Textazo

Patient Information Leaflet: Information for the User

TEXTAZO 2 g + 0,25 g/4 ml powder and solvent for injectable solution for intramuscular use
TEXTAZO 4 g + 0,5 g powder for solution for infusion
piperacillin/tazobactam
Equivalent medicinal product
Please read this leaflet carefully before 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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What TEXTAZO is and what it is used for

TEXTAZO contains the active substances piperacillin and tazobactam.
Piperacillin belongs to a group of medicines known as "broad-spectrum penicillin antibiotics" and is able to kill many types of bacteria.
Tazobactam can prevent certain resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are administered together, they can kill a wider range of bacteria.
TEXTAZO is used in adults and adolescents for the treatment of bacterial infections such as those affecting the respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin, or blood.
TEXTAZO is used in children aged between 2 and 12 years for the treatment of abdominal infections such as appendicitis, peritonitis (infection of the fluid and lining of abdominal organs), and gallbladder (biliary) infections.
TEXTAZO may be used to treat bacterial infections if you have a low number of white blood cells (reduced resistance to infections).

2. What you need to know before using TEXTAZO

Do not use TEXTAZO

• if you are allergic (hypersensitive) to piperacillin, tazobactam, or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to other antibiotic medicines known as penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may also be allergic to this medicine;
• if you are allergic (hypersensitive) to lidocaine (contained in the solvent vials for intramuscular administration).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using TEXTAZO.
Take special care

• if you are prone to allergies or have previously suffered from allergic reactions (see section “Do not use TEXTAZO”). If you have multiple allergies, inform your doctor or nurse before this medicine is administered;
• if you develop skin irritation (cutaneous rash), your doctor should carefully monitor your health condition. If skin lesions worsen, treatment with TEXTAZO must be discontinued. Very rarely, severe skin reactions may occur (Stevens-Johnson syndrome and toxic epidermal necrolysis);
• if you experience severe and persistent diarrhoea during or after treatment. In this case, you must inform your doctor or nurse immediately;
• if you have low levels of potassium in the blood. Your doctor should check kidney function before administering this medicine and may perform periodic blood tests during treatment;
• if you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also section “Other medicines and TEXTAZO”), or if unexpected bleeding occurs during treatment. In such cases, inform your doctor or nurse. Bleeding manifestations are more likely to occur in patients with renal impairment;
• if you develop seizures during treatment. In this case, inform your doctor or nurse, especially if you have kidney problems (renal dysfunction);
• if you think you have developed a new infection or if the infection has worsened. In this case, inform your doctor or nurse.

During treatment with this medicine, especially with prolonged therapy, you may experience a
reduction in the number of white blood cells (leukopenia, neutropenia). Therefore, periodic monitoring is recommended.
Hemophagocytic lymphohistiocytosis
Cases of a condition in which the immune system produces abnormally high numbers of white blood cells called histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis), have been reported. This condition can be life-threatening if not diagnosed and treated early. If you develop multiple symptoms such as fever, swollen lymph nodes, feeling of weakness, mental confusion, shortness of breath, easy bruising, or skin rash, contact your doctor immediately.
Children
The safety and efficacy of Textazo in children aged 0 to 2 years have not been established.
Other medicines and TEXTAZO
Inform your doctor or healthcare provider if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.
Use this medicine with caution and inform your doctor if you are taking:

• probenecid, a medicine used to treat high levels of uric acid (gout);
• medicines used to thin the blood or treat blood clots (heparin, warfarin, or aspirin);
• medicines used to relax muscles during surgery (non-depolarizing muscle relaxants, such as vecuronium). Inform your doctor if you are undergoing anesthesia;
• methotrexate, a medicine used to treat certain cancers, arthritis, or a skin disease (psoriasis);
• medicines containing other antibiotics (tobramycin or gentamicin); inform your doctor if you have kidney problems.

