TAZOCIN 4 g/0.5 g Proszek do sporządzania roztworu do infuzji dożylnej

Treść ulotki

1. Tazocin 2 g/0.25 g powder for solution for infusion, 4 g/0.5 g powder for solution for infusion
   1. What is Tazocin and what it is used for
   2. What you need to know before you use Tazocin
   3. How to use Tazocin
   4. Possible side effects
   5. How to store Tazocin
   6. Package Contents and Other Information
2. Tazocin
   1. What is Tazocin and what is it used for
   2. What you need to know before you use Tazocin
   3. How to use Tazocin
   4. Possible side effects
   5. How to store Tazocin
   6. Contents of the pack and other information

Tazocin 2 g/0.25 g powder for solution for infusion, 4 g/0.5 g powder for solution for infusion

piperacillin/tazobactam

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

Contents of this leaflet

• 1. What Tazocin is and what it is used for
• 2. What you need to know before you use 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 it is used for

Piperacillin belongs to the class of medicines known as "broad-spectrum penicillin antibiotics"
and is able to kill many types of bacteria. Tazobactam may prevent some resistant bacteria
from surviving the effects of piperacillin. This means that when piperacillin and tazobactam
are administered together, they can kill more types of bacteria.
Tazocin is used in adults and adolescents for the treatment of bacterial infections, such as those
affecting the lower respiratory tract (lungs), the urinary tract (kidneys and bladder), the abdomen, the skin or the
blood. Tazocin can be used for the treatment of bacterial infections in patients with a low number
of white blood cells (reduced resistance to infections).
Tazocin 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 tissue lining the abdominal organs) and
gallbladder (biliary) infections. Tazocin can be used for the treatment of bacterial infections in
patients with a low number of white blood cells (reduced resistance to infections).
In some severe infections, the doctor may consider using Tazocin in association with other antibiotics.

2. What you need to know before you use Tazocin

Do not use Tazocin

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Tazocin:

• if you suffer from allergies. If you suffer from several allergies, make sure to inform your doctor or other healthcare professional before taking this product;
• if you suffer from diarrhoea before treatment or if you develop diarrhoea during or after treatment. In this case, make sure to inform your doctor or other healthcare professional immediately. Do not take other medicines for diarrhoea without first consulting your doctor;
• if you have low levels of potassium in your blood. Your doctor may want to check your kidney function before you take this medicine and may perform regular blood tests during treatment;
• if you have problems with your kidneys or liver or if you are on haemodialysis. Your doctor may want to check your kidney function before you take this medicine and may perform regular blood tests during treatment;
• If you are taking another antibiotic called vancomycin. Taking Tazocin and vancomycin at the same time can increase the risk of kidney damage (see also section

(called anticoagulants) to avoid excessive blood clotting (see also the
section "Other medicines and Tazocin") or if unexpected bleeding occurs during
treatment. In this case, you should inform your doctor or other healthcare professional immediately;

• if you develop seizures during treatment. In this case, you should inform your doctor or other healthcare professional immediately;
• if you think you have developed a new infection or if the infection has worsened. In this case, you should inform your doctor or other healthcare professional immediately.

Haemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces a higher amount than normal of white blood cells called histiocytes and lymphocytes, resulting in inflammation (haemophagocytic lymphohistiocytosis) have been reported. This condition can be life-threatening if not diagnosed and
treated early. If you develop several symptoms such as fever, swollen lymph nodes, feeling of
weakness, feeling dizzy, shortness of breath, bruising or skin rash,
contact your doctor immediately.
If you notice signs or symptoms of an allergic reaction along with chest pain, inform your
doctor immediately. These may be signs of a condition called Kounis syndrome.
If you notice unexplained muscle pain, tenderness or weakness and/or dark urine, inform
your doctor immediately. These may be signs of muscle damage (called rhabdomyolysis), which
can lead to kidney problems.

