Daptomycin 500 mg powder for solution for injection/infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Daptomycin

Disponible des:

Reddy Holding GmbH

Codi ATC:

J01XX09

Designació comuna internacional (DCI):

Daptomycin

formulario farmacéutico:

Powder for solution for injection/infusion

Área terapéutica:

daptomycin

Estat d'Autorització:

Not marketed

Data d'autorització:

2024-03-22

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Daptomycin 350 mg Powder for solution for injection/infusion
Daptomycin 500 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 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 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 any of

Fitxa tècnica

Health Products Regulatory Authority
22 March 2024
CRN00C0VZ
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin 500 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin 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
Powder for solution for injection/infusion
A pale 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.
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 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 experience in patients
with the administration of daptomycin as an injection over 2 min