Dovprela (previously Pretomanid FGK)

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Pretomanid

Saadav alates:

Mylan IRE Healthcare Limited

ATC kood:

J04

INN (Rahvusvaheline Nimetus):

pretomanid

Terapeutiline rühm:

Antimycobacterials

Terapeutiline ala:

Tuberculosis, Multidrug-Resistant

Näidustused:

Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Toote kokkuvõte:

Revision: 9

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-07-31

Infovoldik

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOVPRELA 200 MG TABLETS
PRETOMANID
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 START TAKING 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, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dovprela is and what it is used for
2.
What you need to know before you take Dovprela
3.
How to take Dovprela
4.
Possible side effects
5.
How to store Dovprela
6.
Contents of the pack and other information
1.
WHAT DOVPRELA IS AND WHAT IT IS USED FOR
Dovprela contains the active substance pretomanid, a type of
antibiotic. Antibiotics are medicines used
to kill bacteria that cause diseases.
Dovprela is used in combination with two other medicines called
linezolid and bedaquiline to treat
tuberculosis that affects the lungs, when the disease has become
resistant to many other antibiotics:
•
extensively drug resistant tuberculosis or
•
treatment-intolerant or multidrug-resistant tuberculosis
It is used in adults 18 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOVPRELA
DO NOT TAKE DOVPRELA
•
if you are allergic to pretomanid, antibiotics of the group called
nitroimidazoles, or any of the
other ingredients of this medicine (listed in section 6)
Since pretomanid must be used in combination with other medicines
against tuberculosis – linezolid
and bedaquiline – please make sure that you

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Dovprela 200 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg pretomanid.
Excipient with known effect
Each tablet contains 294 mg lactose (as monohydrate) and 5 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White to off-white oval tablet debossed with M on one side and P200 on
the other side.
Tablet dimensions: 18 × 9 mm.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dovprela is indicated in combination with bedaquiline and linezolid,
in adults, for the treatment of
pulmonary extensively drug resistant (XDR), or treatment-intolerant or
nonresponsive multidrug-
resistant (MDR) tuberculosis (TB), see sections 4.2, 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
Treatment with pretomanid should be initiated and monitored by a
physician experienced in the
management of multidrug-resistant tuberculosis.
Pretomanid should be administered by directly observed therapy (DOT)
or in accordance with local
practice.
Posology
The recommended dosage is 200 mg (one tablet) pretomanid once daily,
for 26 weeks.
A longer duration of therapy may be considered in patients who have
not responded adequately to
treatment at 26 weeks on a case by case basis (see section 5.1).
Pretomanid should be administered only in combination with bedaquiline
(400 mg once daily for
2 weeks followed by 200 mg 3 times per week [with at least 48 hours
between doses] orally for a total
of 26 weeks) and linezolid (600 mg daily orally for up to 26 weeks).
3
The product information for bedaquiline and linezolid should be
consulted for a