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

Other medicines and Tazocin
Tell your doctor or other healthcare professional if you are taking, have recently taken or are planning to
take any other medicines, including those available without a prescription. Some medicines
may interact with piperacillin and tazobactam.
They include:

• medicine for gout (probenecid), which may increase the time it takes for piperacillin and tazobactam to be eliminated from the body;
• medicines to thin the blood or to treat blood clots (e.g. heparin, warfarin or aspirin);
• medicines used to relax muscles during surgery. Tell your doctor if you are going to have general anaesthesia;
• methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam may increase the time it takes to eliminate methotrexate from the body;
• medicines that can reduce the level of potassium in the blood (e.g. tablets that increase urine production or some anticancer medicines);
• medicines containing other antibiotics such as tobramycin, gentamicin or vancomycin. Tell your doctor if you have kidney problems. 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 results
Tell your doctor or laboratory personnel that you are taking Tazocin if you need to provide a
blood or urine sample.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or other healthcare professional for advice before taking this medicine.
The doctor will decide whether Tazocin is suitable for you.
Piperacillin and tazobactam can reach the baby in the womb or pass through breast milk.
If you are breastfeeding, your doctor will decide whether Tazocin is suitable for you.

Driving and operating machinery
It is not expected that Tazocin will affect your ability to drive or operate machinery.

Tazocin contains sodium
Tazocin 2 g/0.25 g
This medicine contains 130 mg of sodium (the main component of cooking salt / table salt) in each vial. This is equivalent to 6.5% of the maximum recommended daily intake of sodium
for an adult.
Tazocin 4 g/0.5 g
This medicine contains 261 mg of sodium (the main component of cooking salt / table salt) in each vial. This is equivalent to 13% of the maximum recommended daily intake with
diet for an adult.
This factor should be taken into consideration if you are following a diet with a controlled sodium
intake.

3. How to use Tazocin

The doctor or another healthcare professional will administer this medicine to you by infusion (an
infusion of 30 minutes) into a vein.

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

Adults and adolescents over 12 years of age
The usual dose is 4 g/0.5 g of piperacillin/tazobactam administered every 6-8 hours into a vein
(directly into the bloodstream).
Children aged between 2 and 12 years
The usual dose for children with abdominal infections is 100 mg/12.5 mg/kg of body weight of
piperacillin/tazobactam administered every 8 hours into a vein (directly into the bloodstream). The usual dose
for children with a low number of white blood cells is 80 mg/10 mg/kg of body weight of
piperacillin/tazobactam administered every 6 hours into a vein (directly into the bloodstream).
The 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 Tazocin.
Tazocin will be administered until the complete disappearance of signs of infection (from 5 to 14 days).
Patients with kidney problems
The doctor may need to reduce the dose of Tazocin or the frequency with which it is administered to you. The
doctor may also prescribe blood tests to check the correctness of the treatment dose, especially if you have to take this medicine for a prolonged period.

If you take more Tazocinthan you should
Since a doctor or another healthcare professional will administer Tazocin to you, it is unlikely that you will be
treated with the wrong dose. However, if you experience adverse effects, such as convulsions, or
think that you have been given an excessive dose, inform your doctor immediately.

If you miss a dose of Tazocin
If you think that you have not been given a dose of Tazocin, inform your doctor or a
healthcare professional immediately.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Contact a doctor immediatelyif you experience any of these potentially serious side effects:
Serious side effects (whose frequency is indicated in parentheses) are:

• severe skin rash that initially appears as reddish, target-like spots or circular patches often with central blisters on the trunk. Other signs include ulcers in the mouth, throat, nose, on the extremities, genitals and reddened, swollen eyes (conjunctivitis). The rash may progress to widespread blisters or widespread skin peeling and may be potentially fatal. These could be signs of Stevens-Johnson syndrome (frequency not known), bullous dermatitis (frequency not known), exfoliative dermatitis (frequency not known) or toxic epidermal necrolysis (rare);
• a skin condition accompanied by fever, characterized by numerous small blisters filled with liquid appearing within large areas of swollen and reddened skin, known as acute generalized exanthematous pustulosis (frequency not known);
• severe allergic reaction 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 (frequency not known);
• swelling of the face, lips, tongue or other parts of the body, wheezing, whistling or difficulty breathing (allergic reactions including anaphylactic shock, frequency not known);
• sudden chest pain that may be induced by an allergic reaction known as Kounis syndrome (frequency not known);
• severe rash or hives (uncommon), itching or rash on the skin (common);
• inflammation of the liver (hepatitis, frequency not known), yellowing of the skin or the whites of the eyes (jaundice, frequency not known);
• low levels of red blood cells (anemia, common), excessive destruction of red blood cells causing unjustified shortness of breath, urine that is red or brown in color (hemolytic anemia, frequency not known);
• low levels of platelets, which can lead to bleeding, bruising (thrombocytopenia, common);
• low levels of white blood cells, blood cells that fight infections (leukopenia, uncommon or neutropenia, frequency not known);
• very low levels of a type of white blood cells called granulocytes (agranulocytosis, rare);
• high levels of platelets (thrombocytosis, frequency not known);
• high levels of a type of white blood cells called eosinophils (eosinophilia, frequency not known);
• low levels of all types of blood cells, including platelets (pancytopenia, frequency not known);
• severe or persistent diarrhea associated with fever or weakness (pseudomembranous colitis, rare);
• decreased potassium in the blood (uncommon);
• seizures (convulsions), observed in patients treated with high doses or with kidney problems (uncommon);
• severe muscle pain, tenderness or weakness (rhabdomyolysis, frequency not known).

