TYGACIL

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

TIGECYCLINE

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

J01AA12

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensetning:

TIGECYCLINE 50 MG/DOSE

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

WYETH LEDERLE S.R.L, ITALY

Terapeutisk område:

TIGECYCLINE

Indikasjoner:

TYGACIL is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older:Complicated Skin and Skin Structure Infections:Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates ), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis .Complicated Intra-abdominal Infections:Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. angino

Autorisasjon dato:

2018-04-20

Preparatomtale

Tygacil LPD WC 141221
1
2021-0074639
TYGACIL
®
FULL PRESCRIBING INFORMATION
TIGECYCLINE 50 mg
POWDER FOR SOLUTION FOR I.V. INFUSION
WARNING: ALL-CAUSE MORTALITY
AN INCREASE IN ALL-CAUSE MORTALITY HAS BEEN OBSERVED IN A
META-ANALYSIS OF PHASE 3 AND 4 CLINICAL TRIALS
IN TYGACIL-TREATED PATIENTS VERSUS COMPARATOR. THE CAUSE OF THIS
MORTALITY RISK DIFFERENCE OF 0.6%
(95% CI 0.1, 1.2) HAS NOT BEEN ESTABLISHED. TYGACIL SHOULD BE RESERVED
FOR USE IN SITUATIONS WHEN
ALTERNATIVE TREATMENTS ARE NOT SUITABLE _[SEE INDICATIONS AND USAGE
(1.4), WARNINGS AND PRECAUTIONS (5.1, _
_5.2) AND ADVERSE REACTIONS (6.1)]. _
1 INDICATIONS AND USAGE
TYGACIL is indicated for the treatment of infections caused by
susceptible strains of the designated
microorganisms in the conditions listed below for patients 18 years of
age and older:
_1.1 COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS _
_ _
Complicated skin and skin structure infections caused by
_Escherichia coli, Enterococcus faecalis_
(vancomycin-susceptible isolates),
_Staphylococcus aureus_
(methicillin-susceptible and -resistant isolates),
_Streptococcus agalactiae_
,
_Streptococcus anginosus_
grp. (includes
_S. anginosus, S. intermedius,_
and
_S. _
_constellatus_
),
_Streptococcus pyogenes_
,
_Enterobacter cloacae_
,
_Klebsiella pneumoniae_
, and
_Bacteroides _
_fragilis_
.
_1.2 COMPLICATED INTRA-ABDOMINAL INFECTIONS _
Complicated intra-abdominal infections caused by
_Citrobacter freundii_
,
_Enterobacter cloacae_
,
_Escherichia _
_coli_
,
_Klebsiella oxytoca_
,
_Klebsiella pneumoniae_
,
_Enterococcus faecalis_
(vancomycin-susceptible isolates),
_Staphylococcus aureus_
(methicillin-susceptible and -resistant isolates),
_Streptococcus anginosus_
grp.
(includes
_S. anginosus, S. intermedius,_
and
_S. constellatus_
),
_Bacteroides fragilis, Bacteroides _
_thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus,
Clostridium perfringens,_
and
_Peptostreptococcus micros_
.
_1.3 COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA _
Community-acquired bacterial pneumonia caused by
_Streptococcus