LINEZOLID 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Linezolid Eugia, 2 mg/mL, solution for infusion
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Linezolid Eugia and what is it used for
4. Important information before taking Linezolid Eugia
   1. When not to take Linezolid Eugia
   2. Warnings and precautions
   3. When to exercise special caution when taking Linezolid Eugia
   4. Linezolid Eugia and other medicines
   5. Linezolid Eugia with food and drink
   6. Pregnancy and breastfeeding and fertility
   7. Driving and using machines
   8. Linezolid Eugia contains glucose
   9. This should be taken into account in patients with diabetes.
   10. Linezolid Eugia contains sodium
   11. This should be taken into account in patients controlling their sodium intake.
5. How to take Linezolid Eugia
   1. Adults
   2. Use in children and adolescents
   3. Taking a higher dose of Linezolid Eugia than recommended
   4. Missing a dose of Linezolid Eugia
6. Possible side effects
   1. Other side effects
   2. Common (may affect up to 1 in 10 people)
   3. Not very common (may affect up to 1 in 100 people)
   4. Rare (may affect up to 1 in 1,000 people)
   5. Unknown frequency (cannot be estimated from the available data)
   6. Reporting side effects
7. How to store Linezolid Eugia
8. Package contents and other information
   1. What Linezolid Eugia contains
   2. What Linezolid Eugia looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 02/2024
   7. Information intended for healthcare professionals only
   8. Linezolid Eugia, 2 mg/mL, solution for infusion Linezolidum
   9. Dosage and administration
   10. Recommended dosage and duration of treatment for adults
   11. Children and adolescents
   12. Elderly patients
   13. Renal impairment:
   14. Severe renal impairment (i.e. creatinine clearance below 30 mL/min):
   15. Hepatic impairment
   16. Severe hepatic impairment (Child-Pugh class C):
   17. Overdose
   18. Instructions for use
   19. Incompatibilities

Leaflet accompanying the packaging: patient information

Linezolid Eugia, 2 mg/mL, solution for infusion

For adults
Linezolidum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Linezolid Eugia and what is it used for
• 2. Important information before taking Linezolid Eugia
• 3. How to take Linezolid Eugia
• 4. Possible side effects
• 5. How to store Linezolid Eugia
• 6. Package contents and other information

1. What is Linezolid Eugia and what is it used for

Linezolid Eugia contains the active substance linezolid. Linezolid is an antibiotic from the oxazolidinone group, which inhibits the growth of certain bacteria (microorganisms) that cause infections. The medicine is used to treat pneumonia and some skin or soft tissue infections. The doctor will decide if Linezolid Eugia is the right medicine to treat the infection diagnosed in the patient.

2. Important information before taking Linezolid Eugia

When not to take Linezolid Eugia

Warnings and precautions

Before starting treatment with Linezolid Eugia, the patient should discuss it with their doctor, pharmacist or nurse.
If the patient answers "yes" to any of the following questions, it means that Linezolid Eugia may not be the right medicine for them. In such a case, they should tell their doctor, who will examine their overall health and blood pressure before starting treatment and will monitor them during treatment or may decide to use another, more suitable treatment.
If the patient is unsure whether the following situations apply to them, they should ask their doctor:

• if the patient has high blood pressure and is taking medicines for it, or is not taking them,
• if the patient has been diagnosed with hyperthyroidism,
• if the patient has a pheochromocytoma (a tumor of the adrenal gland) or a carcinoid syndrome (caused by hormonal tumors with symptoms such as diarrhea, hot flashes, wheezing),
• if the patient has been diagnosed with bipolar affective disorder, schizoaffective disorder, confusion (disorientation) or other mental disorders,
• if the patient has experienced hyponatremia (low sodium levels in the blood) or is taking medicines that lower sodium levels in the blood, such as certain diuretics (also called "water pills"), such as hydrochlorothiazide,
• if the patient is taking any opioid medicines.

