Daptomycin Anfarm 350 mg powder for solution for injection or infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

ATC code:

J01XX09

INN (International Name):

DAPTOMYCIN 50 mg/ml

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

DAPTOMYCIN 50 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-05-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAPTOMYCIN ANFARM 350 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
daptomycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Anfarm is and what it is used for
2.
What you need to know before you are given Daptomycin Anfarm
3.
How Daptomycin Anfarm is given
4.
Possible side effects
5.
How to store Daptomycin Anfarm
6.
Contents of the pack and other information
1.
WHAT DAPTOMYCIN ANFARM IS AND WHAT IT IS USED FOR
The active substance in Daptomycin Anfarm powder for solution for
injection or infusion is
daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain
bacteria. Daptomycin Anfarm 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 Anfarm 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
Anfarm.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DAPTOMYCIN ANFARM
YOU SHOULD NOT BE GIVEN DAPTOMYCIN ANFARM
If you are allergic to daptomycin

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Daptomycin Anfarm 350 mg powder for solution for injection or infusion
Daptomycin Anfarm 500 mg powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin Anfarm 350 mg powder for solution for injection or infusion
Each vial contains 350 mg daptomycin.
After reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%)
solution, 1 ml of solution contains
50 mg of daptomycin.
Daptomycin Anfarm 500 mg powder for solution for injection or infusion
Each vial contains 500 mg daptomycin.
After reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%)
solution, 1 ml of solution contains
50 mg of daptomycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
A lyophilised yellow or yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daptomycin Anfarm 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 Anfarm should
be co-administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate
use of antibacterial