Piperacillin/tazobactam Sandoz 4 g/0,5 g

Leaflet attached to the packaging: patient information

Piperacillin/Tazobactam Sandoz 4 g/0.5 g

4 g + 500 mg, powder for solution for infusion

Piperacillin + Tazobactam

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Piperacillin/Tazobactam Sandoz 4 g/0.5 g and what is it used for
• 2. Important information before using Piperacillin/Tazobactam Sandoz 4 g/0.5 g
• 3. How to use Piperacillin/Tazobactam Sandoz 4 g/0.5 g
• 4. Possible side effects
• 5. How to store Piperacillin/Tazobactam Sandoz 4 g/0.5 g
• 6. Contents of the packaging and other information

1. What is Piperacillin/Tazobactam Sandoz 4 g/0.5 g and what is it used for

Piperacillin is a broad-spectrum penicillin antibiotic. It can kill many types of bacteria. Tazobactam can prevent the survival of some bacteria that are resistant to piperacillin. This means that when piperacillin and tazobactam are administered together, more types of bacteria are killed. Piperacillin/Tazobactam Sandoz 4 g/0.5 g is used in adults and adolescents to treat bacterial infections such as lower respiratory tract infections (lungs), urinary tract infections (kidneys and bladder), abdominal cavity infections, skin or blood infections. Piperacillin/Tazobactam Sandoz 4 g/0.5 g may be used to treat bacterial infections in patients with a low white blood cell count (with reduced resistance to infections). Piperacillin/Tazobactam Sandoz 4 g/0.5 g is used in children aged 2 to 12 years to treat abdominal cavity infections, such as appendicitis, peritonitis (inflammation of the membrane lining the abdominal cavity), and cholecystitis. Piperacillin/Tazobactam Sandoz 4 g/0.5 g can be used to treat bacterial infections in patients with a low white blood cell count (with reduced resistance to infections). In some severe infections, the doctor may consider using Piperacillin/Tazobactam Sandoz 4 g/0.5 g together with other antibiotics.

2. Important information before using Piperacillin/Tazobactam Sandoz 4 g/0.5 g

When not to use Piperacillin/Tazobactam Sandoz 4 g/0.5 g

If the patient is allergic to piperacillin or tazobactam. If the patient is allergic to such antibiotics as penicillins, cephalosporins, or other beta-lactamase inhibitors, as they may also be allergic to Piperacillin/Tazobactam Sandoz 4 g/0.5 g.

Warnings and precautions

Discuss with your doctor, pharmacist, or nurse before using Piperacillin/Tazobactam Sandoz 4 g/0.5 g, during its use, or after treatment: if the patient has an allergy. If the patient has several types of allergies, they must inform their doctor or other healthcare professional before receiving the medicine. if the patient has diarrhea before starting treatment, during its use, or after treatment. They should immediately inform their doctor or other healthcare professional. Do not take any anti-diarrheal medication without consulting a doctor. if the patient has low potassium levels in the blood. The doctor may recommend a kidney function test before using the medicine and regular blood tests during treatment. if the patient is taking vancomycin antibiotic at the same time as Piperacillin/Tazobactam Sandoz 4 g/0.5 g, the risk of kidney damage may be increased (see also Piperacillin/Tazobactam Sandoz 4 g/0.5 g and other medicines in this leaflet). if the patient has kidney or liver problems or is undergoing hemodialysis. The doctor may recommend a kidney function test before starting treatment and regular blood tests during treatment. if the patient is taking certain medicines (e.g., anticoagulants) that prevent excessive blood clotting (see also "Piperacillin/Tazobactam Sandoz 4 g/0.5 g and other medicines" in this leaflet) or if unexpected bleeding occurs during treatment. In such cases, they should immediately inform their doctor or other healthcare professional. if the patient experiences seizures during treatment. In such cases, they should inform their doctor or other healthcare professional. if the patient feels that a new infection has developed or an existing infection has worsened. In such cases, they should inform their doctor or other healthcare professional. Hemophagocytic lymphohistiocytosis Cases of a disease in which the immune system produces too many normally harmless white blood cells called histiocytes and lymphocytes, leading to inflammation, have been reported. This disease can be life-threatening if not diagnosed and treated early. If multiple symptoms occur, such as fever, lymph node enlargement, weakness, dizziness, shortness of breath, cyanosis, or skin rash, they should immediately contact their doctor.

