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LIZEDIA 2 MG/ML SOLUTION FOR INFUSION

Active substance(s): LINEZOLID

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Package leaflet: Information for the user
Lizedia 2 mg/ml solution for infusion
Linezolid
Read all of this leaflet carefully before this medicine is given to you, 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 or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Lizedia 2 mg/ml solution for infusion is and what it is used for
2. What you need to know before you are treated with Lizedia 2 mg/ml solution for infusion
3. How Lizedia 2 mg/ml solution for infusion is given
4. Possible side effects
5. How to store Lizedia 2 mg/ml solution for infusion
6. Contents of the pack and other information

1. What Lizedia 2 mg/ml solution for infusionis and what it is used for
Lizedia 2 mg/ml solution for infusion is an antibiotic of the oxazolidinones group that works
by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat
pneumonia and some infections in the skin or under the skin. Your doctor will have decided if
Lizedia 2 mg/ml solution for infusion is suitable to treat your infection.

2. What you need to know before you are treated with Lizedia 2 mg/ml solution for
infusion
You should not be treated with Lizedia 2 mg/ml solution for infusion:
− if you are allergic to linezolid or any of the other ingredients of this medicine (listed in
section 6).
− if you are taking or have taken within the last 2 weeks any medicines known as
monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline,
moclobemide). These medications may be used to treat depression or Parkinson’s disease.
− if you are breast-feeding. This is because it passes into breast milk and could affect the
baby.
Lizedia 2 mg/ml solution for infusion may not be suitable for you if you answer yes to any of
the following questions. In this case tell your doctor as he/she will need to check your general
health and your blood pressure before and during your treatment or may decide that another
treatment is better for you.
Ask your doctor if you are not sure whether these categories apply to you:



Do you have high blood pressure, whether or not you are taking medicines for this?
Have you been diagnosed with an overactive thyroid?














Do you have a tumour of the adrenal glands (phaeochromocytoma) or carcinoid
syndrome (caused by tumours of the hormone system with symptoms of diarrhoea,
flushing of the skin, wheezing)?
Do you suffer from manic depression, schizoaffective disorder, mental confusion or
other mental problems?
Are you taking any of the following medicines?
decongestant, cold or flu remedies containing pseudoephedrine or phenylpropanolamine
medicines used to treat asthma such as salbutamol, terbutaline, fenoterol
antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors) for
example amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine,
fluvoxamine, imipramine, lofepramine, paroxetine, sertraline
medicines used to treat migraine such as sumatriptan and zolmitriptan
medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine)
medicines which increase your blood pressure, such as noradrenaline (norepinephrine),
dopamine and dobutamine
medicines used to treat moderate to severe pain, such as pethidine
medicines used to treat anxiety disorders, such as buspirone
an antibiotic called rifampicin

Warnings and precautions
Talk to your doctor before you are given this medicine if you:
• bruise and bleed easily
• are anaemic (have low red blood cells)
• are prone to getting infections
• have a history of seizures
• have liver problems or kidney problems particularly if you have dialysis
• have diarrhoea
Tell your doctor immediately if during treatment you suffer from:
• problems with your vision such as blurred vision, changes in colour vision, difficulty in
seeing detail or if your field of vision becomes restricted.
• loss of sensitivity in your arms or legs or a sensation of tingling or pricking in your arms
or legs.
• you may develop diarrhea while taking or after taking antibiotics, including Lizedia 2
mg/ml solution for infusion. If this becomes severe or persistent or you notice that your
stool contains blood or mucus, you should stop being given Lizedia 2 mg/ml solution for
infusion immediately and consult your doctor. In this situation, you should not take
medicines that stop or slow bowel movement.
• recurrent nausea or vomiting, abdominal pain or rapid breathing.
Other medicines and Lizedia 2 mg/ml solution for infusion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including medicines obtained without a prescription.
There is a risk that Lizedia 2 mg/ml solution for infusion may sometimes interact with certain
other medicines to cause side effects such as changes in blood pressure, temperature or heart
rate.
Tell your doctor if you are taking or have taken within the last 2 weeks the following
medicines as you must not be given Lizedia 2 mg/ml solution for infusion if you are already
taking these medicines or have taken them recently. (See also Section 2 above “Do not use
Lizedia 2 mg/ml solution for infusion”).
• monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline,
moclobemide). These may be used to treat depression or Parkinson’s disease.

Also tell your doctor if you are taking the following medicines. Your doctor may still decide
to give you Lizedia 2 mg/ml solution for infusion but will need to check your general health
and your blood pressure before and during your treatment. In other cases, your doctor may
decide that another treatment is better for you.










