LINEZOLID KALCEKS

Package leaflet: Information for the user

Linezolid Kalceks, 2 mg/mL, solution for infusion
Linezolidum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

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

Linezolid Kalceks contains the active substance linezolid. Linezolid is an antibiotic belonging to the class of antibiotics known as oxazolidinones, which works by stopping the growth of certain bacteria (microorganisms) that cause infections. This medicine is used to treat pneumonia and certain skin and soft tissue infections in adults. Your doctor will decide whether this medicine is appropriate for treating your specific infection.

2. Important information before administering Linezolid Kalceks

When not to give Linezolid Kalceks

• if the patient is allergic to linezolid or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently taking or has taken within the last 2 weeks a medicine from a group called monoamine oxidase inhibitors (MAOIs, e.g. phenelzine, isocarboxazid, selegiline, moclobemide). These medicines may be used in the treatment of depression or Parkinson's disease.
• if the patient is breastfeeding. The medicine passes into human milk and may harm the infant.

Warnings and precautions
Before starting treatment with Linezolid Kalceks, discuss this with the doctor or nurse.
Linezolid Kalceks may not be suitable for the patient if the answer to any of the following questions is yes. In such cases, talk to the doctor, as general health condition and blood pressure should be checked before and during treatment. The doctor may also decide to use a different medicine.
If in doubt whether any of the following situations apply to the patient, consult the doctor.

• Does the patient have high blood pressure, regardless of whether they are taking medication for it?
• Has the patient been diagnosed with hyperthyroidism?
• Does the patient have a tumour of the adrenal gland (pheochromocytoma) or carcinoid syndrome (caused by tumours in the hormonal system, associated with symptoms such as diarrhoea, skin flushing, wheezing)?
• Does the patient have bipolar depression, schizoaffective disorders, disorientation, or other psychiatric disorders?
• Has the patient previously experienced hyponatraemia (low sodium levels in the blood), or is the patient taking medicines that reduce sodium levels in the blood, e.g. certain diuretics (also known as "water tablets"), such as hydrochlorothiazide?
• Is the patient taking opioids?

Concomitant use of certain medicines, including antidepressants and opioids, with Linezolid Kalceks may lead to serotonin syndrome, a potentially life-threatening condition (see section 2 "Linezolid Kalceks and other medicines" and section 4).
When to exercise caution when using Linezolid Kalceks
Inform the doctor before administering the medicine if the patient:

• is elderly
• has a tendency to bruise or bleed
• has anaemia (low number of red blood cells)
• has a tendency to infections
• has had seizures in the past
• has impaired liver or kidney function, especially if the patient is on dialysis
• has diarrhoea

Immediately inform the doctor if the patient experiences any of the following during treatment:

• vision problems, e.g. blurred vision, changes in colour vision, difficulty perceiving details, or narrowing of the visual field.
• loss of sensation in the hands or feet, or a feeling of tingling or pricking in the hands and feet.
• diarrhoea may occur during or after taking antibiotics, including Linezolid Kalceks. If severe, persistent diarrhoea occurs, or if blood or mucus appears in the stool, stop taking the medicine immediately and contact the doctor. In such cases, do not take medicines that stop or slow down intestinal movements.
• recurring nausea or vomiting, abdominal pain, or rapid breathing.
• unexplained muscle pain, tenderness, or weakness and (or) darkening of urine. These may be symptoms of a serious condition called rhabdomyolysis (muscle breakdown), which may lead to kidney damage.
• nausea and general malaise, including muscle weakness, headache, confusion, and memory disturbances, which may indicate hyponatraemia (low sodium levels in the blood).

Linezolid Kalceks and other medicines
Tell the doctor or nurse about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take. There is a risk of interactions between Linezolid Kalceks and other medicines. These interactions may lead to adverse effects, such as changes in blood pressure, body temperature, or heart rate.
Inform the doctor if the patient is currently taking or has taken any of the following medicines within the last 2 weeks, because Linezolid Kalceks must not be administered during treatment with or shortly after treatment with these medicines (see also section 2 above, "When not to give Linezolid Kalceks"):

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

Also inform the doctor if the patient is taking any of the following medicines. The doctor may still administer Linezolid Kalceks, but monitoring of the patient's general health condition and blood pressure before and during treatment will be necessary. In other cases, the doctor may decide that another medicine would be more suitable for the patient.

• Decongestants used for cold or flu containing pseudoephedrine or phenylpropanolamine.
• Certain medicines used to treat asthma, e.g. salbutamol, terbutaline, fenoterol.
• Tricyclic antidepressants or SSRIs (selective serotonin reuptake inhibitors). Many medicines belong to these groups, e.g. amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, lofepramine, paroxetine, sertraline.
• Medicines used to treat migraines, e.g. sumatriptan and zolmitriptan.
• Medicines used to treat sudden, severe allergic reactions, e.g. adrenaline (epinephrine).
• Medicines that increase blood pressure, e.g. noradrenaline (norepinephrine), dopamine, dobutamine.
• Opioids, e.g. pethidine – used to treat moderate to severe pain.
• Anxiolytic medicines, e.g. buspirone.
• Anticoagulant medicines, e.g. warfarin.
• An antibiotic called rifampicin.

Linezolid Kalceks with food, drink and alcohol

• During treatment, limit consumption of foods such as aged cheeses, yeast extracts, soybean products (e.g. soy sauce), and alcoholic beverages, especially draught beer and wine. This is because Linezolid Kalceks may react with a substance called tyramine, naturally present in certain foods. This interaction may cause an increase in blood pressure.
• If a pulsating headache occurs after eating or drinking, seek immediate medical advice from a doctor or nurse.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult the doctor before using this medicine.
The effect of Linezolid Kalceks in pregnant women is unknown. Therefore, unless otherwise advised by the doctor, the medicine should not be used during pregnancy.
Breastfeeding must not be performed during treatment, as this medicine passes into human milk and may harm the infant.

Driving and operating machinery
This medicine may cause dizziness and visual disturbances. In such cases, do not drive or operate any machinery. Remember that general malaise may affect the ability to drive and operate machinery.

Linezolid Kalceks contains glucose
The medicine contains approximately 12 g of glucose per dose (300 mL). This should be taken into account in patients with diabetes.

Linezolid Kalceks contains sodium
This medicine contains 114 mg of sodium (the main component of table salt) per dose (300 mL). This corresponds to 5.7% of the maximum recommended daily dietary sodium intake for adults.

3. How Linezolid Kalceks is administered

Adults
The medicine will be administered as an infusion (intravenous infusion) by a doctor or qualified medical personnel. The recommended dose for adult patients (aged 18 years and older) is 300 mL of solution (600 mg of linezolid) given twice daily directly into the bloodstream (intravenously) via infusion over a period of 30 to 120 minutes.
If the patient is undergoing dialysis, this medicine should be administered after completion of dialysis.
Treatment usually lasts from 10 to 14 days, but may last up to 28 days. Efficacy and safety of this medicine have not been established for treatment periods longer than 28 days. The decision on the duration of treatment will be made by the doctor.
During treatment with Linezolid Kalceks, the doctor should perform regular blood tests to monitor the patient's haematopoietic system function.
The doctor should monitor the patient's vision if the patient is receiving this medicine for longer than 28 days.

Use in children and adolescents
Linezolid Kalceks is generally not used in the treatment of children and adolescents (under 18 years of age).

Use of a higher than recommended dose of Linezolid Kalceks
If you feel that the dose received was too high, contact your doctor or nurse immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the side effects listed below occur in a patient taking Linezolid Kalceks, the patient should immediately inform the doctor or nurse:
Serious side effects (with frequency in parentheses) are as follows:

