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

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Cilastatin sodium; Imipenem monohydrate

Dostupné s:

Pfizer Ltd

ATC kód:

J01DH51

INN (Mezinárodní Name):

Cilastatin sodium; Imipenem monohydrate

Dávkování:

500mg ; 500mg

Léková forma:

Powder for solution for infusion

Podání:

Intravenous

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 05010202; GTIN: 0304090013569 0304090013576

Informace pro uživatele

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPENEM/CILASTATIN 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET:
1.
What Imipenem/Cilastatin is and what it is used for
2.
What you need to know before you use Imipenem/Cilastatin
3.
How to use Imipenem/Cilastatin
4.
Possible side effects
5.
How to store Imipenem/Cilastatin
6.
Contents of the pack and other information
1.
WHAT IMIPENEM/CILASTATIN IS AND WHAT IT IS USED FOR
Imipenem/Cilastatin 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 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 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 may be used to treat bacterial infection of the
blood which might be
associated with a type of infection mentioned above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIPENEM/CILASTATIN
DO NOT USE IMIPENEM/CILASTATIN
-
if you are allergic to imip

Charakteristika produktu

OBJECT 1
IMIPENEM/CILASTATIN 500 MG/500 MG POWDER FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 09-Apr-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion
2. Qualitative and quantitative composition
Each vial contains 530 mg of Imipenem monohydrate and 530 mg of
Cilastatin sodium corresponding to
500 mg of Imipenem and 500 mg of Cilastatin.
Excipient(s) with known effect:
Each vial contains 1.6 mmol (37.5 mg) of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
Off white to yellowish white hygroscopic powder.
4. Clinical particulars
4.1 Therapeutic indications
Imipenem/Cilastatin 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 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 represent the
quantity of imipenem/cilastatin to be
administered.
The daily dose of Imipenem/Cilastatin 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).
Adults and adolescents
For patients with normal renal function (creatinine clearance of
≥90ml/min), the recommended dose