Daptomycin Accordpharma 500 mg powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Daptomycin

Available from:

Accord Healthcare Ireland Ltd.

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:

2020-01-17

Patient Information leaflet

PT/H/2173/001-002/IA/008, ver 00, AUG 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN ACCORDPHARMA 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 Accordpharma is and what it is used for
2.
What you need to know before you are given Daptomycin Accordpharma
3.
How Daptomycin Accordpharma is given
4.
Possible side effects
5.
How to store Daptomycin Accordpharma
6.
Contents of the pack and other information
1.
WHAT DAPTOMYCIN ACCORDPHARMA IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Accordpharma powder for solution
for injection/infusion is
daptomycin. Daptomycin is an antibacterial that can stop the growth of
certain bacteria. Daptomycin
Accordpharma 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 Accordpharma 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
Accordpharma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIV

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00C5WN
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin Accordpharma 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 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.
pH after reconstitution: Between 4.0 to 5.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daptomycin Accordpharma 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
Accordpharma 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 minutes.