Teicoplanine SUN 400 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing

Šalis: Nyderlandai

kalba: olandų

Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Veiklioji medžiaga:

TEICOPLANINE 400 mg/flacon

INN (Tarptautinis Pavadinimas):

TEICOPLANINE 400 mg/flacon

Vaisto forma:

Poeder en oplosmiddel voor oplossing voor injectie, Poeder en oplosmiddel voor oplossing voor infusie

Sudėtis:

NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE

Vartojimo būdas:

Intraveneus gebruik, Intramusculair gebruik, Oraal gebruik

Leidimo data:

1900-01-01

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEICOPLANINE SUN 200 MG, POEDER EN OPLOSMIDDEL VOOR OPLOSSING VOOR
INJECTIE/INFUSIE OF ORALE
OPLOSSING
TEICOPLANINE SUN 400 MG, POEDER EN OPLOSMIDDEL VOOR OPLOSSING VOOR
INJECTIE/INFUSIE OF ORALE
OPLOSSING
teicoplanin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Teicoplanin SUN is and what it is used for
2.
What you need to know before you are given Teicoplanin SUN
3.
How to use Teicoplanin SUN
4.
Possible side effects
5.
How to store Teicoplanin SUN
6.
Contents of the pack and other information
1.
WHAT TEICOPLANIN SUN IS AND WHAT IT IS USED FOR
Teicoplanin SUN is an antibiotic. It contains the active substance
teicoplanin. It works by killing the
bacteria that cause infections in your body.
Teicoplanin SUN 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.
Teicoplanin SUN 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 TEICOPLANIN SUN
DO NOT USE TEICOPLANIN SUN:
-
if you are allergic to teicoplanin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
2
TAL

Prekės savybės

V001
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Teicoplanine SUN 200 mg, poeder en oplosmiddel voor oplossing voor
injectie/infusie of orale
oplossing
Teicoplanine SUN 400 mg, poeder en oplosmiddel voor oplossing voor
injectie/infusie of orale
oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each powder vial contains 200 mg teicoplanin equivalent to not less
than 200,000 IU.
After reconstitution, the solution will contain 200 mg teicoplanin in
3.0 ml.
Each powder vial contains 400 mg teicoplanin equivalent to not less
than 400,000 IU.
After reconstitution, the solution will contain 400 mg teicoplanin in
3.0 ml.
For the full list of excipients, see section 6.1.
Excipient with known effect
This medicinal product contains 9.45 mg sodium per vial, equivalent to
0.5% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion or oral
solution
Powder for solution for injection/infusion or oral solution:
White-ivory spongy lyophilized powder.
Solvent:
Clear, colourless and odourless liquid
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teicoplanin SUN 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.
Teicoplanin SUN 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 MET