Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xerava

Document Subject

Generated Narrative: MedicinalProductDefinition mpb6aaef38fe85ec54174ec8e0149fcca6

identifier: http://ema.europa.eu/identifier/EU/1/18/1312/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xerava 50 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b6aaef38fe85ec54174ec8e0149fcca6

identifier: http://ema.europa.eu/identifier/EU/1/18/1312/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xerava

Attesters

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

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.

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 Xerava fights 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 or breast-feeding, 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.

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.

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 (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 (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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

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
Heussstra e 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 local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Viatris bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva
PAION Deutschland GmbH
Tel: + 49 800 4453 4
PAION Deutschland GmbH
Te .: + 49 800 4453 4Luxembourg/Luxemburg
PAION Deutschland GmbH
T l/Tel: + 49 800 4453 4 esk republika PAION Deutschland GmbH
Tel: + 49 800 4453 4453<{e-mail}> Magyarorsz g
PAION Deutschland GmbH
Tel.: + 49 800 4453 4Danmark
PAION Deutschland GmbH
Tlf: + 49 800 4453 4Malta PAION Deutschland GmbH
Tel: + 49 800 4453 4Deutschland PAION Deutschland GmbH
Tel: + 49 800 4453 4Nederland PAION Deutschland GmbH
Tel: + 49 800 4453 4Eesti PAION Deutschland GmbH
Tel: + 49 800 4453 4Norge PAION Deutschland GmbH
Tlf: + 49 800 4453 4
Viatris Hellas Ltd : +30 210 0100 sterreich PAION Deutschland GmbH
Tel: + 49 800 4453 4Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal PAION Deutschland GmbH
Tel: + 49 800 4453 4Hrvatska
PAION Deutschland GmbH
Tel: + 49 800 4453 4Rom nia BGP Products SRL Tel: +40 372 579 Ireland
Slovenija PAION Deutschland GmbH
Tel: + 49 800 4453 4PAION Deutschland GmbH
Tel: + 49 800 4453 4 sland PAION Deutschland GmbH
S mi: + 49 800 4453 4Slovensk republika
PAION Deutschland GmbH
Tel: + 49 800 4453 4Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland PAION Deutschland GmbH
Puh/Tel: + 49 800 4453 4
PAION Deutschland GmbH
: + 49 800 4453 4Sverige PAION Deutschland GmbH
Tel: + 49 800 4453 4Latvija
PAION Deutschland GmbH
Tel: + 49 800 4453 4United Kingdom (Northern Ireland) PAION Deutschland GmbH
Tel: + 49 800 4453 4This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site: