Xerava

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

eravacycline

Available from:

PAION Deutschland GmbH

ATC code:

J01AA

INN (International Name):

eravacycline

Therapeutic group:

Antibacterials for systemic use,

Therapeutic area:

Infection; Bacterial Infections

Therapeutic indications:

Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2018-09-20

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XERAVA 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
eravacycline
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 c

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xerava 50 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg eravacycline.
After reconstitution, each mL contains 10 mg eravacycline.
After further dilution, 1 mL contains 0.3 mg eravacycline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
Pale yellow to dark yellow cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xerava is indicated for the treatment of complicated intra-abdominal
infections (cIAI) in adults (see
sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose regimen is 1 mg/kg eravacycline every 12 hours
for 4 to 14 days.
_Strong CYP3A4 inducers _
In patients co-administered strong CYP3A4 inducers the recommended
dose regimen is 1.5 mg/kg
eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and
4.5).
_ _
_Elderly (≥ 65 years old) _
No dose adjustment is required in elderly patients (see section 5.2).
_ _
_Renal impairment _
No dose adjustment is necessary in patients with renal impairment or
in patients undergoing
haemodialysis. Eravacycline may be administered without regard to the
timing of haemodialysis (see
section 5.2).
_ _
_Hepatic impairment _
No dose adjustment is necessary in patients with hepatic impairment
(see sections 4.4, 4.5 and 5.2).
_ _
_Paediatric population _
The safety and efficacy of Xerava in children and adolescents less
than 18 years of age have not been
established. No data are available. Xerava should not be used in
children aged under 8 years because
of teeth discolouration (see sections 4.4 and 4.6).
3
Method of administration
Intravenous use.
Xerava is administered only by intravenous infusion over approximately
1 hour (see section 4.4).
For instructions on reconstitution