• Swelling, particularly of the face and neck (not common), wheezing and (or) difficulty breathing (rare). These may be symptoms of an allergic reaction, and treatment with this medicine may need to be discontinued.
• Severe skin reactions, such as: raised, purple rash caused by inflammation of blood vessels (rare); severe rash developing rapidly, with blisters or peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis) (rare); redness and peeling of the skin (dermatitis) (not common).
• Vision disturbances (not common), such as blurred vision (not common), changes in colour perception (frequency not known), difficulty in seeing details (frequency not known), loss of vision (frequency not known), or narrowing of the visual field (rare).
• Severe diarrhoea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), rarely leading to life-threatening complications (not common).
• Recurrent nausea or vomiting, abdominal pain, or rapid breathing (rare).
• Seizures or convulsions (not common).
• Serotonin syndrome (frequency not known): Inform the doctor if, during concomitant use of antidepressant medicines known as SSRIs or opioids, symptoms such as excessive agitation, confusion, hallucinations, stiffness, tremor, lack of coordination, convulsions, rapid heartbeat, severe breathing problems, and diarrhoea occur (suggesting serotonin syndrome) (see section 2).
• Bleeding or bruising of unknown cause, possibly due to changes in blood cell counts affecting blood clotting or leading to anaemia (reduced platelet count or low red blood cell count) (common).
• Changes in the number of certain blood cells, which may affect the ability to fight infections (not common); signs of infection include: fever (common), sore throat (not common), mouth ulcers (not common), and fatigue (not common).
• 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 may lead to kidney damage.
• Pancreatitis (not common).
• Transient ischaemic attacks (transient disturbances in blood flow to the brain, causing temporary symptoms such as loss of vision, limb weakness, slurred speech, loss of consciousness) (not common).
• "Ringing" in the ears (tinnitus) (not common).

Numbness, tingling, and changes in visual acuity have been reported by patients who have taken this medicine for longer than 28 days. If a patient experiences worsening of vision, they should contact the doctor immediately.

Other side effects

Common (may occur in not more than 1 in 10 people)

• Fungal infections, particularly of the vagina or "thrush" in the mouth
• Sleep disturbances
• Headache
• Metallic taste in the mouth
• Dizziness
• Increased blood pressure
• Diarrhoea, nausea or vomiting, local or general abdominal pain, constipation, indigestion
• Itching, rash
• Local pain
• Changes in certain blood test results, including tests measuring proteins, salts or enzymes used to assess kidney, liver function or blood sugar levels

Not common (may occur in not more than 1 in 100 people)

• Vaginitis or inflammation of the external genital organs in women
• Decreased platelet count
• Hyponatraemia (low sodium levels in the blood)
• Tingling or numbness sensation
• Weakness and (or) sensory changes
• Changes in heart rate (e.g. increased rate)
• Inflammation of veins (including at the infusion site)
• Abdominal pain (gastritis), bloating, dry mouth, tongue swelling, irritation or discoloration
• Urticaria
• Increased sweating
• Kidney function disturbances, increased creatinine levels, more frequent urination
• Chills, feeling of fatigue, pain at or near the infusion site
• Increased thirst sensation

Rare (may occur in not more than 1 in 1,000 people)

• Superficial tooth discoloration, reversible with professional dental cleaning (manual removal of tartar)
• Disorders in red blood cell formation (sideroblastic anaemia)

Frequency not known (frequency cannot be estimated from available data)

• Hair loss (alopecia)

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Linezolid Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton,
overwrap, and on the bag after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging (in the overwrap and carton) until use
to protect from light.
After opening:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and
between 2°C and 8°C.
From a microbiological point of view, if the method of opening does not exclude the risk of
microbiological contamination, the product should be used immediately. If not used immediately,
the responsibility for storage duration and conditions lies with the user.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Linezolid Kalceks contains

• The active substance is linezolid.

Each mL of solution contains 2 mg of linezolid.
Each 300 mL infusion bag contains 600 mg of linezolid.

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

What Linezolid Kalceks looks like and contents of the pack
Linezolid Kalceks is a clear, colourless to yellowish infusion solution, practically free from visible particles.
Linezolid Kalceks is available as 300 mL solution in a single-use infusion bag, enclosed in a laminated foil overwrap. The bags are packed in a cardboard box.
Pack sizes: 1 or 10 infusion bags
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Sweden Linezolid Kalceks 2 mg/ml infusion solution
Czech Republic Linezolid Kalceks
France LINEZOLIDE KALCEKS 2 mg/mL, solution for infusion
Spain Linezolid Kalceks 2 mg/ml solution for infusion EFG
Lithuania Linezolid Kalceks 2 mg/ml infusion solution
Latvia Linezolid Kalceks 2 mg/ml solution for infusion
Germany Linezolid Kalceks 2 mg/ml infusion solution
Poland Linezolid Kalceks
Slovakia Linezolid Kalceks 2 mg/ml infusion solution

