Ertapenem SUN

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

ertapenem sodium

Tilgængelig fra:

SUN Pharmaceutical Industries (Europe) B.V.

INN (International Name):

ertapenem

Terapeutisk gruppe:

ertapenem

Terapeutisk område:

Bacterial Infections

Terapeutiske indikationer:

TreatmentErtapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):- Intra-abdominal infections- Community acquired pneumonia- Acute gynaecological infections- Diabetic foot infections of the skin and soft tissue (see section 4.4)PreventionErtapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Autorisation status:

Authorised

Autorisation dato:

2022-07-15

Indlægsseddel

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERTAPENEM SUN 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ertapenem
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, nurse or
pharmacist.
-
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, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ertapenem SUN is and what it is used for
2.
What you need to know before you are given Ertapenem SUN
3.
How to use Ertapenem SUN
4.
Possible side effects
5.
How to store Ertapenem SUN
6.
Contents of the pack and other information
1.
WHAT ERTAPENEM SUN IS AND WHAT IT IS USED FOR
Ertapenem SUN contains ertapenem which is an antibiotic of the
beta-lactam group. It has the ability
to kill a wide range of bacteria (germs) that cause infections in
various parts of the body.
Ertapenem SUN can be given to persons 3 months of age and older.
Treatment:
Your doctor has prescribed Ertapenem SUN because you or your child has
one (or more) of the
following types of infection:

Infection in the abdomen

Infection affecting the lungs (pneumonia)

Gynaecological infections

Skin infections of the foot in diabetic patients.
Prevention:

Prevention of surgical site infections in adults following surgery of
the colon or rectum.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ERTAPENEM SUN
DO NOT USE ERTAPENEM SUN
-
if you are allergic to the active substance (ertapenem) or any of the
other ingredients of this
medicine (listed in section 6)
-
if you are allergic to antibiotics such as penicillins, cephalosporins
or carbapenems (which are
used to treat various infections).
WARNINGS AND PRECAUTIONS
Talk to

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ertapenem SUN 1 g powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g ertapenem.
After reconstitution, the vial contains concentrate of approximately
100 mg/ml.
Excipient(s) with known effect
Each 1 g dose contains approximately 6.87 mEq of sodium (approximately
158 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion. Off-white to pale
yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
Ertapenem SUN is indicated in paediatric patients (3 months to 17
years of age) and in adults for the
treatment of the following infections when caused by bacteria known or
very likely to be susceptible
to ertapenem and when parenteral therapy is required (see sections 4.4
and 5.1):

Intra-abdominal infections

Community acquired pneumonia

Acute gynaecological infections

Diabetic foot infections of the skin and soft tissue (see section 4.4)
Prevention
Ertapenem SUN is indicated in adults for the prophylaxis of surgical
site infection following elective
colorectal surgery (see section 4.4).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Intravenous use.
_Treatment_
_Adults and adolescents (13 to 17 years of age)_
: The dose of Ertapenem SUN is 1 gram (g) given once
a day, see section 6.6.
_Infants and children (3 months to 12 years of age)_
: The dose of Ertapenem SUN is 15 mg/kg given
twice daily (not to exceed 1 g/day), see section 6.6.
3
_Prevention_
_Adults: _
To prevent surgical site infections following elective colorectal
surgery, the recommended
dose is 1 g administered as a single intravenous dose to be completed
within 1 hour prior to the
surgical incision.
_Paediatric population _
The safety and efficacy of Ertapenem SUN in children below 3 months of
age have not yet