Linezolid 2 Mg/Ml Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER Linezolid 2 mg/ml Solution for Infusion
Linezolid
Read all of this leaflet carefully before you are given 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.
• Linezolid 2 mg/ml Solution for Infusion is called ‘Linezolid Infusion’ in this leaflet.
What is in this leaflet:
1. What Linezolid Infusion is and what it is used for
2. What you need to know before you are given Linezolid Infusion
3. How to use Linezolid Infusion
4. Possible side effects
5. How to store Linezolid Infusion
6. Contents of the pack and other information
1. WHAT LINEZOLID INFUSION IS AND WHAT IT IS USED FOR
Linezolid Infusion is an antibiotic of the oxazolidinones group. The active substance is linezolid. Linezolid 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LINEZOLID INFUSION
You should not be treated with Linezolid Infusion:
• If you are allergic (hypersensitive) 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 may be used to treat depression or Parkinson’s disease
• If you are breast-feeding. This is because linezolid passes into breast milk and could affect your baby.
• If you are 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.
Warnings and precautions
Linezolid Infusion may not be suitable for you if you answer yes to any of the following questions. In these cases 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
- used to treat moderate to severe pain, such as pethidine
- medicines used to treat anxiety disorders, such as buspirone
- an antibiotic called rifampicin Take special care with Linezolid Infusion.
Talk to your doctor, pharmacist or nurse 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
Talk to your doctor or pharmacist 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 prickling in your arm or legs.
• diarrhoea while taking or after taking antibiotics, including Linezolid Infusion. If this becomes severe or persistent or you notice that your stool contains blood or mucus, you should stop taking Linezolid 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 Linezolid Infusion
There is a risk that Linezolid 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 Linezolid Infusion must not be taken if you are already taking these medicines or have taken them recently (see also section 2 “You should not be treated with Linezolid 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 using the following medicines.
Your doctor may still decide to give you Linezolid 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), 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.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Linezolid Infusion with food and drink
• You can take Linezolid Infusion 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 Linezolid Infusion 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, pharmacist or nurse immediately.
Pregnancy, breast-feeding and fertility
The effect of Linezolid Infusion in pregnant women is not known. Therefore, it should not be taken during pregnancy unless advised by your doctor.
If you are pregnant, 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 taking Linezolid Infusion because it passes into breast milk and could affect the baby.
Driving and using machines
Linezolid Infusion 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.
Linezolid Infusion contains glucose and sodium
Glucose
Each ml of Linezolid Infusion contains 45.7 mg of glucose (13.7 g of glucose per bag). Tell your doctor or nurse if you are diabetic.
Sodium
Each ml of Linezolid Infusion contains 0.38 mg of sodium (114 mg of sodium in one bag). Tell your doctor or nurse if you are on a low sodium diet.
3. HOW TO USE LINEZOLID INFUSION
Adults
This medicine will be given to you through a drip (by infusion into a vein) by a doctor or healthcare professional. The recommended dose for adults (18 years and older) is 300 ml (600 mg of linezolid) twice daily which is given over a period of 30 to 120 minutes.
If you are on kidney dialysis, you should be given Linezolid 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 taking Linezolid Infusion, your doctor should
• perform regular blood tests to monitor your blood count
• monitor your eyesight if you take Linezolid Infusion for more than 28 days.
Use in children and adolescents
Linezolid Infusion is not normally used to treat children and adolescents (under 18 years old).
If you receive more Linezolid Infusion than you should
If you are concerned that you may have been given too much Linezolid Infusion, tell your doctor or nurse at once.
If you miss a dose of Linezolid 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 your doctor or nurse at once.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Linezolid Infusion can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist or nurse immediately if you notice any of these side effects during
your treatment with Linezolid 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 taking Linezolid 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 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 Infusion . 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 “You should not be treated with Linezolid Infusion”).
Numbness, tingling or blurred vision have been reported by patients who have been given Linezolid
Infusion 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 side effects (may affect up to 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 specific 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 side effects (may affect up to 1 in 100 people):
• Inflammation of the vagina or genital area in women
• Sensation such as tingling or feeling numb
• Blurred vision
• “Ringing” in the ears (tinnitus)
• 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 side effects (may affect up to 1 in 1000 people):
• Restricted field of vision
• Superficial tooth discolouration, removable with professional dental cleaning (manual descaling)
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
• Sideroblastic 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 cell count
• Weakness and/or sensory changes
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.
Reporting of side effects
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.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LINEZOLID INFUSION
Keep this medicine out of the sight and reach of children.
Hospital staff will make sure that Linezolid Infusion
• is not used after the expiry date which is stated on the bag label after “EXP". The expiry date refers to the last day of that month.
• is not frozen and is kept correctly in its wrapping in order to protect from light.
• is given to you as soon as the connector cap on the bag has been removed.
• is only used if the solution is clear and does not contain particles.
Do not throw away via wastewater or household waste. Your pharmacist or nurse should dispose of medicines that are no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Linezolid Infusion contains
The active substance is linezolid. Each ml of solution contains 2 milligrams of linezolid.
The other ingredients are glucose monohydrate (a type of sugar), sodium citrate, citric acid anhydrous, hydrochloric acid and sodium hydroxide for pH adjustment and water for injections.
What Linezolid Infusion looks like and contents of the pack
Linezolid Infusion is presented as a clear solution in single infusion bags containing 300 ml (600 mg linezolid) of solution.
The bags are supplied in boxes of 1, 10 or 25 bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
Infomed Fluids S.R.L
50 Theodor Pallady blvd, District 3,
032266 Bucharest, Romania
Tel: +40 21 345 02 22
Fax: +40 21 345 3185
E-mail: office@infomedfluids.ro
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom
Austria
France
Germany
Italy
Poland
Romania
Spain
Linezolid 2 mg/ml Solution for Infusion Linezolid Panpharma 2 mg/ml Infusionslosung Linezolid Panpharma 2 mg/ml Solution pour Perfusion Linezolid Rotexmedica 2 mg/ml Infusionslosung Linezolid Infomed Linezolid Infomed
Linezolid Infomed 2 mg/ml Solutie Perfuzabila Linezolid G.E.S. 2 mg/ml solucion para perfusion EFG
This leaflet was last revised in MM/YYYY
[To be completed nationally]
The following information is intended for healthcare professionals only:
For further information, consult the Summary of Product Characteristics (SPC).
Dosage and Method of Administration
Linezolid 2 mg/ml Solution for Infusion 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 dosage should be administered IV twice daily.
Posology
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.
|
Infections |
Dosage |
Duration of treatment |
|
Nosocomial pneumonia |
600 mg twice daily |
10-14 Consecutive days |
|
Community acquired pneumonia | ||
|
Complicated skin and soft tissue infections |
600 mg twice daily |
Older people
No dose adjustment is required.
Patients with renal impairment:
No dose adjustment is required.
Patients with severe renal impairment (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, Linezolid 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 impairment:
No dose adjustment is required. However, there are limited clinical data and it is recommended that Linezolid 2 mg/ml Solution for Infusion should be used in such patients only when the anticipated benefit is considered to outweigh the theoretical risk.
Paediatric population:
There are insufficient data on the safety and efficacy of linezolid in children and adolescents (< 18 years old) to establish dosage recommendations (see sections 5.1 and 5.2). Therefore, until further data are available, use of linezolid in this age group is not recommended.
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.
Linezolid 2 mg/ml Solution for Infusion is compatible with the following solutions:
• Glucose 5% (50 mg/ml) Solution for Infusion,
• Sodium chloride 0.9% (9 mg/ml) Solution for Infusion,
Incompatibilities
This medicinal product must not be mixed with other medicinal products. If Linezolid 2 mg/ml Solution for Infusion 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.
Linezolid 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.
Shelf Life
24 months
After opening: The product should be used immediately.