Cubicin
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-12-2022
Karatteristiċi tal-prodott
(SPC)
15-12-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
14-12-2022
Ingredjent attiv:
daptomycin
Disponibbli minn:
Merck Sharp & Dohme B.V.
Kodiċi ATC:
J01XX09
INN (Isem Internazzjonali):
daptomycin
Grupp terapewtiku:
Antibacterials for systemic use,
Żona terapewtika:
Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial
Indikazzjonijiet terapewtiċi:
Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Sommarju tal-prodott:
Revision: 37
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2006-01-19
Fuljett ta 'informazzjoni
1
ANNEX I
SUMMARY OF PRODUCT C
HARA
CTERISTICS
2
1.
NAME OF THE MEDI
CINAL PRODUCT
Cubicin 350
mg powder for
solution for injection or infusion
Cubicin 500 mg
powder for solution for in
jection or infusion
2.
QUALIT
ATIVE AND QUANTITATI
VE COMPOSITION
Cubicin 350 mg powder for solution for i
njection or infusion
Each vial contains 350
mg daptomycin.
One ml provid
es 50
mg of dapt
omycin after reconstitution with 7
ml of sodium chloride 9
mg/ml
(0.9 %) solution.
Cubicin 500
mg powder for so
lution for injection or infusion
Each vial contains 500
mg daptomycin.
One ml provides 5
0
mg of daptomycin after reconstitution w
ith 10 ml of sodium chloride 9 mg/ml
(0.9 %) solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for injection or infusion
A pal
e yellow to light brown lyophili
sed cake or powder.
4.
CLINICAL PARTICUL
ARS
4.1
THERAPEUTIC INDICATIONS
Cubicin is indicated fo
r the treatment of t
he foll
owing infections (see se
ctions 4.4 and 5.1).
-
Adult and paediatric (1 to 17 years of age) patients with c
omplicated skin and soft
-tissue
infections (cSSTI).
-
Adult patients with right-sided infec
tive endocardi
tis (RIE) due to
Staph
ylococcus aureus.
It is
rec
ommended that the decisi
on to use daptomyc
in should t
ake into account t
he antibacterial
susceptibi
lity of the organism and should
be based on expert advice. See sections 4.
4 and 5.1.
-
Adult and paediatric (1
to 17 years of a
ge) patients with Staphylococcus aureus bacteraemia
(SAB).
In adults, use i
n bacteraem
ia should be assoc
iated with RIE or with cSSTI, while in
paediatric patients,
use in bacteraemia should be associated w
ith cSSTI.
Daptomycin is active ag
ainst Gram posit
ive ba
cteria only (see sec
tion 5.
1). In mixed infections
where
Gram negativ
e and/or ce
rtain types of ana
erobic bacteria are suspect
ed, Cubicin should be
co-adminis
tered with appropriate antibacterial agent
(s).
Consideration s
hould be given
to official guidance
on the appropriate u
se of a
ntibacterial agents.
4.
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT C
HARA
CTERISTICS
2
1.
NAME OF THE MEDI
CINAL PRODUCT
Cubicin 350
mg powder for
solution for injection or infusion
Cubicin 500 mg
powder for solution for in
jection or infusion
2.
QUALIT
ATIVE AND QUANTITATI
VE COMPOSITION
Cubicin 350 mg powder for solution for i
njection or infusion
Each vial contains 350
mg daptomycin.
One ml provid
es 50
mg of dapt
omycin after reconstitution with 7
ml of sodium chloride 9
mg/ml
(0.9 %) solution.
Cubicin 500
mg powder for so
lution for injection or infusion
Each vial contains 500
mg daptomycin.
One ml provides 5
0
mg of daptomycin after reconstitution w
ith 10 ml of sodium chloride 9 mg/ml
(0.9 %) solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for injection or infusion
A pal
e yellow to light brown lyophili
sed cake or powder.
4.
CLINICAL PARTICUL
ARS
4.1
THERAPEUTIC INDICATIONS
Cubicin is indicated fo
r the treatment of t
he foll
owing infections (see se
ctions 4.4 and 5.1).
-
Adult and paediatric (1 to 17 years of age) patients with c
omplicated skin and soft
-tissue
infections (cSSTI).
-
Adult patients with right-sided infec
tive endocardi
tis (RIE) due to
Staph
ylococcus aureus.
It is
rec
ommended that the decisi
on to use daptomyc
in should t
ake into account t
he antibacterial
susceptibi
lity of the organism and should
be based on expert advice. See sections 4.
4 and 5.1.
-
Adult and paediatric (1
to 17 years of a
ge) patients with Staphylococcus aureus bacteraemia
(SAB).
In adults, use i
n bacteraem
ia should be assoc
iated with RIE or with cSSTI, while in
paediatric patients,
use in bacteraemia should be associated w
ith cSSTI.
Daptomycin is active ag
ainst Gram posit
ive ba
cteria only (see sec
tion 5.
1). In mixed infections
where
Gram negativ
e and/or ce
rtain types of ana
erobic bacteria are suspect
ed, Cubicin should be
co-adminis
tered with appropriate antibacterial agent
(s).
Consideration s
hould be given
to official guidance
on the appropriate u
se of a
ntibacterial agents.
4.
Aqra d-dokument sħiħ
