGAL

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: February 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

The following text is an extract from the Summary of Product Characteristics (SmPC), provided as guidance for the administration of Piperacillin/Tazobactam Kabi. When determining the suitability of use in a specific patient, the prescribing physician must be familiar with the full SmPC.

Incompatibilities with solvents and other medicinal products

RINGER'S LACTATE solution is NOT compatible with Piperacillin/Tazobactam Kabi.

When piperacillin/tazobactam is used concomitantly with another antibiotic (e.g. AMINOGLYCOSIDE), the drugs must be administered SEPARATELY. Mixing Piperacillin/Tazobactam Kabi with an aminoglycoside in vitro may result in substantial inactivation of the aminoglycoside.

Piperacillin/Tazobactam Kabi must be ADMINISTERED via a separate infusion set from any other medicinal product, unless compatibility has been demonstrated.

Due to chemical instability, Piperacillin/Tazobactam Kabi MUST NOT be used with solutions containing SODIUM BICARBONATE.

Piperacillin/Tazobactam Kabi MUST NOT be added to BLOOD PRODUCTS or ALBUMIN HYDROLYSATES.

Instructions for use

Piperacillin/tazobactam is to be administered by intravenous infusion (over 30 minutes).

Intravenous route

Each vial must be reconstituted with the volume of solvent indicated in the following table, using one of the compatible solvents for reconstitution. Shake gently with rotary movements until dissolved. If mixed continuously, reconstitution is usually achieved within 5 to 10 minutes (see handling details below).

• Solvents compatible for reconstitution:
  • 0.9% (9 mg/ml) sodium chloride injectable solution
  • Sterile water for injections(1)

(1) The maximum recommended volume of sterile water for injections per dose is 50 ml.

Reconstituted solutions must be withdrawn from the vial using a syringe. After reconstitution as indicated, the amount withdrawn from the vial with a syringe will provide the nominal quantity of piperacillin and tazobactam.

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

• 0.9% (9 mg/ml) sodium chloride injectable solution
• 5% glucose
• 6% dextran in 0.9% sodium chloride