Linezolid Aurobindo

Package leaflet: Information for the user

Linezolid Aurobindo 2 mg/ml infusion solution

For adults
Generic medicine
Please 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Linezolid Aurobindo is an antibiotic belonging to the oxazolidinone group that works by inhibiting the growth of certain bacteria causing infections. It is used in adults to treat pneumonia and certain skin or soft tissue infections. Your doctor will decide whether Linezolid Aurobindo is appropriate for treating your infection.

2. What you need to know before taking Linezolid Aurobindo

Do not use Linezolid Aurobindo

• If you are allergic 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 medicines may be used to treat depression or Parkinson's disease.
• If you are breastfeeding, as Linezolid Aurobindo passes into breast milk and may affect your baby.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Linezolid Aurobindo.
Linezolid Aurobindo may not be suitable for you if you answer yes to any of the following questions.
In such cases, inform your doctor, who may need to monitor your general health condition and blood pressure before and during treatment, or may decide that an alternative treatment is more appropriate for you.
If you are unsure whether these conditions apply to you, consult your doctor.

• Do you have high blood pressure, whether or not you are taking medication for it?
• Have you been diagnosed with an overactive thyroid?
• Do you have a tumor of the adrenal glands (pheochromocytoma) or carcinoid syndrome (caused by hormone-producing tumors with symptoms such as diarrhea, skin flushing, wheezing)?
• Do you suffer from manic depression, schizoaffective disorder, mental confusion, or other mental health problems?
• Are you taking any of the following medicines?
• Decongestants for cold or flu 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 severe and sudden allergic reactions such as adrenaline (epinephrine);
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine;
• Medicines used to treat moderate to severe pain, such as meperidine;
• Medicines used to treat anxiety disorders, such as buspirone;
• An antibiotic called rifampicin.

Take special care with Linezolid Aurobindo
Inform your doctor before being treated with this medicine if:

• You develop bruising or bleed easily;
• You are anemic (have low levels of red blood cells in your blood);
• You tend to develop 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 details, or narrowing of your visual field;
• Loss of sensation in arms or legs, or tingling or prickling sensations in arms or legs;
• Recurrent nausea or vomiting, abdominal pain, or rapid breathing.

You may develop diarrhea during or after taking antibiotics, including Linezolid Aurobindo. If this becomes severe or persistent, or if you notice blood or mucus in your stools, you must stop taking Linezolid Aurobindo immediately and consult your doctor. In this situation, you should not take medicines that block or slow down intestinal movement.

Other medicines and Linezolid Aurobindo
There is a risk that Linezolid Aurobindo may interact with certain other medicines, causing undesirable effects such as changes in blood pressure, body temperature, or heart rate.
Inform your doctor if you are taking or have taken within the last 2 weeks the following medicines, as Linezolid Aurobindo must not be taken if you are already taking these medicines or have recently taken them. (See also section 2 above “Do not take Linezolid Aurobindo”).

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

Also inform your doctor if you are taking the following medicines. Your doctor may still decide to prescribe Linezolid Aurobindo, but will need to monitor your general health and blood pressure before and during treatment. In other cases, your doctor may decide that an alternative treatment is more suitable for you.

• Decongestant remedies for cold or flu containing pseudoephedrine or phenylpropanolamine;
• Certain medicines used to treat asthma such as salbutamol, terbutaline, fenoterol;
• Certain antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors). There are many of these, including amitriptyline, cipramil, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline;
• Medicines used to treat migraine such as sumatriptan and zolmitriptan;
• Medicines used to treat severe and sudden allergic reactions such as adrenaline (epinephrine);
• Medicines that increase blood pressure, such as noradrenaline (norepinephrine), dopamine, and dobutamine;
• Medicines used to treat moderate to severe pain, such as meperidine;
• Medicines used to treat anxiety disorders, such as buspirone;
• Medicines that inhibit blood clotting, such as warfarin.

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicine, including those obtained without a prescription.

Linezolid Aurobindo with food, drinks, and alcohol
You may take Linezolid Aurobindo before, during, or after a meal.

• Avoid eating large amounts of aged cheese, yeast extracts, or soybean extracts (e.g., soy sauce), and avoid drinking alcohol, especially draught beer and wine. Linezolid may react with a substance called tyramine, which is naturally present in certain foods. This interaction may increase blood pressure.
• If you develop a throbbing headache after eating or drinking, inform your doctor or pharmacist immediately.

Pregnancy, breastfeeding, and fertility
The effect of Linezolid Aurobindo in pregnant women is unknown. Therefore, it should not be taken during pregnancy unless advised by your doctor. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not breastfeed while taking Linezolid Aurobindo, as the medicine passes into breast milk and may affect your baby.

Driving and using machines
Linezolid Aurobindo 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 Aurobindo contains glucose
Each ml of Linezolid Aurobindo contains 45.7 mg of glucose (13.7 g of glucose per bag).
To be considered in patients with diabetes mellitus.

Linezolid Aurobindo contains sodium
Each ml of Linezolid Aurobindo contains 0.38 mg of sodium (114 mg of sodium per bag).
To be considered in patients on a low-sodium diet.

