Teicoplanin Hikma 400mg Powder for solution for injection/infusion or oral solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Teicoplanin

Διαθέσιμο από:

Hikma Farmacêutica (Portugal) S.A.

Φαρμακολογική κατηγορία (ATC):

J01XA; J01XA02

INN (Διεθνής Όνομα):

Teicoplanin

Δοσολογία:

400 milligram(s)

Φαρμακοτεχνική μορφή:

Powder for solution for injection/infusion

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Glycopeptide antibacterials; teicoplanin

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2018-04-06

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
TEICOPLANIN HIKMA 200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR
ORAL SOLUTION
TEICOPLANIN HIKMA 400 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR
ORAL SOLUTION
Teicoplanin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Hikma is and what it is used for
2. What you need to know before you
take Teicoplanin Hikma
3. How to take Teicoplanin Hikma
4. Possible side effects
5. How to store Teicoplanin Hikma
6. Contents of the pack and other information
1.
WHAT TEICOPLANIN HIKMA IS AND WHAT IT IS USED FOR
Teicoplanin Hikma is an antibiotic. It contains a medicine called
‘teicoplanin’. It works by
killing the bacteria that
cause infections in your body.
Teicoplanin Hikma 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 Hikma can be used to treat some infections caused by ‘
_Clostridioides difficile_
’
bacteria in the gut. For this,
the solution is taken by mouth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEICOPLANIN HIKMA
DO NOT TAKE TEICOPLANIN HIKMA:
•
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 taking Teicoplanin
Hikma:
•
if you are allergic to an antibiotic called ‘vancomycin’
•
if

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
14 December 2022
CRN00D7D5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teicoplanin Hikma 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.
After reconstitution, the solutions will contain 200 mg of teicoplanin
in 3.0 ml and 400 mg in 3.0 ml.
Excipient(s) with known effect: 10 mg of sodium per vial
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for Injection/infusion or oral solution.
White to yellowish lyophilized powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teicoplanin Hikma 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 Hikma is also indicated as an alternative oral treatment
for _Clostridioides 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 concentrations should be monitored at steady
state after completion of the loading dose regimen in
order to ensure th