Children under 2 years of age

Piperacillin with tazobactam is not recommended for children under 2 years of age due to insufficient data on safety and efficacy.

Piperacillin/Tazobactam Sandoz 4 g/0.5 g and other medicines

Tell your doctor or other healthcare professional about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. Some medicines may interact with piperacillin and tazobactam. These include: a medicine used to treat gout (probenecid); it may prolong the elimination of piperacillin and tazobactam from the body; medicines used to reduce blood clotting or treat blood clots (e.g., heparin, warfarin, or acetylsalicylic acid); medicines used to relax muscles during surgery; if you are to undergo general anesthesia, inform your doctor about taking Piperacillin/Tazobactam Sandoz 4 g/0.5 g; methotrexate (a medicine used to treat cancer, arthritis, or psoriasis); piperacillin and tazobactam may prolong the elimination of methotrexate from the body; medicines that reduce potassium levels in the blood (e.g., diuretics or certain anticancer medicines); medicines containing other antibiotics: tobramycin, gentamicin, or vancomycin; if you have kidney problems, inform your doctor. Taking Piperacillin/Tazobactam Sandoz 4 g/0.5 g and vancomycin at the same time may increase the risk of kidney damage, even if you do not have kidney problems. Effect on laboratory test results If you need to have a blood or urine test, inform your doctor or laboratory staff that you are taking Piperacillin/Tazobactam Sandoz 4 g/0.5 g.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or other healthcare professional before using this medicine. The doctor will decide whether Piperacillin/Tazobactam Sandoz 4 g/0.5 g is suitable for you. Piperacillin and tazobactam may pass into the fetus or baby through breast milk. The doctor will decide whether Piperacillin/Tazobactam Sandoz 4 g/0.5 g can be given to pregnant or breastfeeding women.

Driving and using machines

Taking Piperacillin/Tazobactam Sandoz 4 g/0.5 g should not affect your ability to drive or operate machinery.

Piperacillin/Tazobactam Sandoz 4 g/0.5 g contains sodium

Piperacillin/Tazobactam Sandoz 4 g/0.5 g contains 217 mg of sodium (the main component of common salt) per dose. This is equivalent to 11% of the maximum recommended daily intake of sodium in the diet for adults. This amount should be taken into account for patients on a low-salt diet.

3. How to use Piperacillin/Tazobactam Sandoz 4 g/0.5 g

Piperacillin/Tazobactam Sandoz 4 g/0.5 g is administered to the patient by a doctor or other healthcare professional through an infusion (drip) into a vein. Dosage The dose of the medicine depends on the type of infection, the patient's age, and the presence of kidney problems.

Adults and adolescents over 12 years of age

Typically, a dose of 4 g + 0.5 g of piperacillin with tazobactam is administered every 6 to 8 hours into one of the patient's veins (directly into the bloodstream).

Children aged 2 to 12 years

In children with abdominal cavity infections, the usual dose is 100 mg + 12.5 mg of piperacillin with tazobactam per kilogram of body weight, administered every 8 hours into one of the veins (directly into the bloodstream). Children with a low white blood cell count are usually given 80 mg + 10 mg of piperacillin with tazobactam per kilogram of body weight every 6 hours into one of the veins. The doctor calculates the dose of Piperacillin/Tazobactam Sandoz 4 g/0.5 g based on the child's weight, but no single dose will exceed 4 g + 0.5 g. The medicine is used until the infection symptoms have completely resolved (for 5 to 14 days).

Patients with kidney problems

The doctor may reduce the dose or frequency of administration of Piperacillin/Tazobactam Sandoz 4 g/0.5 g. They may also recommend regular blood tests to ensure that the dose of the medicine is appropriate, especially if it needs to be used for a longer period.

Using a higher dose of Piperacillin/Tazobactam Sandoz 4 g/0.5 g than recommended

Since Piperacillin/Tazobactam Sandoz 4 g/0.5 g is administered by a doctor or other healthcare professional, it is unlikely that the patient will receive an incorrect dose. However, if side effects occur (such as seizures) or the patient thinks they have received too much medicine, they should immediately inform their doctor.

