Daptomycin Hospira

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

daptomycin

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

J01XX09

INN (Kansainvälinen yleisnimi):

daptomycin

Terapeuttinen ryhmä:

Antibacterials for systemic use,

Terapeuttinen alue:

Soft Tissue Infections; Skin Diseases, Bacterial

Käyttöaiheet:

Daptomycin 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 isrecommended 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, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-03-22

Pakkausseloste

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN HOSPIRA 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
daptomycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Daptomycin Hospira is and what it is used for
2.
What you need to know before you are given Daptomycin Hospira
3.
How Daptomycin Hospira is given
4.
Possible side effects
5.
How to store Daptomycin Hospira
6.
Contents of the pack and other information
1.
WHAT DAPTOMYCIN HOSPIRA IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Hospira powder for solution for
injection/infusion is daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain
bacteria. Daptomycin Hospira is used in
adults and in children and adolescents (age from 1 to 17 years) to
treat infections of the skin and the
tissues below the skin. It is also used to treat infections in the
blood when associated with skin infection.
Daptomycin Hospira is also used in adults to treat infections in the
tissues that line the inside of the heart
(including heart valves) which are caused by a type of bacteria called
_Staphylococcus aureus._
It is also
used to treat infections in the blood caused by the same type of
bacteria when associated with heart
infection.
Depending on the type of infection(s) that you have, your doctor may
also prescribe other antibacterials
while you are receiving treatment with Daptomycin Hospira.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN HOSPIRA
YOU SHOULD NOT BE GIVEN DAPTOMYCIN HOSPIRA
If

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Daptomycin Hospira 350 mg powder for solution for injection/infusion
Daptomycin Hospira 500 mg powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin Hospira 350 mg powder for solution for injection/infusion
Each vial contains 350 mg daptomycin.
One mL provides 50 mg of daptomycin after reconstitution with 7 mL of
sodium chloride 9 mg/mL
(0.9%) solution for injection.
Daptomycin Hospira 500 mg powder for solution for injection/infusion
Each vial contains 500 mg daptomycin.
One mL provides 50 mg of daptomycin after reconstitution with 10 mL of
sodium chloride 9 mg/mL
(0.9%) solution for injection.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Daptomycin Hospira 350 mg powder for solution for injection/infusion
Powder for solution for injection/infusion.
A light yellow to light brown lyophilised cake or powder.
Daptomycin Hospira 500 mg powder for solution for injection/infusion
Powder for solution for injection/infusion.
A light yellow to light brown lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daptomycin is indicated for the treatment of the following infections
(see sections 4.4 and 5.1).
-
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
(see sections 4.4 and 5.1).
-
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.
3
Daptomycin is active against Gram positive bacteria only (see section
5.1). In mixed infec