Piperacillin/tazobactam Kabi 4 g + 0,5 g

Leaflet accompanying the packaging: information for the user

Piperacillin/Tazobactam Kabi 2 g + 0.25 g, powder for solution for infusion

Piperacillin/Tazobactam Kabi 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.
­
In case of any doubts, consult a doctor or nurse.
­
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Piperacillin/Tazobactam Kabi 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 resistant to piperacillin from surviving. This means that when piperacillin and tazobactam are given together, more strains of bacteria will be killed. Piperacillin/Tazobactam Kabi is used in adults and adolescents to treat bacterial infections of the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdominal cavity infections, skin and blood infections. Piperacillin/Tazobactam Kabi can be used to treat bacterial infections in patients with a low white blood cell count (reduced resistance to infections). Piperacillin/Tazobactam Kabi 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). Piperacillin/Tazobactam Kabi 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 Piperacillin/Tazobactam Kabi together with other antibiotics.

2. Important information before using Piperacillin/Tazobactam Kabi

When not to use Piperacillin/Tazobactam Kabi

• If the patient is allergic to piperacillin or tazobactam, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to antibiotics called penicillins, cephalosporins, or other beta-lactamase inhibitors, as they may be allergic to Piperacillin/Tazobactam Kabi.

Warnings and precautions

Before starting treatment with Piperacillin/Tazobactam Kabi, the patient should discuss with their doctor or nurse:

• If the patient has allergies. If the patient has multiple allergies, they should make sure to tell their doctor or healthcare professional before taking the medicine.
• If the patient has diarrhea before treatment or if it occurs during or after treatment. The patient should immediately inform their doctor or healthcare professional. The patient should not take any medicines for diarrhea without consulting their doctor.
• If the patient has low potassium levels in the blood. It is possible that the doctor will check the patient's kidneys and perform regular blood tests during treatment.
• If the patient has kidney or liver problems, or is undergoing hemodialysis. It is possible that the doctor will check the patient's kidneys and perform regular blood tests during treatment.
• If the patient is taking medicines that prevent excessive blood clotting, called anticoagulants (see also Piperacillin/Tazobactam Kabi and other medicinesin this leaflet), or if unexpected bleeding occurs during treatment. The patient should then immediately tell their doctor or healthcare professional.
• If the patient is taking the antibiotic vancomycin at the same time as Piperacillin/Tazobactam Kabi, the risk of kidney damage may be increased (see also Piperacillin/Tazobactam Kabi and other medicinesin this leaflet).
• If the patient experiences seizures during treatment. The patient should then immediately tell their doctor or healthcare professional.
• If the patient thinks they have a new infection or if an existing infection worsens. In such cases, the patient should tell their doctor or healthcare professional.
• If the patient experiences severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). The patient should stop using Piperacillin/Tazobactam Kabi and immediately consult their doctor if they experience any of the symptoms listed in section 4.

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

Children under 2 years of age

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

Piperacillin/Tazobactam Kabi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about any medicines they plan to take. 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 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 the patient is to undergo general anesthesia, they should inform their doctor about the use of this medicine;
• 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 the patient has kidney problems, they should tell their doctor. The simultaneous use of Piperacillin/Tazobactam Kabi and vancomycin may increase the risk of kidney damage, even if the patient does not have kidney problems.

Effect on laboratory test results

If the patient is to have a blood or urine test, they should tell their doctor or healthcare professional that they are taking Piperacillin/Tazobactam Kabi.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether Piperacillin/Tazobactam Kabi is suitable for the patient. Piperacillin and tazobactam may pass into the baby in the womb or through breast milk. If the patient is breastfeeding, the doctor will decide whether Piperacillin/Tazobactam Kabi is suitable for the patient.

Driving and using machines

Taking Piperacillin/Tazobactam Kabi is unlikely to affect the patient's ability to drive or use machines.
Piperacillin/Tazobactam Kabi 2 g + 0.25 gcontains 112 mg of sodium (the main component of common salt) in each vial. This corresponds to 5.6% of the maximum recommended daily sodium intake in the diet for adults.
Piperacillin/Tazobactam Kabi 4 g + 0.5 gcontains 224 mg of sodium (the main component of common salt) in each vial. This corresponds to 11.2% of the maximum recommended daily sodium intake in the diet for adults.
The patient should keep this in mind if they are controlling their sodium intake.