3. How to take Linezolid Aurobindo

Adults
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine will be administered to you as an intravenous infusion (through a vein) by a doctor or healthcare professional.
The recommended dose for adults (18 years of age and older) is 300 ml (600 mg of linezolid) twice daily, given directly into the bloodstream (intravenously) via infusion over a period of 30 to 120 minutes.
If you are undergoing renal dialysis, Linezolid Aurobindo will be administered after the dialysis session.
A treatment course usually lasts from 10 to 14 days, but may extend up to 28 days. The safety and efficacy of this medicine have not been established for periods longer than 28 days.
Your doctor will decide how long you should continue treatment.
During treatment with Linezolid Aurobindo, your doctor will regularly perform blood tests to monitor your blood cell counts.
Your doctor will monitor your vision if your treatment with Linezolid Aurobindo lasts longer than 28 days.

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

If you take more Linezolid Aurobindo than you should
If you think you have been given too much Linezolid Aurobindo, inform your doctor or nurse immediately.

If you forget to use Linezolid Aurobindo
Since this medicine will be administered under close medical supervision, it is very unlikely that you will miss a dose. However, if you think you have missed a dose of treatment, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor, nurse or pharmacist if you notice any of the following side effects during treatment with Linezolid Aurobindo:

• skin reactions such as red, painful and peeling skin (dermatitis), rash, itching or swelling, particularly around the face and neck. This may be a sign of an allergic reaction and you may need to stop taking Linezolid Aurobindo;
• vision problems such as blurred vision, changes in colour vision, difficulty seeing details or narrowing of the visual field;
• severe diarrhoea containing blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in rare cases may progress to life-threatening complications;
• recurrent nausea or vomiting, abdominal pain or rapid breathing;
• seizures or convulsions have been reported with Linezolid Aurobindo. You must inform your doctor if you experience agitation, confusion, delirium, stiffness, tremor, lack of coordination and convulsions while taking antidepressants known as SSRIs (see section 2). Numbness, tingling sensations or blurred vision have been reported in patients treated with Linezolid Aurobindo for more than 28 days. If you have vision problems, you should consult your doctor as soon as possible.

Other side effects include:
Common (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 the results of certain blood tests measuring kidney or liver function or blood sugar levels;
• 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 anaemia;
• difficulty falling asleep;
• increased blood pressure;
• anaemia (low red blood cell count);
• changes in the number of certain blood cells that may affect the ability to fight infections;
• rash;
• itching;
• dizziness;
• localized or general abdominal pain;
• constipation;
• indigestion;
• localized pain;
• fever.

Uncommon (may affect up to 1 in 100 people):

• inflammation of the vagina or other genital area disorders in women;
• sensation of tingling or numbness;
• blurred vision;
• ringing in the ears (tinnitus);
• inflammation of veins;
• dry or painful mouth, swollen, painful or discoloured tongue;
• pain at the infusion site and surrounding area;
• need to urinate more frequently;
• chills;
• feeling of fatigue or thirst;
• inflammation of the pancreas;
• increased sweating;
• changes in blood proteins, salts or enzymes measuring kidney or liver function;
• convulsions;
• hyponatraemia (low sodium levels in the blood);
• kidney failure;
• reduced platelet count;
• abdominal swelling;
• transient ischaemic attack (temporary disruption of blood flow to the brain causing short-term symptoms such as loss of vision, weakness in arms and legs, confused speech and loss of consciousness);
• pain at injection site;
• skin inflammation;
• increased creatinine;
• stomach ache;
• changes in heart rate frequency (e.g. increased rate).

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

• narrowed visual field;
• superficial tooth discoloration, removable by dental cleaning (manual removal).

Not known: frequency cannot be estimated from the available data

• serotonin syndrome (symptoms include rapid heartbeat, confusion, abnormal sweating, hallucinations, involuntary movements, coldness 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 cell count);
• alopecia (hair loss);
• changes in colour vision or difficulty seeing details;
• reduction in blood cell counts;
• weakness and/or sensory changes.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Linezolid Aurobindo

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 stated on the bag label after "Exp" and that it is administered immediately after breaking the seal.
Staff will also visually inspect the solution before use, and only clear solutions without visible particles will be used. Furthermore, it will be checked that the solution is stored correctly in its packaging to protect the product from light.
This medicine does not require any special storage temperature.
After opening:
From a microbiological standpoint, the product should be used immediately, unless the method of opening excludes the risk of microbial contamination. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Linezolid Aurobindo contains

• 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.

Description of the appearance of Linezolid Aurobindo and contents of the pack
Concentrate for solution for infusion.
Linezolid Aurobindo is an isotonic, clear, colourless to slightly yellow solution, free from visible particles, with a pH range of 4.4–5.2.
Linezolid Aurobindo solution for infusion is supplied as a clear solution in an infusion bag containing 300 ml (600 mg linezolid) of solution.
The bags are supplied in cartons containing 1, 5, 10, and 25 bags.
Not all pack sizes may be marketed.