If any of the following side effects worsen, or if you notice any 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;
• formation of antibodies in the blood that attack red blood cells (positive direct Coombs test), prolongation of blood clotting time (prolongation of activated partial thromboplastin time);
• reduction of proteins in the blood;
• headache, insomnia;
• abdominal pain, vomiting, nausea, constipation, stomach disorders;
• increased liver enzymes in the blood;
• abnormal values in blood tests of kidney function;
• fever, reaction at the injection site.

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

• prolongation of blood clotting time (prolongation of prothrombin time), reduction of blood sugar;
• 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; joint and muscle pain;
• chills.

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

• nosebleeds;
• inflammation of the mucous membranes lining the mouth.

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

• appearance of bruises with small spots, prolonged bleeding time;
• bullous skin disease characterized by blisters on the skin and mucous membranes (linear IgA disease);
• 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 signs of altered brain function (encephalopathy) and seizures.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at: https://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 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 package and vial after
Exp. The expiry date refers to the last day of that month.
Intact vials: do not store at a temperature above 25°C.
For single use only. Any remaining solution must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Tazocin 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).
• The other ingredients are citric acid monohydrate and disodium edetate (EDTA).

Description of the Appearance of Tazocin and Package Contents
Tazocin 2 g/0.25 g is a powder ranging in color from white to off-white, supplied in a vial.
The packs contain 1, 5, 10, 12, 25 or 50 vials.
Tazocin 4 g/0.5 g is a powder ranging in color from white to off-white, supplied in a vial.
The packs contain 1, 5, 10, 12, 25 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pfizer Italia S.r.l. – Via Isonzo, 71 – 04100 Latina

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

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Tazocin 2 g + 0.25 g powder for solution for infusion – 12 vials of powder
Tazocin 4 g + 0.5 g powder for solution for infusion – 1 vial of powder
Tazocin 4 g + 0.5 g powder for solution for infusion – 12 vials of powder
---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals.
Note: Use for bloodstream infections caused by E. coli and K. pneumoniae (ceftriaxone-non-susceptible) producing
extended-spectrum beta-lactamase (ESBL) is not recommended in adult patients.

Instructions for Use
Tazocin must be administered by intravenous infusion (a 30-minute drip).

Intravenous Use
Reconstitute each vial with the volume of solvent indicated in the following table, using one of the compatible
solvents for reconstitution. Swirl to dissolve. With constant swirling, reconstitution generally takes 5 to 10
minutes (for further information on handling, see below).

*Compatible solvents for reconstitution:

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

The maximum recommended volume of sterile water for injection per dose is 50 ml.
The reconstituted solution must be withdrawn from the vial using a syringe. Once reconstituted as
instructed, the content of the vial withdrawn with the syringe will provide the amount of piperacillin and
tazobactam stated 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:

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

Incompatibilities
When Tazocin is used concurrently with another antibiotic (e.g. aminoglycosides), the
substances must be administered separately. Mixing beta-lactam antibiotics with
aminoglycosides in vitrocan cause substantial inactivation of the aminoglycoside. However, it has
been established that amikacin and gentamicin are compatible with Tazocin in vitrousing certain diluents at
specific concentrations (see below Co-administration of Tazocin with Aminoglycosides).
Tazocin must not be mixed with other substances in the same syringe or infusion bottle as compatibility
has not been established.
Due to chemical instability, Tazocin must not be used with solutions containing only sodium
bicarbonate.
Tazocin is compatible with Ringer’s lactate solution and for co-administration via a Y-piece
connector.
Tazocin must not be added to blood products or albumin hydrolysates.

