B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Xerava 50 mg powder for concentrate for solution for infusion eravacycline

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Xerava is and what it is used for

• 2. What you need to know before you are given Xerava

• 3. How you will be given Xerava

• 4. Possible side effects

• 5. How to store Xerava

• 6. Contents of the pack and other information

1. What Xerava is and what it is used for

What Xerava is

Xerava is an antibiotic medicine that contains the active substance eravacycline. It belongs to a group of antibiotics called ‘tetracyclines’ which work by stopping the growth of certain infectious bacteria.

What Xerava is used for

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

2. What you need to know before you are given Xerava

You must not receive Xerava:

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

• - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline.

Warnings and precautions

Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:

Anaphylactic reactions

Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics. These can develop suddenly and can potentially be life-threatening. Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava. Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).

Diarrhoea

Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava. If you develop diarrhoea during or after your treatment, tell your doctor straight away. Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).

Infusion site reactions

Xerava is given by an infusion (drip) directly into your vein. Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.

New infection

Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow. This is called ‘overgrowth’ or ‘superinfection’. Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.

Pancreatitis

Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas. Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.

Liver problems

Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations. Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.

Other medicines and Xerava

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John’s Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. Xerava is not recommended for use during pregnancy as it can:

• permanently stain your unborn child’s teeth
• delay the natural formation of the bones of your unborn child.

It is not known if Xerava passes into breast milk. Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child’s teeth permanently. Ask your doctor for advice before breast-feeding your baby.

Driving and using machines

Xerava may affect your ability to drive or use machines safely. Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.

3. How you will be given Xerava

Xerava will be given to you by a doctor or nurse.

The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.

Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John’s Wort.

It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.

A course of treatment usually lasts for 4 to 14 days. Your doctor will decide how long you should be treated for.

If you are given more Xerava than you should

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will be given too much. Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.

If you miss a dose of Xerava

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will miss a dose. Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:

• Rash
• Swelling of the face
• Feeling lightheaded or faint
• Tightness of the chest
• Breathing difficulties
• Fast heartbeat
• Losing consciousness

Tell your doctor or nurse straightaway if you develop diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Other side effects may include:

Common side effects (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 causing pain and swelling (phlebitis)
• Redness or swelling at the site of the injection

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

• Diarrhoea
• Allergic reaction
• Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
• Rash
• Dizziness
• Headache
• Increased sweating
• Abnormal blood test results for liver

Tell your doctor or nurse if you have any of these side effects.

Other tetracycline antibiotics

Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline. These include sensitivity to light, headaches, vision problems, or abnormal blood tests. Tell your doctor or nurse if you notice any of these during your treatment with Xerava.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xerava

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

Do not use this medicine after the expiry date which is stated on the vial label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C-8°C). Keep the vial in the carton in order to protect from light.

Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately. If not, it may be stored at room temperature and used within 12 hours.

Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if it appears to contain any particles or the solution is cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Xerava contains

• – The active substance is eravacycline. Each vial contains 50 mg of eravacycline.

• – The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium

hydroxide (for pH adjustment).

What Xerava looks like and contents of the pack

Xerava is a pale yellow to dark yellow cake 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 for injections. The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.

Xerava is available in packs containing 1 vial or multipacks comprising 12 cartons, each containing 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PAION Deutschland GmbH

HeussstraBe 25

52078 Aachen

Germany

Manufacturer

Patheon Italia S.p.A.

2° Trav. SX. Via Morolense, 5

03013 Ferentino (FR)

Italy

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: http : // . europa.eu.

The following information is intended for healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.

Xerava must not be mixed with other medicinal products. If the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/mL (0.9%) solution for injection.

The dose should be calculated based on the patient’s weight; 1 mg/kg body weight.

Instructions for reconstitution

Aseptic technique must be followed when preparing the infusion solution. Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely. Shaking or rapid movement should be avoided as it may cause foaming.

Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if particles are present or the solution is cloudy.

Preparation of the infusion solution

For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/mL (0.9%) solution for injection. The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL. See example calculations in Table 1.

Gently invert the bag to mix the solution.

Table 1 Example calculations for weights ranging from 40 kg to 200 kg1

Patient weight (kg)	Total Dose (mg)	Number of vials to reconstitute	Total volume to be diluted (mL)	Recommended infusion bag size
40	40	1	4	100 mL
60	60	2	6	250 mL
80	80	2	8	250 mL
100	100	2	10	250 mL
150	150	3	15	500 mL
200	200	4	20	500 mL

1The exact dose needs to be calculated based on the specific patient weight.

