Invanz

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

ertapenem sodium

Διαθέσιμο από:

Merck Sharp & Dohme B.V.

Φαρμακολογική κατηγορία (ATC):

J01DH03

INN (Διεθνής Όνομα):

ertapenem

Θεραπευτική ομάδα:

Antibacterials for systemic use,

Θεραπευτική περιοχή:

Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial

Θεραπευτικές ενδείξεις:

TreatmentTreatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:intra-abdominal infections;community-acquired pneumonia;acute gynaecological infections;diabetic foot infections of the skin and soft tissue.PreventionInvanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Περίληψη προϊόντος:

Revision: 26

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2002-04-18

Φύλλο οδηγιών χρήσης

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INVANZ 1
g powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUAN
T
ITATIVE COMPOSITION
Each vial contains 1.0
g ertapenem.
Excipient(s)
with known
effect
Each 1.0
g dose contains approximately 6.0
mEq of sodium (approximately 137
mg).
For the
full list of excipients,
see section 6.1.
3.
PHA
RMACEUTICAL FORM
Powder fo
r concentrate for solution for infusion.
White to off-white powder.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
INVANZ is indicated in paediatri
c patients (3
months to 17
years of age
) and in adults for t
he
treatment of the follow
i
ng infections when caused by bacteria kno
wn or very likely to be susceptible
to e
rtapenem and w
hen parenteral therapy is required (see sections
4.4 and 5.1):

Intra-abdo
minal infections

Community acquired pneumonia

Acute gynaecol
ogical infections

Diabetic
foot infections of the skin and soft tiss
ue (see section 4.4)
Prevention
INVANZ is indicated
in adults for the prophylaxis of surgical site infection following
electiv
e
colorectal surgery
(see section 4.4).
Consideration shoul
d be given to official gui
d
ance on the appropriate use of antibacter
ial agents.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
Posology
Treatment
Adults and adolescents (13
to 17 years of age): The
dose of INVANZ is 1
gram (g) given once a day
by the intrave
nous route (
see section
6.6).
Infants and children (3
months to 12 years of age): The dose of INVANZ is 15
mg/kg given tw
ice
daily (not to exceed 1
g/day) by the intravenous route (see section
6.6).
3
Prevention
Adults:
To prevent surgical site infections
following elective colore
ctal surgery
, the recommended
dosage is 1 g administered as a single intravenous d
ose to be comp
leted within 1
hour prior to the
surgical incision.
Paediatric population
The safety and efficacy of INVANZ in children below 3
month
s of age have not yet been
established.
No data are available.
Renal impairment
INVANZ may be us

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INVANZ 1
g powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUAN
T
ITATIVE COMPOSITION
Each vial contains 1.0
g ertapenem.
Excipient(s)
with known
effect
Each 1.0
g dose contains approximately 6.0
mEq of sodium (approximately 137
mg).
For the
full list of excipients,
see section 6.1.
3.
PHA
RMACEUTICAL FORM
Powder fo
r concentrate for solution for infusion.
White to off-white powder.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
INVANZ is indicated in paediatri
c patients (3
months to 17
years of age
) and in adults for t
he
treatment of the follow
i
ng infections when caused by bacteria kno
wn or very likely to be susceptible
to e
rtapenem and w
hen parenteral therapy is required (see sections
4.4 and 5.1):

Intra-abdo
minal infections

Community acquired pneumonia

Acute gynaecol
ogical infections

Diabetic
foot infections of the skin and soft tiss
ue (see section 4.4)
Prevention
INVANZ is indicated
in adults for the prophylaxis of surgical site infection following
electiv
e
colorectal surgery
(see section 4.4).
Consideration shoul
d be given to official gui
d
ance on the appropriate use of antibacter
ial agents.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
Posology
Treatment
Adults and adolescents (13
to 17 years of age): The
dose of INVANZ is 1
gram (g) given once a day
by the intrave
nous route (
see section
6.6).
Infants and children (3
months to 12 years of age): The dose of INVANZ is 15
mg/kg given tw
ice
daily (not to exceed 1
g/day) by the intravenous route (see section
6.6).
3
Prevention
Adults:
To prevent surgical site infections
following elective colore
ctal surgery
, the recommended
dosage is 1 g administered as a single intravenous d
ose to be comp
leted within 1
hour prior to the
surgical incision.
Paediatric population
The safety and efficacy of INVANZ in children below 3
month
s of age have not yet been
established.
No data are available.
Renal impairment
INVANZ may be us