Sivextro

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tedizolid phosphate

Available from:

Merck Sharp & Dohme B.V.

ATC code:

J01XX11

INN (International Name):

tedizolid phosphate

Therapeutic group:

Antibacterials for systemic use, , Other antibacterials

Therapeutic area:

Soft Tissue Infections; Skin Diseases, Bacterial

Therapeutic indications:

Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.

Product summary:

Revision: 21

Authorization status:

Authorised

Authorization date:

2015-03-23

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIVEXTRO 200 MG FILM-
COATED TABLETS
tedizolid phosphate
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 yo
ur doctor or pharmacist.
-
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 or pharmacist. This
includes an
y possible side
effec
ts not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
What Sivextro is and what it is used for
2.
What you need to know before you take Sivextro
3.
How to take Sivextro
4.
Possible side effects
5.
How to store
Sivextro
6.
Contents of the pack and other information
1.
WHAT SIVEXTRO
IS AND WHAT IT IS USED FOR
Sivextro
is an antibiotic that contains the active substance
tedizolid phosphate
. It belongs to a group of
medicines called
“
oxazolidinones
”
.
It is used to treat
adults
and adolescents 12
years of age and older
with
infections of the skin and
tissues below the skin.
It works by stopping the growth of certain bacteria which
can cause
serious infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIVEXTRO
DO NOT TAKE
SIVEXTRO
•
if you are allergic to tedizolid phosphate or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Your doctor will have decided if
Sivextro
is suitable to treat your infection.
Talk to your doctor or
nurse
before taking
Sivextro if
any of the following
apply to you
:
-
are
suffering from diarrhoea, or have suffered from diarrhoea whilst
(or up to 2
months after)
taking antibiotics in the past.
-
are
allergic to other
medicines
belonging to
the group “
oxazolidinones
”
(e.g., linezolid,
cycloserine).
-
have a history of bleeding or
easy bruising (which may be a sign of low numbers of platelets,
the sma

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sivextro 200
mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-
coated tablet contains 200
mg
tedizolid phosphate.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Film-
coated tablet
(tablet).
Oval (13.8
mm long by 7.4
mm wide) yellow film
-
coated tablet debossed with “TZD” on the obverse
side and “200” on the
reverse side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sivextro
is indicated
for the treatment of
acute bacterial
skin and skin structure
infections (
ABSSSI) in
adults
and adolescents 12
years of age and older
(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
Tedizolid phosphate
film-
coated tablets or
powder for concentrate for
solution for infusion may be
used as
initial therapy.
Patients who commence treatment on the parenteral formulation may be
switched to the oral presentation when clinically indicated.
Recommended dose and duration
The recommended
dosage
for adults and adolescents 12
years of age and older
is 200
mg once daily
for 6 days.
The safety and efficacy of tedizolid phosphate when administered for
periods longer than 6
days have
not been established
(see section
4.4).
Missed dose
If a dose is missed,
it should be taken as soon as possible anytime up to 8
hours prior to the next
scheduled dose. If less than 8
hours remains before the next dose, then the patient should wait until
the
next scheduled dose.
Patients should not take a double dose to
compensate for a missed dose.
Elderly (
≥65
years)
No dosage adjustment is required (see section
5.2).
The clinical experience in patients ≥75
years is
limited.
H
epatic impairment
No dosage adjustment is required (see section
5.2).
3
Renal
impairment
No dosage adjustment is required (see section
5.2).
Paediatric population
The safety and efficacy of
tedizolid phosphate i