Taking Linezolid Eugia with certain other medicines, including antidepressants and opioids, may lead to a potentially life-threatening condition called serotonin syndrome (see section 2 "Linezolid Eugia and other medicines" and section 4).

When to exercise special caution when taking Linezolid Eugia

Before starting treatment with Linezolid Eugia, the patient should discuss it with their doctor, pharmacist or nurse if they have any of the following conditions:

• are elderly;
• have a tendency to bleed or bruise;
• have anemia (too few red blood cells);
• are prone to infections;
• have a history of seizures;
• have liver or kidney problems (especially if they are on dialysis);
• have diarrhea.

The patient should immediately inform their doctor if they experience any of the following during treatment:

• vision disturbances, such as blurred vision, changes in color vision, difficulty seeing details or narrowing of the visual field;
• loss of sensation in hands or feet, or a feeling of tingling in hands or feet;
• diarrhea may occur during or after antibiotic treatment, including with Linezolid Eugia. If the diarrhea is severe or persistent, or if there is blood or mucus in the stool, the patient should stop taking Linezolid Eugia and consult their doctor; they should not take medicines that slow down or stop bowel movements;
• recurring nausea or vomiting, abdominal pain or rapid breathing;
• nausea and malaise, including muscle weakness, headache, confusion and memory disturbances, which may indicate hyponatremia (low sodium levels in the blood).

Linezolid Eugia and other medicines

Linezolid Eugia may sometimes interact with other medicines and cause side effects, such as changes in blood pressure, body temperature or heart rate.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken.
If the patient has taken any of the following medicines in the last 2 weeks, they should tell their doctor, as it is contraindicatedto take Linezolid Eugia (see also section 2 above, "When not to take Linezolid Eugia"):

• monoamine oxidase inhibitors (MAOIs, e.g. phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used to treat depression or Parkinson's disease.

The patient should also tell their doctor if they are taking any of the following medicines. The doctor may decide to continue treatment with Linezolid Eugia, but will monitor the patient's overall health and blood pressure before and during treatment. In other cases, the doctor may decide to use another, more suitable treatment.

• Medicines that reduce nasal congestion, used in colds and flu, containing pseudoephedrine or phenylpropanolamine.
• Certain medicines used to treat asthma, such as salbutamol, terbutaline, fenoterol.
• Certain antidepressants, such as tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs). This is a large group of medicines, and includes: amitriptyline, citalopram, clomipramine, doxepin, dosulepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraines, such as sumatriptan and zolmitriptan.
• Medicines used to treat severe allergic reactions, such as adrenaline.
• Medicines that increase blood pressure, such as noradrenaline, dopamine and dobutamine.
• Opioids, such as pethidine, used to treat moderate to severe pain.
• Medicines used to treat anxiety disorders, such as buspirone.
• Medicines that prevent blood clotting, such as warfarin.
• An antibiotic called rifampicin.

Linezolid Eugia with food and drink

Linezolid Eugia can be taken before, during or after a meal.

• The patient should avoid consuming large amounts of mature cheese, yeast extracts or soy (i.e. soy sauce) and drinking alcohol, especially beer and wine. The medicine may interact with a substance called tyramine, which occurs naturally in some foods and increases blood pressure.
• If the patient experiences a pulsating headache after eating or drinking, they should immediately tell their doctor, pharmacist or nurse.

Pregnancy and breastfeeding and fertility

The effects of Linezolid Eugia in pregnant women are not known, so it should not be taken during this time, unless prescribed by a doctor. If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The patient should not breastfeed while taking Linezolid Eugia, as it passes into breast milk and may affect the baby.

Driving and using machines

Linezolid Eugia may cause dizziness or vision disturbances. If these symptoms occur, the patient should not drive or operate any machines. They should remember that malaise can affect their ability to drive or operate machines.

Linezolid Eugia contains glucose

Each 1 mL of Linezolid Eugia solution contains 45.7 mg of glucose (13.7 g of glucose in one infusion bag).

This should be taken into account in patients with diabetes.