For patients weighing > 40 kg – 49 kg :

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

For patients weighing 50 kg – 100 kg :

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

For patients weighing >100 kg :

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

Infusion

The infusion solution should be inspected visually for particulate matter prior to administration. Reconstituted and diluted solutions containing visible particles or that are cloudy in appearance should be discarded.

Following dilution, Xerava is administered intravenously over approximately 1 hour. The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.

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

For single use only, any unused solution should be discarded.

Package leaflet: Information for the patient

Xerava 100 mg powder for concentrate for solution for infusion eravacycline

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Xerava is and what it is used for

• 2. What you need to know before you are given Xerava

• 3. How you will be given Xerava

• 4. Possible side effects

• 5. How to store Xerava

• 6. Contents of the pack and other information

1. What Xerava is and what it is used for

What Xerava is

Xerava is an antibiotic medicine that contains the active substance eravacycline. It belongs to a group of antibiotics called ‘tetracyclines’ which work by stopping the growth of certain infectious bacteria.

What Xerava is used for

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

2. What you need to know before you are given Xerava

You must not receive Xerava:

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

• - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because

you may also be allergic to eravacycline.

Warnings and precautions

Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:

Anaphylactic reactions

Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics. These can develop suddenly and can potentially be life-threatening. Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava. Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).

Diarrhoea

Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava. If you develop diarrhoea during or after your treatment, tell your doctor straight away. Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).

Infusion site reactions

Xerava is given by an infusion (drip) directly into your vein. Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.

New infection

Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow. This is called ‘overgrowth’ or ‘superinfection’. Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.

Pancreatitis

Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas. Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.

Liver problems

Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations. Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.

Other medicines and Xerava

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John’s Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. Xerava is not recommended for use during pregnancy as it can:

• permanently stain your unborn child’s teeth
• delay the natural formation of the bones of your unborn child.

It is not known if Xerava passes into breast milk. Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child’s teeth permanently. Ask your doctor for advice before breast-feeding your baby.

Driving and using machines

Xerava may affect your ability to drive or use machines safely. Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.

3. How you will be given Xerava

Xerava will be given to you by a doctor or nurse.

The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.

Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John’s Wort.

It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.

A course of treatment usually lasts for 4 to 14 days. Your doctor will decide how long you should be treated for.

If you are given more Xerava than you should

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will be given too much. Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.

If you miss a dose of Xerava

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will miss a dose. Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:

• Rash
• Swelling of the face
• Feeling lightheaded or faint
• Tightness of the chest
• Breathing difficulties
• Fast heartbeat
• Losing consciousness

Tell your doctor or nurse straightaway if you develop diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Other side effects may include:

Common side effects (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 causing pain and swelling (phlebitis)
• Redness or swelling at the site of the injection

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

• Diarrhoea
• Allergic reaction
• Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
• Rash
• Dizziness
• Headache
• Increased sweating
• Abnormal blood test results for liver

Tell your doctor or nurse if you have any of these side effects.

Other tetracycline antibiotics

Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline. These include sensitivity to light, headaches, vision problems, or abnormal blood tests. Tell your doctor or nurse if you notice any of these during your treatment with Xerava.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xerava

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

Do not use this medicine after the expiry date which is stated on the vial label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C-8°C). Keep the vial in the carton in order to protect from light.

Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately. If not, it may be stored at room temperature and used within 12 hours.

Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if it appears to contain any particles or the solution is cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Xerava contains

• – The active substance is eravacycline. Each vial contains 100 mg of eravacycline.

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

What Xerava looks like and contents of the pack

Xerava is a pale yellow to dark yellow cake 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 for injections. The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.

Xerava is available in packs containing 1 vial or multipacks comprising 12 cartons, each containing 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PAION Deutschland GmbH

HeussstraBe 25

52078 Aachen

Germany

Manufacturer

Patheon Italia S.p.A.

2° Trav. SX. Via Morolense, 5

03013 Ferentino (FR)

Italy

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: http : // . europa.eu.

The following information is intended for healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.

Xerava must not be mixed with other medicinal products. If the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/mL (0.9%) solution for injection.

The dose should be calculated based on the patient’s weight; 1 mg/kg body weight.

