PROSPECTO : INFORMATION FOR THE USER

Piperacilina/Tazobactam Kabi 4 g/0.5 g powder for solution for infusion EFG

Piperacilina/tazobactam

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or nurse.

-If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to use Piperacilina/Tazobactam Kabi

4.Possible adverse effects

5Storage of Piperacilina/Tazobactam Kabi

6.Contents of the package and additional information

Piperacilina belongs to a group of medicines called broad-spectrum penicillin antibiotics and can destroy many types of bacteria. Tazobactam may prevent some resistant bacteria from surviving the effects of piperacilina. In this way, by administering piperacilina and tazobactam together, more types of bacteria are destroyed.

Piperacilina/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. Piperacilina/tazobactam can be used to treat bacterial infections with low white blood cell counts (less resistance to infections).

Piperacilina/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 gallbladder infections. Piperacilina/tazobactam can be used to treat bacterial infections with low white blood cell counts (less resistance to infections).

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

No use Piperacilina/Tazobactam Kabi

-if you are allergic to piperacilina or tazobactam or to any of the other components of this medication (listed in section 6).

-if you are allergic to antibiotics called penicilinas, cefalosporinas, or other inhibitors of betalactamasas, as you may be allergic to Piperacilina/Tazobactam Kabi.

Warnings and precautions

Consult your doctor or nurse before starting to use Piperacilina/Tazobactam Kabi:

• if you have allergies. If you have multiple allergies, make sure to tell your doctor or another healthcare professional before receiving this product.
• if you had diarrhea before treatment or if you start having it during or after treatment. In this case, make sure to tell your doctor or another healthcare professional immediately. Do not take any medication for diarrhea without consulting your doctor first.
• if you have low levels of potassium in your blood. Your doctor may want to examine your kidneys before receiving this medication and may perform blood tests periodically during treatment.
• if you have kidney or liver problems, or if you receive hemodialysis. Your doctor may want to examine your kidneys before receiving this medication and may perform blood tests periodically during treatment.
• if you are using certain medications (called anticoagulants) to prevent excessive blood clotting (see alsoUse of Piperacilina/Tazobactam Kabi with other medicationsin this prospectus) or if you experience unexpected bleeding during treatment. In this case, you must inform your doctor or another healthcare professional immediately.
• if you are taking another antibiotic called vancomicina at the same time as Piperacilina/Tazobactam, this may increase the risk of kidney damage (see alsoUse of Piperacilina / Tazobactam Fresenius Kabiwith other medicationsin this prospectus).
• if you experience seizures during treatment. In this case, you must inform your doctor or another healthcare professional immediately.
• if you think you have developed a new infection or if your infection has worsened. In this case, you must inform your doctor or another healthcare professional immediately.
• if you have severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, pharmacological reaction with eosinophilia and systemic symptoms (DRESS), generalized acute exanthematous pustulosis (AGEP). Stop using Piperacilina / Tazobactam Fresenius Kabi and seek medical attention immediately if you notice any of the symptoms described in section 4.

Lymphohistiocytosis hemophagocytic

Cases of a disease in which the immune system produces too many normal white blood cells called histiocytes and lymphocytes, causing inflammation (lymphohistiocytosis hemophagocytic) have been reported. This disease can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swelling of lymph nodes, feeling weak, feeling dizzy, difficulty breathing, bruises or skin rash, contact your doctor immediately.

Children under 2 years

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

Use of Piperacilina/Tazobactam Kabi with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication. Some medications may interact with piperacilina or tazobactam.

These include:

• a medication for gout (probenecid). This product may increase the time it takes for piperacilina and tazobactam to be eliminated from the body
• medications used to thin the blood or to treat blood clots (for example, heparin, warfarin, or acetylsalicylic acid).
• medications used to relax muscles during surgery. Inform your doctor if you are going to undergo general anesthesia.
• methotrexate (a medication used to treat cancer, arthritis, or psoriasis). Piperacilina and tazobactam may increase the time it takes for methotrexate to be eliminated from the body.
• medications that decrease the level of potassium in the blood (for example, diuretics or some cancer medications).
• medications that contain other antibiotics such as tobramicina, gentamicina, or vancomicina. Inform your doctor if you have kidney problems.TakingPiperacilina/Tazobactamand vancomicina at the same time may increase the risk of kidney damage even if you do not have kidney problems.