Co-administration of Tazocin with Aminoglycosides
Due to in vitroinactivation of the aminoglycoside by beta-lactam antibiotics, it is
recommended to administer Tazocin and the aminoglycoside separately. When concomitant therapy with
aminoglycosides is indicated, Tazocin and the aminoglycoside must be reconstituted and diluted
separately.

In circumstances where co-administration is recommended, Tazocin is compatible for simultaneous co-
administration, via infusion with a Y-piece connector, only with the following
aminoglycosides and under the following conditions:

* The dose of aminoglycoside must be based on the patient’s weight, the state of the infection (severe or
potentially life-threatening) and renal function (creatinine clearance).
The compatibility of Tazocin with other aminoglycosides has not been established. Only the concentrations and
diluents of amikacin and gentamicin have been found to be compatible for co-administration via a Y-piece
connector, together with the Tazocin dose, as reported in the table above.
Simultaneous co-administration via a Y-piece connector under conditions other than
those above may result in inactivation of the aminoglycoside by Tazocin.

Tazocin

2 g +0.25 g/4 ml powder and solvent for injectable solution for intramuscular use
Piperacillin/tazobactam

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tazocin is and what it is used for
• 2. What you need to know before you use 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 known as “broad-spectrum penicillin antibiotics”
and is able to kill many types of bacteria. Tazobactam can prevent some resistant bacteria
from surviving the effects of piperacillin. This means that, when piperacillin and tazobactam
are administered together, they can kill more types of bacteria.
Tazocin is used in adults, children (from 2 years of age and above) and adolescents for the treatment of
bacterial infections, such as those affecting the lower respiratory tract (lungs) or the urinary tract
(kidneys and bladder).
In certain serious infections, the doctor may consider using Tazocin in association with other antibiotics.

2. What you need to know before you use Tazocin

Do not use Tazocin

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

Warnings and precautions
Talk to your doctor or pharmacist before using Tazocin.

• If you have allergies. If you have several allergies, tell your doctor or pharmacist before taking this medicine.
• If you suffer from diarrhoea before, or if you develop diarrhoea during or after treatment. In this case, you must inform your doctor or pharmacist immediately. Do not take medicines against diarrhoea without first consulting your doctor.
• If you have low levels of potassium in your blood. Your doctor may decide to check your kidney function before giving you this medicine and may prescribe you to undergo periodic blood tests during treatment.
• If you have problems with your kidneys or liver or if you are undergoing haemodialysis. Your doctor may decide to check your kidney function before giving you this medicine and may prescribe you to undergo periodic blood tests during treatment.
• If you are taking another antibiotic called vancomycin. Taking Tazocin and vancomycin at the same time may increase the risk of kidney damage (see also section
• If you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also the “Other medicines and Tazocin” section in this leaflet), or if unexpected bleeding occurs during treatment. In this case, you must inform your doctor or pharmacist immediately.
• If you develop convulsions during treatment. In this case, you must inform your doctor or pharmacist.
• If you think you have developed a new infection or if the infection has worsened. In this case, you must inform your doctor or pharmacist.

Haemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces a higher amount than normal of white blood cells called histiocytes and lymphocytes have been reported, resulting in inflammation
(haemophagocytic lymphohistiocytosis). This condition can be life-threatening if not diagnosed and
treated early. If you develop several symptoms such as fever, swollen lymph nodes, feeling of
weakness, feeling dizzy, shortness of breath, bruising or rash,
contact your doctor immediately.
If you notice muscle pain, tenderness or weakness and/or dark urine, inform your doctor immediately as this could be a sign of muscle degeneration (rhabdomyolysis) which can lead to kidney problems.

Children
The use of Tazocin is not recommended in children under 2 years of age due to insufficient
data on safety and efficacy.

