Linezolid Aurovitas 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Linezolid Aurovitas 2 mg/ml infusion solution EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Linezolid Aurovitas is and what it is used for
2. What you need to know before using Linezolid Aurovitas
3. How to use Linezolid Aurovitas
4. Possible side effects
5. How to store Linezolid Aurovitas
6. Contents of the pack and other information

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

Linezolid is an antibiotic belonging to the oxazolidinone group that works by preventing the growth of certain bacteria (germs) that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used to treat pneumonia and certain skin or soft tissue infections. Your doctor will have determined whether linezolid is appropriate for treating your infection.

2. What you need to know before using Linezolid Aurovitas

Do not use Linezolid Aurovitas

• if you are allergic to linezolid or to 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), such as phenelzine, isocarboxazid, selegiline, or moclobemide. These medicines are usually used to treat depression or Parkinson's disease.
• if you are breastfeeding. This medicine passes into breast milk and could affect your baby.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Linezolid Aurovitas.

Linezolid may not be suitable for you if you answer yes to any of the following questions. In such cases, inform your doctor, as they may need to monitor your general health and blood pressure before and during treatment, or may decide that another treatment is more appropriate for you.

Ask your doctor if you are unsure whether any of the following apply to you:

• You have high blood pressure, whether or not you are taking medication for it.
• You have been diagnosed with hyperactive thyroid (hyperthyroidism).
• You have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system, associated with symptoms such as diarrhea, skin flushing, and wheezing).
• You suffer from manic depression, schizophrenia, mental confusion, or other mental health problems.
• You have a history of hyponatremia (low sodium levels in the blood) or take medicines that reduce sodium levels in the blood, e.g., certain diuretics such as hydrochlorothiazide.
• You are taking any opioid medicines.

Using certain medicines, including antidepressants and opioids, together with linezolid may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Linezolid Aurovitas”).

Take special care with Linezolid Aurovitas

Inform your doctor before using this medicine if:

• you are elderly.
• you bruise easily or bleed excessively.
• you have anemia (low red blood cell count).
• you are prone to infections.
• you have a history of seizures.
• you have liver or kidney problems, especially if you are on dialysis.
• you have diarrhea.

Inform your doctor immediately if, during treatment, you experience:

• vision problems such as blurred vision, changes in color vision, difficulty seeing clearly, or a reduction in your field of vision.
• loss of sensation in your arms or legs, or a tingling or burning sensation in your arms or legs.
• diarrhea may occur while taking or after taking antibiotics, including linezolid. If diarrhea becomes severe, persists for a long time, or if you notice blood or mucus in your stools, stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or slow down intestinal movements.
• repeated nausea or vomiting, abdominal pain, or rapid breathing.
• muscle pain without apparent cause, tenderness, weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• dizziness and malaise with muscle weakness, headache, confusion, and memory impairment, which may indicate hyponatremia (low sodium levels in the blood).

Other medicines and Linezolid Aurovitas

Linezolid may sometimes interact with certain medicines and cause adverse effects such as changes in blood pressure, body temperature, or heart rate.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Inform your doctor if you are taking or have taken within the last 2 weeks the following medicines, as you must not use linezolid if you are still taking them or have recently taken them (see also section 2 above “Do not use Linezolid Aurovitas”):

• monoamine oxidase inhibitors (MAOIs), such as phenelzine, isocarboxazid, selegiline, or moclobemide. These medicines are commonly used to treat Parkinson's disease.

Also inform your doctor if you are taking the following medicines. Your doctor may decide to treat you with linezolid, but will need to assess your general condition and blood pressure before and during treatment. In other cases, your doctor may decide that another treatment is more suitable for you.

• Cold decongestants containing pseudoephedrine or phenylpropanolamine.
• Certain medicines used to treat asthma, such as salbutamol, terbutaline, or fenoterol.
• Certain antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many medicines in this group, including amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, or sertraline.
• Medicines used to treat migraines, such as sumatriptan or zolmitriptan.
• Medicines used to treat sudden severe allergic reactions, such as adrenaline (epinephrine).
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine.
• Opioids (e.g., 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.