Effects on laboratory tests

If you need to provide a blood or urine sample, tell your doctor or laboratory personnel that you are using Piperacilina/tazobactam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if Piperacilina/Tazobactam Kabi is suitable for you.

Piperacilina and tazobactam may pass into the fetus or through breast milk. If you are breastfeeding a child, your doctor will decide if Piperacilina/Tazobactam Kabi is suitable for you.

Driving and operating machinery

The use of Piperacilina/Tazobactam Kabi is not expected to affect your ability to drive or operate machinery

Piperacilina/Tazobactam Kabi 4 g/0.5 gcontains224mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 11.2% of the maximum daily sodium intake recommended for an adult.

Your doctor or another healthcare professional will administer this medication through intravenous infusion (into a vein with a drip over 30 minutes). The dose of medication you receive will depend on the illness you are being treated for, your age, and whether you have any kidney problems.

Adults and adolescents 12 years or older

The recommended dose is 4 g/0.5 g of piperacilina/tazobactam administered every 6-8 hours through a vein (directly into the bloodstream).

Children 2 to 12 years old

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

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

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

Patients with kidney problems

Your doctor may need to reduce the dose of Piperacilina/Tazobactam Kabi or the frequency of administration. Your doctor may also want to perform blood tests to ensure you receive the correct dose of treatment, especially if you need to use this medication for a long time.

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 side effects, such as seizures, or think you have been given too much medication, tell your doctor immediately.

If you forget to use Piperacilina/Tazobactam Kabi

If you think you have not received a dose of Piperacilina/Tazobactam Kabi, tell your doctor or another healthcare professional immediately.

If you have any other questions about using this medication, ask your doctor or nurse.

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

Consult your doctor immediately if you experience any of the potentially serious side effects of Piperacilina/Tazobactam.

The serious side effects (frequency in parentheses) of Piperacilina/Tazobactam Kabi are:

• severe skin eruptions [Stevens-Johnson syndrome, bullous dermatitis (unknown), exfoliative dermatitis (unknown), toxic epidermal necrolysis (rare)] that initially appear as red spots or circular patches with central blisters on the trunk. Other signs include mouth, throat, nose, limb, genital, and conjunctivitis (red and swollen eyes) ulcers. The rash may progress to blistering or generalized skin peeling and, potentially, be fatal
• potentially severe allergic reaction (medication reaction with eosinophilia and systemic symptoms) that can affect the skin and other major organs such as the kidneys or liver
• a skin disease (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small pustules filled with liquid that appear on large areas of swollen and red skin

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

-shortness of breath, wheezing, or difficulty breathing (unknown)

-severe rash or urticaria (rare), itching, or skin eruption (frequent)

-yellowing of the eyes and skin (unknown)

-blood cell damage [symptoms include: shortness of breath when not expected, urine

of red or brown color (unknown), nasal bleeding (rare), and small bruises (unknown),severe decrease in white blood cells in the blood (rare)]

• persistent or severe diarrhea accompanied by fever or weakness (rare)

If any of the following serious side effects occur, or if you experience any side effect not mentioned in this leaflet, inform your doctor or another healthcare professional.

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

• diarrhea

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

• yeast infection
• decrease in platelets, decrease in red blood cells or hemoglobin (blood pigment), abnormal laboratory tests (direct Coombs test positive), prolonged blood clotting time (activated partial thromboplastin time prolonged)
• decrease in blood proteins
• headache, insomnia
• abdominal pain, vomiting, nausea, constipation, stomach discomfort
• increase in liver enzymes in the blood
• skin eruptions, itching
• abnormal kidney function tests
• fever, reaction at the injection site

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

• decrease in white blood cells in the blood (leucopenia), prolonged blood clotting time (prothrombin time prolonged)
• decrease in potassium in the blood, decrease in blood sugar
• seizures (convulsions), observed in patients receiving high doses or with renal problems
• low blood pressure, inflammation of the veins (pain or redness in the affected area), skin redness
• increase in a breakdown product of blood pigment (bilirubin)
• skin reactions with redness, skin lesions, urticaria
• muscle and joint pain
• chills

