SIVEXTRO FILM-COATED TABLET 200MG

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

TEDIZOLID PHOSPHATE

제공처:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Name):

TEDIZOLID PHOSPHATE

패키지 단위:

6tablet Tablets

Manufactured by:

Patheon Inc

환자 정보 전단

SIVEXTRO
Film-
coated tablet 200mg
Tedizolid phosphate (200mg
)
1
CONSUMER
MEDICATION INFORMATION LEAFLET (RIMUP)
WHAT IS IN THIS LEAFLET
1.
What Sivextro is used for
2.
How Sivextro works
3.
Before you use
Sivextro
4.
How to use Sivextro
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Sivextro
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SIVEXTRO IS USED FOR
ACUTE BACTERIAL SKIN AND SKIN STRUCTURE
INFECTIONS (ABSSSI)
also known as
complicated skin and soft tissue
infections (cSSTI) or
complicated skin
and skin structure infections (cSSSI),
caused by susceptible isolates of the
following gram-
positive microorganisms,
in adults (18 years of age or older)
HOW SIVEXTRO WORKS
Sivextro is an antibiotic that contains the
active substance tedi
zolid phosphate.
It
belongs to a group of medicines called
oxazolidinones.
It works by stopping the growth of
certain bacteria
which can cause serious
infections.
It is also effective against
infections that are resistant to other types
of antibiotics i
ncluding methicillin
-
resistant
Staphylococcus aureus
(MRSA).
BEFORE YOU USE 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
Talk to your doctor or pharmacist before
taking Sivextro if you are suffering from
diarrhoea, or have suffered from
diarrhoea whilst taking antibiotics in the
past.
OTHER OXAZOLIDINONES
Talk to your doctor or pharmacist before
taking Sivextro if you are a
llergic to
other oxazolidinones (e.g., linezolid).
DIARRHOEA
Contact your doctor straight away if you
suffer from diarrhoea during or after
your treatment.
Do not take any
medicine to treat your diarrhoea without
first checking with your doctor.
CHILDR
EN AND ADOLESCENTS
This medicine should not be used in
children and adolescents as it has not
been studied enough
in these
populations.
OTHER MEDICINES AND SIVEXTRO
Tell your doctor or pharmacist if

제품 특성 요약

LOCAL PRODUCT CIRCULAR
LPC-MK1986-MF-022021b
SIVEXTRO
FILM-COATED TABLET 200MG
SIVEXTRO
LYOPHILIZED POWDER FOR SOLUTION
FOR INFUSION 200MG PER VIAL
(tedizolid phosphate)
1
INDICATIONS AND USAGE
1.1
Acute Bacterial Skin and Skin Structure Infections
SIVEXTRO is an oxazolidinone-class antibacterial indicated for the
treatment of acute
bacterial skin and skin structure infections (ABSSSI) caused by
susceptible isolates of the
following
Gram-positive
microorganisms:
Staphylococcus
aureus
(including
methicillin-
resistant [MRSA] and methicillin-susceptible [MSSA] isolates),
Streptococcus pyogenes
,
Streptococcus
agalactiae
,
Streptococcus
anginosus
Group
(including
Streptococcus
anginosus
,
Streptococcus intermedius
, and
Streptococcus constellatus
), and
Enterococcus
faecalis
.
1.2
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only
to treat ABSSSI
that are proven or strongly suspected to be caused by susceptible
bacteria. When culture
and susceptibility information are available, they should be
considered in selecting or
modifying antibacterial therapy. In the absence of such data, local
epidemiology and
susceptibility patterns may contribute to the empiric selection of
therapy.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage
The recommended dosage of SIVEXTRO is 200 mg administered once daily
for six (6) days
either orally (with or without food) or as an intravenous (IV)
infusion in patients 18 years of
age or older.
The recommended dosage and administration is described in Table 1.
Table 1
Dosage of SIVEXTRO
Infection
Route
Dosage
Frequency
Infusion
Time
Duration
of
Treatment
Acute
Bacterial
Skin
and
Skin
Structure
Infection
(ABSSSI)
Intravenou
s
200 mg
Once daily
1 hour
6 days
Oral
200 mg
Once daily
Not
Applicable
No dose adjustment is necessary when changing from intravenous to oral
SIVEXTRO.
If patients miss a dose, they should take it as soon as possible
anytime up to 8 hours prior to
their next sch