Patient leaflet - Piperacillin / Tazobactam Qilu 2 g / 0.25 g powder for solution for infusion
1. What Piperacillin / Tazobactam Qilu is and what it is used for
Piperacillin / Tazobactam Qilu contains the active substances piperacillin and tazobactam.
Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.
This medicine is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin / Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
This medicine is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin / Tazobactam Qilu may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
In certain serious infections, your doctor may consider using Piperacillin / Tazobactam Qilu in combination with other antibiotics.
2. What you need to know before you are given Piperacillin / Tazobactam Qilu
Piperacillin / Tazobactam Qilu must not be given
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 Piperacillin / Tazobactam Qilu.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Piperacillin / Tazobactam Qilu: • if you have allergies. If you have several
allergies, make sure you tell your doctor or other healthcare professional before receiving this medicine.
if you are suffering from diarrhoea before, or
if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor. • if you are taking another antibiotic called
vancomycin at the same time as Piperacillin / Tazobactam Qilu, this may increase the risk of kidney injury (see also other medicines and Piperacillin / Tazobactam Qilu in this leaflet) • if you have low levels of potassium in your blood.
Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment. • if you have kidney or liver problems, or are
receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.
if you are taking certain medicines (called
anticoagulants) to avoid an excess of blood clotting (see also ‘Other medicines and Piperacillin / Tazobactam Qilu’) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.
if you develop convulsions during the treatment.
In this case, you should inform your doctor or other healthcare professional.
if you think you developed a new or worsening
infection. In this case, you should inform your doctor or other healthcare professional.
There have been reports about a disease in which the immune system makes too many of otherwise normal white blood cells called histiocytes and lymphocytes, resulting in inflammation (haemophagocytic lymphohistiocytosis). This condition may be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, feeling lightheaded, 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, tell your doctor immediately. This may be a sign of a condition called Kounis syndrome.
If you notice unexplained muscle pain, tenderness or weakness and/or dark coloured urine, tell your doctor immediately. This may be a sign of muscle breakdown (called rhabdomyolysis) which may lead to kidney problems.
Children
This medicine is not recommended for use in children below the age of 2 years due to insufficient data on safety and efficacy.
Other medicines and Piperacillin / Tazobactam Qilu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam.
These include:
- medicine for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.
- medicines to thin your blood or to treat blood clots (such as heparin, warfarin or aspirin). • medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.
- methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
- medicines that reduce the level of potassium in your blood (such as tablets enhancing urination or some medicines for cancer).
- medicines containing the other antibiotics tobramycin, gentamicin or vancomycin. Tell your doctor if you have kidney problems. Taking Piperacillin / Tazobactam Qilu and vancomycin at the same time may increase the risk of kidney injury even if you have no kidney problems.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are having Piperacillin / Tazobactam Qilu if you have to provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or other healthcare professional for advice before receiving this medicine. Your doctor will decide if Piperacillin / Tazobactam Qilu is right for you.
Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if this medicine is right for you.
Driving and using machines
The use of this medicine is not expected to affect the ability to drive or use machines.
Piperacillin / Tazobactam Qilu contains sodium
Piperacillin / Tazobactam Qilu 2 g / 0.25 g: This medicine contains 108 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 5.4 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How Piperacillin / Tazobactam Qilu is given
Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 30 minutes) into one of your veins.
Dosage
The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.
Adults and adolescents above 12 years of age The usual dose is 4 g / 0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Use in children from 2 to 12 years of age The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream). The usual dose for children with low white blood cell counts is 80 mg / 10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).
Your doctor will calculate the dose depending on your child’s weight but each individual dose will not exceed 4 g / 0.5 g of Piperacillin / Tazobactam Qilu.
You will be given this medicine until the sign of infection has gone completely (5 to 14 days).
Use in patients with kidney problems
Your doctor may need to reduce the dose of this medicine or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.
If you receive more Piperacillin / Tazobactam Qilu than you should
As you will receive this medicine from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions, or think you have been given too much, tell your doctor immediately.
If you miss a dose of Piperacillin / Tazobactam Qilu
If you think you have not been given a dose of this medicine, tell your doctor or other healthcare professional immediately.
