Prospect: information for the user

Linezolid Aurovitas 2 mg/ml solution for infusion EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Linezolid Aurovitas

3.How to use Linezolid Aurovitas

4.Possible adverse effects

5.Storage of Linezolid Aurovitas

6.Contents of the package and additional information

Linezolid is an antibiotic from the oxazolidinones group that acts by preventing the growth of certain bacteria (germs) that cause infections.

It is used for the treatment of pneumonia and some skin or subcutaneous tissue infections. Your doctor will have decided if linezolid is suitable for treating your infection.

No use Linezolid Aurovitas

-If you are allergic to linezolid or any of the other ingredients in this medicine (listed in section 6).

-If you are taking or have taken in the last 2 weeks any medicine called monoamine oxidase inhibitors (MAOIs such as, for example, phenelzine, isocarboxazid, selegiline, 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 the baby.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to useLinezolidAurovitas.

Linezolid may not be suitable for you if you answeryesto any of the following questions. In that case, inform your doctor, as he/she will need to monitor your general health and blood pressure before and during treatment or may decide that another treatment is better for you.

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

•Do you have high blood pressure, whether or not you are taking medicines to treat it?

•Have you been diagnosed with hyperthyroidism?

•Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by tumors in the hormonal system that present with symptoms of diarrhea, skin flushing, wheezing)?

•Do you suffer from manic depression, schizophrenia, confusion or other mental problems?

•Have you had low sodium levels in your blood (hyponatremia) or are you taking medicines that lower sodium levels in the blood, e.g., some diuretics, such as hydrochlorothiazide?

•Are you taking any opioids?

The use of certain medicines, including antidepressants and opioids, together with linezolid may cause a potentially fatal serotonin syndrome (see “Other medicines and Linezolid Aurovitas”).

Be particularly careful with Linezolid Aurovitas

Inform your doctor before using this medicine if:

-You are elderly.

-You bruise easily and bleed.

-You have anaemia (low red blood cell count).

-You are prone to infections.

-You have a history of convulsions.

-You have liver or kidney problems, especially if you are on dialysis.

-You have diarrhoea.

Inform your doctor immediately if during treatment you experience:

-Visual problems such as blurred vision, changes in colour vision, difficulty seeing clearly or if you notice that your field of vision is reduced.

-Loss of sensation in your arms or legs or a feeling of pins and needles in your arms or legs.

-Diarhoea that becomes severe, lasts a long time, or contains blood or mucus. Stop taking this medicine immediately and consult your doctor. In this situation, do not take medicines that stop or slow down bowel movements.

-Recurring nausea or vomiting, abdominal pain or rapid breathing.

-A feeling of dizziness and discomfort with muscle weakness, headache, confusion and memory deterioration, which may be indicative of hyponatremia (low sodium levels in the blood).

Other medicines and Linezolid Aurovitas

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

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.

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

-Monamine oxidase inhibitors (MAOIs, such as, for example, phenelzine, isocarboxazid, selegiline, moclobemide). These medicines are usually used to treat Parkinson's disease.

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

-Decongestants for colds that contain pseudoephedrine or phenylpropanolamine.

-Some medicines used to treat asthma such as salbutamol, terbutaline, fenoterol.

-Some antidepressants called tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many types of these medicines, 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 severe allergic reactions such as adrenaline (epinephrine).

-Medicines that increase blood pressure such as noradrenaline (norepinephrine), 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.

Use of Linezolid Aurovitas with food, drink and alcohol

-You can take this medicine before, during or after meals.

-Avoid eating large amounts of strong cheese, yeast extracts or soya seed extracts (e.g., soy sauce) and alcoholic drinks, especially barrel beer and wine. The reason is that this medicine may react with a natural substance called tyramine that is present in some foods. This interaction may cause an increase in your blood pressure.

-If you start with a headache after eating or drinking, inform your doctor, pharmacist or nurse immediately.

Pregnancy, breastfeeding and fertility

The effect of linezolid on 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not breastfeed while using linezolid because this medicine passes into breast milk and could affect your baby.

Driving and operating machines

Linezolid may cause dizziness or visual problems. If this happens, do not drive or operate machines. Remember that if you do not feel well you may be affected in your ability to drive or operate machines.

