PITAZ 2 G/0.25 G POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Pitaz 2 g/0.25 g powder for solution for infusion EFG

piperacillin/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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Pitaz is and what it is used for
2. What you need to know before you are given Pitaz
3. How Pitaz is given

1. Possible side effects
2. Storage of Pitaz
3. Contents of the pack and further information

1. What Pitaz is and what it is used for

Piperacillin/Tazobactam contains the active substances piperacillin and tazobactam.

Piperacillin belongs to a group of medicines called “broad-spectrum penicillin antibiotics” and can kill many types of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. By administering piperacillin and tazobactam together, more types of bacteria are killed.

This medicine 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. This medicine can be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

This medicine is used in children between 2 and 12 years old to treat infections in the abdomen, such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and infections of the gallbladder.

This medicine can 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 you are given Pitaz

Do not use Pitaz

• if you are allergic to piperacillin or tazobactam;
• if you are allergic to antibiotics called penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may be allergic to piperacillin/tazobactam.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting piperacillin/tazobactam:

• if you have allergies. If you have multiple allergies, make sure to inform your doctor or other healthcare professional before receiving this product.
• if you have diarrhea before treatment or if you start having it during or after treatment. In this case, make sure to tell your doctor or other healthcare professional immediately. Do not take any medicine for diarrhea without consulting your doctor first.
• if you have low potassium levels in your blood. Your doctor may want to examine your kidneys before you receive this medicine and may perform periodic blood tests during treatment.
• if you are taking another antibiotic called vancomycin at the same time as this medicine, this may increase the risk of kidney injury (see also “Other medicines and Pitaz” in this leaflet).
• if you are using certain medicines (called anticoagulants) to prevent excessive blood clotting (see also “Other medicines and Pitaz” in this leaflet) or if you experience unexpected bleeding during treatment. In this case, you must inform your doctor or other healthcare professional immediately.
• if you develop seizures during treatment. In this case, you should inform your doctor or other healthcare professional.
• if you think you have developed a new infection or if it has worsened. In this case, you should inform your doctor or other healthcare professional.

Hemophagocytic lymphohistiocytosis

There have been reports of a disease in which the immune system produces too many white blood cells, namely histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis). This disease can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swelling of the lymph nodes, feeling of weakness, feeling of dizziness, difficulty breathing, bruising, or skin rash, contact your doctor immediately.

Children

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

Other medicines and Pitaz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. Some medicines may interact with piperacillin or tazobactam. For example:

• medicines that decrease potassium levels in the blood (e.g., diuretic pills or some cancer medicines);
• medicines used to relax muscles during surgery. Inform your doctor if you are going to have general anesthesia;
• medicines used to thin the blood or treat blood clots (e.g., heparin, warfarin, or aspirin);
• 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;
• a medicine for gout (probenecid). This medicine may increase the time it takes for piperacillin and tazobactam to be eliminated from the body;
• medicines containing other antibiotics, such as tobramycin, gentamicin, or vancomycin.

Tell your doctor if you have kidney problems. The use of piperacillin/tazobactam and vancomycin at the same time may increase the risk of kidney injury even if you do not have kidney problems.

Effect on laboratory tests

If you need to provide a blood or urine sample, tell your doctor or laboratory staff that you are using this medicine.

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.

Piperacillin and tazobactam may pass to the baby in the womb or through breast milk.

If you are pregnant or breastfeeding, your doctor will decide if this medicine is suitable for you.

Driving and using machines

It is not expected that the use of this medicine will affect your ability to drive or use machines.

Pitaz contains sodium

This medicine contains 108 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 5.4% of the maximum recommended daily intake of sodium for an adult.

3. How to use Pitaz

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor or nurse will administer this medicine to you by intravenous infusion (into a vein with a drip over 30 minutes).

Dose

The dose of medicine that you will be given depends on the disease you are being treated for, your age, and whether you have kidney problems.

Adults and adolescents over 12 years of age

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

Children from 2 to 12 years of age

The recommended dose for children with abdominal infections is 100 mg/12.5 mg/kg body weight of piperacillin/tazobactam administered every 8 hours into a vein. The recommended dose for children with low white blood cell counts is 80 mg/10 mg/kg body weight of piperacillin/tazobactam administered every 6 hours into a vein.

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

You will be given this medicine until the signs of infection have completely disappeared (5 to 14 days).

Patients with kidney problems

It may be necessary for your doctor to reduce the dose of piperacillin/tazobactam or the frequency of administration. Your doctor may also want to perform a blood test to ensure you are receiving the correct dose of treatment, especially if you need to use this medicine for a long time.

If you use more Pitaz than you should

Since a doctor or other healthcare professional will administer piperacillin/tazobactam to you, 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 medicine, tell your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Pitaz

If you think you have missed a dose of this medicine, tell your doctor or nurse immediately.

If you have any further questions about 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 everybody gets them.

Consult a doctor immediately if you experience any of these potentially serious side effects of piperacillin/tazobactam.

• severe skin rashes (Stevens-Johnson syndrome, bullous dermatitis, exfoliative dermatitis (frequency not known), toxic epidermal necrolysis (rare)) that initially appear as reddish spots or circular patches with central blisters on the trunk. Other signs include ulcers in the mouth, throat, nose, limbs, genitals, and conjunctivitis (red and swollen eyes).