The following information is intended for healthcare professionals only:
Note: Use for bacteraemia due to extended-beta-lactamase (ESBL) producing E. coli and K. pneumonia (ceftriaxone non-suseptible), is not recommended in adult patients.
Shelf life after reconstitution/dilution
Reconstituted solution in vial
Chemical and physical in-use stability has been demonstrated for up to 48 hours when stored in a refrigerator at 2-8°C and for 5 hours when stored at 20 - 25°C, when reconstituted with one of the compatible solvents for reconstitution (see “Instructions for use” below).
Diluted reconstituted solution, for infusion Chemical and physical in-use stability has been demonstrated for up to 48 hours when stored in a refrigerator at 2-8°C and for 6 hours when stored at 20 - 25°C, when diluted with one of the compatible solvents for dilution at the suggested dilution volume (see “Instructions for use” below).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.
Instructions for use
Piperacillin / Tazobactam Qilu will be given by intravenous infusion (a drip for 30 minutes).
The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.
Preparation of the solution for infusion
The powder of each vial should be reconstituted with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. It should be swirled until dissolved. When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).
Content of
vial
Volume of
solvent* to be
added to each vial
Approximate concentration after reconstitution
2 g/0.25 g (2 g
piperacillin
and 0.25 g
tazobactam)
10 ml 193.2 mg/ml
(Containing
171.7 mg/ml of Piperacillin and 21.5 mg/ml of Tazobactam)
*Compatible solvents for reconstitution:
- Sodium chloride 9 mg/ml (0.9 %) solution for injection
- Sterile water for injections (1)
Glucose 50 mg/ml (5 %) solution for infusion
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If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
See a doctor immediately if you experience any of these potentially serious side effects of Piperacillin / Tazobactam Qilu:
The serious side effects (with frequency in brackets) of piperacillin / tazobactam are: • serious skin rashes [Stevens-Johnson
syndrome, dermatitis bullous (Not known), dermatitis exfoliative (Not known), toxic epidermal necrolysis (Rare)] appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include 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 and potentially may be life-threatening.
severe potentially fatal allergic condition
(drug reaction with eosinophilia and systemic symptoms) that can involve the skin and most importantly other organs under the skin such as the kidney and the liver.
a skin condition (acute generalised
exanthematous pustulosis) accompanied by fever, which consists of numerous tiny fluid filled blisters contained within large areas of swollen and reddened skin.
swelling of the face, lips, tongue or other parts of
the body (Not known)
shortness of breath, wheezing or trouble
breathing (allergic reactions including anaphylactic shock, Not known)
sudden chest pain which may occur with an
allergic reaction known as Kounis syndrome (Not known)
severe rash or hives (Uncommon), itching or
rash on the skin (Common)
inflammation of the liver (hepatitis, Not known),
yellow staining of the skin or whites of the eyes (jaundice, Not known)
low levels of red blood cells (anaemia,
Common), excessive breakdown of red blood cells which causes being breathless when you do not expect it, red or brown urine (haemolytic anaemia, Not known)
low levels of platelets, which can lead to
bleeding and bruising (thrombocytopenia, Common)
low levels of white blood cells, which
fight infection (leukopenia, Uncommon or neutropenia, Not known)
very low levels of a type of white blood cell
called granulocytes (agranulocytosis, Rare) • high levels of platelets (thrombocytosis, Not
known)
high levels of a type of white blood cells called
eosinophils (eosinophilia, Not known) • low levels of all types of blood cells, including
platelets (pancytopenia, Not known) • severe or persistent diarrhoea accompanied by a
fever or weakness (pseudomembranous colitis, Rare).
decreased blood potassium (Uncommon) • seizures (convulsions), seen in patients on high
dose, or with kidney problems (Uncommon) • intense muscle pain, tenderness or weakness
(rhabdomyolysis, Not known)
If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other healthcare professional.