Linezolid Eugia contains sodium

Each 1 mL of Linezolid Eugia solution contains 0.38 mg of sodium (114 mg of sodium in one infusion bag).

This should be taken into account in patients controlling their sodium intake.

3. How to take Linezolid Eugia

Adults

This medicine should always be taken as directed by the doctor, pharmacist or nurse. If the patient is unsure, they should consult their doctor, pharmacist or nurse.
This medicine will be administered by infusion (into a vein) by a doctor or a qualified medical professional.
The recommended dose for adults (aged 18 and over) is 300 mL of solution (600 mg of linezolid) twice a day, administered directly into the bloodstream (intravenously) by infusion over 30 to 120 minutes.
If the patient is on dialysis, they should receive Linezolid Eugia after dialysis.
Treatment usually lasts from 10 to 14 days, but may also last up to 28 days. The safety and efficacy of using this medicine for longer than 28 days have not been established. The doctor will decide how long the treatment should last.
During treatment with Linezolid Eugia, the doctor will recommend regular blood tests to monitor the patient's blood count.
If treatment with Linezolid Eugia lasts more than 28 days, the doctor should recommend an eye examination for the patient.

Use in children and adolescents

Linezolid Eugia is not usually used to treat children and adolescents (under 18 years of age).

Taking a higher dose of Linezolid Eugia than recommended

If the patient is concerned that they have received a higher dose of Linezolid Eugia than recommended, they should immediately consult their doctor or nurse.

Missing a dose of Linezolid Eugia

The medicine is administered under close supervision, so it is unlikely that a dose will be missed. If the patient thinks that a dose has been missed, they should immediately tell their doctor or nurse. They should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Linezolid Eugia can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects during treatment with Linezolid Eugia, they should immediately tell their doctor, nurse or pharmacist.
Serious side effects (with frequency in parentheses) of Linezolid Eugia include:

• Severe skin disorders (not very common) swelling, especially around the face and neck (unknown) wheezing and (or) difficulty breathing (rare). These may be symptoms of an allergic reaction and it may be necessary to stop taking Linezolid Eugia. Skin reactions, such as a purple, raised rash caused by vasculitis

(rare), redness, peeling of the skin (skin inflammation) (not very common), rash (common), itching (common).

• Vision disturbances, such as blurred vision (not very common), changes in color vision, difficulty seeing details (frequency not known) or narrowing of the visual field (rare).
• Severe diarrhea with blood and (or) mucus (inflammation of the colon, including antibiotic-associated pseudomembranous colitis), rarely leading to life-threatening complications.
• Recurring nausea or vomiting, abdominal pain or rapid breathing (rare).
• Seizures or convulsions (not very common).
• Serotonin syndrome (frequency not known): if the patient experiences excessive stimulation, confusion, hallucinations, muscle stiffness, lack of coordination, seizures, rapid heartbeat, serious breathing problems and diarrhea (suggesting serotonin syndrome) while taking antidepressant medicines, known as SSRIs or opioids, they should tell their doctor (see section 2).
• Unexplained bleeding or bruising, which may be due to changes in the number of certain blood cells that can affect blood clotting or lead to anemia (common).
• Changes in the number of certain blood cells, which can affect the ability to fight infections (common) certain signs of infection include: any fever (common), sore throat (not very common), mouth ulcers (not very common) and fatigue (not very common).
• Pancreatitis (not very common).
• Seizures (not very common).
• Transient ischemic attacks (transient disturbances of blood flow to the brain, causing short-term symptoms such as loss of vision, weakness of the arms and legs, slurred speech and loss of consciousness) (not very common).
• "Ringing" in the ears (tinnitus) (not very common).

Patients who received Linezolid Eugia for more than 28 days reported feelings of numbness, tingling or blurred vision. If the patient experiences vision disturbances, they should consult their doctor as soon as possible.

