Label: Information for the Patient

Xerava 100 mg Powder for Concentrate for Solution for Infusion

eravaciclina

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

What is Xerava

Xerava is an antibiotic that contains the active ingredient eravaciclina. It belongs to a group of antibiotics called «tetraciclinas» that act by stopping the growth of certain infectious bacteria.

What is Xerava used for

Xerava is used to treat adults with a complicated infection in the abdomen.

Do not receive Xerava

• if you are allergic to eravaciclina or any of the other components of this medication (listed in section 6).
• if you are allergic to any antibiotic in the tetracycline group (e.g., minocycline and doxycycline), as you may also be allergic to eravaciclina.

Warnings and precautions

Consult your doctor or nurse before starting Xerava if you are concerned about any of the following:

Anaphylactic reactions

Anaphylactic reactions (allergic reactions) have been reported with other tetracycline antibiotics. These reactions can occur suddenly and be potentially life-threatening.Seek medical attention immediatelyif you suspect you are experiencing an anaphylactic reaction during treatment with Xerava. The symptoms to watch for are skin rash, facial swelling, dizziness or fainting, chest tightness, difficulty breathing, rapid heartbeat, or loss of consciousness (see also section 4).

Dysentery

Consult your doctor or nurse if you have dysentery before receiving Xerava. If you experience dysentery during or after treatment,inform your doctor immediately. Do not take any medication to treat dysentery without consulting your doctor first (see also section 4).

Reactions at the infusion site

Xerava is administered through direct infusion into a vein.Inform your doctor or nurseif you notice any of the following effects at the infusion site during or after treatment: skin redness, skin rash, inflammation, and pain or tenderness.

New infection

Although Xerava fights certain bacteria, other bacteria and fungi may continue to grow. This is called "overgrowth" or "superinfection." Your doctor will closely monitor you for any new infections or interrupt treatment with Xerava and administer another treatment as needed.

Pancreatitis

Severe abdominal and back pain with fever may be a sign of pancreatitis. Inform your doctor or nurse if you experience any of these adverse effects during treatment with Xerava.

Hepatic problems

Inform your doctor if you have liver problems or are overweight, especially if you are also taking itraconazole (a medication used to treat fungal infections), ritonavir (a medication used to treat viral infections), or clarithromycin (an antibiotic), as your doctor will monitor you for possible adverse effects.

Children and adolescents

This medication should not be used in children and adolescents under 18 years old, as it has not been sufficiently studied in these populations. Xerava should not be used in children under 8 years old, as it may permanently discolor their teeth.

Other medications and Xerava

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication, such as rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine, and phenytoin (used to treat epilepsy), hypericum (a plant-based medication used to treat depression and anxiety), itraconazole (a medication used to treat fungal infections), ritonavir, atazanavir, lopinavir, and saquinavir (medications used to treat viral infections), and cyclosporine (a medication used to suppress the immune system).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before receiving this medication. Xerava is not recommended during pregnancy, as it may:

• permanently discolor the fetus's teeth;
• delay the natural formation of the fetus's bones.

It is not known if Xerava passes into breast milk. The long-term use of similar antibiotics by breastfeeding mothers may permanently discolor their child's teeth. Consult your doctor before breastfeeding your child.

Driving and operating machinery

Xerava may affect your ability to drive or operate machinery. Do not drive or operate machinery if you feel dizzy, disoriented, or unstable after receiving this medication.

Your doctor or nurse will administer Xerava.

The recommended dose for adults depends on body weight and is 1 mg/kg every 12 hours. Your doctor may increase the dose (1.5 mg/kg every 12 hours) if you are taking other medications such as rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.

You will receive it directly into a vein (intravenously) over approximately 1 hour.

Treatment cycles usually last from 4 to 14 days. Your doctor will decide how long you should receive treatment.

If you receive more Xerava than you should

You will receive Xerava in a hospital. Therefore, it is unlikely that you will receive an excessive amount. Inform your doctor or nurse immediately if you are concerned that you may have received an excessive amount of Xerava.

If you forget a dose of Xerava

You will receive Xerava in a hospital. Therefore, it is unlikely that you will forget a dose. Inform your doctor or nurse immediately if you are concerned that you may have forgotten a dose.

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

Seek urgent medical attentionif you suspect you are having an allergic reaction or experience any of the following symptoms during treatment with Xerava:

• skin rash
• swelling of the face
• sensation of dizziness or fainting
• chest tightness
• difficulty breathing
• rapid heartbeat
• loss of consciousness

Inform your doctor or nurse immediatelyif you experience diarrhea during or after treatment. Do not take any medication to treat diarrhea without consulting your doctor first.

