PIPERACILLINA E TATSOBAKTAM IBIJEN 2 G/0.25 G Порошок для инъекционного/инфузионного раствора

Содержание инструкции

1. Piperacillina e Tazobactam Ibigen 2 g/0,25 g e 4g/0.5g powder for solution for infusion
   1. What is Piperacillina e Tazobactam Ibigen and what is it used for?
   2. What you need to know before using Piperacillina e Tazobactam Ibigen
   3. How to use Piperacillina e Tazobactam Ibigen
   4. Possible side effects
   5. How to store Piperacillina e Tazobactam Ibigen
   6. Contents of the pack and other information

Piperacillina e Tazobactam Ibigen 2 g/0,25 g e 4g/0.5g powder for solution for infusion

Read this leaflet carefully before you start 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 only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Piperacillina e Tazobactam Ibigen is and what it is used for
• 2. What you need to know before you are given Piperacillina e Tazobactam Ibigen
• 3. How to administer Piperacillina e Tazobactam Ibigen
• 4. Possible side effects
• 5. How to store Piperacillina e Tazobactam Ibigen
• 6. Contents of the pack and other information

1. What is Piperacillina e Tazobactam Ibigen and what is it used for?

Piperacillina belongs to the group of antibiotic drugs known as “broad-spectrum penicillins”, capable of killing many types of bacteria. Tazobactam can prevent the resistance of some bacteria to piperacillina. This means that when piperacillina and tazobactam are administered together, more types of bacteria are killed.
Piperacillina e Tazobactam Ibigen is indicated in adults and adolescents for the treatment of bacterial infections affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillina e Tazobactam Ibigen can be used to treat infections in patients with a low number of white blood cells (reduced resistance to infections).
Piperacillina e Tazobactam Ibigen is indicated in children aged between 2 and 12 years for the treatment of abdominal infections, such as appendicitis, peritonitis (infection of the fluid and tissue lining the abdominal organs) and gallbladder (biliary) infections.
Piperacillina e Tazobactam Ibigen can be used for the treatment of bacterial infections in patients with a low number of white blood cells (reduced resistance to infections).
Your doctor may use Piperacillina e Tazobactam Ibigen in combination with other antibiotics in some serious infections.

2. What you need to know before using Piperacillina e Tazobactam Ibigen

Do not use Piperacillina e Tazobactam Ibigen

• 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 Piperacillina e Tazobactam Ibigen

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Piperacillina e Tazobactam Ibigen:

• if you have allergies. If you have several allergies, tell your doctor or healthcare professional before taking this product
• if you suffer from diarrhoea before treatment or if you have diarrhoea during or after treatment. In this case, inform your doctor or healthcare professional immediately. Do not take medicines for diarrhoea before talking to your doctor
• if you think your infection is getting worse or you have a new infection. In this case, you should inform your doctor or healthcare professional
• if you are taking another antibiotic called vancomycin together with Piperacillina e Tazobactam Ibigen, it may increase the risk of kidney problems (see also “Other medicines and Piperacillina e Tazobactam Ibigen” in this leaflet)
• if you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also “Other medicines and Piperacillina e Tazobactam Ibigen” in this leaflet) or if unexpected bleeding occurs during treatment. In this case, you should inform your doctor or healthcare professional immediately
• if you have liver or kidney problems, or are undergoing haemodialysis. Your doctor may require a check of your kidneys before giving you this medicine and may require regular blood tests during treatment
• if you have seizures during treatment. In this case, you should inform your doctor or healthcare professional
• if you have low levels of potassium in your blood. Your doctor may require a check of your kidneys before taking this medicine and may require regular blood tests during treatment

Children
The use of piperacillin/tazobactam is not recommended in children under 2 years of age, due to
a lack of sufficient safety and efficacy data.

