Sivextro 200mg powder for concentrate for solution for infusion vials

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Tedizolid phosphate

Доступна с:

Merck Sharp & Dohme Ltd

код АТС:

J01XX11

ИНН (Международная Имя):

Tedizolid phosphate

дозировка:

200mg

Фармацевтическая форма:

Powder for solution for infusion

Администрация маршрут:

Intravenous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 05010700; GTIN: 7640167150618

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIVEXTRO
® 200 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
tedizolid phosphate
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 RECEIVING 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 Sivextro is and what it is used for
2.
What you need to know before you are given Sivextro
3.
How you will be given
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 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 ARE GIVEN SIVEXTRO
_ _
DO NOT USE 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 being given 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)
being treated with antibiotics in the past.
-
are allergic to other medicines belonging to the group
“oxazolidinones” (e.g., linezolid,
cycloserine).
-
are taking certain medicines known a

Характеристики продукта

OBJECT 1
SIVEXTRO 200 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 27-Jun-2018 | Merck Sharp &
Dohme Limited
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
Sivextro 200 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains disodium tedizolid phosphate corresponding to 200
mg tedizolid phosphate.
After reconstitution each mL contains 50 mg tedizolid phosphate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
Sivextro is indicated for the treatment of acute bacterial skin and
skin structure infections (ABSSSI) 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
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 one when clinically indicated.
_Recommended dose and duration _
The recommended dosage 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 in patients (see section 4.4).
_Missed dose_
If a dose is missed it should be given to the patient 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 physician should wait
until the next scheduled dose. A double dose should not be given to
compensate for a missed dose.
_Elde