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PIPERACILLIN/TAZOBACTAM 2G/0.25G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): PIPERACILLIN / TAZOBACTAM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Piperacillin/Tazobactam 2 g/0.25 g
powder for solution for infusion
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion is and what it is
used for
2. What you need to know before you use Piperacillin/Tazobactam 2 g/0.25 g powder for
solution for infusion
3. How to use Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
4. Possible side effects
5. How to store Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
6. Contents of the pack and other information

1. What Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion is and
what it is used for
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.
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion 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 2 g/0.25 g powder for solution for infusion may
be used to treat bacterial infections in patients with low white blood cell counts
(reduced resistance to infections).
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion 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 2 g/0.25 g powder for solution for infusion 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 2 g/0.25 g
powder for solution for infusion in combination with other antibiotics.

2. What you need to know before you use Piperacillin/Tazobactam 2 g/0.25 g powder
for solution for infusion
Do not use Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
• if you are allergic to piperacillin or tazobactam or any of the other ingredients of this
medicine (see section 6).
• if you are allergic to antibiotics known as penicillins, cephalosporins or other
beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam 2 g/0.25 g
powder for solution for infusion.

Warning and Precautions
Talk to your doctor before using Piperacillin/Tazobactam 2 g/0.25 g powder for solution
for infusion
• if you have allergies. If you have several allergies, make sure you tell your doctor or other
healthcare professional before receiving this product.
• 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 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.

The following information is intended for medical or healthcare professionals only:

Instructions for use
Piperacillin/tazobactam 2 g/0.25 g is administered by intravenous infusion
(a drip for over 30 minutes).

Intravenous use
Reconstitute each vial with the volume of solvent shown in the tablet below, using one of the
compatible solvents for reconstitution. Swirl until dissolved (for details on handling, please
see below).
Content of vial

Volume of solvent* to be added to vial

2 g/0.25 g (2 g piperacillin and 0.25 g
tazobactam)

10 ml

*compatible solvents for reconstitution:
• 0.9% (9 mg/ml) sodium chloride solution for injection
• Sterile water for injection(1)
• Glucose 5%
(1)
Maximum recommended volume of sterile water for injection per dose is 50 ml
The reconstitute solution 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 taxobactam.

• 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 prevent blood clots
(see also Other medicines and Piperacillin/Tazobactam in this leaflet) 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 (fits) 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.

Children below 2 years
Piperacillin/tazobactam is not recommended for use in children below the age of 2 years due
to insufficient data on safety and effectiveness.

Other Medicines and Piperacillin/Tazobactam
Tell your doctor or other healthcare professional if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. Some medicines may
interact with piperacillin and tazobactam.
These include:
• medicines for gout (e.g. 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 (e.g. 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 (e.g. diuretics - medicines that
increase the amount of urine you produce or some medicines for cancer).
• medicines containing the other antibiotics tobramycin or gentamicin. This is particularly
important if you have kidney problems. Tell your doctor if this applies to you.

Effect on laboratory tests
Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam 2 g/0.25 g
powder for solution for infusion 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. Your
doctor will decide if Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion 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 Piperacillin/Tazobactam 2 g/0.25 g powder for
solution for infusion is right for you.

Driving and using machines
The use of Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion is not expected
to affect the ability to drive or use machines.

Important information about some of the ingredients of
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion contains
4.72 mmol (109 mg) of sodium.
This should be taken into consideration if you are on a controlled-sodium diet.

3. How to use Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
Your doctor or other healthcare professional will give you this medicine through an infusion
(a drip for 30 minutes) into one of your veins. 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.

Use in adults and adolescents aged 12 years or older
The recommended dose is 4 g/0.5 g piperacillin/tazobactam given every 6-8 hours, which is
given into one of your veins (directly into the blood stream).

Use in children aged 2 to 12 years
The recommended 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 the daily dose will not
exceed 4 g/0.5 g of Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion.
You will be given Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion until the
sign of infection has gone completely (5 to 14 days).

The reconstituted solution may be further diluted to the desired volume (e.g. 50 ml to 150 ml)
with one of the following compatible solvents:
• 0.9% (9 mg/ml)
• Glucose 5%
This medicinal product must not be mixed with other medicinal products except those
mentioned above.
Whenever piperacillin/tazobactam is used concurrently with another antibiotic
(e.g. aminoglycosides), the substances must be administered separately. The mixing of
beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of
the aminoglycoside.
Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle
since compatibility has not been established.
Piperacillin/tazobactam should be administered through an infusion set separately from any other
drugs unless compatibility is proven.
Due to chemical instability, piperacillin/tazobactam should not be used in solutions containing only
sodium bicarbonate.
Lactated Ringer’s solution is not compatible with piperacillin/tazobactam.
Piperacillin/tazobactam should not be added to blood products or albumin hydrolysates.

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Use in patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin/Tazobactam 2 g/0.25 g powder for
solution for infusion 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 2 g/0.25 g powder for solution for
infusion than you should
As you will receive Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion 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 2 g/0.25 g powder for solution
for infusion
If you think you have not been given a dose of Piperacillin/Tazobactam 2 g/0.25 g powder for
solution for infusion, tell your doctor or other healthcare professional immediately.
If you have any further questions on 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 everybody gets them.
See a doctor immediately if you experience any of these potentially serious side effects of
piperacillin/Tazobactam:
Uncommon: may affect up to 1 in 100 people
• severe rash or hives
Rare: may affect up to 1 in 1,000 people
• serious skin rashes [toxic epidermal necrolysis 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 decrease in white blood cells and nosebleeds (signs of damage to blood cells)
• severe or persistent diarrhoea accompanied by a fever or weakness
Not known: cannot be estimated from the available data
• swelling of the face, lips, tongue or other parts of the body
• serious skin rashes [Stevens-Johnson syndrome and dermatitis bullous 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].
• shortness of breath, wheezing or trouble breathing
• yellowing of the eyes or skin
• being breathless when you do not expect it, red or brown urine and small spot bruising
(signs of damage to blood cells)

Other side effects:
If any of the following side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or other healthcare professional.
Very common: may affect more than 1 in 10 people
• diarrhoea
Common: may affect up to 1 in 10 people
• itching or rash on the skin
• yeast infection
• decrease in platelets and red blood cells
• prolonged blood clotting time
• abnormal lab test (positive direct Coombs)
• 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: may affect up to 1 in 100 people
• decrease in white blood cells
• decreased blood potassium, decrease blood sugar
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the
affected area), reddening of skin
• increase of blood pigment breakdown product (bilirubin)
• joint and muscle pain
• chills
Rare: may affect up to 1 in 1,000 people
• inflammation of the mucous lining of the mouth
Not known: cannot be estimated from the available data
• increase of platelets
• Inflammation of the liver
• kidney failure, inflammation of the kidney
Piperacillin therapy has been associated with an increased incidence of fever and rash in
cystic fibrosis patients.

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 via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion
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 label
after “EXP”.
The expiry date refers to the last day of that month.
Unopened vials: This medicinal product does not require any special temperature
storage conditions.
Keep the vials in the outer carton.
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 to protect
the environment.

6. Contents of the pack and other information
What Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion contains
• The active substances are piperacillin and tazobactam.
• Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
• There are no other ingredients.

What Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion looks like
and contents of the pack
Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion is a white to off-white
powder for solution for infusion packaged in glass vials.
Packs containing 1 or 12 vials.

Marketing Authorisation Holder and Manufacturer:
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire, CV31 3RW
United Kingdom
This leaflet was last revised in 02/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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