Linezolid Aurovitas contains glucose

This medicine contains glucose. Patients with diabetes mellitus should note that this medicine contains 45.7 mg of glucose per ml of solution (13.7 g of glucose per bag).

Linezolid Aurovitas contains sodium

Patients on low-sodium diets should note that this medicine contains 0.38 mg (0.02 mmol) of sodium pereach ml of solution(114 mg of sodium per bag).

Adults

Follow exactly the administration instructions for this medication contained in this leaflet or indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

This medication will be administered to you by a doctor or other healthcare professional through an intravenous infusion.

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

If you are on dialysis, use linezolid after each session.

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

While using linezolid, your doctor will perform periodic blood tests to monitor your blood count.

If you use linezolid for more than 28 days, your doctor should monitor your vision.

Use in children and adolescents

Linezolid is not usually used in children or adolescents (under 18 years).

Using more Linezolid Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

Missing a dose of Linezolid Aurovitas

As this medication is administered under close supervision, it is very unlikely that a dose will be missed. If you think you have forgotten to administer a dose of treatment, inform your doctor or nurse. Do not use a double dose to compensate for the missed dose.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor, nurse or pharmacist immediatelyif you notice any of the following side effects while taking linezolid.

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

-Severe skin changes (rare), swelling, particularly around the face and neck (rare), shortness of breath or difficulty breathing (rare). This may be a sign of an allergic reaction and may require discontinuation of linezolid treatment. Skin reactions such as purple elevated rash due to inflammation of blood vessels (rare), red, painful and scaly skin (dermatitis) (rare), skin rash (frequent), itching (frequent).

-Visual problems (rare), such as blurred vision (rare), changes in color perception (unknown), difficulty seeing clearly (unknown) or if you notice a reduction in your visual field (rare).

-Severe diarrhea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may lead to complications that can be life-threatening (rare).

-Repeated nausea or vomiting, abdominal pain or rapid breathing (rare).

-There have been reports of seizures or convulsions (rare) in patients taking linezolid.

-Serotonin syndrome (unknown). Inform your doctor if you experience agitation, confusion, delirium, rigidity, tremors, clumsiness, seizures, rapid heart rate, severe respiratory problems, and diarrhea (suggestive of serotonin syndrome) while also taking antidepressants called ISRS or opioids (see section 2).

-Unexplained bruising or purpura, which may be due to an alteration in the number of certain blood cells that can affect blood clotting or produce anemia (frequent).

-Reduction in the number of white blood cells that can affect the ability to fight infections (rare). Some signs of infection include: fever (frequent), sore throat (rare), mouth ulcers (rare), and fatigue (rare).

-Pancreatitis (rare).

-Seizures (rare).

-Transient ischemic attacks (temporary alteration 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) (rare).

-Tinnitus (ringing in the ears) (rare).

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

Other side effects include:

Frequent: may affect up to 1 in 10 people

-Fungal infections, especially in the vagina or mouth.

-Headache.

-Metalllic taste.

-Diarrhea, nausea, or vomiting.

-Alteration of some blood test results, including results of protein, salt, or enzyme tests that measure liver, kidney function, or blood sugar levels.

-Difficulty sleeping.

-Increased blood pressure.

-Anemia (reduction in the number of red blood cells).

-Dizziness.

-Abdominal pain, localized or generalized.

-Constipation.

-Indigestion.

-Localized pain.

-Reduction in platelet count.

Rare: may affect up to 1 in 100 people

-Vaginal or genital area inflammation in women.

-Sensation of numbness or tingling.

-Swelling, discomfort, changes in tongue color.

-Dry mouth.

-Pain at the injection site (route) or around it.

-Vein inflammation (including location where the infusion is administered).

-Increased need to urinate.

-Chills.

-Thirst.

-Increased sweating.

-Hyponatremia (low sodium levels in blood).

-Renal failure.

-Abdominal swelling.

-Pain at the injection site.

-Increased creatinine.

-Stomach pain.

-Changes in heart rhythm (e.g., increased heart rate).

-Reduction in blood cell count.

-Weakness and/or sensory changes.

Rare: may affect up to 1 in 1,000 people

-Change in the color of the tooth surface, which disappears with professional dental cleaning procedures.