The rash can progress to blistering or general peeling of the skin and can be potentially fatal;

• potentially serious allergic reaction (drug reaction with eosinophilia and systemic symptoms) that can affect the skin and other major organs of the body such as the kidneys and liver;
• a skin disease (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small pus-filled blisters that appear in large areas of swollen and reddened skin;
• swelling of the face, lips, tongue, or other parts of the body (frequency not known);
• shortness of breath, wheezing, or difficulty breathing (frequency not known);
• severe skin rash or hives (uncommon), itching or skin rash (common);
• yellowing of the eyes or skin (frequency not known);
• damage to blood cells (symptoms include: shortness of breath when not expected, urine of red or brown color (frequency not known), nosebleeds (rare), and small bruises (frequency not known)), severe decrease in white blood cells in the blood (rare);
• severe or persistent diarrhea accompanied by fever or weakness (rare).

If any of the following side effects get worse or if you notice any side effect not mentioned in this leaflet, tell your doctor or other healthcare professional.

Side effects that are very common(may affect more than 1 in 10 people)

• diarrhea

Side effects that are common(may affect up to 1 in 10 people)

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

Side effects that are uncommon(may affect up to 1 in 100 people)

• decrease in white blood cells (leukopenia), prolonged blood coagulation time (prolonged prothrombin time)
• decrease in potassium levels in the blood, decrease in blood sugar levels
• seizures (convulsions), observed in patients receiving high doses or with kidney problems
• low blood pressure, inflammation of the veins (which is perceived as pain when touched or redness of the affected area), redness of the skin
• increase in a breakdown product of blood pigment (bilirubin)
• skin reactions with redness, formation of skin lesions, hives
• muscle and joint pain
• chills

Side effects that are rare(may affect up to 1 in 1,000 people)

• severe decrease in white blood cells (agranulocytosis), nosebleeds
• severe colon infection, inflammation of the mouth mucosa
• shedding of the top layer of the skin all over the body (toxic epidermal necrolysis)

Side effects with frequency not known(frequency cannot be estimated from the available data)

• severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), decrease in white blood cells (neutropenia), decrease in red blood cells due to premature destruction, increase in platelets, increase in a specific type of white blood cells (eosinophilia)
• allergic reactions and severe allergic reaction
• liver inflammation, yellowing of the skin or the whites of the eyes
• severe allergic reaction affecting the whole body with skin and mucous membrane lesions, blisters, and various skin rashes (Stevens-Johnson syndrome), severe allergic disease affecting the skin and other organs such as the kidneys and liver (drug reaction with eosinophilia and systemic symptoms), numerous small pus-filled blisters contained within large areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)
• kidney function problems and kidney problems
• a type of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in greater numbers
• 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 the combination piperacillin/tazobactam, may cause manifestations of altered brain function (encephalopathy) and seizures.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitaz

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month stated.

Unopened vials: This medicine does not require special storage conditions.

For single use only. Discard any unused solution.

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

6. Contents of the pack and further information

The active substances are piperacillin and tazobactam. Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g.

There are no other ingredients.

Appearance of Pitaz and contents of the pack

White or almost white powder or loose powder

30 ml Type I glass vials, sealed with a 20 mm bromobutyl rubber stopper and a gray aluminum or flip-off cap suitable for parenteral preparation.

Pack sizes: 1 or 10 vials per box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: August 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products http://www.aemps.gob.es.

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This information is intended only for healthcare professionals:

How to store Pitaz

Unopened vials: This medicine does not require special storage conditions.

Reconstituted/diluted solution: From a microbiological point of view, the product should be used immediately.

If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C.

Instructions for Use

Pitaz will be administered by intravenous infusion (drip over 30 minutes).

Reconstitution and dilution will be performed under aseptic conditions. The solution must be visually inspected for particles and discoloration before administration. The solution should only be used if it is transparent and free of particles.

Intravenous Use

Reconstitute each vial with the volume of solvent shown in the following table, using one of the compatible solvents for reconstitution. Shake until dissolved. If shaken constantly, reconstitution generally occurs within 5 to 10 minutes (see handling details below).

• Compatible solvents for reconstitution:
  • Sodium chloride injection solution 0.9% (9 mg/ml)
  • Sterile water for injection (the maximum recommended volume of sterile water for injection per dose is 50 ml).
  • 5% Glucose

The reconstituted solutions should be withdrawn from the vial with a syringe. After reconstitution as indicated, the vial content withdrawn with the syringe will provide the amount indicated on the label of piperacillin and tazobactam.

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

• Sodium chloride injection solution 0.9% (9 mg/ml)
• 5% Glucose
• Lactated Ringer's injection
• Hartmann's solution
• Ringer's acetate
• Ringer's acetate/malate

Incompatibilities

This medication should not be mixed with others, except as mentioned below.

Whenever this medication is used simultaneously with another antibiotic (e.g., aminoglycosides), the medications should be administered separately. The mixture of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.

Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle, as compatibility has not been established.

Due to chemical instability, piperacillin/tazobactam should not be used with solutions that only contain sodium bicarbonate.

Piperacillin/tazobactam should not be added to hemoderivatives or albumin hydrolysates.

Visually inspect the solution before use. It should only be used if the solution is transparent and particle-free.

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Concomitant Administration of Pitaz with Aminoglycosides

Due to the in vitro inactivation of aminoglycosides by beta-lactam antibiotics, it is recommended to administer piperacillin/tazobactam and the aminoglycoside separately. Piperacillin/tazobactam and the aminoglycoside should be reconstituted and diluted separately when concomitant treatment with aminoglycosides is indicated.