Other side effects

Common (may affect up to 1 in 10 people)

• fungal infections, especially of the vagina or oral thrush,
• headache,
• metallic taste in the mouth,
• diarrhea, nausea or vomiting,
• changes in some blood test results, including those measuring protein, salt or enzyme levels, used to assess kidney or liver function or blood sugar levels,
• sleep disturbances,
• increased blood pressure,
• anemia (too few red blood cells),
• dizziness,
• abdominal pain or discomfort,
• constipation,
• indigestion,
• localized pain,
• decreased platelet count.

Not very common (may affect up to 1 in 100 people)

• vaginal or genital thrush in women,
• sensory disturbances, such as tingling or numbness,
• swelling, pain or discoloration of the tongue,
• dry mouth,
• pain or discomfort at the infusion site (drip),
• phlebitis (inflammation of the vein, including at the infusion site),
• need to urinate more often,
• chills,
• feeling thirsty,
• increased sweating,
• low sodium levels in the blood (hyponatremia),
• kidney failure,
• bloating,
• pain at the injection site,
• increased creatinine levels in the blood,
• abdominal pain,
• changes in heart rhythm (e.g. rapid heartbeat),
• decreased blood cell count,
• weakness and (or) sensory changes.

Rare (may affect up to 1 in 1,000 people)

• superficial tooth discoloration, which can be removed by a dentist (manual removal of tartar).

Unknown frequency (cannot be estimated from the available data)

• hair loss.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Linezolid Eugia

The medicine should be stored out of sight and reach of children.
Medical staff will ensure that Linezolid Eugia is not used after the expiry date stated on the bag and that it is used immediately after opening the infusion bag.
The person administering the medicine will check the solution before use, as only a clear solution without visible particles can be used. The medicine should not be used in series connection. Unused solution should be discarded. Bags with partially used contents should not be connected.
Linezolid Eugia 2 mg/mL solution for infusion is compatible with the following solutions: 5% glucose solution for intravenous infusion, 0.9% sodium chloride solution for intravenous infusion, Ringer's solution with lactate for injection (Hartmann's solution).
For information on storage, see section 5 "How to store Linezolid Eugia".

6. Package contents and other information

What Linezolid Eugia contains

The active substance is linezolid.
Each 1 mL contains 2 mg of linezolid.
Each 300 mL infusion bag contains 600 mg of linezolid.

• The other ingredients are: glucose monohydrate, sodium citrate, citric acid monohydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Linezolid Eugia looks like and contents of the pack

Solution for infusion.
Linezolid Eugia, solution for infusion, is an isotonic, clear, colorless to slightly yellow solution, without visible particles, with a pH between 4.4 and 5.2.
The packaging of Linezolid Eugia, solution for infusion, is a multi-layer polypropylene (PP) infusion bag containing 300 mL of infusion solution (600 mg of linezolid), equipped with a port system, in a cardboard box.
Pack sizes:
1 infusion bag, in a cardboard box,
5 infusion bags, in a cardboard box,
10 infusion bags, in a cardboard box,
25 infusion bags, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Generiques - Lyon
26 avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:
Linezolide Arrow 2 mg/ml, solution pour perfusion
Germany:
Linezolid PUREN 2 mg/ml Infusionslösung
Italy:
Linezolid Aurobindo
Poland:
Linezolid Eugia
Portugal:
Linezolida Aurobindo
Spain:
Linezolid Aurovitas 2 mg/ml solución para perfusión EFG

Date of last revision of the leaflet: 02/2024

Information intended for healthcare professionals only

Linezolid Eugia, 2 mg/mL, solution for infusion Linezolidum

WARNING:
Before administering Linezolid Eugia, the healthcare professional should read the Summary of Product Characteristics.
Linezolid is not effective in treating infections caused by Gram-negative bacteria. If a Gram-negative infection is diagnosed or suspected, appropriate treatment for these bacteria should be initiated.

Dosage and administration

Treatment with linezolid should only be started in a hospital setting and after consultation with a specialist in microbiology or infectious diseases.
In patients who have started treatment with the intravenous form, it may be possible to switch to the oral form if clinically indicated. In this case, no dose adjustment is necessary, as the bioavailability of linezolid after oral administration is approximately 100%.
The infusion solution should be administered over 30 to 120 minutes.
The recommended dose of linezolid should be administered intravenously (iv) twice a day.