Other medicines and Tazocin
Tell your doctor or pharmacist if you are taking, have recently taken or might take, or must
take any other medicines, including those available without a prescription.
Some medicines can interact with piperacillin and tazobactam. These include:

• Medicine for gout (probenecid). It may increase the time it takes to eliminate piperacillin and tazobactam from the body.
• Medicines to make the blood more fluid or to treat blood clots (e.g. heparin, warfarin or aspirin).
• Medicines used to relax muscles during surgery. Tell your doctor if you are going to have general anaesthesia.
• Methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam may increase the time it takes to eliminate methotrexate from the body.
• Medicines that can reduce the level of potassium in the blood (e.g. tablets that increase urine production or some medicines for cancer).
• Medicines containing the other antibiotics tobramycin, gentamicin or vancomycin. Tell your doctor if you have kidney problems. Taking Tazocin and vancomycin at the same time may cause acute kidney damage even if you do not have any kidney problems.

Effect on laboratory tests
Tell your doctor or laboratory personnel that you are taking Tazocin if you need to provide a
blood or urine sample.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine. The doctor will decide
whether Tazocin is suitable for you.
Piperacillin and tazobactam can pass to the baby in the womb or through breast milk. If you are
breastfeeding, your doctor will decide whether Tazocin is suitable for you.

Driving and operating machinery
It is not expected that the use of Tazocin will impair the ability to drive and operate machinery.

Tazocin contains sodium
This medicine contains 130 mg of sodium (the main component of table salt/cooking salt) per
vial. This is equivalent to 6.5% of the recommended maximum daily intake of
salt with the diet of an adult.

3. How to use Tazocin

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Tazocin 2 g + 0.25 g / 4 ml must be administered with intramuscular injection.
The solvent vial contains lidocaine, present in each package of Tazocin 2 g + 0.25 g / 4 ml must be
used exclusively for intramuscular use.
Do not exceed 2 g of piperacillin/0.25 g of tazobactam per injection site.
Adult patients
Generally, the recommended daily dose is 12 g of piperacillin/1.5 g of tazobactam to be
administered in separate doses every 6 or 8 hours. Higher daily doses of 18 g piperacillin/2.25g
tazobactam may be administered in separate doses in cases of severe infections.
The dosage and frequency of Tazocin 2 g + 0.25 g / 4 ml depends on the severity and location
of the infection and the type of suspected pathogens.
The usual dose for adults is from 2 g/0.25 g every 12 hours to 2 g/0.25 g every 6 hours to be administered with
intramuscular injection.
Tazocin must be used until the complete disappearance of the signs of infection (5-14 days). The duration of
treatment must be established following the doctor's instructions. If you have any doubts about the use of
this medicine, consult your doctor.
Patients with kidney problems
Your doctor may need to reduce the dose of Tazocin or the frequency of administration. The
doctor may also perform blood tests to ensure that the prescribed dose for treatment is
correct, especially if you will need to take this medicine for a prolonged period.

Instructions for use

• 1. Shake the vial to detach the powder from the bottom;
• 2. Remove the plastic cap with a reversible opening from the vial to expose the central portion of the rubber stopper and keep it. Avoid touching the central portion of the rubber stopper with your hand.

• 3. Draw with a syringe the solvent contained in the vial and introduce it into the vial containing the powder;
• 4. Place the plastic cap on the rubber stopper to avoid touching the central portion of the stopper with your fingers. Shake vigorously until the powder is completely dissolved. With constant shaking, dissolution should occur within about 10 minutes;

• 5. Let the resulting solution rest until the foam disappears. Make sure that the resulting solution is clear and free of undissolved particles.
• 6. Remove the plastic cap and draw the solution with a 5 ml syringe;
• 7. Inject the reconstituted solution deep into a muscle.

If you use more Tazocin than you should
If you think you have used an excessive dose of medicine or if side effects appear, such as
convulsions, inform your doctor immediately.

