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:

Actavis UK 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: 5012617020802

Informace pro uživatele

Imipenem/Cilastatin all strengths powder for solution 1 vial packs PIL
UK
item no: AAAI4227
print proof no: 01
origination date: 16/10/2015
originated by: MB
revision date:
revised by:
dimensions: 240x280
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Profile
2.
3.
date sent:
16/10/2015
supplier: IL/Dobfar Facta
technically app. date: 23/10/2015
min pt size: 7pt
TECHNICAL APPROVAL
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 or
pharmacist.
•
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
•
The full name of this product is Imipenem/Cilastatin
500mg/500mg Powder for Solution for Infusion but
within the leaflet it will be referred to as Imipenem/
Cilastatin powder.
WHAT IS IN THIS LEAFLET:
1
WHAT IMIPENEM/CILASTATIN POWDER IS AND
WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU USE
3
HOW TO USE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT IMIPENEM/CILASTATIN POWDER IS AND
WHAT IT IS USED FOR
Imipenem/Cilastatin powder 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 powder
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
• Complicated urinary tract infections
• Complicated skin and soft tissue infections
Imipenem/C

Charakteristika produktu

OBJECT 1
IMIPENEM/CILASTATIN 500MG/500MG POWDER FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 12-Nov-2014 | Accord-UK Ltd
1. Name of the medicinal product
Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion
2. Qualitative and quantitative composition
Each vial contains 500 mg imipenem (as 530 mg imipenem monohydrate)
and 500 mg cilastatin (as 530
mg cilastatin sodium salt).
Excipient with known effect:
Imipenem/Cilastatin 500mg/500mg powder for solution for infusion
contains 20 mg sodium hydrogen
carbonate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White to almost white or light (pale) yellow powder.
4. Clinical particulars
4.1 Therapeutic indications
Imipenem/Cilastatin 500mg/500mg Powder for Solution for Infusion 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 500mg/500mg Powder for Solution for Infusion 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 500mg/500mg Powder
for Solution for Infusion
represent the quantity of imipenem/cilastatin to be administered.
The daily dose of Imipenem/Cilastatin 500mg/500mg Powder for Solution
for Infusion should be based
on the type and severity of infection, the pathogen(s) isolated, the
patient's renal function and body weight
(s