Cubicin 500mg powder for concentrate for solution for infusion vials

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Daptomycin

זמין מ:

Merck Sharp & Dohme Ltd

קוד ATC:

J01XX09

INN (שם בינלאומי):

Daptomycin

כמות:

500mg

טופס פרצבטיות:

Powder for solution for infusion

מסלול נתינה (של תרופות):

Intravenous

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5037021001803

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CUBICIN® 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 Cubicin is and what it is used for
2.
What you need to know before you are given Cubicin
3.
How Cubicin is given
4.
Possible side effects
5.
How to store Cubicin
6.
Contents of the pack and other information
1.
WHAT CUBICIN IS AND WHAT IT IS USED FOR
The active substance in Cubicin powder for solution for injection or
infusion is daptomycin.
Daptomycin is an antibacterial that can stop the growth of certain
bacteria. Cubicin 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.
Cubicin 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 Cubicin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CUBICIN
YOU SHOULD NOT BE GIVEN CUBICIN
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

מאפייני מוצר

OBJECT 1
CUBICIN 350 MG POWDER FOR SOLUTION FOR INJECTION
OR INFUSION
Summary of Product Characteristics Updated 08-Mar-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Cubicin
®
350 mg powder for solution for injection or infusion
Cubicin
®
500 mg powder for solution for injection or infusion
2. Qualitative and quantitative composition
Cubicin 350 mg powder for solution for injection or 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.
Cubicin 500 mg powder for solution for injection or 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 or infusion
A pale yellow to light brown lyophilised cake or powder.
4. Clinical particulars
4.1 Therapeutic indications
Cubicin 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, Cubicin should be co-
administered with appropriate antibacterial agent(s).
Consideration should be given to o