If you forget to use Tazocin
If you think you have forgotten a dose of Tazocin, inform your doctor or pharmacist immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The serious side effects of Tazocin are:

• severe skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis) which initially manifest as reddish spots or as circular blisters 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 increase with widespread blisters or skin peeling which can potentially be life-threatening; severe skin inflammation that causes peeling over extensive areas of the body (exfoliative dermatitis)
• severe allergic condition potentially fatal (drug reaction with eosinophilia and systemic symptoms) that can involve the skin and especially other subcutaneous organs such as the kidney and liver
• a skin condition (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small pustules filled with liquid contained within large areas of swollen and reddened skin
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath, wheezing or difficulty breathing
• sudden chest pain that may occur with an allergic reaction known as Kounis syndrome
• intense rash, itching or hives on the skin
• yellowing of the eyes or skin
• damage to blood cells (signs include: unexpected breathlessness, urine that is red or brown, nosebleeds and bruising)
• severe or persistent diarrhea accompanied by fever or weakness
• muscle pain, tenderness or weakness and/or dark urine (rhabdomyolysis, frequency not known).

If you notice any of the above side effects, consult your doctor immediately.
Other side effects:
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 infections
• reduction of platelets, reduction of the number of red blood cells or blood pigment/hemoglobin, abnormal laboratory test (positive direct Coombs test), prolonged bleeding time (prolonged activated partial thromboplastin time)
• reduction of albumin protein in the blood, reduction of total proteins in the blood
• headache, insomnia
• abdominal pain, vomiting, nausea, indigestion, stomach discomfort
• increase of some enzymes in the blood (increased alanine aminotransferase, increased aspartate aminotransferase)
• skin rashes, itching
• increase of muscle metabolism product in the blood (increased creatinine in the blood)
• fever, reaction at the injection site

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

• reduction of white blood cells (leukopenia), prolongation of blood clotting time (prolonged prothrombin time)
• reduction of potassium in the blood (hypokalaemia), reduction of sugar in the blood (glucose)
• seizures, reported in patients taking high doses or who have kidney problems;
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)
• flushed skin with hot flushes
• increase of blood pigment degradation product (bilirubin)
• skin reactions with redness and formation of lesions on the skin (exanthema, erythema multiforme), hives
• joint and muscle pain
• chills

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

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

Frequency not known (cannot be estimated from the 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 premature degradation (hemolytic anemia), appearance of bruises with small spots (purpura), prolonged bleeding time
• increase of platelets, increase of a specific type of white blood cells (eosinophilia)
• severe allergic reaction
• jaundice (yellowing of the skin or whites of the eyes)
• severe allergic reaction spreading throughout the body with rash on the skin and mucous membranes and various skin eruptions (Stevens-Johnson syndrome), severe allergic condition involving the skin and other subcutaneous organs such as the kidney and liver (drug reaction with eosinophilia and systemic symptoms), numerous small pustules filled with liquid contained within large areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis)
• skin reactions with blister formation (bullous dermatitis) blistering skin disease characterized by vesicles on the skin and mucous membranes (linear IgA disease) poor kidney function and kidney problems
• accumulation of eosinophils, a type of white blood cells, in the lungs (eosinophilic pneumonia)
• acute disorientation and confusion (delirium).

Therapy with piperacillin has been associated with an increased incidence of fever and rash in patients affected
by cystic fibrosis.
Beta-lactam antibiotics, including piperacillin tazobactam, can lead to manifestations of signs
of altered brain function (encephalopathy) and seizures.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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/en/content/segnalazioni-reazioni-avverse.
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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, vial and ampoule
after “Exp.”. The expiry date refers to the last day of that month.
Intact vials: do not store at a temperature above 25ºC.
Single use only.
Reconstituted solution: after reconstitution the solution must be administered immediately.
Discard any unused solution.
Do not dispose of any medicine in 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 Tazocin contains

• The active ingredients are piperacillin (as sodium salt) and tazobactam (as sodium salt). Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt)
• The other ingredients are disodium edetate (EDTA) and citric acid monohydrate
• The solvent vial contains lidocaine hydrochloride and water for injections.

Description of the appearance of Tazocin and contents of the pack
Tazocin 2 g + 0.25 g/4 ml is a white to off-white powder, supplied in a vial.
The packs contain 1 glass vial containing the powder + 1 glass solvent vial of 4 ml.

Marketing authorisation holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Wyeth Lederle S.r.l.,
Via Franco Gorgone – Zona Industriale
95100 Catania