Piperacillin/tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Piperacilina/Tazobactam Accord Healthcare 2 g/0.25 g powder for solution for infusion EFG

Piperacilina/Tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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. Thus, when piperacillin and tazobactam are administered together, a wider range of bacteria 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 Accord Healthcare in combination with other antibiotics.

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

Do not use Piperacilina/Tazobactam Accord Healthcare

• if you are allergic to piperacillin or tazobactam.
• if you are allergic to antibiotics known as penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may be allergic to Piperacilina/Tazobactam Accord Healthcare.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Piperacilina/Tazobactam Accord Healthcare

• 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 had diarrhea before treatment or if you develop diarrhea during or after treatment. In this case, inform your doctor or other healthcare professional immediately. Do not take any medication for diarrhea without first consulting your doctor.
• If you have low blood potassium levels. Your doctor may wish to examine your kidneys 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 wish 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 Piperacilina/Tazobactam. This may increase the risk of kidney damage (see also “Other medicines and Piperacilina/Tazobactam Accord Healthcare” in this leaflet).
• If you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also “Other medicines and Piperacilina/Tazobactam Accord Healthcare” in this leaflet) or if you experience unexpected bleeding during treatment. In this case, inform your doctor or other healthcare professional immediately.
• If you experience seizures during treatment. In this case, inform your doctor or other healthcare professional immediately.
• If you think you have developed a new infection or if your infection has worsened. In this case, inform your doctor or other healthcare professional immediately.

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

Children The use of piperacillin/tazobactam is not recommended in children under 2 years of age, as there is insufficient data available on safety and efficacy in this population.

Other medicines and Piperacilina/Tazobactam Accord Healthcare

Inform your doctor or healthcare professional if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. 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 medicines).
• medicines containing other antibiotics such as tobramycin, gentamicin, or vancomycin. Inform your doctor if you have kidney problems. Taking Piperacilina/Tazobactam Accord Healthcare and vancomycin together may increase the risk of kidney injury, even if you do not have kidney problems.

Effects on laboratory tests

If you need to provide a blood or urine sample, inform your doctor or laboratory staff that you are taking Piperacilina/Tazobactam Accord Healthcare.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or healthcare professional before using this product.

Your doctor will decide whether Piperacilina/Tazobactam is suitable for you.

Piperacillin and tazobactam may pass to the baby in the womb or through breast milk. If you are breastfeeding, your doctor will decide whether Piperacilina/Tazobactam Accord Healthcare is suitable for you.

Driving and using machines

Piperacilina/Tazobactam Accord Healthcare is not expected to affect your ability to drive or use machines.

Piperacilina/Tazobactam Accord Healthcare contains sodium

Piperacilina/Tazobactam Accord Healthcare 2 g/0.25 g powder for solution for infusion EFG

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

Piperacilina/Tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

This medicine contains 216 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 10.8% of the maximum daily recommended sodium intake for an adult.

This should be taken into account if you are on a low-sodium diet.

3. How to use Piperacillin/Tazobactam Accord Healthcare

Your doctor or another healthcare professional will administer this medicine by intravenous infusion (into a vein via an infusion pump over 30 minutes).

Dosage

The dose of medicine you will be given depends on the condition being treated, your age, and whether or not you have kidney problems.

Adults and adolescents aged 12 years and older

The recommended dose is 4 g/0.5 g piperacillin/tazobactam administered every 6–8 hours via a vein (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 via a vein (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 via a vein (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 Piperacillin/Tazobactam Accord Healthcare.

You will be administered Piperacillin/Tazobactam Accord Healthcare 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 Piperacillin/Tazobactam Accord Healthcare or 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 Piperacillin/Tazobactam Accord Healthcare than you should:

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

If you have taken more piperacillin/tazobactam than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Piperacillin/Tazobactam Accord Healthcare

If you think a dose of Piperacillin/Tazobactam Accord Healthcare has not been administered, tell your doctor or another 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 the following potentially serious adverse effects of Piperacillin/Tazobactam.