3. How to use Piperacillin/Tazobactam Kabi

The medicine will be administered by a doctor or other healthcare professional through intravenous infusion (lasting 30 minutes).
The dose of the medicine given to the patient depends on the disease being treated, the patient's age, and any kidney problems they may have.

Adult patients and adolescents over 12 years of age

The recommended dose is 4 g of piperacillin and 0.5 g of tazobactam administered intravenously (directly into the blood) every 6-8 hours.

Children aged 2 to 12 years

For children with abdominal cavity infections, the recommended dose is 100 mg of piperacillin and 12.5 mg of tazobactam per kilogram of body weight, administered intravenously (directly into the blood) every 8 hours. The dose usually used in children with a low white blood cell count is 80 mg of piperacillin and 10 mg of tazobactam per kilogram of body weight, administered intravenously (directly into the blood) every 6 hours.
The doctor will calculate the dose of the medicine based on the child's body weight, but each individual dose of Piperacillin/Tazobactam Kabi will not exceed 4 g + 0.5 g.
The patient will receive Piperacillin/Tazobactam Kabi until the infection symptoms have completely resolved (for 5 to 14 days).

Patients with kidney disease

The doctor may recommend reducing the dose of Piperacillin/Tazobactam Kabi or the frequency of administration. It is possible that the doctor will perform blood tests to ensure that the correct dose of the medicine is being administered, especially if the patient is receiving the medicine for a long time.

Using a higher than recommended dose of Piperacillin/Tazobactam Kabi

Piperacillin/Tazobactam Kabi will be administered by a doctor or other healthcare professional, so it is unlikely that the wrong dose will be given. However, if the patient experiences side effects, such as seizures, or thinks they have received too much medicine, they should immediately tell their doctor.

Missing a dose of Piperacillin/Tazobactam Kabi

If the patient thinks they have missed a dose of Piperacillin/Tazobactam Kabi, they should immediately tell their doctor or healthcare professional.
In case of any further doubts about the use of this medicine, the patient should consult their 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 potentially serious side effects of Piperacillin/Tazobactam Kabi, they should immediately consult their doctor.
Serious side effects (with frequency in parentheses) of piperacillin with tazobactam include:

• severe skin reactions [Stevens-Johnson syndrome, bullous dermatitis (frequency not known), exfoliative dermatitis (frequency not known), toxic epidermal necrolysis (rare)], initially appearing as reddened patches with a target-like shape or round patches, often with centrally located blisters, occurring on the torso; additionally, 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;
• a severe, potentially life-threatening allergic reaction (drug reaction with eosinophilia and systemic symptoms), which may involve the skin and, more importantly, other organs under the skin, such as the kidneys and liver;
• a skin disease (acute generalized exanthematous pustulosis) with accompanying fever, which manifests as numerous small blisters filled with fluid, located on a swollen and reddened large 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 skin or whites of the eyes (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 the patient experiences any worsening of side effects or any side effects not listed in the leaflet, they should tell their doctor or healthcare professional.
Very common side effects (may occur in more than 1 in 10 patients):

• diarrhea.

Common side effects (may occur in less than 1 in 10 patients):

• 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;
• skin rash, itching;
• abnormal kidney function test results;
• fever, reaction at the injection site.

Uncommon side effects (may occur in less than 1 in 100 patients):

• −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 involving redness, skin changes, hives;
• joint and muscle pain;
• chills.

Rare side effects (may occur in less than 1 in 1000 patients):

• significant reduction in white blood cell count (agranulocytosis), nosebleeds;
• severe colon inflammation, mouth mucosa inflammation;
• peeling of the outer skin layer all over the body (toxic epidermal necrolysis).

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

• significant reduction in red blood cell count, white blood cell count, and platelet count (pancytopenia), reduced white blood cell count (neutropenia), reduced red blood cell count due to premature damage 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 reaction with eosinophilia and systemic symptoms), numerous small blisters filled with fluid, located on a swollen and reddened large area of skin, with fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis);
• reduced kidney function and kidney problems;
• a lung disease in which eosinophils (a type of white blood cell) appear in the lungs in increasing numbers;
• acute disorientation and confusion (delirium).

