Label: information for the patient

Sivextro 200mg powder for concentrate for solution for infusion

tedizolid phosphate

Read this label carefully before starting to receive this medication, as it contains important information for you.

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

-If you have any questions,consultyour doctor or nurse.

-If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section4.

1.What Sivextro is and for what it is used

2.What you need to know before Sivextro is administered

3.How Sivextro will be administered

4.Possible adverse effects

5.Storage of Sivextro

6.Contents of the package and additional information

Sivextro is an antibiotic that contains the active ingredient tedizolid phosphate. It belongs to a group of medications called "oxazolidinones".

It is used for the treatment of skin and soft tissue infections in adults and adolescents 12 years of age and older.

It works by stopping the proliferation of certain bacteria that can cause severe infections.

Do not use Sivextro:

• if you are allergic to tedizolid phosphate or any of the other components of this medication (listed in section6).

Warnings and precautions

Your doctor will decide if Sivextro is suitable for treating your infection.

Consult your doctor or nurse before Sivextro is administered if you have any of the following conditions:

• if you have diarrhea or have had diarrhea when treated with antibiotics (or up to 2months after taking them) in the past.
• if you are allergic to other medications belonging to the group of “oxazolidinones” (for example, linezolid, cycloserine).
• if you have a history of bleeding or easy bruising (which may be a sign of low platelet count, the small cells involved in blood clotting).
• if you have kidney problems.
• if you are taking certain medications for depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors), opioidsor MAOIs (monoamine oxidase inhibitors).The use of these medications with tedizolid phosphate may lead to a serotonin syndrome, a potentially life-threatening condition (with symptoms such as disorientation, difficulty concentrating, high temperature, increased reflexes, difficulty coordinating muscle movements).See Other medications and Sivextro for examples.
• if you are taking certain medications for migraine, known as “triptans”. See Other medications and Sivextro for examples.

Consult your doctor or pharmacist if you are unsure if you are taking any of these medications.

Dysentery

Consult your doctor immediately if you experience diarrhea during or after treatment. Do not take any medication to treat diarrhea without consulting your doctor first.

Antibiotic resistance

Bacteria can become resistant to antibiotic treatment over time. This is when antibiotics cannot stop the proliferation of bacteria or treat the infection. Your doctor will decide if you should be given Sivextro to treat your infection.

Possible side effects

Some side effects have been observed with Sivextro or other members of the oxazolidinones class when administered for a period exceeding the recommended duration for Sivextro. Inform your doctor immediately if you experience any of the following side effects while taking Sivextro:

• low white blood cell count
• anemia (low red blood cell count)
• bleeding or easy bruising
• numbness in hands or feet (e.g. numbness, tingling, or sharp pain)
• any vision problems, such as blurred vision, changes in color perception, difficulty seeing details, or restricted visual field.

Children

This medication should not be used in children under 12years, as it has not been sufficiently studied in this population.

Other medications and Sivextro

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. It is especially important to inform your doctor if you are also taking:

• amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine, imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline, sertraline, duloxetine, and venlafaxine(used to treat depression).There is a risk that tedizolid phosphate may interact with certain medications, including those listed, and cause adverse effects such as changes in blood pressure or temperature.
• sumatriptan, zolmitriptan (used to treat migraine)
• opioids (such as fentanyl)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or nurse before using this medication.

The safety of Sivextro during breastfeeding is unknown. Consult your doctor before breastfeeding your baby.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or tired after using this medication.

Sivextro contains sodium

This medication contains less than 1mmol of sodium (23mg) per vial; it is essentially “sodium-free”.

Sivextro will be administered by a doctor or nurse.

It will be administered through a direct infusion into a vein (intravenously) for approximately 1 hour.

You will receive a 200 mg Sivextro infusion once a day, for 6 days.

Consult a doctor if you do not improve, or if you worsen after 6 days.

If you are given more Sivextro than you should

Inform your doctor or nurse immediately if you think you may have been given too much Sivextro.

If you forget a Sivextro dose

Inform your doctor or nurse immediately if you think you may have missed a dose.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Consult your doctor immediatelyif you experience diarrhea during or after your treatment.

Other side effects may include:

Frequent side effects (may affect up to 1 in 10people):

• Nausea
• Vomiting
• Headache
• Itching all over the body
• Fatigue
• Dizziness
• Pain or inflammation at the infusion site.

