Zepraxen 500mg powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DAPTOMYCIN

Available from:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC code:

J01XX09

INN (International Name):

DAPTOMYCIN 500 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

DAPTOMYCIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-10-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZEPRAXEN 500 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 Zepraxen is and what it is used for
2. What you need to know before you are given Zepraxen
3. How Zepraxen is given
4. Possible side effects
5. How to store Zepraxen
6. Contents of the pack and other information
1. WHAT ZEPRAXEN IS AND WHAT IT IS USED FOR
The active substance in Zepraxen powder for solution for injection or
infusion is daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain
bacteria. Zepraxen 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.
Zepraxen 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 Zepraxen.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEPRAXEN
YOU SHOULD NOT BE GIVEN ZEPRAXEN
If you are allergic to daptomycin or to sodium hydroxide or to any of
the other ingredients of this
medicine (listed in section 6).
If this a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zepraxen 350 mg powder for solution for injection/infusion
Zepraxen 500 mg powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zepraxen 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.
Zepraxen 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
Zepraxen 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, Zepraxen 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 patient