Other medicines and Piperacillina e Tazobactam Ibigen
Tell your doctor or healthcare professional if you are taking, have recently taken or
may take any other medicines, including those obtained without a prescription.
Some medicines can interact with piperacillin and tazobactam.
These include:

• medicines for gout (probenecid), which can increase the time it takes to eliminate piperacillin and tazobactam from your body
• medicines to thin the blood or treat blood clots (e.g. heparin, warfarin or aspirin)
• medicines used to relax muscles during surgery. Tell your doctor if you are about to undergo general anaesthesia
• methotrexate (a medicine used to treat some cancers, arthritis or psoriasis). Piperacillin and tazobactam may increase the time it takes to eliminate methotrexate
• medicines used to reduce potassium levels in the blood (such as diuretics or some cancer medicines)
• medicines containing other antibiotics, such as tobramycin, gentamicin or vancomycin. Tell your doctor if you have kidney problems. Taking Piperacillina e Tazobactam Ibigen and vancomycin at the same time may increase the risk of kidney damage even if you do not have kidney problems.

Effects on laboratory tests
Tell your doctor or laboratory personnel that you are taking Piperacillina e
Tazobactam Ibigen if you need to have blood or urine tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or healthcare professional for advice before
taking this medicine. The doctor will decide if Piperacillina e Tazobactam Ibigen is
suitable for you.
Piperacillin and tazobactam can be absorbed by the baby when in the womb
or through breastfeeding. If you are breastfeeding, your doctor will decide if you can
use Piperacillina e Tazobactam Ibigen.

Driving and using machines
Taking Piperacillina e Tazobactam Ibigen does not appear to impair the ability to drive
vehicles or use machines.

Piperacillina e Tazobactam Ibigen 2g/0.25g contains sodium
This medicine contains 108 mg of sodium (the main component of table salt) per
vial. This is equivalent to 5.4% of the recommended maximum daily intake with the
diet of
an adult.

Piperacillina e Tazobactam Ibigen 4g/0.5g contains sodium
This medicine contains 16 mg of sodium (the main component of table salt) per
vial. This is equivalent to 10.8% of the recommended maximum daily intake with
the diet of
an adult.

3. How to use Piperacillina e Tazobactam Ibigen

The doctor or healthcare professional will administer this medicine to you via intravenous
infusion (30 minutes) into one of your veins.

Dosage
The dose of medicine that will be administered to you depends on the condition you are being
treated for, your
age, and any existing kidney problems.

Adults and adolescents over 12 years of age
The usual dose is 4 g/0.5 g piperacillin/tazobactam administered every 6-8 hours, intravenously
(directly into the bloodstream).

Children between 2 and 12 years of age
The usual dosage in children with abdominal infections is 100 mg/12.5 mg/kg of
piperacillin/tazobactam administered every 8 hours intravenously (directly into the bloodstream).
The usual dosage in children with a reduced number of white blood cells is 80 mg/10 mg/kg of
piperacillin/tazobactam administered every 6 hours intravenously (directly into the bloodstream).
Your doctor will calculate the dosage based on the child's weight, but the daily dosage
should not exceed 4 g/0.5 g of Piperacillina e Tazobactam Ibigen.
Piperacillina e Tazobactam Ibigen will be administered until the complete disappearance of signs
of infection (from 5 to 14 days).

Patients with kidney problems
If you have kidney problems, your doctor may need to reduce the dosage of Piperacillina e
Tazobactam Ibigen or the frequency of administration. Your doctor may also request
blood tests to ensure you are receiving the correct dosage, especially if you need to
take this medicine for a long time.

If you take more Piperacillina e Tazobactam Ibigen than you should
Since Piperacillina e Tazobactam Ibigen will be administered by the doctor or healthcare
professional, it is unlikely that you will be given an excessive dose. However, if you notice adverse
effects, such as convulsions, or think you have received too much medicine, inform
your doctor immediately.

If you forget to take Piperacillina e Tazobactam Ibigen
If you think you have not been given a dose of Piperacillina e Tazobactam Ibigen,
inform your doctor or healthcare professional immediately.
If you have any doubts about the use of this medicine, ask your doctor or other healthcare
professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Consult a doctor immediatelyif you experience any of these potentially serious side effects.
The serious side effects (their frequency is indicated in brackets) of Piperacillina e Tazobactam Ibigen are:

