Ertapenem AptaPharma 1g powder for concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ERTAPENEM SODIUM

Available from:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC code:

J01DH03

INN (International Name):

ERTAPENEM SODIUM 1 g

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ERTAPENEM SODIUM 1 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-10-18

Patient Information leaflet

PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERTAPENEM APTAPHARMA 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 AptaPharma is and what it is used for
2.
What you need to know before you are given Ertapenem AptaPharma
3.
How to use Ertapenem AptaPharma
4.
Possible side effects
5.
How to store Ertapenem AptaPharma
6.
Contents of the pack and other information
1.
WHAT ERTAPENEM APTAPHARMA IS AND WHAT IT IS USED FOR
Ertapenem AptaPharma 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 AptaPharma can be given to persons 3 months of age and
older.
Treatment:
Your doctor has prescribed Ertapenem AptaPharma 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 APTAPHARMA
DO NOT USE ERTAPENEM APTAPHARMA
-
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 a

Summary of Product characteristics

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Ertapenem AptaPharma 1 g powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1,0 g ertapenem (as ertapenem sodium).
Excipient with known effect
Each vial contains approximately 6,0 mEq of sodium (approximately 137
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
white to yellowish powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment_
Ertapenem AptaPharma 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 AptaPharma 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
_Treatment_
_Adults and adolescents (13 to 17 years of age)_
: The dose of Ertapenem AptaPharma is 1 gram (g) given
once a day by the intravenous route (see section 6.6).
Page 3 of 19
_Infants and children (3 months to 12 years of age)_
: The dose of Ertapenem AptaPharma is 15 mg/kg
given twice daily (not to exceed 1 g/day) by the intravenous route
(see section 6.6).
_Prevention_
_Adults: _
To prevent surgical site infections following elective colorectal
surgery, the recommended dosage
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 AptaPharma in chi