Use of Linezolid Aurovitas with food, drinks, and alcohol

• You may take this medicine before, during, or after meals.
• Avoid eating excessive amounts of mature cheese, yeast extracts, or soybean seed extracts (e.g., soy sauce), and alcoholic beverages, especially draught beer and wine. This is because this medicine can react with a substance called tyramine, naturally present in certain foods. This interaction may cause an increase in your blood pressure.
• If you develop a headache after eating or drinking, inform your doctor, pharmacist, or nurse immediately.

Pregnancy, breastfeeding, and fertility

The effect of linezolid in pregnant women is unknown. Therefore, pregnant women should not use this medicine unless advised by their doctor. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while using linezolid, as this medicine passes into breast milk and could affect your baby.

Driving and using machines

Linezolid may cause dizziness or vision problems. If this occurs, do not drive or operate machinery. Remember that if you do not feel well, your ability to drive or operate machinery may be impaired.

Linezolid Aurovitas contains glucose

1 ml of linezolid solution contains 45.7 mg of glucose (13.7 g of glucose in a bag). Inform your doctor or nurse if you have diabetes.

Linezolid Aurovitas contains sodium

This medicine contains 0.38 mg of sodium (main component of table/cooking salt) in each ml of solution (114 mg of sodium per bag). This corresponds to 5.7% of the maximum daily sodium intake recommended for an adult.

Inform your doctor or nurse if you are on a low-sodium diet.

3. How to use Linezolid Aurovitas

Adults

Follow exactly the instructions for administration of this medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

This medicine will be administered by a doctor or other healthcare professional via intravenous infusion (as a drip into a vein).

The recommended dose for adults (18 years and older) is 300 ml (600 mg of linezolid) twice daily, administered directly into the bloodstream (intravenously) as an infusion over a period of 30 to 120 minutes.

If you are on a dialysis programme, take linezolid after each dialysis session.

The usual duration of treatment is 10 to 14 days, but may be extended up to 28 days. The safety and efficacy of this medicine have not been established for treatment periods longer than 28 days. Your doctor will decide the appropriate duration of your treatment.

While you are receiving linezolid, your doctor will perform periodic blood tests to monitor your blood count.

If you are treated with linezolid for more than 28 days, your doctor will monitor your vision.

Use in children and adolescents

Linezolid is not normally used in children and adolescents (under 18 years of age).

If you use more Linezolid Aurovitas than you should

If you think you have been given more linezolid than you should have, inform your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount administered.

If you forget to use Linezolid Aurovitas

As this medicine is administered under close supervision, it is highly unlikely that a dose will be missed. If you think a dose of your treatment has been missed, inform your doctor or nurse. Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor, nurse, or pharmacist immediately if you notice any of the following adverse effects while being treated with linezolid.

The most serious adverse effects of linezolid (frequency in parentheses) are:

• Severe skin reactions (uncommon), swelling, particularly around the face and neck (uncommon), wheezing and/or difficulty breathing (rare). These may be signs of an allergic reaction, and treatment with linezolid may need to be stopped. Skin reactions such as raised purple rash due to inflammation of blood vessels (rare), red, sore, scaly skin (dermatitis) (uncommon), skin rash (common), itching (common).
• Vision problems (uncommon), such as blurred vision (uncommon), changes in color perception (not known), difficulty seeing clearly (not known), or if you notice a reduction in your field of vision (rare).
• Severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in rare circumstances could lead to complications that may become life-threatening (uncommon).
• Repeated nausea or vomiting, abdominal pain, or rapid breathing (rare).
• Seizures or convulsions have been reported (uncommon) in patients treated with linezolid.
• Serotonin syndrome (frequency not known). Inform your doctor if you experience restlessness, confusion, delirium, stiffness, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems, or diarrhoea (suggestive of serotonin syndrome) while also being treated with antidepressants known as SSRIs or opioids (see section 2).
• Unexplained bleeding or bruising, which may be due to a disturbance in the number of certain blood cells affecting blood clotting or causing anaemia (common).
• Reduction in the number of blood cells that can affect the ability to fight infections (uncommon). Some signs of infection include: fever (common), sore throat (uncommon), mouth ulcers (uncommon), and fatigue (uncommon).
• Rhabdomyolysis (rare): signs and symptoms include unexplained muscle pain, tenderness or weakness, and/or dark urine. These may be signs of a serious condition called rhabdomyolysis (muscle breakdown), which can lead to kidney damage.
• Inflammation of the pancreas (uncommon).
• Convulsions (uncommon).
• Transient ischaemic attacks (temporary disruption of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, difficulty speaking, and loss of consciousness) (uncommon).
• Ringing in the ears (tinnitus) (uncommon).