Recommended dosage and duration of treatment for adults

The duration of treatment depends on the type of pathogen, location and severity of the infection, as well as the patient's clinical response to treatment.
The following recommendations for the duration of treatment are based on those used in clinical trials. In some types of infections, shorter treatment may be sufficient, but there are no clinical trial data to support this.
The maximum treatment duration is 28 days. The safety and efficacy of using linezolid for longer than 28 days have not been established.
In infections with concomitant bacteremia, there is no need to increase the dose or extend the treatment duration. The dosage recommendations for the infusion solution are the same and are as follows:

Children and adolescents

The safety and efficacy of linezolid in children and adolescents (under 18 years of age) have not been established. The available data are described in sections 4.8, 5.1 and 5.2 of the Summary of Product Characteristics, but it has not been possible to establish a recommended dosage.

Elderly patients

Dose adjustment is not necessary.

Renal impairment:

Dose adjustment is not necessary.

Severe renal impairment (i.e. creatinine clearance below 30 mL/min):

Dose adjustment is not necessary. Due to the unknown clinical significance of increased exposure (up to 10 times) to the two main metabolites of linezolid in patients with severe renal impairment, linezolid should be used with caution and only in patients for whom the expected benefit outweighs the theoretical risk.
As approximately 30% of the linezolid dose is eliminated from the body during a 3-hour hemodialysis session, patients on dialysis should receive Linezolid Eugia after dialysis. The main metabolites of linezolid are partially eliminated by hemodialysis, but their concentrations remain significantly higher after dialysis than in patients with normal renal function or mild to moderate renal impairment. Therefore, in patients on dialysis with severe renal impairment, linezolid should be used with caution and only if the expected benefit outweighs the theoretical risk.
There are no data on the use of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or other renal impairment treatments.

Hepatic impairment

Patients with mild to moderate hepatic impairment (Child-Pugh class A or B):
dose adjustment is not necessary.

Severe hepatic impairment (Child-Pugh class C):

As linezolid is metabolized by non-enzymatic processes, it is expected that hepatic impairment will not significantly affect its metabolism. Therefore, dose adjustment is not recommended. Due to limited clinical data, linezolid should only be used in these patients if the expected benefit outweighs the theoretical risk (see sections 4.4 and 5.2 of the Summary of Product Characteristics).

Overdose

There is no specific antidote.
No cases of linezolid overdose have been reported. The following information may be useful in the event of an overdose.
Supportive treatment should be used to maintain vital functions and renal function should be maintained.
About 30% of the linezolid dose is eliminated from the body during a 3-hour hemodialysis session, but there are no data on the elimination of linezolid by peritoneal dialysis or hemoperfusion.

Instructions for use

The medicine is for single use only. Immediately before administration, remove the outer foil (outer bag), check the bag for integrity by squeezing it firmly for one minute. If the bag is leaking, do not use it, as it may have lost its sterility. Before administration, check the solution. Only a clear solution without visible particles can be used. Do not use bags in series connection. Unused solution should be discarded. Do not connect bags with partially used contents.
Linezolid Eugia 2 mg/mL solution for infusion is compatible with the following solutions: 5% glucose solution for intravenous infusion, 0.9% sodium chloride solution for intravenous infusion, Ringer's solution with lactate for injection (Hartmann's solution).
For information on storage, see section 5 "How to store Linezolid Eugia".

Incompatibilities

Do not add other substances to the solution. If linezolid is to be administered with other medicines, each medicine should be administered separately, according to its administration instructions. Similarly, if the same intravenous line is to be used to administer different medicines in sequence, the line should be flushed with a compatible infusion solution before and after administering linezolid.
Linezolid Eugia 2 mg/mL solution for infusion is physically incompatible with the following medicines: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium and sulfamethoxazole with trimethoprim. It is also chemically incompatible with sodium salt of ceftriaxone.