Administration of piperacillin has been associated with a higher incidence of fever and rash in patients with cystic fibrosis.
Beta-lactam antibiotics, including piperacillin with tazobactam, may cause symptoms of encephalopathy and seizures.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Piperacillin/Tazobactam Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vials after "EXP". The expiry date refers to the last day of the month stated.
Unopened vials
Do not store above 25°C. Store the vials in the outer packaging.
For single use only. Unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Piperacillin/Tazobactam Kabi contains

• The active substances of the medicine are piperacillin and tazobactam. Piperacillin/Tazobactam Kabi 2 g + 0.25 g Each vial contains 2 g of piperacillin as sodium salt and 0.25 g of tazobactam as sodium salt. Piperacillin/Tazobactam Kabi 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 medicine does not contain any other ingredients.

What Piperacillin/Tazobactam Kabi looks like and contents of the pack

Piperacillin/Tazobactam Kabi is a white or almost white lyophilized powder for solution for infusion.
Piperacillin/Tazobactam Kabi 2 g + 0.25 g is available in 15 ml and 50 ml vials made of colorless glass (type II), with a halobutyl rubber stopper and an aluminum flip-off cap, in a cardboard box.
Piperacillin/Tazobactam Kabi 4 g + 0.5 g is available in 50 ml vials made of colorless glass (type II), with a halobutyl rubber stopper and an aluminum flip-off cap, in a cardboard box.
The packaging contains 1, 5, or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

LABESFAL - Laboratorios Almiro S.A.
FRESENIUS KABI GROUP
3465-157 Santiago de Besteiros
Portugal
Regarding Piperacillin/Tazobactam Kabi 4 g + 0.5 g
MITIM S.r.l.
Via Cacciamali n°34-36-38
25125 Brescia
Italy
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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

Austria
Piperacillin/Tazobactam Kabi 4 g/0.5 g Pulver zur Herstellung einer Infusionslösung
Belgium
Piperacilline/Tazobactam Fresenius Kabi N.V. 2 g/0.25 g poeder voor oplossing voor infusie/poudre pour solution pour perfusion/Pulver zur Herstellung einer Infusionslösung
Piperacilline/Tazobactam Fresenius Kabi N.V. 4 g/0.5 g poeder voor oplossing voor infusie/poudre pour solution pour perfusion/Pulver zur Herstellung einer Infusionslösung
Bulgaria
Пиперацилин/Тазобактам Каби 2 g/0.25 g прах за инфузионен разтвор
Пиперацилин/Тазобактам Каби 4 g/0.5 g прах за инфузионен разтвор
Cyprus
Piperacillin/Tazobactam Kabi 2 g/0.25 g, Κόνις για διάλυμα προς έγχυση
Piperacillin/Tazobactam Kabi 4 g/0.5 g, Κόνις για διάλυμα προς έγχυση
Czech Republic
Piperacillin/Tazobactam Kabi 4 g/0.5 g
Denmark
Estonia
Piperacillin/Tazobactam Fresenius Kabi 2 g/0.25 g Pulver til infusionsvæske, opløsning
Piperacillin/Tazobactam Fresenius Kabi 4 g/0.5 g Pulver til infusionsvæske, opløsning
Piperacillin/Tazobactam Fresenius Kabi
Finland
Piperacillin/Tazobactam Fresenius Kabi 2 g/0.25 g infuusiokuiva-aine, liuosta varten
Piperacillin/Tazobactam Fresenius Kabi 4 g/0.5 g infuusiokuiva-aine, liuosta varten
France
Piperacilline/Tazobactam Kabi 2 g/0,25 g, poudre pour solution pour perfusion
Piperacilline/Tazobactam Kabi 4 g/0,5 g, poudre pour solution pour perfusion
Greece
Piperacillin/Tazobactam Kabi 2 g/0,25 g, Κόνις για διάλυμα προς έγχυση
Piperacillin/Tazobactam Kabi 4 g/0,5 g, Κόνις για διάλυμα προς έγχυση
Spain
Piperacillin/Tazobactam Kabi 2 g/0,25 g Polvo para solución para perfusión
Piperacillin/Tazobactam Kabi 4 g/0,5 g Polvo para solución para perfusión
Netherlands
Ireland
Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Germany
Piperacillin/Tazobacatm Kabi 2 g/0,25 g Pulver zur Herstellung einer Infusionslösung
Piperacillin/Tazobacatm Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslösung
Norway
Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g pulver til infusjonsvæske, oppløsning
Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g pulver til infusjonsvæske, oppløsning
Poland
Piperacillin/Tazobactam Kabi 2 g + 0,25 g, proszek do sporządzania roztworu do infuzji
Piperacillin/Tazobactam Kabi 4 g + 0,5 g, proszek do sporządzania roztworu do infuzji
Portugal
Piperacilina/Tazobactam Kabi 2 g/0,25 g
Piperacilina/Tazobactam Kabi 4 g/0,5 g
Romania
Piperacillin/Tazobactam Kabi 2 g/0,25 g, pulbere pentru soluţie perfuzabilă
Piperacillin/Tazobactam Kabi 4 g/0,5 g, pulbere pentru soluţie perfuzabilă
Slovakia
Slovenia
Piperacillin/Tazobactam Kabi 2 g/0,25 g
Piperacillin/Tazobactam Kabi 4 g/0,5 g
Piperacilin/tazobaktam Kabi 2 g/0,25 g prašek za raztopino za infundiranje
Piperacilin/tazobaktam Kabi 4 g/0,5 g prašek za raztopino za infundiranje
Sweden
Piperacillin/Tazobactam Fresenius Kabi 2 g/0,25 g Powder for solution for infusion
Piperacillin/Tazobactam Fresenius Kabi 4 g/0,5 g Powder for solution for infusion
Hungary
Piperacillin/Tazobactam Kabi 4 g/0,5 g por oldatos infúzióhoz
United Kingdom
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
Date of last revision of the leaflet:18.04.2022
---------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