Decongestant cold or flu remedies containing pseudoephedrine or phenylpropanolamine.
Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.
Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake
inhibitors). There are many of these, including amitriptyline, cipramil, clomipramine,
dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine,
sertraline.
Medicines used to treat migraine such as sumatriptan and zolmitriptan.
Medicines used to treat sudden, severe allergic reactions such as adrenaline (epinephrine).
Medicines which increase your blood pressure, such as noradrenaline (norepinephrine),
dopamine and dobutamine.
Medicines used to treat moderate to severe pain, such as pethidine.
Medicines used to treat anxiety disorders, such as buspirone.
Medicines that stop blood clotting, such as warfarin.

Lizedia 2 mg/ml solution for infusion with food and drink
• Avoid eating large amounts of mature cheese, yeast extracts, or soya bean extracts, for
example soy sauce and drinking alcohol, especially draught beers and wine. This is
because this medicine may react with a substance called tyramine which is naturally
present in some foods. This interaction may cause an increase in your blood pressure.
• If you develop a throbbing headache after eating or drinking, tell your doctor or
pharmacist immediately.
Pregnancy, breast-feeding and fertility
The effect of Linezolid in pregnant women is not known. Therefore it should not be used in
pregnancy unless advised by your doctor. If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
You should not breast-feed when being given Lizedia 2 mg/ml solution for infusion because it
passes into breast milk and could affect the baby.
Driving and using machines
Linezolid may make you feel dizzy or experience problems with your vision. If this happens,
do not drive or operate any machinery. Remember that if you are unwell your ability to drive
or operate machinery may be affected.
Lizedia 2 mg/ml solution for infusion contains glucose monohydrate and sodium
Each 1 ml of Lizedia 2 mg/ml solution for infusion contains 45.7 mg glucose monohydrate
(13.7 g glucose in one bag). Tell your doctor or nurse if you are diabetic.
Each 1 ml of Lizedia 2 mg/ml solution for infusion solution contains 0.38 mg sodium (114
mg sodium in one bag).
Tell your doctor or nurse if you are on a low sodium diet.

3. How Lizedia 2 mg/ml solution for infusion is given
Adults

This medicine will be given to you through a drip (by infusion into a vein) by a doctor or
healthcare professional. The usual dose for adults (18 years and older) is 300 ml (600 mg
linezolid) twice daily which is given directly into the blood stream (intravenously) by a drip
over a period of 30 to 120 minutes.
If you are on kidney dialysis, you should be given Lizedia 2 mg/ml solution for infusion after
dialysis.
A course of treatment usually lasts 10 to 14 days, but can last up to 28 days. The safety and
effectiveness of this medicine have not been established for treatment periods longer than 28
days. Your doctor will decide how long you should be treated.
While you are given Lizedia 2 mg/ml solution for infusion your doctor should perform
regular blood tests to monitor your blood count.
Your doctor should monitor your eyesight if you are given Lizedia 2 mg/ml solution for
infusion for more than 28 days.
Use in children and adolescents
Lizedia 2 mg/ml solution for infusion is not normally used to treat children and adolescents
(under 18 years old).
If you receive more Lizedia 2 mg/ml solution for infusion than you should
If you are concerned that you may have been given too much Lizedia 2 mg/ml solution for
infusion tell your doctor or a nurse at once.
If you miss a dose of Lizedia 2 mg/ml solution for infusion
As you will be given this medicine under close supervision, it is very unlikely that you will
miss a dose. If you think that you have missed a dose of treatment, tell a doctor or nurse at
once.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor, nurse or pharmacist immediately if you notice any of these side effects
during your treatment with Lizedia 2 mg/ml solution for infusion






skin reactions such as red sore skin and flaking (dermatitis), rash, itching, or swelling,
particularly around the face and neck. This may be the sign of an allergic reaction and it
may be necessary for you to stop receiving Lizedia 2 mg/ml solution for infusion
problems with your vision such as blurred vision, changes in colour vision, difficulty in
seeing detail or if your field of vision becomes restricted.
severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including
pseudomembranous colitis), which in very rare circumstances may develop into
complications that are life-threatening.
recurrent nausea or vomiting, abdominal pain or rapid breathing.
fits or seizures have been reported with Linezolid. You should let your doctor know if
you experience agitation, confusion, delirium, rigidity, tremor, incoordination and seizure
while also taking antidepressants known as SSRI’s (see section 2).

Numbness, tingling or blurred vision have been reported by patients who have been given
Linezolid for more than 28 days. If you experience difficulties with your vision you should
consult your doctor as soon as possible.

