Daptomycin Dr. Reddys 500 mg powder for solution for injection/infusion

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Beszerezhető a:

Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain

ATC-kód:

J01XX09

INN (nemzetközi neve):

DAPTOMYCIN 500 mg

Gyógyszerészeti forma:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Összetétel:

DAPTOMYCIN 500 mg

Recept típusa:

POM

Terápiás terület:

ANTIBACTERIALS FOR SYSTEMIC USE

Termék összefoglaló:

Licence number in the source country: NOT APPLICAPABLE

Engedélyezési státusz:

Authorised

Engedély dátuma:

2022-08-23

Betegtájékoztató

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN DR. REDDYS 350 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION
DAPTOMYCIN DR. REDDYS 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 DR. REDDYS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN DR. REDDYS
3.
HOW DAPTOMYCIN DR. REDDYS IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DAPTOMYCIN DR. REDDYS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DAPTOMYCIN DR. REDDYS IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Dr. Reddys powder for solution for
injection/infusion is
daptomycin. Daptomycin is an antibacterial that can stop the growth of
certain bacteria. Daptomycin
Dr. Reddys 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 Dr. Reddys 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 Dr.
Reddys.
2. WHAT YOU N

Termékjellemzők

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daptomycin Dr. Reddys 350 mg powder for solution for
injection/infusion
Daptomycin Dr. Reddys 500 mg powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin
Dr.
Reddys
350 mg
powder
for
solution
for
injection/infusion
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.
Daptomycin
Dr.
Reddys
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 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 Dr. Reddys 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 Dr. Reddys should be coadministered with appropriate
antibacterial agent(s).
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Consideration should be given to official guidance on the appropri