DAPTOMYCIN CLONMEL

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

DAPTOMYCIN

זמין מ:

Clonmel Healthcare Ltd

קוד ATC:

J01XX09

INN (שם בינלאומי):

DAPTOMYCIN

כמות:

500 Milligram

טופס פרצבטיות:

Pdr for Soln Inj/Inf

סוג מרשם:

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

איזור תרפויטי:

daptomycin

מצב אישור:

Not Marketed

תאריך אישור:

2017-07-14

עלון מידע

What is in this leaflet
1. What Daptomycin Clonmel is and what it is
used for
2. What you need to know before you are given
Daptomycin Clonmel
3. How Daptomycin Clonmel is given
4. Possible side effects
5. How to store Daptomycin Clonmel
6. Contents of the pack and other information
1. What Daptomycin Clonmel is and what it is
used for
The
active
substance
in
Daptomycin
Clonmel
powder
for
solution for injection or infusion is daptomycin. Daptomycin is
an antibiotic that can stop the growth of certain bacteria.
What is it used for?
Daptomycin Clonmel 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 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
_Staphylococcus 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
antibiotics
while
you
are
receiving treatment with Daptomycin Clonmel.
2. What you need to know before you are given
Daptomycin Clonmel
You must not be given Daptomycin Clonmel
•
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 applies to you, tell your doctor or nurse. If you think you
may be allergic, ask your doctor or nurse for advice.
Warnings and precautions
Talk to your doctor or nurse before you are given Daptomycin
Clonmel:
• if you have, or have previously had kidney problems. Your
doctor may need to change the dose of Daptomycin Clonmel
(see section 3 of this leaflet)
• occasionally,
patients
receiving
Daptomycin
Clonmel
may
develop
tender
or
aching
muscles
or
muscle
weakness
(see section 4 of this leaflet for more information). If this
happens tell your doctor. Your doctor will make sure you have
a blood test and will advise whether or not to conti

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daptomycin Clonmel 500 mg powder for solution for Injection or
Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin Clonmel 500 mg Powder for solution for infusion or
injection: Each vial contains 500 mg daptomycin.
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially ‘sodium-free’.
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 or infusion
A pale yellow to light brown lyophilised cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daptomycin Clonmel is indicated for the treatment of the following
infections (see sections 4.4 and 5.1).
Adult and paediatric (2 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 patients with_ Staphylococcus aureus_ bacteraemia (SAB) when
associated with RIE or 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
Clonmel 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 same
doses