Missing a dose of Piperacillin/Tazobactam Sandoz 4 g/0.5 g

If the patient suspects that a dose of Piperacillin/Tazobactam Sandoz 4 g/0.5 g has not been administered, they should immediately inform their doctor or other healthcare professional. If you have any further doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If the patient experiences any of the following potentially serious side effects, they should immediately consult their doctor:

Serious side effects of Piperacillin/Tazobactam Sandoz 4 g/0.5 g (frequencies in parentheses):

severe skin rash [Stevens-Johnson syndrome, blistering skin rash (frequency unknown), exfoliative dermatitis (frequency unknown), toxic epidermal necrolysis (rarely)] initially appearing on the torso as red spots in the shape of targets or round spots, often with blisters in the central part. Additional symptoms include: ulcers in the mouth, throat, nose, limbs, genitals, and conjunctivitis (redness and swelling of the eyes). The rash may progress to widespread blisters or skin peeling and become life-threatening. severe allergic reaction that can lead to death (drug-induced reaction with eosinophilia and systemic symptoms) and may involve the skin and, most importantly, other organs, such as the kidneys and liver (frequency unknown) acute generalized exanthematous pustulosis, a skin condition characterized by the rapid appearance of numerous small, pus-filled blisters on large areas of reddened skin (frequency unknown) swelling of the face, lips, tongue, or other parts of the body (frequency unknown) shortness of breath, wheezing, or difficulty breathing (frequency unknown) severe rash or hives (uncommon), itching or rash on the skin (common) yellowing of the eyes or skin (frequency unknown) blood cell damage [symptoms include: unexpected shortness of breath, red or brown urine (frequency unknown), nosebleeds (rarely), and the appearance of small bruises (frequency unknown)], significant decrease in white blood cell count (rarely) severe or persistent diarrhea, accompanied by fever or weakness (rarely) If any of the following side effects worsen or any side effects not listed in this leaflet occur, tell your doctor or healthcare professional. Very common side effects(may occur in more than 1 in 10 people): diarrhea Common side effects(may occur in less than 1 in 10 people): fungal infection decreased platelet count, decreased red blood cell count, or decreased hemoglobin level, abnormal laboratory test result (positive direct Coombs test), prolonged blood clotting time (prolonged partial thromboplastin time) decreased protein level in the blood headache, insomnia abdominal pain, vomiting, nausea, constipation, indigestion increased liver enzyme activity rash on the skin, itching abnormal kidney function test results fever, reaction at the injection site Uncommon side effects(may occur in less than 1 in 100 people): decreased white blood cell count (leukopenia), prolonged blood clotting time (prolonged prothrombin time) decreased potassium level in the blood, decreased sugar level in the blood seizures observed in patients taking high doses of the medicine or with kidney problems low blood pressure, vein inflammation (felt as pain or redness in the affected area) redness of the skin increased bilirubin level in the blood skin reactions with redness, skin changes, or hives joint and muscle pain chills Rare side effects(may occur in less than 1 in 1000 people): significant decrease in white blood cell count (agranulocytosis), nosebleeds severe colon infection, mouth ulceration separation of the outer layer of the skin all over the body [toxic epidermal necrolysis (Lyell's syndrome)] Side effects with unknown frequency(frequency cannot be estimated from available data): significant decrease in red blood cell count, white blood cell count, and platelet count (pancytopenia), decreased white blood cell count (neutropenia), decreased red blood cell count due to their premature breakdown or degradation, minor bruising, prolonged bleeding time, increased platelet count, increased eosinophil count (a type of white blood cell) allergic reaction, including severe reaction anaphylaxis liver inflammation, yellowing of the skin or whites of the eyes severe allergic reaction affecting the whole body, with skin and mucous membrane rash, blisters, and other skin lesions (Stevens-Johnson syndrome), severe allergic reaction affecting the skin and other organs, such as the kidneys and liver (drug-induced reaction with eosinophilia and systemic symptoms), numerous small, fluid-filled blisters on large areas of swollen, reddened skin, accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis) kidney problems, confusion (delirium) Reporting side effects If side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Piperacillin/Tazobactam Sandoz 4 g/0.5 g

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month. Unopened vials/bottles: There are no special storage instructions. Storage conditions for the reconstituted and diluted medicine: see the information at the end of the leaflet "Information intended for healthcare professionals only". The medicine is 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 medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Piperacillin/Tazobactam Sandoz 4 g/0.5 g contains

The active substances are piperacillin and tazobactam. Each vial or bottle of Piperacillin/Tazobactam Sandoz 4 g/0.5 g contains 4 g of piperacillin (as piperacillin sodium) and 0.5 g of tazobactam (as tazobactam sodium). The medicine does not contain any other ingredients besides the active substances.

