Deltyba

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Delamanid

Available from:

Otsuka Novel Products GmbH

ATC code:

J04AK06

INN (International Name):

delamanid

Therapeutic group:

Antimycobacterials

Therapeutic area:

Tuberculosis, Multidrug-Resistant

Therapeutic indications:

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product summary:

Revision: 25

Authorization status:

Authorised

Authorization date:

2014-04-27

Patient Information leaflet

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DELTYBA 50 MG FILM-COATED TABLETS
delamanid
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 Deltyba is and what it is used for
2.
What you need to know before you take Deltyba
3.
How to take Deltyba
4.
Possible side effects
5.
How to store Deltyba
6.
Contents of the pack and other information
1.
WHAT DELTYBA IS AND WHAT IT IS USED FOR
Deltyba contains the active substance delamanid, an antibiotic for the
treatment of tuberculosis in the
lung caused by bacteria that are not killed by the most commonly used
antibiotics to treat tuberculosis.
It must always be taken together with other medicines for treating
tuberculosis.
Deltyba is used in adults, adolescents, children and infants who are
weighing at least 10 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DELTYBA
DO NOT TAKE DELTYBA:
-
if you are allergic to delamanid or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have very low levels of albumin, in the blood.
-
if you are taking medicines that strongly increase the activity of a
certain liver enzyme called
‘CYP450 3A4’ (e.g. carbamazepine [a medicine used to treat
epilepsy and prevent seizures]).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or

Summary of Product characteristics

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
Deltyba 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg delamanid.
Excipient with known effect
Each film-coated tablet contains 100 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Round, yellow, film-coated tablet, 11.7 mm in diameter, debossed with
‘DLM’ and ‘50’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deltyba is indicated for use as part of an appropriate combination
regimen for pulmonary multi-drug
resistant tuberculosis (MDR-TB) in adults, adolescents, children and
infants with a body weight of at
least 10 kg when an effective treatment regimen cannot otherwise be
composed for reasons of
resistance or tolerability (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 delamanid should be initiated and monitored by a
physician experienced in the
management of multidrug-resistant
_Mycobacterium tuberculosis_
.
Delamanid must always be administered as part of an appropriate
combination regimen for the
treatment of multidrug-resistant tuberculosis (MDR-TB) (see sections
4.4 and 5.1). Treatment with an
appropriate combination regimen should continue after completion of
the 24-week delamanid
treatment period according to WHO guidelines.
It is recommended that delamanid is administered by directly observed
therapy (DOT).
Posology
_Adults _
The recommended dose for adults is 100 mg twice daily for 24 weeks.
_Adolescents and children _
Paediatric patients with a body weight of
3
-
≥