Daptomycin 350 mg powder for solution for injection/infusion

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Daptomycin

Доступно од:

hameln pharma gmbh

АТЦ код:

J01XX09

INN (Међународно име):

Daptomycin

Фармацеутски облик:

Powder for solution for injection/infusion

Терапеутска област:

daptomycin

Статус ауторизације:

Not marketed

Датум одобрења:

2022-12-09

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
daptomycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 is and what it is used for
2.
What you need to know before you are given Daptomycin
3.
How Daptomycin is given
4.
Possible side effects
5.
How to store Daptomycin
6.
Contents of the pack and other information
1.
WHAT DAPTOMYCIN IS AND WHAT IT IS USED FOR
The active substance in Daptomycin 350 mg powder for solution for
injection/infusion is daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain
bacteria. Daptomycin 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN
YOU SHOULD NOT BE GIVEN DAPTOMYCIN
If you are allergic to daptomycin or to sodium hydroxide or to any of
the other ingredients of this
medicine (listed in

Карактеристике производа

Health Products Regulatory Authority
21 March 2024
CRN00DSWV
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin 350 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin 350 mg powder for solution for injection/infusion
Each vial contains 350 mg daptomycin.
After reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%)
solution, 1 ml of solution contains 50 mg of daptomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
A lyophilized yellow or yellowish powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daptomycin 350 mg powder for solution for injection/infusion 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.
Daptomycin is active against Gram positive bacteria only (see section
5.1). In mixed infections where Gram negative and/or
certain types of anaerobic bacteria are suspected, Daptomycin 350 mg
powder for solution for injection/infusion should be
co-administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Clinical studies in patients employed infusion of daptomycin over at
least 30 minutes. There is no clinical experi