Targocid 400mg powder and solvent for solution for injection vials

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Teicoplanin

Доступно од:

Sanofi

АТЦ код:

J01XA02

INN (Међународно име):

Teicoplanin

Дозирање:

400mg

Фармацеутски облик:

Powder and solvent for solution for injection

Пут администрације:

Oral; Intramuscular; Intravenous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 05010700; GTIN: 5015265300159

Информативни летак

IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
▼
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 ARE GIVEN
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.
-
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 Targocid is and what it is used for
2. What you need to know before you are given Targocid
3. How to use Targocid
4. Possible side effects
5. How to store Targocid
6. Contents of the pack and other information
1. WHAT TARGOCID IS AND WHAT IT IS USED FOR
Targocid is an antibiotic. It contains a medicine called
‘teicoplanin’. It works by killing the bacteria that cause
infections in your body.
Targocid is used in adults and children (including newborn
babies) to treat bacterial infections of:
-
the skin and underneath the skin - sometimes called
‘soft tissue’
-
the bones and joints
-
the lung
-
the urinary tract
-
the heart - sometimes called ‘endocarditis’
-
the abdominal wall - peritonitis
-
the blood, when caused by any of the conditions listed
above
Targocid can be used to treat some infections caused by
‘_Clostridium difficile_’ bacteria in the gut. For this, the
solution
is taken by mouth.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN TARGOCID
DO NOT USE TARGOCID IF:
•
you are allergic to teicoplanin or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are
given Targocid if:
•
you are allergic to an antibiotic called ‘vancomycin’
•
you have had a flushing of your upper p

Карактеристике производа

OBJECT 1
TARGOCID 400MG
Summary of Product Characteristics Updated 01-Feb-2018 | SANOFI
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
Targocid 400mg powder for solution for injection/infusion or oral
solution
2. Qualitative and quantitative composition
Each vial contains 400 mg teicoplanin equivalent to not less than
400,000 IU.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection/infusion or oral solution
Powder for solution for injection/infusion or oral solution: spongy
ivory coloured homogeneous mass
4. Clinical particulars
4.1 Therapeutic indications
Targocid is indicated in adults and in children from birth for the
parenteral treatment of the following
infections (see sections 4.2, 4.4 and 5.1):
• complicated skin and soft tissue infections,
• bone and joint infections,
• hospital acquired pneumonia,
• community acquired pneumonia,
• complicated urinary tract infections,
• infective endocarditis,
• peritonitis associated with continuous ambulatory peritoneal
dialysis (CAPD),
• bacteraemia that occurs in association with any of the indications
listed above.
Targocid is also indicated as an alternative oral treatment for
_Clostridium difficile_ infection-associated
diarrhoea and colitis.
Where appropriate, teicoplanin should be administered in combination
with other antibacterial agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dose and duration of treatment should be adjusted according to the
underlying type and severity of
infection and clinical response of the patient, and patient factors
such as age and renal function.
Measurement of serum concentrations
Teicoplanin trough serum concentra