Other side effects include:
Common (likely to occur in less than 1 in 10 people):



















Fungal infections especially vaginal or oral “thrush”
Headache
Metallic taste in the mouth
Diarrhoea, nausea or vomiting
Changes in some blood test results including those measuring your kidney or liver
function or blood sugar levels
Unexplained bleeding or bruising, which may be due to changes in the numbers of certain
cells in the blood which may affect blood clotting or lead to anaemia
Difficulty in sleeping
Increased blood pressure
Anaemia (low red blood cell)
Changes in numbers of certain cells in the blood which may affect your ability to fight
infection
Skin rash
Itching skin
Dizziness
Localised or general abdominal pain
Constipation
Indigestion
Localised pain
Fever

Uncommon (likely to occur in less than 1 in 100 people):























Inflammation of the vagina or genital area in women
Sensations such as tingling or feeling numb
Blurred vision
“Ringing” in the ears (tinnitus)
Inflammation of the veins
Dry or sore mouth, swollen, sore, or discoloured tongue
Pain at and around the place where the infusion (drip) was given
Inflammation of the veins (including where the infusion (drip) was given)
A need to urinate more often
Chills
Feeling tired or thirsty
Inflammation of the pancreas
Increased sweating
Changes in proteins, salts or enzymes in the blood which measure kidney or liver function
Convulsions
Hyponatraemia (low blood sodium levels)
Kidney failure
Reduction in platelets
Abdominal bloating
Transient ischaemic attacks (temporary disturbance of blood flow to the brain causing
short term symptoms such as loss of vision, leg and arm weakness, slurring of speech and
loss of consciousness)
Injection site pain
Inflammation of the skin





Increase in creatinine
Stomach pain
Changes in heart rate (e.g. increase rate)

Rare (likely to occur in less than 1 in 1000 people):



Restricted field of vision
Superficial tooth discolouration, removable with professional dental cleaning (manual
descaling)

The following side effects have also been reported (frequency not known):









Serotonin syndrome (symptoms include fast heart rate, confusion, abnormal sweating,
hallucinations, involuntary movements chills and shivering)
Lactic acidosis (symptoms include recurrent nausea and vomiting, abdominal pain, over
breathing)
Severe skin disorders
Sideroblastic anaemia ( a type of anaemia (low red blood cells))
Alopecia (hair loss)
Changes in colour vision, difficulty in seeing detail
Decrease of the blood cell count
Weakness and/or sensory changes

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 Yellow Card
Scheme system, throught 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 Lizedia 2 mg/ml solution for infusion
Keep this medicine out of the sight and reach of children.
Hospital staff will make sure that this medicine is not used after the “EXP” date stated on the
box/bag and that it is given to you as soon as the seal is broken. The expiry date refers to the
last day of that month.
This product is for single use only.
After opening: Chemical and physical in-use storage times has been demonstrated for 7 hours
at 2 to 8°C and at 25°C. From a microbiological point of view, unless the method of opening
precludes the risk of microbial contamination, 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.
Hospital staff will also visually inspect the solution prior to use and only clear solution,
without particles will be used. They will also make sure that the solution is kept correctly in
its box and foil wrapping in order to protect from light and out of the reach and sight of
children until it is needed.
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 Lizedia 2 mg/ml solution for infusion contains
-The active substance is linezolid.
Each 1 ml of solution contains 2 mg linezolid.
Each 300 ml infusion bag contains 600 mg linezolid.
-The other ingredients are glucose monohydrate (a type of sugar), sodium citrate, citric acid
anhydrous, hydrochloric acid 1N or sodium hydroxide 1N and water for injections.
What Lizedia 2 mg/ml solution for infusion looks like and contents of the pack
Lizedia 2 mg/ml solution for infusion is presented as a clear colourless to yellow solution in
single infusion dual port multilayer (latex-free) flexible bag, sealed inside a foil overwrap
containing 300 ml (600 mg linezolid) of solution and is packaged in a box.
The bags are supplied in boxes of 1, 5 or 10 infusion bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
6 Dervenakion Str,
15351, Pallini, Attiki,
Greece
Manufacturer
Pharmathen S.A.
6 Dervenakion Str,
15351, Pallini, Attiki,
Greece
and/or
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park,
Paola PLA 3000,
Malta
This leaflet was last revised in 11/2015.