What Piperacillin/Tazobactam Sandoz 4 g/0.5 g looks like and contents of the pack

Piperacillin/Tazobactam Sandoz 4 g/0.5 g is a white or almost white powder for solution for infusion in glass vials or bottles. The vials and bottles are packed in cardboard boxes. Pack sizes: 1, 5, 10, 12, and 50 vials or bottles.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse10 6250 Kundl, Austria Manufacturer/Importer Sandoz GmbH Biochemiestrasse10 6250 Kundl, Austria

For more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa tel. 22 209 70 00 Date of last revision of the leaflet:01/2023 Sandoz logo -----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only

Note: Piperacillin/Tazobactam Sandoz 4 g/0.5 g is not recommended for use in adults with bacteremia caused by E. coliand K. pneumoniae(resistant to ceftriaxone) producing extended-spectrum beta-lactamases (ESBL). After reconstitution and dilution: The chemical and physical stability has been demonstrated for 24 hours at 20-25°C and for 48 hours at 2-8°C. For microbiological reasons, the product should be used immediately after opening. If not used immediately, the user is responsible for the storage conditions. The solution should not be stored for more than 24 hours at 2°C to 8°C, unless reconstitution/dilution was performed under controlled aseptic conditions.

Instructions for use

Piperacillin/Tazobactam Sandoz 4 g/0.5 g is administered through intravenous infusion (30-minute drip). The medicine should be reconstituted and diluted under aseptic conditions. Before administration, check the solution for visible particles and color change. The solution should only be administered if it is clear and free of solid particles.

Intravenous administration

The contents of each vial/bottle should be reconstituted with the indicated volume of one of the compatible solvents. Mix by rotating for 3 minutes until dissolved. This usually occurs within 3 minutes of continuous mixing (detailed information on handling the medicine is provided below).

Compatibility of Piperacillin/Tazobactam Sandoz 4 g/0.5 g with other medicines

If Piperacillin/Tazobactam Sandoz 4 g/0.5 g is administered with another antibiotic (e.g., an aminoglycoside), these products should be administered separately. Mixing beta-lactam antibiotics with aminoglycosides in vitromay cause significant inactivation of the aminoglycoside. However, it has been shown that amikacin and gentamicin are compatible with Piperacillin/Tazobactam Sandoz 4 g/0.5 g in vitroin certain diluents and concentrations (see below Administration of Piperacillin/Tazobactam Sandoz 4 g/0.5 g with aminoglycosides). Piperacillin/Tazobactam Sandoz 4 g/0.5 g should not be mixed with other substances in a syringe or infusion container, as compatibility has not been established. Piperacillin/Tazobactam Sandoz 4 g/0.5 g should be administered through a separate infusion set. Exceptions are medicines that have been proven to be compatible. Due to chemical instability, piperacillin with tazobactam should not be used in solutions containing only sodium bicarbonate. Lactated Ringer's solution (Hartmann's solution) is incompatible with the combined product containing piperacillin with tazobactam. The combined product containing piperacillin with tazobactam should not be added to blood products or albumin hydrolysates.

Administration of Piperacillin/Tazobactam Sandoz 4 g/0.5 g with aminoglycosides

Mixing beta-lactam antibiotics with aminoglycosides in vitromay cause significant inactivation of the aminoglycoside, so it is recommended that Piperacillin/Tazobactam Sandoz 4 g/0.5 g and the aminoglycoside be administered separately. If concurrent administration of an aminoglycoside and Piperacillin/Tazobactam Sandoz 4 g/0.5 g is necessary, they should be reconstituted and diluted separately. If concurrent administration is recommended, Piperacillin/Tazobactam Sandoz 4 g/0.5 g is compatible and can be administered simultaneously through a common Y-site infusion line with the following aminoglycosides and under the following conditions.

* The aminoglycoside dose should be adjusted according to the patient's weight, severity of the infection (severe or life-threatening), and kidney function (creatinine clearance). Compatibility of piperacillin with tazobactam with other aminoglycosides has not been established. Only the concentrations and diluents of amikacin and gentamicin listed above with the specified doses of piperacillin with tazobactam have been established as compatible for simultaneous administration through a common Y-site infusion line. Simultaneous administration through a common Y-site infusion line in any other way than specified above may cause inactivation of the aminoglycoside by piperacillin with tazobactam.