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TAZOCIN 4G/0.5G POWDER FOR SOLUTION FOR INFUSION

Active substance(s): PIPERACILLIN MONOHYDRATE / PIPERACILLIN SODIUM / TAZOBACTAM SODIUM

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The following information is intended for healthcare professionals only:
✪ Instructions for use
Tazocin will be given by intravenous infusion (a drip for 30 minutes).
✪ 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 5 to 10 minutes (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
4 g / 0.50 g (4 g piperacillin and 0.5 g tazobactam)

20 ml

* Compatible solvents for reconstitution:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Sterile water for injections(1)
- Glucose 5%
(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The reconstituted solutions should be withdrawn from the vial by syringe.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reconstituted as directed, the vial contents withdrawn by syringe will provide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:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Glucose 5%
- Dextran 6% in 0.9% (9 mg/ml) sodium chloride
- Lactated Ringers injection
- Hartmann’s solution
- Ringer’s acetate
- Ringer’s acetate/malate
✪ Incompatibilities
Whenever Tazocin 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. However, amikacin and gentamicin were
determined to be compatible
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Package leaflet: Information for the user
Tazocin®
2 g / 0.25 g powder for solution for infusion
Tazocin®
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, 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 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 Tazocin 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.

Tazocin 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.
Tazocin may be used to treat bacterial infections in
patients with low white blood cell counts (reduced
resistance to infections).
Tazocin 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. Tazocin 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 Tazocin in combination 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 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 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 Other medicines and
Tazocin 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.
✪ Children
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 Tazocin
Please 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:
- 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).
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- 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, gentamicin or vancomycin. Tell
your doctor if you have kidney problems.
✪ Effect on laboratory tests
Tell the doctor or laboratory staff that you are
taking Tazocin 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 Tazocin 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 Tazocin
is right for you.
✪ Driving and using machines
The use of Tazocin is not expected to affect the
ability to drive or use machines.
Tazocin contains sodium
Tazocin 2 g / 0.25 g contains 5.67 mmol (130 mg)
of sodium.
Tazocin 4 g / 0.5 g contains 11.35 mmol (261 mg)
of sodium.
This should be taken into consideration if you are
on a controlled-sodium diet.

3. How to use Tazocin
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).
✪ 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 child’s weight but each individual dose will
not exceed 4 g / 0.5 g of Tazocin.
You will be given Tazocin 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 Tazocin 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 Tazocin than you should
As you will receive Tazocin 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.
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✪ If you miss a dose of Tazocin
If you think you have not been given a dose of
Tazocin, tell your doctor or other healthcare professional immediately.
If you have any further questions on 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 everybody gets them.
See a doctor immediately if you experience any
of these potentially serious side effects of Tazocin:
The serious side effects (with frequency in brackets) of Tazocin are:
- serious skin rashes [Stevens-Johnson syndrome, dermatitis bullous (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
(Not known)
- severe rash or hives (Uncommon), itching or
rash on the skin (Common)