The following information is intended for healthcare professionals only:
Lizedia 2 mg/ml solution for infusion
Linezolid
For further information, consult the Summary of Product Characteristics (SmPC).
Dosage and Method of Administration
Linezolid should only be initiated in a hospital environment and after consultation with a
relevant specialist such as a microbiologist or an infectious diseases specialist.
Patients who commence treatment on the parenteral formulation may be switched to either
oral presentation when clinically indicated. In such circumstances, no dose adjustment is
required as linezolid has an oral bioavailability of approximately 100 %.
The solution for infusion should be administered over a period of 30 to 120 minutes.
The recommended linezolid dosage should be administered IV twice daily.
Recommended dosage and duration for adults:
The duration of treatment is dependent on the pathogen, the site of infection and its severity,
and on the patient’s clinical response.
The following recommendations for duration of therapy reflect those used in the clinical
trials. Shorter treatment regimens may be suitable for some types of infection but have not
been evaluated in clinical trials.
The maximum treatment duration is 28 days. The safety and effectiveness of linezolid have
not yet been established for treatment periods longer than 28 days.
No increase in the recommended dosage or duration of treatment is required for infections
associated with concurrent bacteraemia. The dose recommendation for the solution for
infusion and the tablets/granules for oral suspension are identical and are as follows:
Infections
Nosocomial pneumonia
Community acquired
pneumonia
Complicated skin and soft
tissue infections

Dosage and route for twice
daily administration
600 mg twice daily

Duration of treatment
10-14 Consecutive Days

600 mg twice daily

Paediatric Population: There are insufficient data on the pharmacokinetics, safety and
efficacy of linezolid in children and adolescents (< 18 years old) to establish dosage
recommendations. Therefore, until further data are available, use of linezolid in this age group
is not recommended.
Elderly patients: No dose adjustment is required.
Patients with renal insufficiency: No dose adjustment is required.
Patients with severe renal insufficiency (i.e. CLCR < 30 ml/min): No dose adjustment is
required. Due to the unknown clinical significance of higher exposure (up to 10-fold) to the
two primary metabolites of linezolid in patients with severe renal insufficiency, linezolid

should be used with special caution in these patients and only when the anticipated benefit is
considered to outweigh the theoretical risk.
As approximately 30 % of a linezolid dose is removed during 3 hours of haemodialysis,
Lizedia 2 mg/ml solution for infusion should be given after dialysis in patients receiving such
treatment. The primary metabolites of linezolid are removed to some extent by haemodialysis,
but the concentrations of these metabolites are still very considerably higher following
dialysis than those observed in patients with normal renal function or mild to moderate renal
insufficiency. Therefore, linezolid should be used with special caution in patients with severe
renal insufficiency who are undergoing dialysis, and only when the anticipated benefit is
considered to outweigh the theoretical risk.
To date, there is no experience of linezolid administration to patients undergoing continuous
ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than
haemodialysis).
Patients with hepatic insufficiency: Patients with mild to moderate hepatic insufficiency
(Child-Pugh class A or B): No dose adjustment is required.
Patients with severe hepatic insufficiency (Child-Pugh class C): As linezolid is metabolised
by a nonenzymatic process, impairment of hepatic function would not be expected to
significantly alter its metabolism and, therefore, no dose adjustment is recommended.
However, there are no pharmacokinetic data and limited clinical experience of Linezolid in
patients with severe hepatic insufficiency. Linezolid should be used with special caution in
patients with severe hepatic insufficiency and only when the anticipated benefit is considered
to outweigh the theoretical risk.
Instructions for Use and Handling
For single use only. Remove overwrap only when ready to use, then check for minute leaks
by squeezing the bag firmly. If the bag leaks, do not use as sterility may be impaired. The
solution should be visually inspected prior to use and only clear solutions, without particles
should be used. Do not use these bags in series connections. Any unused solution must be
discarded. Do not reconnect partially used bags.
Lizedia 2 mg/ml solution for infusion may exhibit a yellow color that can intensify over time
without adversely affecting potency. Discard unused portions.
Lizedia 2 mg/ml solution for infusion Solution for Infusion is compatible with the following
solutions: 5 % dextrose intravenous infusion, 0.9 % sodium chloride intravenous infusion,
Ringer-lactate solution for injection.
Incompatibilities
Additives should not be introduced into this solution. If linezolid is to be given concomitantly
with other drugs, each drug should be given separately in accordance with its own directions
for use. Similarly, if the same intravenous line is to be used for sequential infusion of several
drugs, the line should be flushed prior to and following linezolid administration with a
compatible infusion solution.
Lizedia 2 mg/ml solution for infusion is known to be physically incompatible with the
following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam,
pentamidine isethionate, erythromycin lactobionate, phenytoin sodium and
sulphamethoxazole / trimethoprim. Additionally, it is chemically incompatible with
ceftriaxone sodium.

This medicinal product must not be mixed with other medicinal products except those
mentioned in section “Instructions for Use and Handling’’.
Shelf Life
After opening: Chemical and physical in-use stability has been demonstrated for 7 hours at 2
to 8°C and at 25°C.
From a microbiological point of view, unless the method of opening precludes the risk of
microbial contamination, the product should be used immediately. If not used immediately,
in-use storage times and conditions are the responsibility of the user.

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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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