Information intended exclusively for healthcare professionals:

IMPORTANT: For detailed information, refer to the Summary of Product Characteristics.
Linezolid is not effective in the treatment of infections caused by Gram-negative bacteria.
In cases of confirmed or suspected infection caused by Gram-negative bacteria, appropriate concomitant therapy directed against these bacteria must be initiated.

Dosage and method of administration
Treatment with linezolid should be initiated only in hospital settings and after consultation with a specialist, e.g. a microbiologist or an infectious disease specialist.
Linezolid in the form of infusion solution may be used as initial therapy.
In patients who have started treatment with an intravenous formulation, a switch to the oral formulation may be made if clinically justified. In such cases, dose adjustment is not required, as the oral bioavailability of linezolid is approximately 100%.

Recommended dosage and duration of treatment in adults: The duration of treatment depends on the type of pathogenic microorganism, site and severity of infection, and the patient's clinical response to therapy.
The treatment duration recommendations presented below are consistent with those used in clinical trials. In certain types of infections, a shorter treatment duration may be sufficient; however, clinical trial data supporting this are lacking.
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.
In infections associated with bacteremia, there is no need to increase the dose or prolong the duration of treatment.
Dosage recommendations for the infusion solution 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. Dosage recommendations cannot be provided.
Elderly patients: No dose adjustment is necessary.
Renal impairment: No dose adjustment is required.
Severe renal impairment (i.e. creatinine clearance <30 mL/min): No dose adjustment is required. However, due to the uncertain clinical significance of increased exposure (up to 10-fold) to the two main metabolites of linezolid in patients with severe renal impairment, linezolid should be used with particular caution and only when the anticipated benefit outweighs the potential risk.
Since approximately 30% of the linezolid dose is removed during a 3-hour hemodialysis session, linezolid should be administered after dialysis in patients undergoing dialysis. Hemodialysis also leads to partial removal of the primary metabolites of linezolid; however, their concentrations remain significantly higher after dialysis than those observed in patients with normal renal function or mild to moderate renal impairment.
Therefore, in patients with severe renal impairment undergoing dialysis, linezolid should be used with particular caution and only when the anticipated benefit outweighs the potential risk.
Currently, there are no data on the use of linezolid in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or other forms of renal replacement therapy different from hemodialysis.
Hepatic impairment: No dose adjustment is required. However, due to limited clinical data, linezolid should be used in these patients only when the anticipated benefit outweighs the potential risk.
Method of administration: Intravenous administration.
The recommended doses of linezolid should be administered intravenously twice daily.
The infusion solution should be administered over a period of 30 to 120 minutes.
Pharmaceutical incompatibilities
Do not add other substances to the solution. If linezolid is to be administered simultaneously with other medicinal products, each should be administered separately according to the recommendations for their use. If solutions of linezolid and other medicinal products are to be administered alternately through the same intravenous line, the line must be flushed before and after administration of linezolid with a compatible solution (see below, “Special precautions and warnings for use”).
Linezolid is physically incompatible with the following medicinal products: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium, and sulfamethoxazole with trimethoprim. In addition, it is chemically incompatible with ceftriaxone sodium.
Special precautions and warnings for use
For single use only.
Remove the protective cover immediately before administration and check for small leaks by firmly squeezing the bag. If the bag leaks, do not use the product, as it may not be sterile.
Inspect the medicinal product before administration. The solution should only be administered if it is clear and free from particulate matter.
Do not use bags connected in series. Unused solution residues must be discarded. Do not connect bags with partially used contents.
Linezolid Kalceks, infusion solution, is compatible with the following solutions:

• 50 mg/mL (5%) glucose infusion solution
• 9 mg/mL (0.9%) sodium chloride infusion solution
• Ringer's lactate solution (Hartmann's solution)

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.