Daptomycin Xellia 350 mg powder for solution for injection/infusion

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Daptomycin

متاح من:

Xellia Pharmaceuticals ApS

ATC رمز:

J01XX; J01XX09

INN (الاسم الدولي):

Daptomycin

جرعة:

350 milligram(s)

الشكل الصيدلاني:

Powder for solution for injection/infusion

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Other antibacterials; daptomycin

الوضع إذن:

Not marketed

تاريخ الترخيص:

2017-09-15

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN XELLIA 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, pharmacist 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Daptomycin Xellia is and what it is used for
2.
What you need to know before you are given Daptomycin Xellia
3.
How Daptomycin Xellia is given
4.
Possible side effects
5.
How to store Daptomycin Xellia
6.
Contents of the pack and other information
1.
WHAT DAPTOMYCIN XELLIA IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Xellia powder for solution for
injection/infusion (referred to as
Daptomycin Xellia throughout this leaflet) is daptomycin. Daptomycin
is an antibacterial that can stop
the growth of certain bacteria.
Daptomycin Xellia 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 Xellia 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
Xellia
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN XELLI

خصائص المنتج

Health Products Regulatory Authority
31 January 2022
CRN00CNZJ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin Xellia 350 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient(s) with known effect
Each vial of 350 mg contains approximately 3,2 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 Xellia 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