Imipenem/Cilastatin AptaPharma 500 mg/500 mg powder for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMIPENEM, CILASTATIN

Available from:

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

ATC code:

J01DH51

INN (International Name):

IMIPENEM 500 mg CILASTATIN 500 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

IMIPENEM 500 mg CILASTATIN 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-02-16

Patient Information leaflet

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPENEM/CILASTATIN APTAPHARMA 500 MG/500 MG POWDER FOR SOLUTION FOR
INFUSION
IMIPENEM/CILASTATIN
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 further questions, ask your doctor 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 of pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Imipenem/Cilastatin AptaPharma is and what it is used for
2.
What you need to know before you use Imipenem/Cilastatin AptaPharma
3.
How to use Imipenem/Cilastatin AptaPharma
4.
Possible side effects
5.
How to store Imipenem/Cilastatin AptaPharma
6.
Contents of the pack and other information
1.
WHAT IMIPENEM/CILASTATIN APTAPHARMA IS AND WHAT IT IS USED FOR
Imipenem/Cilastatin AptaPharma belongs to a group of medicines called
carbapenem antibiotics. It kills
a wide range of bacteria (germs) that cause infections in various
parts of the body in adults and children
one year of age and above.
TREATMENT
Your doctor has prescribed Imipenem/Cilastatin AptaPharma because you
have one (or more) of the
following types of infection:
•
Complicated infections in the abdomen
•
Infection affecting the lungs (pneumonia)
•
Infections that you can catch during or after the delivery of your
baby
•
Complicated urinary tract infections
•
Complicated skin and soft tissue infections
Imipenem/Cilastatin AptaPharma may be used in the management of
patients with low white blood cell
counts, who have fever that is suspected to be due to a bacterial
infection.
Imipenem/Cilastatin AptaPharma may be used to treat bacterial
infection of the blood which might be
associated with a type of infection

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatin AptaPharma 500 mg/500 mg powder for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem
and cilastatin sodium
equivalent to 500 mg cilastatin.
Excipient with known effect:
Each vial contains 37,5 mg (1,6 mmol) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imipenem/Cilastatin AptaPharma is indicated for the treatment of the
following infections in
adults and children 1 year of age and above (see sections 4.4 and
5.1):
•
complicated intra-abdominal infections
•
severe pneumonia including hospital and ventilator-associated
pneumonia
•
intra- and post-partum infections
•
complicated urinary tract infections
•
complicated skin and soft-tissue infections
Imipenem/Cilastatin AptaPharma may be used in the management of
neutropenic patients with
fever that is suspected to be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with, any of the infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose recommendations for Imipenem/Cilastatin AptaPharma represent
the quantity of
imipenem/cilastatin to be administered.
The daily dose of Imipenem/Cilastatin AptaPharma should be based on
the type of infection and
given in equally divided doses based on consideration of degree of
susceptibility of the
pathogen(s) and the patient's renal function (see also section 4.4 and
5.1).
PAGE 2 OF 14
Adults and adolescents
For patients with normal renal function (creatinine clearance of
≥
90 ml/min), the recommended
dose regimens are:
500 mg/500 mg every 6 hours OR
1000 mg/1000 mg every 8 ho