Daptomycin Noridem 500 mg Powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Daptomycin

Available from:

Noridem Enterprises Limited

ATC code:

J01XX; J01XX09

INN (International Name):

Daptomycin

Dosage:

500 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Other antibacterials; daptomycin

Authorization status:

Marketed

Authorization date:

2020-08-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN NORIDEM 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
DAPTOMYCIN NORIDEM 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 Noridem
is and what it is used for
2. What you need to know before you are given Daptomycin Noridem
3. How Daptomycin Noridem
is given
4. Possible side effects
5. How to store Daptomycin Noridem
6. Contents of the pack and other information
The name of your medicine is
DAPTOMYCIN NORIDEM 350 MG & 500 MG POWDER FOR
SOLUTION FOR INJECTION/INFUSION
. In the rest of this leaflet the name of the medicine shall be
Daptomycin Noridem.
1. WHAT DAPTOMYCIN NORIDEM IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Noridem is daptomycin. Daptomycin
is an antibacterial
that can stop the growth of certain bacteria. Daptomycin Noridem
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 Noridem
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 prescrib

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2023
CRN00DV6K
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin Noridem 500 mg Powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient with known effect:
_ _
Each vial of 500 mg contains approximately 2.07 – 6.90 mg sodium.
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 Noridem 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 Noridem
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