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

• severe decrease in white blood cells (agranulocytosis), nasal bleeding
• severe colon infection, inflammation of the mucous membrane of the mouth
• detachment of the top layer of the skin from the entire body (toxic epidermal necrolysis)

Side effects of unknown frequency (cannot be estimated from available data):

• severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), severe decrease in white blood cells (neutropenia), decrease in red blood cells due to premature rupture or degradation, small hematoma, prolonged bleeding time, increase in platelets, increase in a specific type of white blood cells (eosinophilia)
• allergic reaction and severe allergic reaction
• inflammation of the liver, yellowing of the skin or white of the eyes
• severe allergic reaction throughout the body with skin exanthems and mucous membrane, blisters, and multiple skin eruptions (Stevens-Johnson syndrome), severe allergic reactions affecting the skin and other organs such as the kidneys and liver (medication reaction with eosinophilia and systemic symptoms), numerous small pustules filled with liquid that appear on large areas of swollen and red skin accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)
• renal function deficiency and renal problems
• a type of lung disease where eosinophils (a type of white blood cell) appear in the lung in greater numbers
• acute disorientation and confusion (delirium).

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

Betalactam antibiotics, including piperacilina tazobactam, may lead to manifestations of encephalopathy and seizures.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Unopened vials: Do not store at a temperature above 25°C.

For single use only. Dispose of any unused solution.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Piperacilina/Tazobactam Kabi

The active ingredients are piperacilina and tazobactam

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

There are no other components.

Appearance of the product and contents of the package

Piperacilina/Tazobactam Kabi 4 g/0.5 g is a sterile lyophilized white or off-white powder for solution for infusion.

Piperacilina/Tazobactam Kabi 4 g/0.5 g is available in glass vials (type II) of 50 ml closed with a halobutil rubber stopper.

Formats: 1, 5, and 10 vials.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España S.A.

C/ Marina 16-18,

08005 - Barcelona

Spain

Responsible for manufacturing:

LABESFAL - Laboratórios Almiro S.A.U

FRESENIUS KABI GROUP

3465-157 Santiago de Besteiros

PORTUGAL

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: November 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /

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This information is intended solely for healthcare professionals:

The following text is an extract from the Technical Dossier that serves as a guide for the administration of Piperacilina/Tazobactam Kabi. The prescribing physician must be familiar with the Technical Dossier to determine the suitability of use in a specific patient.

Incompatibilities with solvents and other medicines

The RINGER LACTATO solution is not compatible with Piperacilina/Tazobactam Kabi.

When piperacilina/tazobactam is used with another antibiotic (e.g. AMINOGLUCÓSIDO), the medicines must be administered SEPARATELY. The mixture of Piperacilina/Tazobactam Kabi with an aminoglucósido in vitro may cause a substantial inactivation of the aminoglucósido.

Piperacilina/Tazobactam Kabi must be administered through a separate infusion device from any other medicine unless its compatibility has been demonstrated.

Due to chemical instability, Piperacilina/Tazobactam Kabi must not be used with solutions containing BICARBONATO DE SODIO.

Piperacilina/Tazobactam Kabi must not be added to BLOOD PRODUCTS or ALBUMIN HYDROLYSATES.

Instructions for use

Piperacilina/tazobactam will be administered by intravenous infusion (butterfly needle for 30 minutes).

Intravenous administration

It must be reconstituted with the volume of solvent shown in the following table, using one of the compatible solvents for its reconstitution. Shake with rotary movements until it dissolves. If it is shaken constantly, it usually reconstitutes within 5 to 10 minutes (see details of handling below).

Compatible solvents for reconstitution:

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

- Sterile water for injection preparations (1)

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

The reconstituted solutions must be extracted from the vial with a syringe. After reconstitution as indicated, the contents of the vial extracted with a syringe will provide the nominal amount of piperacilina and tazobactam.

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

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

- Glucose 5%

- Dextran 6% in sodium chloride 0.9%