TYGACIL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TIGECYCLINE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

J01AA12

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

TIGECYCLINE 50 MG/DOSE

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic group:

TIGECYCLINE

Therapeutic area:

TIGECYCLINE

Therapeutic indications:

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. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.Community-Acquired Bacterial Pneumonia:Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.

Authorization date:

2022-02-28

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
) רשוא
–
61
.
61 ךיראת
10.61.0161
תילגנאב רישכת םש
םושירה רפסמו
TYGACIL 136.43.31352.01
םושירה לעב םש
רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
הז ספוט
טרפמ
ה
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
ונ טסקט
יחכ
שדח טסקט
ADVERSE REACTIONS
…
The following adverse reactions were
reported (<2%) in patients receiving
TYGACIL in clinical studies: _ _
…
_Hemic and Lymphatic System_:
partial thromboplastin time (aPTT),
prolonged prothrombin time (PT),
eosinophilia, increased international
normalized ratio (INR),
thrombocytopenia
….
The following adverse reactions were
reported (<2%) in patients receiving
TYGACIL in clinical studies: _ _
…
_Hemic and Lymphatic System_:
prolonged activated partial
thromboplastin time (aPTT), prolonged
prothrombin time (PT), eosinophilia,
increased international normalized
ratio (INR), thrombocytopenia
USE IN SPECIFIC
POPULATIONS
8.1 PREGNANCY
TERATOGENIC EFFECTS—
PREGNANCY CATEGORY D _[SEE _
_WARNINGS AND PRECAUTIONS (5.6)] _
Tigecycline was not teratogenic in
the rat or rabbit. In preclinical
safety studies,
14
C-labeled
tigecycline crossed the placenta
and was found in fetal tissues,
including fetal bony structures.
The administration of tigecycline
was associated with slight
reductions in fetal weights and an
increased incidence of minor
skeletal anomalies (delays in bone
ossification) at exposures of
5 times and 1 times the human
daily dose based on AUC in rats
and rabbits, respectively
(28 mcg·hr/mL and 6 mcg·hr/mL
at 12 and 4 mg/kg/day).
8.1 PREGNANCY
TERATOGENIC EFFECTS—
PREGNANCY CATEGORY D _[SEE _
_WARNINGS AND PRECAUTIONS (5.6)] _
Tigecycline was no

Summary of Product characteristics

Tygacil LPD CC
0923
3
1
1
2021-0067888
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
pneumoniae (penicillin-susceptible
isolates), including cases with concurrent bacteremi