Daptomycin Accordpharma 500mg powder for solution for injection / infusion

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DAPTOMYCIN

Boleh didapati daripada:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Kod ATC:

J01XX09

INN (Nama Antarabangsa):

DAPTOMYCIN 500 mg

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Komposisi:

DAPTOMYCIN 500 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIBACTERIALS FOR SYSTEMIC USE

Ringkasan produk:

Licence number in the source country: NOT APPLICAPABLE

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2019-10-24

Risalah maklumat

Page 1 of 6
PATIENT INFORMATION LEAFLET
CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
Trimethoprim 80mg & Sulfamethoxazole 400mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Co-Trimoxazole Crescent Tablets 80 mg/400 mg are and what they
are used for
2.
What you need to know before you take Co-Trimoxazole Crescent Tablets
80 mg/400 mg
3.
How to take Co-Trimoxazole Crescent Tablets 80 mg/400 mg
4.
Possible side effects
5.
How to store Co-Trimoxazole Crescent Tablets 80 mg/400 mg
6.
Contents of the pack and other information
1.
WHAT CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
ARE AND WHAT THEY ARE USED FOR
Co-trimoxazole belongs to a group of medicines called antibacterials.
These medicines work by
killing bacteria.
Co-trimoxazole is used in adults and children aged 6 years and over
for the:
•
treatment and prevention of lung infections (pneumonia or
_Pneumocystis _
pneumonia (PCP))
caused by the bacteria
_Pneumocystis _
_jirovecii_
•
treatment and prevention of toxoplasmosis (an infectious disease)
•
treatment of nocardiosis (an infectious disease affecting either the
lungs or whole body)
•
treatment of urinary tract infections (bladder or kidney infections)
•
treatment of sudden worsening of chronic bronchitis (long term lung
disease)
•
treatment of acute otitis media (an ear infection).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TRIMOXAZOLE CRESCENT TABLETS
80 MG/400 MG
DO NOT TAKE
CO-TRIMOXAZOLE CRESCENT TABLETS 80 MG/400 MG
IF
YOU:
•
are allergic to trimethoprim, sulfam

Ciri produk

Page 1 of 21
1.
NAME OF THE MEDICINAL PRODUCT
Daptomycin Accordpharma 500 mg powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
.
Daptomycin Accordpharma 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.
pH after reconstitution: Between 4.0 to 5.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daptomycin Accordpharma 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 Accordpharma
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 at
least 30 minutes. There is no
clinical experience in patients with the administration of daptomycin
as an injection over 2 minutes.
This mode o