Effect on laboratory test results

• This medicine may alter the results of certain blood and urine tests. Inform your doctor or laboratory staff that you are taking TEXTAZO if you are required to provide a blood or urine sample.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine may pass to the baby through the placental barrier or breast milk. If you are pregnant or breastfeeding, your doctor will evaluate the need for treatment with TEXTAZO, considering the risk/benefit ratio.
Driving and operating machinery
There are insufficient data to determine the effects of this medicine on the ability to drive vehicles or operate machinery.
TEXTAZO contains sodium
TEXTAZO 2 g + 0.25 g/4 ml contains 109 mg of sodium (the main component of table salt) per vial. This corresponds to 5.5% of the maximum daily dietary intake recommended for an adult.
TEXTAZO 4 g + 0.5 g contains 216 mg of sodium (the main component of table salt) per vial. This corresponds to 10.8% of the maximum daily dietary intake recommended for an adult.

3. How to use TEXTAZO

This medicine will be administered by a doctor or trained healthcare professional. If you have any doubts, please consult your doctor or nurse.
The dose and frequency of TEXTAZO administration depend on the severity and type of infection.
The duration of treatment for most indications ranges between 5 and 14 days. However, the duration of treatment should be determined based on the severity and type of infection, as well as your individual health status.
TEXTAZO 2 g + 0.25 g can be administered either by intramuscular injection (into the muscle) or by direct injection into the vein (slow intravenous injection over at least 3–5 minutes, or by continuous infusion over 20–30 minutes).
The vial of solvent containing lidocaine provided in the TEXTAZO 2 g + 0.25 g pack must be used exclusively for intramuscular administration.
TEXTAZO 4 g + 0.5 g can only be administered by slow intravenous injection or by infusion.

Use in adults and children from 12 years of age
TEXTAZO 2 g + 0.25 g/4 ml powder and solvent for injectable solution.
The recommended dose is 2 g + 0.25 g of TEXTAZO, administered every 12 hours by intramuscular injection.
The recommended intravenous dose ranges from a minimum of 2 g + 0.25 g up to a maximum of 4 g + 0.5 g of TEXTAZO, administered every 6, 8, or 12 hours.

TEXTAZO 4 g + 0.5 g powder for infusion solution
The recommended dose is 4 g + 0.5 g of TEXTAZO every 6–8 hours, administered into a vein (directly into the bloodstream).

Use in children from 2 to 12 years of age
The recommended dose for children with abdominal infections is 100 mg / 12.5 mg per kg of body weight of TEXTAZO, administered every 8 hours intravenously (directly into the bloodstream).
The usual dose for children with low white blood cell counts (neutropenic) is 80 mg / 10 mg per kg of body weight of TEXTAZO, administered every 6 hours intravenously (directly into the bloodstream).
The doctor will calculate the dose based on the child’s body weight; however, the dose administered over 30 minutes must not exceed 4 g + 0.5 g of TEXTAZO.

Use in patients with kidney problems (renal impairment)
If you have kidney problems, your doctor may need to reduce the dose of TEXTAZO or the frequency of administration.
Your doctor may also perform blood tests to ensure that the prescribed dose is appropriate, especially if you are to receive this medicine for a prolonged period.
In children undergoing dialysis sessions (mechanical blood filtration), an additional dose of TEXTAZO should be administered after each dialysis session.

If you use more TEXTAZO than you should
Since TEXTAZO will be administered by a doctor or nurse, it is unlikely that you will receive an incorrect dose. However, if adverse effects such as seizures occur, or if you think you have been given too high a dose, inform your doctor or nurse immediately.

If you forget to use TEXTAZO
If you think a dose of TEXTAZO has not been administered, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following serious side effects have been reported with TEXTAZO:

• severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) which initially appear as reddish, target-like spots or circular rashes, often with central blisters on the trunk. Further symptoms include the presence of ulcers in the mouth, throat, nose, extremities, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin, which could potentially be life-threatening
• swelling of the face, lips, tongue, or other parts of the body
• shortness of breath, wheezing, or difficulty breathing
• severe rash, itching, or hives on the skin
• yellowing of the eyes or skin
• damage to blood cells (signs include: unexpected breathlessness, red or brown urine, nosebleeds, and appearance of bruises)
• severe or persistent diarrhoea accompanied by fever or weakness
• unexpected bleeding, especially in patients taking anticoagulants such as warfarin