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

• severe skin rashes [Stevens-Johnson syndrome, bullous dermatitis (not known), exfoliative dermatitis (not known), toxic epidermal necrolysis (rare)], which initially appear as reddish spots or circular lesions 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 may progress to widespread blistering or peeling of the skin and can potentially be fatal.
• potentially serious allergic reaction (drug reaction with eosinophilia and systemic symptoms) that may affect the skin and other vital organs such as the kidneys or liver
• a skin disease (acute generalized exanthematous pustulosis) accompanied by fever, characterized by numerous small fluid-filled pustules appearing on large areas of swollen and reddened skin
• swelling of the face, lips, tongue, or other parts of the body (not known)
• shortness of breath, wheezing, or difficulty breathing (not known)
• severe rash, hives (uncommon), itching, or skin rash (common)
• yellowing of the eyes and skin (not known)
• damage to blood cells [symptoms include: unexpected shortness of breath, red or brown urine (not known), nosebleeds (rare), bruising (not known)], severe decrease in white blood cells in the blood (rare)
• Persistent or severe diarrhoea accompanied by fever or weakness (rare)

If any of the following adverse effects is 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):

• diarrhoea

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

• fungal infection
• decreased platelets, decreased red blood cells or blood pigment/hemoglobin, abnormal laboratory tests (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
• skin rashes, itching
• abnormal kidney blood tests
• fever, reaction at injection site

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

• decreased white blood cells in blood (leucopenia), prolonged blood clotting time (prolonged prothrombin time)
• decreased potassium in blood, decreased blood sugar
• seizures, observed in patients receiving high doses or with kidney problems
• low blood pressure, inflammation of veins (pain on touch or redness of affected area), skin redness
• increased levels of a breakdown product of blood pigment (bilirubin)
• skin reactions with redness, skin lesions, and hives
• muscle and joint pain
• chills

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

• severe decrease in white blood cells (agranulocytosis), nosebleeds
• serious colon infection, inflammation of the mucous membrane of the mouth
• detachment of the upper layer of skin over the entire body (toxic epidermal necrolysis)

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

• severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), decreased white blood cells (neutropenia), decreased red blood cells due to premature rupture or degradation, small bruises, prolonged bleeding time, increased platelets, increased levels of a specific type of white blood cells (eosinophilia)
• allergic reaction and severe allergic reaction
• liver inflammation, yellowing of the skin or whites of the eyes
• severe systemic allergic reaction with skin and mucosal rashes, blisters, and various skin eruptions (Stevens-Johnson syndrome), severe allergic reactions affecting the skin and other organs such as the kidneys and liver (drug reaction with eosinophilia and systemic symptoms), numerous small fluid-filled pustules appearing on large areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)
• impaired kidney function and kidney problems
• a type of lung disease in which eosinophils (a type of white blood cell) 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 cause signs of brain function disturbance (encephalopathy) and seizures.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You can 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 Accord Healthcare

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

Do not use this medicine after the expiry date stated on the carton and vial after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Reconstituted and/or diluted solutions must be used immediately.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage-in-use duration and conditions prior to use are the responsibility of the user.

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

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

6. Contents of the pack and other information

Composition of Piperacillin/Tazobactam Accord Healthcare:

Piperacillin/Tazobactam Accord Healthcare 2 g/0.25 g powder for solution for infusion EFG

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

Piperacillin/Tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

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

This medicine contains no other ingredients.

Appearance of the product and contents of the pack

Piperacillin/Tazobactam Accord Healthcare is a white or almost white powder for solution for infusion supplied in a vial.

Pack sizes: 1 vial, 10 vials or 50 vials.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n, Edifici Est, 6th floor.

08039, Barcelona (Spain)

Manufacturer:

Mitim, S.R.L.

Via Cacciamali, 34-38

Brescia

25125 – Italy

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

Date of the last review of this summary: 02/2024

Detailed information on this medicine 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:

Note: Use for bacteremia due to extended-spectrum beta-lactamase (ESBL)-producing E. coli and K. pneumoniae (ceftriaxone non-susceptible) is not recommended in adult patients.

Instructions for use

Piperacillin/Tazobactam Accord Healthcare is 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 listed for reconstitution. Shake gently by rotating until dissolved. With continuous agitation, reconstitution usually occurs within less than 5 to 10 minutes (see details on handling below).

• Compatible solvents for reconstitution:
  • Sodium chloride 9 mg/ml (0.9%) solution for injection
  • 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 vial contents withdrawn with a syringe will provide the nominal amount of piperacillin and tazobactam.

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

• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Sterile water for injections

Incompatibilities

Whenever Piperacillin/Tazobactam Accord Healthcare is used simultaneously with another antibiotic (e.g., aminoglycosides), they must be administered separately. Mixing beta-lactam antibiotics with aminoglycosides in vitro may result in substantial inactivation of the aminoglycoside.

Piperacillin/Tazobactam Accord Healthcare must not be mixed with other substances in a syringe or infusion bottle, as compatibility has not been established.

Due to chemical instability, Piperacillin/Tazobactam Accord Healthcare must not be used with solutions containing only sodium bicarbonate.

Piperacillin/Tazobactam Accord Healthcare is not compatible with Ringer's lactate solution (Hartmann's solution).

Piperacillin/Tazobactam Accord Healthcare must not be added to blood products or albumin hydrolysates.