Other side effects may be:

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

• nausea
• vomiting
• inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
• inflammation of a vein that causes pain and swelling (phlebitis)
• redness or swelling at the injection site
• low levels of fibrinogen in the blood (a protein involved in blood clotting)
• analytical values indicating a decrease in blood clotting ability

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

• diarrhea
• allergic reaction
• inflammation of the pancreas, which causes intense pain in the abdomen or back (pancreatitis)
• skin rash
• dizziness
• headache
• increased sweating
• abnormal liver test results in blood tests

Inform your doctor or nurse if you experience any of these side effects.

Other antibiotics in the tetracycline group

Other side effects have been reported with other tetracyclines, such as minocycline and doxycycline. These include sensitivity to light, headache, vision problems, or abnormalities in blood tests. Inform your doctor or nurse if you notice any of these side effects during treatment with Xerava.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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» and on the box after «CAD». The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 ºC-8 ºC). Store the vial in the packaging to protect it from light.

Once the powder has been reconstituted and diluted and is ready for use, it must be administered immediately. Otherwise, it can be stored at room temperature and used within a period of 12 hours.

Xerava reconstituted must be a clear transparent solution of color between light yellow and orange. Do not use the solution if it appears to contain solid particles or is cloudy.

Composition of Xerava

The active ingredient is eravacycline. Each vial contains 100 mg of eravacycline.

The other components are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the pack

Xerava is a yellowish to dark yellow compact powder in a 10 ml glass vial. The powder for concentrate for solution for infusion (powder for concentrate) will be reconstituted in the vial with 5 ml of water or with 5 ml of a 9 mg/ml (0.9%) sodium chloride solution for injectable preparations. The reconstituted solution will be withdrawn from the vial and added to a 9 mg/ml (0.9 %) sodium chloride solution for injectable preparations bag in the hospital.

Xerava is available in packs containing 1 vial, 10 vials or in multi-pack containers containing 12 boxes, each containing 1 vial.

Only some pack sizes may be marketed.

Marketing Authorization Holder

PAION Pharma GmbH

Heussstraße 25

52078 Aachen

Germany

Manufacturer

PAION Pharma GmbH

Heussstraße 25

52078 Aachen

Germany

PAION Deutschland GmbH

Heussstraße 25

52078 Aachen

Germany

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

Last update of this leaflet:

The detailed information on this medicinal product is available on 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: Before prescribing this medicinal product, consult the SmPC or the Product Information Leaflet.

Xerava must be reconstituted with water for injectable preparations or with a 9 mg/ml (0.9%) sodium chloride solution for injectable preparations and then diluted with a 9 mg/ml (0.9 %) sodium chloride solution for injectable preparations.

Xerava must not be mixed with other medicinal products. If the same intravenous route is used for the sequential infusion of different medicinal products, the route must be washed before and after infusion with a 9 mg/ml (0.9 %) sodium chloride solution for injectable preparations.

The dose must be calculated based on the patient's weight: 1 mg/kg of body weight.

Instructions for reconstitution

Aseptic technique must be followed to prepare the infusion solution. Each vial must be reconstituted with 5 ml of water for injectable preparations or with 5 ml of a 9 mg/ml (0.9%) sodium chloride solution for injectable preparations and gently swirled until the powder is completely dissolved. Agitation or rapid movement must be avoided, as this may cause foaming.

The reconstituted Xerava must be a clear yellowish to orange solution. The solution must not be used if it contains visible solid particles or is turbid.

Preparation of the infusion solution

For administration, the reconstituted solution must be diluted again with a 9 mg/ml (0.9 %) sodium chloride solution for injectable preparations. The calculated volume of the reconstituted solution must be added to the infusion bag until a target concentration of 0.3 mg/ml is achieved, within a range of 0.2 to 0.6 mg/ml. Examples of calculations are presented in Table 1.

Gently invert the bag to mix the solution.

Table 1: Examples of calculations for weights between 40 kg and 200 kg1

1The exact dose must be calculated based on the patient's specific weight.

For patients weighingbetween ≥ 40 kg and 49 kg:

Calculate the required volume of reconstituted solution based on the patient's weight and inject it into a 100 ml infusion bag.

For patients weighingbetween 50 kg and 100 kg:

Calculate the required volume of reconstituted solution based on the patient's weight and inject it into a 250 ml infusion bag.

For patients weighing >100 kg:

Calculate the required volume of reconstituted solution based on the patient's weight and inject it into a 500 ml infusion bag.

Infusion

The infusion solution must be visually inspected to exclude the presence of solid particles before administration.

Solutions reconstituted and diluted with visible solid particles or a turbid appearance must be discarded.

Xerava is administered intravenously over approximately 1 hour. The recommended dosing regimen for Xerava is 1 mg/kg every 12 hours for a period of 4 to 14 days.

The reconstituted and diluted solution must be administered only by intravenous infusion. It must not be administered as an intravenous bolus.

For single use only; the unused solution must be discarded.