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

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia
BBG 3000
Malta
Arrow Génériques – Lyon
26 avenue Tony Garnier, Lyon
France
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
Generis Farmacêutica, S.A.
Rua João de Deus, 19
Amadora 2700-487
Portugal

This medicinal product is authorised in European Economic Area Member States under the following names:
Czech Republic: Linezolid Aurovitas
France: Linezolide Arrow 2 mg/ml, solution pour perfusion
Germany: Linezolid Puren 2 mg/ml Infusionslösung
Italy: Linezolid Aurobindo
Netherlands: Linezolid Aurobindo 2 mg/ml, oplossing voor infusie
Poland: Linezolid Aurovitas
Portugal: Linezolida Aurobindo
Romania: Linezolid Aurobindo 2 mg/ml, solutie perfuzabila
Spain: Linezolid Aurovitas 2 mg/ml solución para perfusión EFG
United Kingdom: Linezolid 2 mg/ml Solution for Infusion

The following information is intended exclusively for physicians or healthcare professionals:
Linezolid Aurobindo 2 mg/ml solution for infusion
Linezolid
IMPORTANT: Refer to the Summary of Product Characteristics before prescribing.
Linezolid is not active against infections caused by Gram-negative pathogens. If Gram-negative pathogens are documented or suspected, specific therapy against these microorganisms should be initiated concomitantly.

Dosage and method of administration
Treatment with linezolid must be initiated exclusively in a hospital setting and after consultation with a qualified specialist, such as a microbiologist or an infectious disease specialist.
Patients starting treatment with the parenteral formulation may subsequently be switched to the oral formulation if clinically indicated. In such cases, no dosage adjustment is required, as the oral bioavailability of linezolid is approximately 100%.
The infusion solution must be administered over a period of 30 to 120 minutes.
The recommended dosage of linezolid should be administered intravenously twice daily.

Recommended dosage and duration of treatment in adults:
The duration of treatment depends on the causative pathogen, the site and severity of infection, and the patient's clinical response.
The following recommendations regarding duration of therapy reflect those used in clinical studies.
Shorter treatment regimens may be appropriate for certain types of infection but have not been evaluated in clinical studies.
The maximum duration of treatment is 28 days. The safety and efficacy of linezolid administered for periods longer than 28 days have not been established.
Dose escalation or prolonged duration of treatment is not required for infections associated with concomitant bacteraemia. The recommended dose for the infusion solution is as follows:

Children: There are insufficient data on the safety and efficacy of linezolid in children and adolescents (<18 years of age) to establish dosage recommendations. Therefore, until further data become available, the use of linezolid in this age group is not recommended.

Elderly patients: No dose adjustment is required.

Patients with renal impairment: No dose adjustment is required.

Patients with severe renal impairment (i.e., creatinine clearance (CLCR) <30 mL/min): No dose adjustment is required. Since the clinical significance of higher exposures (up to 10-fold) to the two primary metabolites of linezolid in patients with severe renal impairment is unknown, linezolid should be used with particular caution in these patients and only if the expected benefit is considered to outweigh the potential risk.

As approximately 30% of a dose of linezolid is removed during 3 hours of hemodialysis, Linezolid Aurobindo should be administered after dialysis in patients undergoing this treatment. The primary metabolites of linezolid are partially removed by hemodialysis, but concentrations of these metabolites remain 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 particular 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 failure (other than hemodialysis).

Patients with hepatic impairment: Patients with mild to moderate hepatic impairment (Child-Pugh class A or B): No dose adjustment is required.

Patients with severe hepatic impairment (Child-Pugh class C): Since linezolid is metabolized via a non-enzymatic process, impaired liver function is not expected to significantly alter its metabolism, and therefore no dose adjustment is recommended. However, pharmacokinetic data and clinical experience with Linezolid Aurobindo 2 mg/mL infusion solution in patients with severe hepatic impairment are limited. Linezolid should be used with particular caution in patients with severe hepatic impairment, and only if the expected benefit is considered to outweigh the potential risk.

Overdose

A specific antidote is not known.

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

Supportive treatment is recommended, together with maintenance of glomerular filtration. Approximately 30% of a dose of linezolid is removed during 3 hours of hemodialysis, but there are no data available on the elimination of linezolid by peritoneal dialysis or hemoperfusion.

Instructions for use and handling

For single use only. Remove the overwrap only immediately before use, then check for minor leaks by firmly squeezing the bag. If leaks are found, the bag must be discarded, as sterility may be compromised. The solution should be inspected visually prior to use, and only clear, particle-free solutions should be used. Do not use these bags in series connections. Unused solution must be discarded. Do not reconnect partially used bags.

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

For information on storage, refer to section 5 "How to store Linezolid Aurobindo".

Incompatibilities

No additives should be introduced into this solution. If linezolid must be administered concomitantly with other medicinal products, each product should be administered separately, in accordance with their respective instructions for use. Similarly, if the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed with a compatible infusion solution before and after administration of linezolid (see section 6.6).

Linezolid is 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 ceftriaxone sodium.