Natlinez 2mg/Ml Solution For Infusion
Read all of this leaflet carefully before you start taking 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 Natlinez is and what it is used for
2. What you need to know before you are given Natlinez
3. How Natlinez is given
4. Possible side effects
5. How to store Natlinez
6. Contents of the pack and other information
Linezolid 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 this medicinal product is suitable to treat your infection.
Do not use Natlinez if you are:
• allergic to linezolid or any of the other ingredients of this medicine (listed in section 6);
• taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease;
• breast-feeding. This is because linezolid passes into breast milk and could affect the baby.
• taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), directly and indirectly acting sympathomimetic agents (including the adrenergic bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine), pethidine or buspirone, unless your doctor has specifically recommended that you should take one of these medicines
This medicinal product 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?
Tell your doctor before you are treated with 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 are on 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 diarrhoea while taking or after taking antibiotics, including linezolid. If this becomes severe or persistent or you notice that your stool contains blood or mucus, you should stop taking linezolid 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.
The use of linezolid in this age group is not recommended.
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
There is a risk that linezolid 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 linezolid must not be used if you are already taking these medicines or have taken them recently. (See also Section 2 above ‘Do not use Natlinez if you are’).
• 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 linezolid, 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.
You can take linezolid either before, during or after a meal.
Avoid eating large amounts of mature cheese, yeast extracts, or soya bean extracts e.g. 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 to 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 taken in pregnancy unless advised by your doctor. Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you may be pregnant or are trying to become pregnant.
You should not breast-feed when taking linezolid 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.
Natlinez contains sodium
This medicinal product contains 1,194 mg sodium per 300 ml infusion bag. To be taken into consideration by patients on a controlled sodium diet.
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 linezolid 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 taking this medicinal product your doctor should perform regular blood tests to monitor your blood count.
Your doctor should monitor your eyesight if linezolid is used for more than 28 days.
Not normally used to treat children and adolescents (under 18 years old).
If you are concerned that you may have been given too much, tell your doctor or a nurse at once.
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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
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:
• 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 taking linezolid.
• serious illness with blistering of the skin, mouth, eyes and genitals. These may be symptoms of Stevens-Johnson Syndrome
• 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 rare circumstances may develop into complications that are life-threatening.
• recurrent nausea or vomiting, abdominal pain or rapidbreathing which may be symptoms of too much acid in the blood.
• 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.
Common side effects (may affect up to 1 in 10 people):
• Fungal infections especially vaginal or oral “thrush”
• 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
• Localised or general abdominal pain
• Localised pain
Uncommon side effects (may affect up to 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
• A need to urinate more often
• 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
• 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 side effects (may affect up to 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 (Not known: frequency cannot be estimated from the available data):
• 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, rapid breathing)
• Severe skin disorders
• Sideroblatic anaemia (a type of anaemia (low red blood cells))
• Alopecia (hair loss)
• Changes in colour vision or difficulty in seeing detail
• Decrease of the blood 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
5. How to store Natlinez
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 infusion bag after EXP. The expiry date refers to the last day of that month.
Keep the infusion bag in the original package and foil wrapping in order to avoid evaporation and protect from light.
The solution should be used as soon as the seal is broken.
Do not use this medicine if you notice after visual inspection that the solution is not clear and contains particles.
6. Contents of the pack and other information
What Natlinez contains
- The active substance is linezolid. Each 1 ml of solution contains 2 mg linezolid.
- The other ingredients are citric acid anhydrous, sodium chloride, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment) and Water for Injections.
Linezolid is a clear, colourless to slightly yellow solution.
It is presented in polyolefine infusion bags inside a foil laminate overwrap. The bag holds 300 ml solution and is packaged in a box. Each box contains 1, 2, 5, 10, 20 or 25 infusion bags.
Not all pack sizes may be marketed.
The marketing authorization holder is
Hospira UK Limited
Royal Leamington Spa
Warwickshire, CV31 3RW
IMPORTANT: Refer to Summary of Product Characteristics before prescribing.
Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if co-infection with a Gram negative pathogen is documented or suspected.
A polyolefine infusion bag inside a laminate overwrap. The bag holds 300 ml solution and is packaged in a box. Each box contains 1, 2, 5, 10, 20 or 25 1, 2, or 10 infusion bags.
A clear, colourless to slightly yellow solution.
Dosage and Method of Administration
Natlinez 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.
Please refer to the Summary of Product Characteristics for information on the posology.
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 solution, 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.
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.
Natlinez 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.
Before opening: 2 years
After opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately
Special Precautions for Storage
Store in the original package (overwrap and carton) until ready to use.