TAZOCIN 4 g + 0.5 g Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Tazocin
3. 2 g + 0.25 g, powder for solution for infusion
4. Tazocin
5. 4 g + 0.5 g, powder for solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Tazocin and what is it used for
7. Important information before using Tazocin
   1. When not to use Tazocin
   2. Warnings and precautions
   3. Children
   4. Tazocin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Tazocin contains sodium
8. How to use Tazocin
   1. Dosage
   2. Adults and children over 12 years
   3. Children aged 2 to 12 years
   4. Patients with kidney disease
   5. Overdose of Tazocin
   6. Missed dose of Tazocin
9. Possible side effects
   1. Reporting side effects
10. How to store Tazocin
11. Contents of the pack and other information
    1. What Tazocin contains
    2. What Tazocin looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    6. Information intended for healthcare professionals only:
    7. How to store Tazocin
    8. Reconstituted solution in the vial
    9. Diluted reconstituted solution for infusion
    10. Instructions for use
    11. Intravenous administration
    12. Incompatibilities
    13. Administration of Tazocin with aminoglycosides

Leaflet accompanying the packaging: information for the user

Tazocin

2 g + 0.25 g, powder for solution for infusion

Tazocin

4 g + 0.5 g, 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.
• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tazocin and what is it used for
• 2. Important information before using Tazocin
• 3. How to use Tazocin
• 4. Possible side effects
• 5. How to store Tazocin
• 6. Contents of the pack and other information

1. What is Tazocin and what is it used for

Piperacillin belongs to a group of medicines called "broad-spectrum penicillins". It is an antibiotic that kills many types of bacteria. Tazobactam may prevent some bacteria that are not sensitive to piperacillin from surviving. This means that when piperacillin and tazobactam are given together, more strains of bacteria will be killed. Tazocin is used in adults and children to treat bacterial infections of the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdominal cavity, skin, and blood. Tazocin can be used to treat bacterial infections in patients with a low white blood cell count (reduced resistance to infections). Tazocin is used in children aged 2 to 12 years to treat infections in the abdominal cavity, including appendicitis, peritonitis (infection of the fluid and membrane inside the abdominal organs), and cholecystitis (infection of the gallbladder). Tazocin can be used to treat bacterial infections in patients with a low white blood cell count (reduced resistance to infections). In some severe infections, the doctor may consider giving Tazocin with other antibiotics.

2. Important information before using Tazocin

When not to use Tazocin

• If you are allergic to piperacillin, tazobactam, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to antibiotics called penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may be allergic to Tazocin.

Warnings and precautions

Before taking Tazocin, discuss with your doctor, pharmacist, or nurse:

• If you have allergies. If you have several allergies, you should be sure to tell your doctor or healthcare worker about them before taking the medicine.
• If you have had diarrhea before treatment or if it occurs during or after treatment. You should immediately inform your doctor or healthcare worker about this. Do not take any medicines for diarrhea without consulting your doctor.
• If you have low potassium levels in your blood. It is possible that your doctor will check your kidneys and perform regular blood tests during treatment.
• If you have kidney or liver problems or are undergoing hemodialysis. It is possible that your doctor will check your kidneys and perform regular blood tests during treatment.
• If you are taking the antibiotic vancomycin at the same time as Tazocin, the risk of kidney damage may be increased (see also Tazocin and other medicinesin this leaflet).
• If you are taking medicines to prevent excessive blood clotting, called anticoagulants (see also Tazocin and other medicinesin this leaflet), or if unexpected bleeding occurs during treatment. You should immediately inform your doctor or healthcare worker about this.
• If you experience seizures during treatment. You should immediately inform your doctor or healthcare worker about this.
• If you think you have a new infection or if an existing infection worsens. In this case, you should inform your doctor or healthcare worker about it.

Hemophagocytic lymphohistiocytosis Cases of a disease in which the immune system produces too many normally harmless white blood cells called histiocytes and lymphocytes, causing inflammation (hemophagocytic lymphohistiocytosis), have been reported. This disease can be life-threatening if not diagnosed and treated early. If you experience many symptoms such as fever, swollen lymph nodes, feeling weak, dizziness, shortness of breath, bluish discoloration, or skin rash, you should contact your doctor immediately.