If you experience any of the above side effects, consult your doctor immediately. For information on the frequency of these reactions, please refer to the details below.
The following adverse reactions are listed in order of frequency.
Common (may affect up to 1 in 10 people)

• diarrhoea, vomiting, nausea
• skin irritation (skin rashes)

Uncommon (may affect up to 1 in 100 people)

• fungal infection (candidiasis superinfection)
• abnormally low white blood cell count (leucopenia, neutropenia) and low platelet count (thrombocytopenia)
• allergic reaction (hypersensitivity)
• headache, insomnia
• low blood pressure (hypotension), inflammation of veins (felt as tenderness or redness in the affected area)
• jaundice (yellowing of the skin or whites of the eyes), inflammation of the mucous membranes in the mouth, constipation, indigestion, stomach discomfort
• increased levels of certain enzymes in the blood (increased alanine aminotransferase, increased aspartate aminotransferase)
• itching, skin rash (urticaria)
• increased levels of a substance in the blood called creatinine (a marker of kidney function)
• fever, reaction at the injection site

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

• abnormally low red blood cell count (including haemolytic anaemia) or low haemoglobin (blood pigment), appearance of bruises with small spots (purpura), nosebleeds (epistaxis), prolonged bleeding time, abnormally high count of a type of white blood cells (eosinophilia)
• severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)
• flushed skin with hot flushes
• severe intestinal infection (pseudomembranous colitis), abdominal pain, liver inflammation (hepatitis), increased levels in the blood of a pigment produced by the breakdown of red blood cells (bilirubin), increased levels of certain blood enzymes (increased alkaline phosphatase in blood, increased gamma-glutamyltransferase)
• skin disorders with redness and formation of lesions on the skin (exanthema, erythema multiforme), and blister formation (bullous dermatitis)
• joint and muscle pain (arthralgia, myalgia)
• reduced kidney function and kidney problems; chills

Very rare (may affect up to 1 in 10,000 people)

• severe reduction in a type of white blood cells (agranulocytosis), marked reduction in platelets (pancytopenia)
• prolonged blood clotting time (prolonged partial thromboplastin time, prolonged prothrombin time), altered results in certain laboratory tests (positive direct Coombs test), increased platelet count (thrombocytosis)
• low potassium levels in the blood (hypokalaemia), low blood sugar levels (hypoglycaemia), low levels of a protein in the blood (hypoalbuminaemia), low levels of total proteins in the blood
• severe skin disorder (toxic epidermal necrolysis), severe widespread allergic reaction affecting the whole body with irritation (rash) on the skin and mucous membranes and formation of lesions or blisters (various skin eruptions, Stevens-Johnson syndrome)
• increased levels of nitrogen in the blood (azotemia)

If you suffer from a severe pancreatic disease (cystic fibrosis), you may be more likely to develop fever and skin irritation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TEXTAZO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry:".
The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 25°C.
The solution must be used immediately after preparation.
Each vial is for single use only; any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TEXTAZO contains
TEXTAZO 2 g + 0,25 g/4 ml powder and solvent for injectable solution

• The active substances are piperacillin and tazobactam. Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt).
• The other components are: Solvent vial: lidocaine hydrochloride, water for injection.

TEXTAZO 4 g + 0.5 g powder for infusion solution

• The active substances are piperacillin and tazobactam. Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt).

Description of the appearance of TEXTAZO and contents of the pack
TEXTAZO 2 g + 0.25 g/4 ml powder and solvent for injectable solution for intramuscular use
Pack containing one vial of powder and one solvent ampoule containing lidocaine hydrochloride 20 mg/ml for injectable solution for intramuscular use. The lidocaine ampoule is for intramuscular use only.
TEXTAZO 4 g + 0.5 g powder for infusion solution
Pack containing one vial of powder.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmatex Italia S.r.l. – Via San Paolo 1 – 20121 Milan - Italy
Manufacturer
Mitim S.r.l. – Via Cacciamali 34-36-38 – 25125 Brescia - Italy

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use

A. Intramuscular use
Textazo 2 g + 0.25 g must be reconstituted with the solvent ampoule supplied in the pack, containing 4 ml of 0.5% lidocaine solution.
The solvent ampoule containing lidocaine supplied in the pack must be used exclusively for intramuscular administration.
Do not exceed a dose of 2 g + 0.25 g of piperacillin/tazobactam per injection site.

