Teicoplanin AptaPharma 200 mg powder and solvent for solution for injection/infusion

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Saatavilla:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC-koodi:

J01XA02

INN (Kansainvälinen yleisnimi):

TEICOPLANIN 200 mg

Lääkemuoto:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Koostumus:

TEICOPLANIN 200 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIBACTERIALS FOR SYSTEMIC USE

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-03-01

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEICOPLANIN APTAPHARMA 200 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
TEICOPLANIN APTAPHARMA 400 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
teicoplanin
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 Teicoplanin AptaPharma is and what it is used for
2.
What you need to know before you are given Teicoplanin AptaPharma
3.
How to use Teicoplanin AptaPharma
4.
Possible side effects
5.
How to store Teicoplanin AptaPharma
6.
Contents of the pack and other information
1.
WHAT TEICOPLANIN APTAPHARMA IS AND WHAT IT IS USED FOR
Teicoplanin AptaPharma is an antibiotic. It contains a medicine called
‘teicoplanin’. It works by
killing the bacteria that cause infections in your body.
Teicoplanin AptaPharma 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 AptaPharma 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 APTAPHARMA DO NOT USE TEICOPLANIN APTAPHARMA 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
Teicoplanin AptaPharma if:
�

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Teicoplanin AptaPharma 200 mg powder and solvent for solution for
injection/infusion
Teicoplanin AptaPharma 400 mg powder and solvent for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg teicoplanin equivalent to not less than 200
000 IU.
After reconstitution, the solutions will contain 200 mg teicoplanin in
3.0 ml.
Each vial contains 400 mg teicoplanin equivalent to not less than 400
000 IU.
After reconstitution, the solutions will contain 400 mg teicoplanin in
3.0 ml.
Excipient with known effect: sodium
Each vial of Teicoplanin AptaPharma 200 mg powder and solvent for
solution for injection/infusion
contains about 10 mg sodium.
Each vial of Teicoplanin AptaPharma 400 mg powder and solvent for
solution for injection/infusion
contains about 10 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection/infusion
Powder for solution for injection/infusion: spongy white-ivory
coloured lyophilized powder.
Solvent: clear, colourless liquid.
Teicoplanin 200 mg reconstituted solution: slightly brownish,
opalescent solution.
Teicoplanin 400 mg reconstituted solution: brownish, opalescent
solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teicoplanin AptaPharma 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 AptaPharma is also indicated as an alternative oral
treatment for
_Clostridium difficile_
infection-associated diarrhoea and colitis.
Where