Rare side effects (may affect up to 1 in 100people):

• Fungal infections (fungus) in the skin, mouth, and vagina (vaginal thrush)
• Itching (including itching caused by allergic reaction), hair loss, acne, rash with redness and/or itching or hives, excessive sweating
• Decreased or loss of sensation in the skin, tingling sensation in the skin
• Heat waves or redness/rubor on the face, neck, or upper chest
• Abscess (inflamed lump with pus)
• Infection, inflammation, or vaginal pruritus
• Anxiety, irritability, agitation, or tremors
• Respiratory tract infection (frontal sinuses, throat, and chest)
• Nasal dryness, chest congestion, cough
• Drowsiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
• Dry mouth, constipation, indigestion, stomach pain (abdomen), hiccups, dry gasps, bright red blood in the stool
• Acid reflux disorder (heartburn, pain, or difficulty swallowing), flatulence/gas
• Joint pain, muscle spasms, back pain, neck pain, pain/mildness in the limbs, decreased hand grip strength
• Blurred vision, "floaters" (small floating shapes in the visual field)
• Lymph node inflammation or enlargement
• Allergic reaction
• Dehydration
• Impaired glucose control
• Anomalies in taste perception
• Slow heart rate
• Fever
• Swelling of ankles and/or feet
• Urine with abnormal odor, abnormalities in blood tests
• Reactions to infusion (chills, tremors, or chills with fever, muscle pain, facial inflammation, weakness, fainting, shortness of breath, chest tightness, and angina)

Unknown frequency (cannot be estimated from available data):

• Bleeding or appearance of petechiae with ease (due to low platelet count, small cells involved in blood clotting)

Reporting of side effects

If you experience any type of side effect, consult your doctor ornurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. 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.

Do not use this medication after the expiration date that appears on the vial label after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe the presence of particles or if the solution is cloudy.

Once opened, this medication must be used immediately. Otherwise, the reconstituted and diluted solution must be stored at room temperature or in a refrigerator between 2°C and 8°C, and administered within 24hours after reconstitution.

The disposal of unused medication and all materials that have come into contact with it, including materials used for reconstitution, dilution, and administration, will be carried out in accordance with local regulations.

Composition of Sivextro

• The active ingredient is tedizolid phosphate. Each vial of powder contains tedizolid phosphate disodium, equivalent to 200mg of tedizolid phosphate.
• The other components are mannitol, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Sivextro is a white to off-white powder for concentrate solution for intravenous infusion, packaged in a glass vial. The powder will be reconstituted in the vial with 4ml of water for injection. The reconstituted solution will be removed from the vial and added to a bag of 0.9% sodium chloride solution for intravenous infusion in the hospital.

Sivextro is available in packages of 1or6vials.

Only certain package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Responsible manufacturer

Patheon Italia S.p.A.

2° Trav. SX Via Morolense, 5

03013 Ferentino

Italy

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {MM/AAAA}.

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Important: Consult the product information before prescribing the medicinal product.

Patients who start treatment with the parenteral formulation can be switched to the oral formulation when clinically indicated.

Sivextro should be reconstituted with water for injection and then diluted in 250ml of 0.9% sodium chloride solution for intravenous infusion.

Only limited data are available on the compatibility of Sivextro with other substances for intravenous administration; therefore, no additives or other medicinal products should be added to the Sivextro vials for single use, nor should they be infused simultaneously. If the same intravenous line is used for the sequential infusion of different medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride solution. Do not use Ringer lactate or Hartmann solution for injection.

Reconstitution

To prepare the infusion solution, follow aseptic technique. Reconstitute the contents of the vial with 4ml of water for injection, and gently rotate the vial until the powder is completely dissolved. Avoid shaking or making rapid movements, as this may cause foaming.

Dilution

The reconstituted solution must be further diluted in 250ml of 0.9% sodium chloride solution for administration. Do not shake the bag. The resulting solution is a clear, colorless or yellowish solution.

Infusion

Visually check that the reconstituted solution does not contain particles before administration. Solutions that contain visible particles should be discarded.

Sivextro should be administered intravenously over approximately 1hour.

The reconstituted solution should be administered exclusively as an intravenous infusion. It should not be administered as a bolus injection. Sivextro should not be mixed with other medicinal products.

Each vial is for single use only.