The following information is an excerpt from the Summary of Product Characteristics, prepared to provide guidance on the administration of Piperacillin/Tazobactam Kabi. The doctor should consult the Summary of Product Characteristics before administering this medicine to a patient.

Incompatibilities with solvents and other medicines

RINGER'S SOLUTION WITH LACTATE (HARTMANN'S SOLUTION) IS INCOMPATIBLE WITH PIPERACILLIN/TAZOBACTAM KABI.

IF PIPERACILLIN/TAZOBACTAM KABI IS ADMINISTERED SIMULTANEOUSLY WITH OTHER ANTIBIOTICS (E.G., AMINOGLYCOSIDES), THESE MEDICINES SHOULD BE ADMINISTERED SEPARATELY. MIXING PIPERACILLIN/TAZOBACTAM KABI WITH AN AMINOGLYCOSIDE IN VITROMAY CAUSE SIGNIFICANT INACTIVATION OF THE AMINOGLYCOSIDE.

Piperacillin/Tazobactam Kabi should not be mixed with other medicines in a syringe or infusion container, as compatibility has not been established.

Due to chemical instability, Piperacillin/Tazobactam Kabi should not be used with solutions containing sodium bicarbonate.

Piperacillin/Tazobactam Kabi should not be added to blood products or albumin hydrolysates. Instructions for use

Piperacillin/Tazobactam Kabi should be administered by intravenous infusion (lasting 30 minutes).

Intravenous administration

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

Contents of the vial

Volume of solvent added to the vial*

2 g + 0.25 g (2 g of piperacillin and 0.25 g of tazobactam)
10 ml
4 g + 0.5 g (4 g of piperacillin and 0.5 g of tazobactam)
20 ml
* Compatible solvents used for dissolution:

• 0.9% (9 mg/ml) sodium chloride injection solution;
• sterile water for injection. The maximum recommended volume of sterile water for injection is 50 ml per dose.

The prepared solution should be withdrawn from the vial using a syringe. After dissolving the powder in the recommended manner, the contents of the vial withdrawn using a syringe will contain the labeled amount of piperacillin and tazobactam.
The 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 injection solution;
• 5% glucose solution;
• 6% dextran solution in 0.9% sodium chloride solution.