Children

The use of piperacillin with tazobactam is not recommended in children under 2 years of age due to the lack of sufficient data on safety and efficacy.

Tazocin and other medicines

Tell your doctor or healthcare worker about all the medicines you are taking now or have taken recently, including those obtained without a prescription. Some medicines may interact with piperacillin and tazobactam. These include:

• Medicine used for gout (probenecid); it may prolong the elimination of piperacillin and tazobactam from the body;
• Medicines that reduce blood clotting or are used to treat blood clots (e.g., heparin, warfarin, acetylsalicylic acid);
• Medicines used to relax muscles during surgery; if you are going to be under general anesthesia, you should tell your doctor about taking Tazocin;
• 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 medicines used to treat cancer);
• Medicines containing other antibiotics: tobramycin, gentamicin, or vancomycin; if you have kidney problems, you should tell your doctor.

Taking Tazocin 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 resultsIf you need to have a blood or urine test, you should tell your doctor or laboratory staff that you are taking Tazocin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether Tazocin is suitable for you. Piperacillin and tazobactam may pass into the body of the unborn child or into breast milk. If you are breastfeeding, your doctor will decide whether Tazocin is suitable for you.

Driving and using machines

Taking Tazocin is unlikely to affect your ability to drive or use machines.

Tazocin contains sodium

Tazocin, 2 g + 0.25 gThe medicine contains 130 mg of sodium (the main component of common salt) in each vial. This is equivalent to 6.5% of the maximum recommended daily intake of sodium in the diet for adults. Tazocin, 4 g + 0.5 gThe medicine contains 261 mg of sodium (the main component of common salt) in each vial. This is equivalent to 13% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into consideration in patients on a controlled sodium diet.

3. How to use Tazocin

The medicine is given by a doctor or nurse as an intravenous infusion (lasting over 30 minutes).

Dosage

The dose of Tazocin given to you will depend on the infection being treated, your age, and any kidney problems you may have.

Adults and children over 12 years

Usually, 4 g of piperacillin and 0.5 g of tazobactam are given intravenously (directly into the blood) every 6-8 hours.

Children aged 2 to 12 years

For children with abdominal infections, usually 100 mg of piperacillin and 12.5 mg of tazobactam per kilogram of body weight are given intravenously (directly into the blood) every 8 hours. For children with a low white blood cell count, the usual dose is 80 mg of piperacillin and 10 mg of tazobactam per kilogram of body weight given intravenously (directly into the blood) every 6 hours. Your doctor will calculate the dose of Tazocin based on your child's body weight, but each individual dose of Tazocin will not exceed 4 g + 0.5 g. Your doctor will give Tazocin until the infection has cleared up completely (for 5 to 14 days).

Patients with kidney disease

Your doctor may recommend reducing the dose of Tazocin or the frequency of administration. It is possible that your doctor will perform blood tests to ensure that the correct dose of Tazocin is being given, especially if you are taking the medicine for a long time.

Overdose of Tazocin

Tazocin will be given by a doctor or nurse, so it is unlikely that you will be given the wrong dose. However, if you experience side effects (e.g., seizures) or think you have been given too much Tazocin, you should tell your doctor immediately.

Missed dose of Tazocin

If you think you have missed a dose of Tazocin, you should tell your doctor or healthcare worker immediately. If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Tazocin can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, you should contact your doctor immediately. Serious side effects of Tazocin (frequency given in brackets) include:

• Severe skin reactions [Stevens-Johnson syndrome, bullous dermatitis (frequency not known), exfoliative dermatitis (frequency not known), toxic epidermal necrolysis (Lyell's syndrome) (rare)], initially appearing as reddened patches with a similar shape to a target or round patches, often with centrally located blisters; in addition, there may be ulcers in the mouth, throat, nose, limbs, genital areas, and conjunctivitis (redness and swelling of the eyes); the rash may develop into widespread blisters or peeling of the skin and may be life-threatening
• Severe, potentially life-threatening allergic reaction (drug rash with eosinophilia and systemic symptoms), which may affect the skin and, more importantly, other organs under the skin, such as the kidneys and liver
• Skin disease (acute generalized exanthematous pustulosis) with accompanying fever. This disease is characterized by numerous small blisters filled with fluid, located on a large, swollen, and reddened area of 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 rash or hives (uncommon), itching or rash on the skin (common)
• Yellowing of the whites of the eyes or skin (frequency not known)
• Blood cell damage [symptoms include: unexpected shortness of breath, red or brown urine (frequency not known), nosebleeds (rare), and minor bruising (frequency not known), significant reduction in white blood cell count (rare)]
• Severe or persistent diarrhea with fever or weakness (rare)

If anyof the side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your doctor or healthcare worker. Very common side effects(may affect more than 1 in 10 people):

• Diarrhea

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

• Fungal infections
• Reduced platelet count, reduced red blood cell count or hemoglobin, abnormal laboratory test results (positive direct Coombs test), prolonged blood clotting time (prolonged activated partial thromboplastin time)
• Reduced protein levels in the blood
• Headache, insomnia
• Abdominal pain, vomiting, nausea, constipation, stomach upset
• Increased liver enzyme activity in the blood
• Rash on the skin, itching
• Abnormal kidney function test results
• Fever, reaction at the injection site

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

• Reduced white blood cell count (leukopenia), prolonged blood clotting time (prolonged prothrombin time)
• Reduced potassium levels in the blood, reduced blood sugar levels
• Seizures observed in patients taking high doses of the medicine or with kidney problems
• Low blood pressure, vein inflammation (feeling of excessive sensitivity to touch or redness of the inflamed area), skin redness
• Increased bilirubin levels (a product of hemoglobin breakdown)
• Skin reactions including redness, skin changes, hives
• Joint and muscle pain
• Chills

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

• Significant reduction in white blood cell count (agranulocytosis), nosebleeds
• Severe colitis, mouth ulcers
• Shedding of the outer layer of the skin all over the body [toxic epidermal necrolysis (Lyell's syndrome)]

Frequency not known(cannot be estimated from the available data):

• Significant reduction in red blood cell count, white blood cell count, and platelet count (pancytopenia), reduction in white blood cell count (neutropenia), reduction in red blood cell count due to premature destruction or degradation, minor bruising, prolonged bleeding time, increased platelet count, increased eosinophil count
• Allergic reaction and severe allergic reaction
• Liver inflammation, yellowing of the skin or whites of the eyes
• Severe allergic reaction affecting the whole body, with a rash on the skin and mucous membranes, blisters, and other skin lesions (Stevens-Johnson syndrome), severe allergic reaction affecting the skin and other organs, such as the kidneys and liver (drug rash with eosinophilia and systemic symptoms), numerous small blisters filled with fluid, located on a large, swollen, and reddened area of skin with fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)
• Kidney problems and impaired kidney function
• Lung disease with an increased number of eosinophils (a type of white blood cell) in the lungs
• Acute confusion and disorientation (delirium)

Administration of piperacillin to patients with cystic fibrosis has been associated with more frequent occurrence of fever and rash. Beta-lactam antibiotics, including piperacillin with tazobactam, may cause symptoms of brain function disorders (encephalopathy) and seizures.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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 or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tazocin

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month. Unopened vials: do not store above 25°C. For single use only. Dispose of 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Tazocin contains

• The active substances are piperacillin and tazobactam. Tazocin, 2 g + 0.25 g: each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt). Tazocin, 4 g + 0.5 g: each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).
• The other ingredients are citric acid monohydrate and disodium edetate (EDTA).

