TARGOCID 200mg POWDER FOR SOLUTION FOR INJECTIONINFUSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TEICOPLANIN

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

J01XA02

Dosage:

200 mg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

TEICOPLANIN 200 mg/vial

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

SANOFI S.P.A

Authorization status:

ACTIVE

Authorization date:

1990-09-29

Patient Information leaflet

TARGOCID 200MG Each vial provides 200mg teicoplanin
presented as a lyophilisate for reconstitution. Each pack
contains an ampoule of diluent. (Water for Injections
Ph.Eur).
TARGOCID 400MG Each vial provides 400 mg teicoplanin
presented as a lyophilisate for reconstitution. Each pack
contains an ampoule of diluent. (Water for Injections
Ph.Eur).
The vials do not contain any preservative.
USES
PROPERTIES
Teicoplanin is a bactericidal, glycopeptide antibiotic,
produced by fermentation of _Actinoplanes teicomyceticus_. It
is active against both aerobic and anaerobic Gram-positive
bacteria.
SPECIES USUALLY SENSITIVE
_Staphylococcus aureus _and coagulase negative staphylococci
(sensitive or resistant to methicillin), streptococci,
enterococci, 
_Listeria monocytogenes_, micrococci, , group  _JK_
_corynebacteria _and Gram-positive anaerobes including
_Clostriduim difficile_, and peptococci.
SPECIES USUALLY RESISTANT
_Nocardia asteroides_, lactobacillus sp, leuconostoc and all
Gram-negative bacteria.
Bactericidal synergy has been demonstrated 
_in vitro _with
aminoglycosides against group D streptococci and
staphylococci.  _In vitro _combinations of teicoplanin with
rifampicin or fluorinated quinolones show primarily
additive effects and sometimes synergy.
One step resistance to teicoplanin could not be obtained 
_in_
_vitro _and multi-step resistance was only reached _in vitro_
after 11-14 passages.
Teicoplanin does not show cross-resistance with other
classes of antibiotics.
SUSCEPTIBILITY TESTING
Sensidiscs are charged with 30 micrograms of teicoplanin.
Strains showing an inhibition zone diameter of 14 mm or
more are susceptible, and those of 10mm or less are
resistant.
INDICATIONS
Targocid is indicated in potentially serious Gram-positive
infections including those which cannot be treated with
other antimicrobial drugs,
eg
penicillins and
cephalosporins.
Targocid is useful in the therapy of serious staphylococcal
infections in patients who cannot receive or who have
failed to respond

Summary of Product characteristics

TARGOCID
® INJECTION
TEICOPLANIN
[sanofi logo]
NAME OF THE MEDICINAL PRODUCT
Targocid 200mg powder for solution for injection/infusion or oral
solution
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
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Targocid is indicated in
adults and in children from birth for the parenteral
treatment of the following infections:
-
Infective endocarditis
-
bacteraemia that occurs in association with any of the indications
listed,
sepsis/ septicaemia
-
joint and bone infections
-
lower respiratory tract infections (pneumonia)
-
Skin and soft tissue infections
-
Complicated urinary tract infections (urosepsis)
-
peritonitis related to continuous ambulatory peritoneal dialysis
(CAPD)
Targocid
is
also
indicated
in
adults
as
an
alternative
oral
treatment
for
_Clostridium difficile_ infection associated diarrhoea and colitis
(CDAD).
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.
POSOLOGY AND METHOD OF ADMINISTRATION (PARENTERAL USE)
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 that a
minimum
trough serum concentration has been reached:

For most Gram-positive infections, teicoplanin trough levels of at
least 10
mg/L when measured by High Performance Liquid Chromatography (HPLC),
or
at
least
15
mg/L
when
measured
by
Fluorescence
Polarization
Immunoassay (FPIA) method.

For endocarditis and other severe infections, teicoplanin trough
levels of
>15 mg/L when measured b