For correct reconstitution, follow the procedure below:

1. Shake the vial containing the lyophilisate to be reconstituted to detach the powder from the bottom of the vial.
2. Remove the plastic flip-off cap from the vial to expose the central portion of the rubber stopper and keep it aside (Fig. 1).
   Always avoid touching the central portion of the rubber stopper with your hands.

Fig. 1
3) Using a syringe, withdraw the solvent containing lidocaine and inject it into the vial containing the lyophilisate.
4) Place the plastic cap back onto the rubber stopper to avoid touching the central portion with fingers. Shake vigorously until the powder is completely dissolved. Under continuous agitation, reconstitution should be completed within 10 minutes (Fig. 2).

Fig. 2
5) Allow the resulting solution to stand until foam disappears and a clear solution is obtained. Ensure that no undissolved particles remain.
6) Remove the plastic cap and withdraw the solution using a 5 ml syringe for intramuscular administration.
After reconstitution, the solution must be administered immediately.
Unused solutions must be discarded.

B. Intravenous use
Reconstitute each vial with the volume of solvent indicated in the table below, using one of the compatible solvents for reconstitution. Rotate gently until dissolved. When continuously rotated, reconstitution usually occurs within 5–10 minutes (for details on handling, see below).

* Compatible solvents for reconstitution:

• 0.9% sodium chloride injectable solution (9 mg/ml)
• Sterile water for injectable preparations
• 5% glucose

The maximum recommended volume of sterile water for injectable preparations for each dose is 50 ml.

The reconstituted solution must be withdrawn from the vial using a syringe. Once reconstituted according to the instructions, the content of the vial withdrawn with the syringe will provide the amount of piperacillin and tazobactam indicated on the label.
Reconstituted solutions may be further diluted to the desired volume (e.g. from 50 ml to 150 ml) with one of the following compatible solvents for intravenous administration:

• 0.9% sodium chloride injectable solution (9 mg/ml)
• 5% glucose
• 6% Dextran in 0.9% sodium chloride

Incompatibilities
This medicinal product must not be mixed with other products except those mentioned in section 6.6 of the SmPC. When Textazo is used concomitantly with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. Mixing beta-lactam antibiotics with an aminoglycoside in vitro may result in substantial inactivation of the aminoglycoside. However, compatibility of amikacin and gentamicin with TEXTAZO has been determined in vitro in certain diluents at specific concentrations (see section Co-administration of TEXTAZO with aminoglycosides). In case of intramuscular administration, piperacillin/tazobactam and aminoglycosides must be reconstituted and administered separately at different injection sites. Textazo must not be mixed with other substances in a syringe or infusion vial, as compatibility has not been established. Due to chemical instability, Textazo must not be used in solutions containing sodium bicarbonate only. Textazo must not be added to blood products or hydrolysed albumins.

Co-administration of TEXTAZO with aminoglycosides
Due to the in vitro inactivation of aminoglycosides by beta-lactam antibiotics, it is recommended that Textazo and aminoglycosides be administered separately. When concomitant therapy with aminoglycosides is indicated, Textazo and the aminoglycoside must be reconstituted and diluted separately.
Under circumstances where co-administration is recommended, Textazo is compatible with simultaneous co-administration via a Y-site infusion line only with the following aminoglycosides, under the following conditions:

*The aminoglycoside dose must be based on the patient's body weight, the severity of the infection (serious or
potentially life-threatening), and renal function (creatinine clearance).
The compatibility of Textazo with other aminoglycosides has not been established. Only the concentration and diluents
for amikacin and gentamicin with the Textazo dose reported in the previous table have been established as
compatible for co-administration by infusion via a Y-site connector. Simultaneous co-administration
via a Y-site connector using different methods from those described above may result in
inactivation of the aminoglycoside by Textazo.
Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with
local applicable regulations.
For single use only. Discard any unused solution.
For further information, consult the Summary of Product Characteristics.