What Tazocin looks like and contents of the pack

Tazocin, 2 g + 0.25 g, is a white or almost white powder in a vial. The pack contains 1, 5, 10, 12, 25, or 50 vials. Tazocin, 4 g + 0.5 g, is a white or almost white powder in a vial. The pack contains 1, 5, 10, 12, 25, or 50 vials. Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium

Manufacturer

Wyeth-Lederle S.r.l Via Franco Gorgone – Zona Industriale 95100 Catania CT Italy Pfizer Service Company BV, Hoge Wei 10, Zaventem, 1930 Belgium

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

Cyprus

• TAZOCIN
• Tazocin
• TAZOCILLINE 2 g/0.25 g, powder for solution for infusion TAZOCILLINE 4 g/0.5 g, powder for solution for infusion
• Tazocin
• Tazocin 2 g / 0.25 g powder for solution for infusion Tazocin 4 g / 0.5 g powder for solution for infusion
• Tazocin
• Tazocin - TAZOCIN 2 g/0.25 g powder for solution for infusion TAZOCIN 4 g/0.5 g powder for solution for infusion

For more information about this medicine, contact your local representative of the marketing authorization holder: Pfizer Polska Sp. z o.o. tel.: 22 335 61 00 Date of last revision of the leaflet:07/2022 Detailed information on this medicine is available on the website: www.urpl.gov.pl -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Note: It is not recommended to use in adults for the treatment of bacteremia caused by E. coliand K. pneumoniae(resistant to ceftriaxone) producing extended-spectrum beta-lactamases (ESBL).

How to store Tazocin

Unopened vial: do not store above 25°C.

Reconstituted solution in the vial

Chemical and physical stability studies have shown that the solution can be stored for up to 12 hours in the refrigerator at 2-8°C, after reconstitution with one of the compatible solvents (see Instructions for use below).

Diluted reconstituted solution for infusion

If the diluted reconstituted solution is prepared using one of the compatible diluents, to the recommended volumes (see Instructions for use below), it retains chemical and physical stability for up to 12 hours if stored in the refrigerator at 2-8°C. From a microbiological point of view, the reconstituted or diluted medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. This time should not exceed 12 hours at 2-8°C.

Instructions for use

Tazocin should be given as an intravenous infusion (over 30 minutes). The medicine should be reconstituted and diluted under aseptic conditions. Before administration, the solution should be inspected for visible particles and color change. The solution should only be administered if it is clear and free of visible particles.

Intravenous administration

The solution should be prepared by adding the recommended volume of one of the following compatible solvents to the vial. The vial should be shaken until the powder is dissolved. The powder usually dissolves within 5 to 10 minutes of continuous shaking (see detailed handling instructions below).

* Compatible solvents used for reconstitution:

• 0.9% (9 mg/ml) sodium chloride solution for injection
• Water for injection
• 5% glucose solution

The maximum recommended volume of water for injection is 50 ml per dose. The reconstituted solution should be withdrawn from the vial using a syringe. After reconstitution of the powder in the recommended manner, the contents of the vial withdrawn with a syringe will contain the labeled amount of piperacillin and tazobactam. The reconstituted solution can be further diluted to the required volume (e.g., 50 ml or 150 ml) with one of the following diluents:

• 0.9% (9 mg/ml) sodium chloride solution for injection
• 5% glucose solution
• 6% dextran solution in 0.9% (9 mg/ml) sodium chloride solution
• Ringer's solution with lactate
• Hartmann's solution
• Ringer's solution with acetate
• Ringer's solution with acetate and malate

Incompatibilities

If Tazocin is given at the same time as another antibiotic (e.g., an aminoglycoside), these products should be given 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 Tazocin in vitroin some diluents at specific concentrations (see below Administration of Tazocin with aminoglycosides). Do not mix Tazocin with other substances in a syringe or infusion container, as compatibility has not been established. Due to chemical instability, Tazocin should not be used with solutions containing only sodium bicarbonate. Tazocin is compatible with Ringer's solution with lactate and can be administered simultaneously through a Y-site infusion set. Do not add Tazocin to blood products or albumin hydrolysates.

Administration of Tazocin with aminoglycosides

Mixing beta-lactam antibiotics with aminoglycosides in vitromay cause significant inactivation of the aminoglycoside. Therefore, it is recommended that Tazocin and aminoglycosides be given separately. If concurrent administration of an aminoglycoside and Tazocin is necessary, they should be reconstituted and diluted separately. If co-administration is recommended, Tazocin is compatible and can be administered simultaneously through a Y-site infusion set only with the following aminoglycosides and under the following conditions.

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