Cases of numbness, tingling, or blurred vision have been reported in patients who have taken linezolid for more than 28 days. If you experience vision problems, consult your doctor as soon as possible.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Fungal infections, especially in the vagina or mouth.

• Headache.

• Metallic taste.

• Diarrhoea, nausea, or vomiting.

• Changes in some blood test results, including tests for proteins, salts, or enzymes measuring liver or kidney function, or blood sugar levels.

• Difficulty sleeping.

• Increased blood pressure.

• Anaemia (reduction in the number of red blood cells).

• Dizziness.

• Localized or generalized abdominal pain.

• Constipation.

• Indigestion.

• Localized pain.

• Reduction in the number of platelets.

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the vagina or female genital area.
• Tingling or numbness sensation.
• Swelling, discomfort, changes in tongue color.
• Dry mouth.
• Pain at the injection site (infusion site) or around it.
• Inflammation of veins (including the site where the infusion line is placed).
• Need to urinate more frequently.
• Chills.
• Feeling thirsty.
• Increased sweating.
• Hyponatraemia (low sodium levels in the blood).
• Hypoglycaemia (low blood sugar levels).
• Kidney failure.
• Abdominal swelling.
• Pain at the injection site.
• Increased creatinine.
• Stomach pain.
• Changes in heart rhythm (e.g., increased heart rate).
• Decrease in blood cell count.
• Weakness and/or sensory changes.

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

• Change in tooth surface color, which resolves with professional dental cleaning procedures.
• Change in tongue surface color to black, with a hairy appearance.

The following adverse effects have also been reported (frequency not known: cannot be estimated from available data)

• Alopecia (hair loss).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Linezolid Aurovitas

Keep this medicine out of the sight and reach of children.

Hospital staff will ensure that this medicine is not used after the expiry date printed on the bag and that it is administered immediately after breaking the seal. They will also visually inspect the solution before use and it will only be used if it is a clear, particle-free solution. They will also ensure that the solution is stored correctly in its original packaging to protect it from light.

This medicine does not require any special storage temperature.

After opening:

From a microbiological point of view, unless the method of opening excludes the risk of bacterial contamination, the product should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Linezolid Aurovitas

• The active substance is linezolid.

Each ml contains 2 mg of linezolid.

Each 300 ml infusion bag contains 600 mg of linezolid.

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

Appearance of the product and contents of the container

Linezolid Aurovitas infusion solution is an isotonic, transparent, colourless to slightly yellow solution, free from visible particles, with a pH range of 4.4 to 5.2.

Linezolid Aurovitas is a transparent solution supplied in individual infusion bags containing 300 ml of solution (600 mg linezolid).

The bags are packaged in cartons containing 1, 5, 10 and 25 bags.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

Or

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of last revision of this leaflet: March 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Linezolid Aurovitas 2 mg/ml solution for infusion EFG

IMPORTANT: Consult the summary of product characteristics before prescribing.

Linezolid is not active against infections caused by Gram-negative pathogenic microorganisms. Concomitant treatment against Gram-negative microorganisms should be initiated if co-infection with Gram-negative pathogenic microorganisms is confirmed or suspected.

Posology and method of administration

Treatment with linezolid should only be initiated in a hospital setting and after assessment by a specialist physician, such as a microbiologist or an infectious disease specialist.