• severe skin rashes [Stevens-Johnson syndrome, bullous dermatitis (not known), exfoliative dermatitis (not known), toxic epidermal necrolysis (rare)] which initially appear as reddish, target-like spots or circular patches often with blisters in the central area of the trunk. Other signs include ulcers in the mouth, throat, nose, on the extremities, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blisters or widespread skin peeling and may be potentially fatal
• severe allergic condition potentially fatal (drug reaction with eosinophilia and systemic symptoms) that can involve the skin and, especially, other organs under the skin, such as the kidney and liver (not known)
• a skin condition (acute generalized exanthematous pustulosis) accompanied by fever, characterized by numerous small blisters filled with liquid appearing within large areas of swollen and reddened skin (not known)
• swelling of the face, lips, tongue or other parts of the body (not known)
• shortness of breath, wheezing or difficulty breathing (not known)
• severe skin rash or hives (uncommon), itching or rash on the skin (common)
• yellowing of the eyes or skin (not known)
• damage to blood cells [signs include: unexplained shortness of breath, red or brown urine (not known), nosebleeds (rare) and pinpoint bruising (not known)], severe decrease in the number of white blood cells (rare)
• severe or persistent diarrhea associated with fever or weakness (rare).

If any of the followingside effects worsen, or if you notice any
other
side effect not listed in this leaflet, inform your doctor or other healthcare professional.

Very common side effects(may affect more than 1 in 10 people)

• diarrhea

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

• yeast infection
• reduction in platelets, reduction in red blood cells or blood pigment/hemoglobin, abnormal values in laboratory tests (positive direct Coombs test), prolongation of blood clotting time (prolongation of activated partial thromboplastin time)
• reduction in blood proteins
• headache, insomnia
• abdominal pain, vomiting, nausea, constipation, stomach disorders
• increased liver enzymes in the blood
• skin rash, itching
• abnormal values in kidney function blood tests
• fever, reaction at the injection site.

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

• decrease in the number of white blood cells (leukopenia), prolongation of blood clotting time (prolongation of prothrombin time)
• reduction in potassium levels in the blood, reduction in blood sugar
• seizures (convulsions) observed in patients treated with high doses or with kidney problems
• low blood pressure, inflammation of the veins (felt as soreness or redness of the affected area), reddened skin
• increase in the blood of a pigment produced by degradation (bilirubin)
• skin reactions with redness, formation of lesions on the skin, hives
• joint and muscle pain
• chills.

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

• severe reduction in white blood cells (agranulocytosis), nosebleeds
• severe infection of the colon, inflammation of the mucous membranes lining the mouth
• detachment of the upper layer of the skin all over the body (toxic epidermal necrolysis).

Not known(frequency cannot be estimated on the basis of available data)

• severe reduction of red blood cells, white blood cells and platelets (pancytopenia), reduction of white blood cells (neutropenia), reduction of red blood cells due to breakage or premature degradation, appearance of bruises with small spots, prolonged bleeding time, increased platelets, increase in a specific type of white blood cells (eosinophilia)
• allergic reaction and severe allergic reaction
• inflammation of the liver, yellowish discoloration of the skin or whites of the eyes
• severe allergic reaction spreading throughout the body with rash on the skin and mucous membranes, blisters and

various skin rashes (Stevens-Johnson syndrome), severe allergic reaction involving the skin and other organs such as the kidney and liver (drug reaction with
eosinophilia and systemic
symptoms), numerous small blisters filled with liquid appearing within
large
areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)

• poor kidney function and kidney problems
• a form of lung disease in which eosinophils (a form of white blood cells) appear in the lung in increased numbers
• acute disorientation and confusion (delirium).

Therapy with piperacillin has been associated with an increased incidence of fever and
skin rashes in patients with cystic fibrosis.
Beta-lactam antibiotics, including piperacillin tazobactam, can lead to
manifestations of
encephalopathy and seizures.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at .
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverseReporting side effects can help provide more information about the safety of this
medicine.

