TAZOCIN 2G/0.25G POWDER FOR SOLUTION FOR INFUSION

Active substance: TAZOBACTAM SODIUM

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The following information is intended for medical or 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The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled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% 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.
- 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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
- If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What TAZOCIN is and what it is used for
2. Before you use TAZOCIN
3. How to use TAZOCIN
4. Possible side effects
5. How to store TAZOCIN
6. Further 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. BEFORE YOU USE TAZOCIN
✪ Do not use TAZOCIN
- if you are allergic (hypersensitive) to piperacillin or tazobactam or any of the other ingredients of TAZOCIN.
- if you are allergic (hypersensitive) to antibiotics known as
penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to TAZOCIN.
✪ Take special care with 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
haemo­ ialysis. Your doctor may want to check your kidd
neys 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.
✪ 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.
✪ Using other medicines
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).
- 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 TAZOCIN
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 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.
8930066 RD
PhC 48

✪ Driving and using machines
The use of TAZOCIN is not expected to affect the ability to drive
or use machines.
Important information about some of the ingredients of
TAZOCIN
TAZOCIN 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium.
TAZOCIN 4 g / 0.5 g contains 11.16 mmol (256 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 aged 12 years or older
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 the daily 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.
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✪ 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.
✪ 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 product,
ask your doctor or other healthcare professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, TAZOCIN 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 of TAZOCIN are:
• serious skin rashes (Stevens-Johnson syndrome, 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
• 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 anti­
coagulants such as warfarin.
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.

✪ Possible side effects are listed according to the
follow­ing frequencies:
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
✪ Common side effects:
- diarrhoea, vomiting, nausea
- skin rashes
✪ Uncommon side effects:
- 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 aminotrans­
ferase 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:
- (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
✪ Very rare side effects:
- 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 body wide 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.
5. HOW TO STORE TAZOCIN
Keep out of the reach and sight of children.
Do not use TAZOCIN 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.
Medicines should not be disposed of via wastewater or
house­ old waste. Ask your pharmacist how to dispose of
h
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER 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: 07/2013
IE: 07/2013
Ref: TA 7_3

with TAZOCIN in vitro in certain diluents at specific concentrations (see Co-administration 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:
Aminoglycoside

TAZOCIN
Dose

TAZOCIN AminoglycoDiluent
side
volume concentration
(ml)
range* (mg/ml)

Acceptable diluents

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

* 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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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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