Patients starting treatment with the parenteral formulation may be switched to any of the oral formulations when clinically indicated. In such cases, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

The solution for infusion should be administered over a period of 30 to 120 minutes.

The recommended dose of linezolid should be administered intravenously (IV) twice daily.

Recommended duration and dosage for treatment in adults:

The duration of treatment depends on the microorganism involved, the site of infection, severity, and the patient's clinical response.

The treatment duration recommendations indicated below reflect those used in clinical trials. For certain types of infection, shorter treatment courses may be appropriate, although this has not been evaluated in clinical trials.

The maximum duration of treatment is 28 days. The safety and efficacy of linezolid have not been established for periods exceeding 28 days.

Bacteraemia-associated infections do not require an increase in the recommended dose or treatment duration. The recommended doses are identical for the infusion solution, tablets, and granules for oral suspension, and are as follows:

Paediatric population: The safety and efficacy of linezolid in children under 18 years of age have not been established. The currently available data are described in sections 4.8, 5.1, and 5.2 of the Summary of Product Characteristics; however, no posological recommendation can be made.

Elderly patients: dose adjustment is not required.

Renal impairment: dose adjustment is not required.

Severe renal impairment (i.e., CrCl <30 ml/min): no dose adjustment is required in these patients. However, because the clinical relevance of exposure to high concentrations (up to 10 times) of the two main metabolites of linezolid in these patients is unknown, this medicinal product should be used with special caution in patients with severe renal impairment and only if the expected benefit outweighs the potential risk.

Since approximately 30% of the dose of linezolid is removed during 3 hours of haemodialysis, linezolid should be administered after dialysis in patients undergoing this treatment. The main metabolites of linezolid are partially removed by haemodialysis, but metabolite concentrations are considerably higher after dialysis than those observed in patients with normal renal function or mild to moderate renal impairment. Therefore, linezolid should be used with special caution in patients with severe renal impairment undergoing dialysis and only if the expected benefit outweighs the potential risk.

To date, there is no experience with the administration of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or other alternative treatments for renal impairment (other than haemodialysis).

Hepatic impairment: in patients with mild to moderate hepatic impairment (Child-Pugh Class A or B): dose adjustment is not required.

Severe hepatic impairment (Child-Pugh Class C): since linezolid is metabolized via a non-enzymatic process, deterioration of hepatic function is not expected to significantly alter its metabolism, and therefore dose adjustment is not recommended. However, clinical data are lacking, and linezolid should be used in these patients only if the expected benefit outweighs the theoretical risk (see sections 4.4 and 5.2).

Overdose

No specific antidote is known.

Cases of overdose have not been reported. However, the following information may be useful:

Supportive measures should be initiated along with maintenance of glomerular filtration. Approximately 30% of the dose of linezolid is removed during 3 hours of haemodialysis, but data on the elimination of linezolid by peritoneal dialysis or haemoperfusion are not available.

Instructions for use and handling

For single use only. Remove the outer packaging only at the time of use, checking for minor leaks by firmly squeezing the bag. In case of leaks, the bag must not be used, as sterility may have been compromised. The solution should be inspected visually before use, and only clear solutions free from particles should be used. Do not use these bags in series connections. Any remaining solution should be discarded. Do not reuse used bags.

Linezolid 2 mg/ml solution for infusion is compatible with the following solutions: 5% glucose for intravenous infusion, 0.9% sodium chloride for intravenous infusion, Ringer's lactate solution for injection (Hartmann's solution for injection).

For information on storage, see section 5 Storage of Linezolid Aurovitas.

Incompatibilities

Additives must not be added to this solution. If linezolid is administered simultaneously with other medicinal products, each should be administered separately according to its instructions for use. Similarly, if the same intravenous line is used for sequential intravenous infusion of multiple drugs, it should be flushed before and after administration of linezolid with a compatible solution.

Linezolid solution for infusion is known to be physically incompatible with the following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, sodium phenytoin, and sulfamethoxazole/trimethoprim. In addition, it is chemically incompatible with sodium ceftriaxone.