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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Piperacillin/Tazobactam 2 g/0.25 g Powder for
Solution for Infusion
Piperacillin/Tazobactam 4 g/0.5 g Powder for
Solution for Infusion
Piperacillin/Tazobactam

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 or pharmacist.
• 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet(see section 4).

What is in this leaflet:
1. What Piperacillin/Tazobactam is and what
it is used for
2. What you need to know before you use
Piperacillin/Tazobactam
3. How to use Piperacillin/Tazobactam
4. Possible side effects
5. How to store Piperacillin/Tazobactam
6. Contents of the pack and other
information

1.

What Piperacillin/Tazobactam 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 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).
Piperacillin/Tazobactam is used in children
aged 2-12 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 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 in
combination with other antibiotics.

2.

What you need to know before
you use Piperacillin/Tazobactam

Do not use Piperacillin/Tazobactam
• if you are allergic (hypersensitive) to
piperacillin or tazobactam.
• if you are allergic (hypersensitive) to
antibiotics known as penicillins,
cephalosporins or other beta-lactamase
inhibitors, as you may be allergic to
Piperacillin/Tazobactam.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Piperacillin/Tazobactam
• 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.
• 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 “Using other medicines” 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 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.

• 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 (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. tablets
enhancing urination or some medicines for
cancer).
• medicines containing the other antibiotics
tobramycin or gentamycin. Tell your doctor
if you have kidney problems.
Effect on laboratory tests
Tell the doctor or laboratory staff that you are
taking Piperacillin/Tazobactam if you have to
provide a blood or urine sample.
Pregnancy and breast-feeding
If you are pregnant, think you may be
pregnant or are trying to become pregnant,
tell your doctor or other healthcare
professional before receiving this product.
Your doctor will decide if Piperacillin/
Tazobactam 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 is right for you.
Driving and using machines
The use of Piperacillin/Tazobactam is not
expected to affect the ability to drive or use
machines.

Piperacillin/Tazobactam 2 g/250 mg contains
4.72 mmol (109 mg) of sodium.
Piperacillin/Tazobactam 4 g/500 mg contains
9.44 mmol (217 mg) of sodium.
This should be taken into consideration if you
are on a controlled sodium diet.

3.

How to use Piperacillin/
Tazobactam

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.
Adults and adolescents aged 12 years and
older
The usual 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).

Children aged 2 to 12 years
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 childʼs weight but the single dose will
not exceed 4 g/0.5 g of
Piperacillin/Tazobactam.

You will be given Piperacillin/Tazobactam until
the sign of infection has gone completely (5 to
14 days).

Patients with kidney problems
Your doctor may need to reduce the dose of
Piperacillin/Tazobactam 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 than you should
As you will receive Piperacillin/Tazobactam
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 Piperacillin/Tazobactam
If you think you have not been given a dose of
Piperacillin/Tazobactam, tell your doctor or
other healthcare professional immediately.

If you have any further questions on the use
of this medicine, ask your doctor or 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, have recently
taken or might take any other medicines.
Some medicines may interact with piperacillin
and tazobactam. These include:

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

After reconstitution (and dilution):
Chemical and physical in-use stability has
been demonstrated for 24 hours at 20-25°C
and for 48 hours at 2-8°C.

From a microbiological point of view, once
opened, 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 has taken place in
controlled and validated aseptic conditions.
Instructions for use
Piperacillin/Tazobactam will be given by
intravenous infusion (a drip for 30 minutes).

draft: 960737, 44052427
laetus code: 000
mat.no.: 00000000

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Intravenous use
Reconstitute each vial with the volume of
solvent shown in the table below, using one of
the compatible solvents for reconstitution.
Swirl until dissolved. When swirled constantly,
reconstitution generally occurs within 3 minutes
(for details on handling, please see below).
Content of vial

Volume of solvent*
to be added to vial

4 g/0.5 g (4 g
piperacillin and 0.5 g
tacobactam)

20 ml

2 g/0.25 g (2 g
piperacillin and 0.25 g 10 ml
tacobactam)

*Compatible solvents for reconstitution:
• water for injection;
• sodium chloride 9 mg/ml (0.9%) solution in
water for injection;
• glucose 50 mg/ml (5%) solution in water for
injection;

Continued on the next page >>

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:

The serious side effects of Piperacillin/
Tazobactam are:
• swelling of the face, lips, tongue or other
parts of the body
• shortness of breath, wheezing or trouble
breathing
• severe rash, itching or hives on the skin
• yellowing of the eyes or skin
• damage to blood cells (the signs include:
being breathless when you do not expect it,
red or brown urine, nosebleeds and
bruising)
• severe or persistent diarrhoea
accompanied by a fever or weakness
• unexpected bleeding, particularly if you are
taking anticoagulants such as warfarin
Other possible side effects

Common side effects (may affect up to 1 in
10 people):
• diarrhoea, vomiting, nausea
• skin rashes.