Very common side effects (may affect more than 1 in 10 people):
- diarrhoea
Common side effects (may affect up to 1 in 10 people): • yeast infection
antibodies in the blood that attack red blood
cells (positive direct Coombs), prolonged blood clotting time (activated partial thromboplastin time prolonged), decrease in blood protein. • headache, sleeplessness
abdominal pain, vomiting, nausea, constipation,
upset stomach
- increase in blood liver enzymes
- abnormal kidney blood tests
- fever, injection site reaction
Uncommon side effects (may affect up to 1 in 100 people):
prolonged blood clotting time (prothrombin time
prolonged), decreased blood sugar
low blood pressure, inflammation of the veins
(felt as tenderness or redness in the affected area), reddening of skin
increase of a blood pigment breakdown product
(bilirubin)
skin reactions with redness, formation of skin
lesions
- joint and muscle pain
- chills
Rare side effects (may affect up to 1 in 1,000 people):
bleeding of the nose, inflammation of the
mucous lining of the mouth
Not known (frequency cannot be estimated from the available data):
small spot bruising, bleeding time prolonged • blistering disease in which blisters form in
the skin and mucous membranes (linear IgA disease)
poor kidney functions and kidney problems • a form of lung disease where eosinophils (a
form of white blood cell) appear in the lung in increased numbers
- acute disorientation and confusion (delirium)
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Beta-lactam antibiotics, including piperacillin / tazobactam, may lead to signs of altered brain function (encephalopathy) and convulsions.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Piperacillin / Tazobactam Qilu
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
Reconstituted solution in vial
Chemical and physical in-use stability has been demonstrated for up to 48 hours when stored in a refrigerator at 2-8°C and for 5 hours when stored at 20 - 25°C, when reconstituted with one of the compatible solvents for reconstitution (see section “The following information is intended for healthcare professionals only”).
Diluted solution for infusion
Chemical and physical in-use stability has been demonstrated for up to 48 hours when stored in a refrigerator at 2-8°C and for 6 hours when stored at 20 - 25°C, when diluted with one of the compatible solvents for dilution at the suggested dilution volume (see section “The following information is intended for healthcare professionals only”).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions.
For single use only. Discard any unused solution.
Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Piperacillin / Tazobactam Qilu contains
The active substances are piperacillin and tazobactam.
Each vial contains 2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as tazobactam sodium).
What Piperacillin / Tazobactam Qilu looks like and contents of the pack
Piperacillin / Tazobactam Qilu 2 g / 0.25 g is an off-white to white cake or powder available in 30 ml glass vial with bromobutyl rubber stoppers and Aluminium plastic combined cap.
Pack sizes: 1, 5, 10, 12, 25 or 50 vials per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40, planta 8,
28046 Madrid,
Spain
Manufacturer
Kymos, S.L.
Ronda De Can Fatjó 7b,
Parc Tecnologic Del Valles Cerdanyola Del Vallès, 08290 Barcelona,
Spain
Eurofins BioPharma Product Testing Budapest Kft. Anonymus utca 6.,
1045 Budapest IV,
Hungary
Netpharmalab Consulting Services
Carretera de Fuencarral 22,
Alcobendas, 28108 - Madrid,
Spain
Distributor
Sun Pharma UK Limited
6-9 The Square, Stockley Park,
Uxbridge, UB11 1FW,
United Kingdom
This leaflet was last revised in 07/2026.
Code No.: XXXXXXXXXXXX
(1) Maximum recommended volume of sterile water for injection per dose is 50 ml.
The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.
The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:
Sodium chloride 9 mg/ml (0.9 %) solution for
injection
Glucose 50 mg/ml (5 %) solution for infusion – Dextran 60 mg/ml (6 %) in sodium chloride
9 mg/ml (0.9 %) solution for injection
Incompatibilities
Whenever Piperacillin / Tazobactam Qilu is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with aminoglycosides, in vitro, can result in substantial inactivation of the aminoglycoside.
Piperacillin / Tazobactam Qilu should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Because of chemical instability, Piperacillin / Tazobactam Qilu should not be used with solutions containing only sodium bicarbonate.
Piperacillin / Tazobactam Qilu is not compatible with lactated Ringer’s solution, Ringer’s acetate solution, Ringer’s acetate/malate solution, and Hartmann solution and for co-administration via a Y-site.
Piperacillin / Tazobactam Qilu should not be added to blood products or albumin hydrolysates.
Co-administration with aminoglycosides
Due to the in vitro inactivation of the
aminoglycoside by beta-lactam antibiotics, Piperacillin / Tazobactam Qilu and the aminoglycoside are recommended for separate administration. Piperacillin / Tazobactam Qilu and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.