5. How to store Piperacillina e Tazobactam Ibigen

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 pack and vial
after “Exp”. The expiry date refers to the last day of that month.
Closed vial: store at a temperature not exceeding 25° C. Store in the
original packaging.
The reconstituted/diluted solution must be used within 5 hours if stored at 20–25°C
and within 24 hours if stored at 2–8°C.
Only clear solutions, free from visible particles, must be used.
For single use only.
Discard any unused solution.
Do not dispose of any medicine in the 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 Piperacillina e Tazobactam Ibigen contains
The active ingredients are piperacillin and tazobactam.
Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as
sodium salt)
Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as
sodium salt)

Description of the appearance of Piperacillina e Tazobactam Ibigen and contents of the pack
White to off-white powder.
Transparent glass vial with rubber stopper with aluminum crimp and flip-
off cap
Pack sizes
Piperacillina e Tazobactam Ibigen 2 g/0.25 g powder for solution for infusion:
1 x 1 vial containing powder for solution for infusion (DE/H/904/01/DC)
10 x 1 vial containing powder for solution for infusion (DE/H/904/01/DC)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano, 2
04011, Aprilia (LT)
Italy
[email protected]

Manufacturer
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano, 2
04011 Aprilia (LT)
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
DE: Piperacillin und Tazobactam Ibisqus 2 g/0.25 g Pulver zur Herstellung einer
Infusionslösung
DE: Piperacillin und Tazobactam Ibisqus 4 g/0.5 g Pulver zur Herstellung einer
Infusionslösung
UK: Piperacillin/Tazobactam 2 g/0.25 g Powder for Solution for Infusion
UK: Piperacillin/Tazobactam 4 g/0.5 g Powder for Solution for Infusion
CZ: PIPERACILLIN/TAZOBACTAM IBIGEN 2g/0.25g prášek pro přípravu infuzního roztoku
CZ: PIPERACILLIN/TAZOBACTAM IBIGEN 4g/0.5g prášek pro přípravu infuzního roztoku
AT: Piperacillin und Tazobactam Ibigen 2 g/ 0.25 g Pulver zur Herstellung einer
Infusionslösung
AT: Piperacillin und Tazobactam Ibigen 4 g/0.5 g Pulver zur Herstellung einer
Infusionslösung

The following information is intended exclusively for doctors or healthcare professionals
Instructions for use
Piperacillina e Tazobactam Ibigen is administered by intravenous infusion (over 30 minutes)

Intravenous Infusion
Each vial of Piperacillina e Tazobactam Ibigen 2 g/0.25 g must be reconstituted with the
volume of solvent as shown in the following table, using one of the compatible
solvents for reconstitution. Shake until dissolved. When shaken
constantly, reconstitution occurs within 5 – 8 minutes (details for handling
are given below).

*Compatible solvents for reconstitution:

• Sodium chloride 0.9% (9 mg/ml) solution for injection
• Water for injections
• Glucose 5% solution 50 ml is the maximum recommended volume of water for injections

The reconstituted solutions must be drawn up from the vial with a syringe. When
reconstituted as indicated, the content of the vial drawn up with the syringe will correspond to
the amount of piperacillin and tazobactam stated on the label.
The solution may be further diluted to the desired volume (e.g. 50 ml up
to 150 ml) using the following solvents:

• Sodium chloride 0.9% (9 mg/ml) solution for injection
• Glucose 5% solution When prepared under aseptic conditions, chemical and physical stability has been demonstrated during use for 5 hours at 20-25° C and for 24 hours at 2-8° C. From a microbiological point of view, the product must be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user. The solution must be visually inspected for the presence of particles and to obtain a clear solution before administration. The solution must

be used only if clear and free of particles

Incompatibilities
Whenever Piperacillina e Tazobactam Ibigen is used concomitantly with another
antibiotic, particularly an aminoglycoside, the drugs must not be mixed in
intravenous solutions or administered simultaneously due to physical
incompatibility. Mixing Piperacillina e Tazobactam Ibigen with an aminoglycoside in vitro
may result in substantial inactivation of the aminoglycosides.
Piperacillina e Tazobactam Ibigen must not be mixed with other drugs in the same
syringe or infusion bag as compatibility has not been established.
Due to chemical instability, Piperacillina e Tazobactam Ibigen must not be used
with solutions containing only sodium bicarbonate.
Piperacillina e Tazobactam Ibigen must not be added to blood derivatives or hydrolysed proteins.
Ringer's lactate solution is not compatible with Piperacillina e Tazobactam Ibigen.