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- yellowing of the eyes or skin (Not known)
- damage to blood cells [the signs include: being
breathless when you do not expect it, red or
brown urine (Not known), nosebleeds (Rare) and
small spot bruising (Not known)], severe decrease in white blood cells (Rare)
- severe or persistent diarrhoea accompanied by a
fever or weakness (Rare)
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
- decrease in platelets, decrease of red blood
cells or blood pigment / haemoglobin, abnormal
lab test (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
- skin rash, itching
- abnormal kidney blood tests
- fever, injection site reaction
✪ Uncommon side effects (may affect up to 1
in 100 people):
- decrease in white blood cells (leukopenia),
prolonged blood clotting time (prothrombin time
prolonged)
- decreased blood potassium, 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, nettle rash
- joint and muscle pain
- chills
✪ Rare side effects (may affect up to 1 in 1,000
people):
- severe decrease in white blood cells, bleeding
of the nose
- serious infection of the colon, inflammation of
the mucous lining of the mouth
- detachment of the top layer of the skin all over
the body (toxic epidermal necrolysis)
✪ Not known side effects (cannot be estimated
from the available data):
- severe decrease of red blood cells, white blood
cells and platelets (agranulocytosis), decrease
in white blood cells (neutropenia), decrease of
red blood cells due to premature breakdown or
degradation, small spot bruising, bleeding time
prolonged, increase of platelets, increase of a
specific type of white blood cells (eosinophilia)
- allergic reaction and severe allergic reaction
- inflammation of the liver, yellow staining of the
skin or whites of the eyes
- serious body wide allergic reaction with skin
and mucous lining rashes, blistering and various skin eruptions (Stevens-Johnson Syndrome),
severe allergic condition involving skin and
other organs such as the kidney and the liver
(drug reaction with eosinophilia and systemic
symptoms), numerous tiny fluid filled blisters
contained within large areas of swollen and
reddened skin accompanied by fever (acute
generalised exanthematous pustulosis), skin
reactions with blistering (dermatitis bullous)
- poor kidney functions and kidney problems
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
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 carton and vial after “EXP”.
The expiry date refers to the last day of that
month.
Unopened vials: Do not store above 25°C.
For single use only. Discard any unused solution.
Do not throw away any medicines via wastewater
or house­hold waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help protect the environment.
6. Contents of the pack and other information
✪ What Tazocin 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).
Each vial contains 4 g piperacillin (as sodium
salt) and 0.5 g tazobactam (as sodium salt).
- The other ingredients are citric acid monohydrate
and edetate disodium (EDTA).
✪ What Tazocin looks like and contents of the
pack
Tazocin 2 g / 0.25 g is a white to off-white powder
supplied in a vial.
Packs containing 1, 5, 10, 12, 25 or 50 vials.
Tazocin 4 g / 0.5 g is a white to off-white powder
supplied in a vial.
Packs containing 1, 5, 10, 12, 25 or 50 vials.
Not all pack sizes may be marketed.
✪ Marketing Authorisation Holder and Manufacturer
UK MA Holder: Pfizer Limited, Ramsgate Road,
Sandwich, Kent CT13 9NJ, United Kingdom.
Ireland MA Holder: Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24, Ireland
Malta MA Holder: Pfizer Hellas S.A.
243, Messoghion Avenue, 154 51 N. Psychiko,
Greece
Manufacturer:
Wyeth Lederle s.r.l.
Via Franco Gorgone, Zona Industriale
95100 Catania Italy
This leaflet was last revised in
UK: 05/2016
IE: 05/2016
Ref: TA 12_0 UK & IE

with Tazocin in vitro in certain diluents at specific concentrations (see Coadministration of Tazocin with aminoglycosides below).
Tazocin should not be mixed with other substances in a syringe or infusion
bottle since compatibility has not been established.
Because of chemical instability, Tazocin should not be used with solutions
containing only sodium bicarbonate.
Tazocin is compatible with lactated Ringer’s solution and for co-administration
via a Y-site.
Tazocin should not be added to blood products or albumin hydrolysates.
✪ Co-administration of Tazocin with aminoglycosides
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Tazocin and the aminoglycoside are recommended for separate administration. Tazocin and the aminoglycoside should be reconstituted and diluted
separately when concomitant therapy with aminoglycosides is indicated.
In circumstances where co-administration is recommended, Tazocin is compatible for simultaneous co‑administration via Y‑site infusion only with the
following aminoglycosides under the following conditions:
Tazocin
Dose

Tazocin
Diluent
volume
(ml)

Amikacin

2 g / 0.25 g
4 g / 0.5 g

50, 100,
150

1.75 – 7.5

0.9% sodium chloride
or 5% glucose

Gentamicin

2 g / 0.25 g
4 g / 0.5 g

50, 100,
150

0.7 – 3.32

0.9% sodium chloride
or 5% glucose

Aminoglycoside

Aminoglycoside
Acceptable diluents
concentration
range* (mg/ml)

* The dose of aminoglycoside should be based on patient weight, status of
infection (serious or life‑threatening) and renal function (creatinine clearance).
Compatibility of Tazocin with other aminoglycosides has not been established.
Only the concentration and diluents for amikacin and gentamicin with the
dose of Tazocin listed in the above table have been established as compatible
for co‑administration via Y‑site infusion. Simultaneous co-administration via
Y‑site in any manner other than listed above may result in inactivation of the
aminoglycoside by Tazocin.

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Date 9 MAY 16
Text Size (body) 9 pt
Colour :

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Black

09/05/16 12.04

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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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