Daptomycin Melita Pharm 350mg Powder for Solution for Injection or Infusion

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

DAPTOMYCIN

Tilgængelig fra:

Melita Pharm, S.L. C/Roma, 6-10, 08023 - Barcelona,, Spain

ATC-kode:

J01XX09

INN (International Name):

DAPTOMYCIN 350 mg

Lægemiddelform:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Sammensætning:

DAPTOMYCIN 350 mg

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Authorised

Autorisation dato:

2017-09-29

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN MELITA PHARM 350 MG POWDER FOR SOLUTION FOR INJECTION OR
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 Melita Pharm is and what it is used for
2. What you need to know before you are given Daptomycin Melita Pharm
3. How Daptomycin Melita Pharm is given
4. Possible side effects
5. How to store Daptomycin Melita Pharm
6. Contents of the pack and other information
1. WHAT DAPTOMYCIN MELITA PHARM IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Melita Pharm powder for solution
for injection or infusion
is daptomycin. Daptomycin is an antibacterial that can stop the growth
of certain bacteria.
Daptomycin Melita Pharm 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.
Daptomycin Melita Pharm 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
bacterium called
_Staphyloccocus aureus_
and to treat infections in the blood caused by the same bacterium when
associated with skin or 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
Melita Pharm.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN MELITA PHARM
YOU SHOULD NOT BE GIVEN DAPTOMYCIN MELITA PHARM
If you are allergic to daptomycin or to sodium hydroxid

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daptomycin Melita Pharm 350 mg powder for solution for injection or
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A pale yellow to light brown lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daptomycin Melita Pharm 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
Melita Pharm 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 30
minutes. There is no
clinical experience in patients with the administration of daptomycin
as an injection over 2
minutes. This mode of administration was only studied in healthy
subjects. However, when
compared with the