Uncommon side effects (may affect up to 1
in 100 people):
• thrush
• (abnormal) decrease in white blood cells
(leukopenia, neutropenia) and platelets
(thrombocytopenia)
• allergic reaction
• headache, sleeplessness
• low blood pressure, inflammation of the
veins (felt as tenderness or redness in the
affected area)
• jaundice (yellow staining of the skin or
whites of the eyes), inflammation of the
mucous lining of the mouth, constipation,
indigestion, stomach upset
• increase of certain enzymes in the blood
(alanine aminotransferase increased,
aspartate aminotransferase increased)
• itching, nettle rash
• increase of muscle metabolism product in
the blood (blood creatinine increased)
• fever, injection site reaction
• yeast infection (candidal superinfection).

Rare side effects (may affect up to 1 in 1,000
people):
• (abnormal) decrease of red blood cells or
blood pigment/haemoglobin, (abnormal)
decrease of red blood cells due to
premature breakdown (degradation)
(haemolytic anaemia), small spot bruising
(purpura), bleeding of the nose (epistaxis)
and bleeding time prolonged, (abnormal)
increase of a specific type of white blood
cells (eosinophilia)
• severe allergic reaction
(anaphylactic/anaphylactoid reaction,
including shock)
• flushed red skin
• a certain form of infection of the colon
(pseudomembranous colitis), abdominal
pain
• inflammation of the liver (hepatitis),
increase of a blood pigments breakdown
product (bilirubin), increase of certain
enzymes in the blood (blood alkaline
phosphatase increased,
gamma-glutamyltransferase increased)
• skin reactions with redness and formation
of skin lesions (exanthema, erythema
multiforme), skin reactions with blistering
(bullous dermatitis)
• joint and muscle pain
• poor kidney functions and kidney problems
• rigors chill/rigidity.

For storage conditions of the reconstituted
and diluted medicinal product, see at the end
of the package leaflet ʻThe following
information is intended for medical or
healthcare professionals onlyʼ.
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 contains
• Active substances:
The active substances are piperacillin and
tazobactam.
Each vial contains 2 g piperacillin (as
sodium salt) and 0.25 g tazobactam (as
sodium salt).
Each (vial) or bottle contains 4 g piperacillin
(as sodium salt) and 0.5 g tazobactam (as
sodium salt).
• Other ingredients:
The medicinal product contains no other
ingredients than the active substances.
What Piperacillin/Tazobactam looks like
and contents of the pack
Piperacillin/Tazobactam 2 g/0.25 g is a white
to off-white powder for solution for infusion
packaged in glass vials. The vials are packed
in carton boxes.
Each box contains 1, 5, 10, 12 or 50 glass
vials.

Piperacillin/Tazobactam 4 g / 0.5 g] is a white
to off-white powder for solution for infusion
packaged in glass vials or bottles. The bottles
or vials are packed in carton boxes.
Each box contains 1, 5, 10, 12 or 50 glass
vials or bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK.
Manufacturer:
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl,
Austria.

This leaflet was last revised in 06/2014

Very rare side effects (may affect up to 1 in
10,000 people):
• severe decrease of granular white blood
cells (agranulocytosis), severe decrease of
red blood cells, white blood cells and
platelets (pancytopenia)
• prolonged time for blood clot formation
(prolonged partial thromboplastin time,
prothrombin time prolonged), abnormal lab
test (positive direct Coombs), increase of
platelets (thrombocythaemia)
• decrease of potassium in the blood
(hypokalaemia), decrease of blood sugar
(glucose), decrease of the blood protein
albumin, decrease of blood total protein
• detachment of the top layer of the skin all
over the body (toxic epidermal necrolysis),
serious bodywide allergic reaction with skin
and mucous lining rashes and various skin
eruptions (Stevens-Johnson Syndrome)
• blood urea nitrogen increased.
Piperacillin therapy has been associated with
an increased incidence of fever and rash in
cystic fibrosis patients.

Reporting 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
theYellow Card Scheme:
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

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 label after
EXP. The expiry date refers to the last day of
that month.
Powder:
This medicinal product does not require any
special storage conditions.

• glucose 50 mg/ml (5%) solution in sodium
chloride 9 mg/ml (0.9%) solution.

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 in
water for injection;
• glucose 50 mg/ml (5%) solution in water for
injection;
• dextran (grade 40) 60 mg/ml (6%) solution
in sodium chloride 9 mg/ml (0.9%) solution.

draft: 960737, 44052427
laetus code: 000
mat.no.: 00000000

Incompatibilities
This product must not be mixed or
co-administrated with any aminoglycoside.
The mixing of beta-lactam antibiotics with an

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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
with solutions containing only sodium
bicarbonate.

Lactated Ringer's (Hartmannʼs) solution is not
compatible with Piperacillin/Tazobactam.
Piperacillin/Tazobactam should not be added
to blood products or albumin hydrolysates.

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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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