Also, the following side effects have been reported (frequency unknown:cannot be estimated from available data)

-Alopecia (hair loss).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

The hospital staff will ensure that this medication is not used after the expiration 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 only use it if it is a clear and particle-free solution. They will also ensure that the solution is properly stored in its original packaging to protect it from light.

This medication does not require any special storage temperature..

After opening:

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

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Linezolid Aurovitas

-The active ingredient is linezolid.

Each milliliter 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 injection.

Appearance of the product and contents of the package

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

Linezolid Aurovitas is a transparent solution that is presented in individual infusion bags containing 300 mL of solution (600 mg of linezolid).

The bags are presented in boxes of 1, 5, 10, and 25 bags.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2024

This information is intended solely for healthcare professionals:

Linezolid Aurovitas 2 mg/ml infusion solution EFG

IMPORTANT: Consult the technical data sheet before prescribing.

Linezolid is not active against infections caused by Gram-negative pathogenic microorganisms. Concomitant treatment with Gram-negative pathogens should be initiated if there is certainty or suspicion of coinfection with Gram-negative pathogens.

Dosage and administration

Linezolid treatment should only be initiated in a hospital setting and after evaluation by a specialist physician, such as a microbiologist or an infectious diseases specialist.

Patients who initiate treatment with the parenteral formulation may switch to any of the oral presentations when clinically indicated. In this case, no dose adjustment is required, as the oral bioavailability of linezolid is approximately 100%.

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

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

Recommended duration and dosage for adult treatment:

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

The recommendations for treatment duration listed below reflect those used in clinical trials. For some types of infections, it may be advisable to prescribe shorter treatments, 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 when administered for periods exceeding 28 days.

Community-acquired pneumonia does not require an increased dose or treatment duration.The recommended doses are identical for the infusion solution, tablets, and oral suspension granules, and are as follows:

Pediatric population:the safety and efficacy of linezolid have not been established in children under 18 years of age. The available data are described in sections 4.8, 5.1, and 5.2 of the technical data sheet, but no posological recommendation can be made.

Geriatric population:no dose adjustment is required.

Renal impairment:no dose adjustment is required.

Severe renal impairment (i.e., CLCR<30>no dose adjustment is required in these patients. Due to the unknown clinical relevance of exposure to high concentrations (up to 10 times) of the two main metabolites of linezolid, this medication should be used with caution in patients with severe renal impairment and only if the expected benefit outweighs the potential risk.

Since approximately 30% of the linezolid dose is eliminated during 3 hours of hemodialysis, linezolid should be administered after dialysis in patients receiving this treatment. The main metabolites of linezolid are eliminated in part by hemodialysis, but their concentrations are significantly higher after dialysis than in patients with normal renal function or mild to moderate renal impairment. Therefore, linezolid should be used with 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 alternative treatments for renal impairment (other than hemodialysis).

Severe hepatic impairment:patients with mild to moderate hepatic impairment (Class A or B in the Child-Pugh scale): No dose adjustment is required.

Severe hepatic impairment (Class C in the Child-Pugh scale):since linezolid is metabolized by a non-enzymatic process, it is not expected that impaired liver function will significantly alter its metabolism, and therefore no dose adjustment is recommended. However, there are no clinical data available, 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.

No cases of overdose have been reported. However, the following information may be useful:

It is recommended to establish supportive measures along with maintenance of glomerular filtration. Approximately 30% of the linezolid dose is eliminated during 3 hours of hemodialysis, but there are no data on the elimination of linezolid by peritoneal dialysis or hemoperfusion.

Instructions for use and handling

For single use only. Remove the outer packaging only at the time of use, checking for minor leaks by pressing firmly on the bag. If leaks are detected, do not use, as it may have lost its sterility. The solution should be visually inspected before use and only used if it is transparent and free of particles. Do not use these bags in series connections. Discard any remaining solution. Do not reuse used bags.

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

For information on storage, see section 5 of the Linezolid Aurovitas technical data sheet.

Incompatibilities

No additives should be added to this solution. If linezolid is administered simultaneously with other medications, each should be administered separately according to its instructions for use. Similarly, if the same intravenous route is used for the sequential infusion of multiple medications, it should be flushed before and after the administration of linezolid with a compatible solution.

It is known that linezolid infusion solution is physically incompatible with the following compounds: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium, and sulfamethoxazole/trimethoprim. Additionally, it is chemically incompatible with ceftriaxona sodium.