Instructions for reconstitution

Aseptic technique must be followed when preparing the infusion solution. Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely. Shaking or rapid movement should be avoided as it may cause foaming.

Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if particles are present or the solution is cloudy.

Preparation of the infusion solution

For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/mL (0.9%) solution for injection. The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL. See example calculations in Table 1.

Gently invert the bag to mix the solution.

Table 1 Example calculations for weights ranging from 40 kg to 200 kg1

Patient weight (kg)	Total Dose (mg)	Number of vials to reconstitute	Total volume to be diluted (mL)	Recommended infusion bag size
40	40	1	4	100 mL
60	60	2	6	250 mL
80	80	2	8	250 mL
100	100	2	10	250 mL
150	150	3	15	500 mL
200	200	4	20	500 mL

1The exact dose needs to be calculated based on the specific patient weight.

For patients weighing > 40 kg – 49 kg :

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

For patients weighing 50 kg – 100 kg :

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

For patients weighing >100 kg :

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

Infusion

The infusion solution should be inspected visually for particulate matter prior to administration. Reconstituted and diluted solutions containing visible particles or that are cloudy in appearance should be discarded.

Following dilution, Xerava is administered intravenously over approximately 1 hour. The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.

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

For single use only, any unused solution should be discarded.

Package leaflet: Information for the patient

Xerava 100 mg powder for concentrate for solution for infusion eravacycline

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Xerava is and what it is used for

• 2. What you need to know before you are given Xerava

• 3. How you will be given Xerava

• 4. Possible side effects

• 5. How to store Xerava

• 6. Contents of the pack and other information

1. What Xerava is and what it is used for

What Xerava is

Xerava is an antibiotic medicine that contains the active substance eravacycline. It belongs to a group of antibiotics called ‘tetracyclines’ which work by stopping the growth of certain infectious bacteria.

What Xerava is used for

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

2. What you need to know before you are given Xerava

You must not receive Xerava:

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

• - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because

you may also be allergic to eravacycline.

Warnings and precautions

Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:

Anaphylactic reactions

Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics. These can develop suddenly and can potentially be life-threatening. Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava. Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).

Diarrhoea

Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava. If you develop diarrhoea during or after your treatment, tell your doctor straight away. Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).

Infusion site reactions

Xerava is given by an infusion (drip) directly into your vein. Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.

New infection

Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow. This is called ‘overgrowth’ or ‘superinfection’. Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.

Pancreatitis

Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas. Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.

Liver problems

Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations. Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.

Other medicines and Xerava

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John’s Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. Xerava is not recommended for use during pregnancy as it can:

• permanently stain your unborn child’s teeth
• delay the natural formation of the bones of your unborn child.

It is not known if Xerava passes into breast milk. Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child’s teeth permanently. Ask your doctor for advice before breast-feeding your baby.

Driving and using machines

Xerava may affect your ability to drive or use machines safely. Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.

3. How you will be given Xerava

Xerava will be given to you by a doctor or nurse.

The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.

Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John’s Wort.

It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.

A course of treatment usually lasts for 4 to 14 days. Your doctor will decide how long you should be treated for.

If you are given more Xerava than you should

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will be given too much. Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.

If you miss a dose of Xerava

Xerava will be given to you in hospital by a doctor or nurse. It is, therefore, unlikely that you will miss a dose. Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:

• Rash
• Swelling of the face
• Feeling lightheaded or faint
• Tightness of the chest
• Breathing difficulties
• Fast heartbeat
• Losing consciousness

Tell your doctor or nurse straightaway if you develop diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Other side effects may include:

Common side effects (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 causing pain and swelling (phlebitis)
• Redness or swelling at the site of the injection

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

• Diarrhoea
• Allergic reaction
• Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
• Rash
• Dizziness
• Headache
• Increased sweating
• Abnormal blood test results for liver

Tell your doctor or nurse if you have any of these side effects.

Other tetracycline antibiotics

Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline. These include sensitivity to light, headaches, vision problems, or abnormal blood tests. Tell your doctor or nurse if you notice any of these during your treatment with Xerava.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xerava

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

Do not use this medicine after the expiry date which is stated on the vial label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C-8°C). Keep the vial in the carton in order to protect from light.

Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately. If not, it may be stored at room temperature and used within 12 hours.

Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if it appears to contain any particles or the solution is cloudy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Xerava contains

• – The active substance is eravacycline. Each vial contains 100 mg of eravacycline.

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