Primaxin IV 500mg powder for solution for infusion monovials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Cilastatin sodium; Imipenem monohydrate

Beszerezhető a:

Organon Pharma (UK) Ltd

ATC-kód:

J01DH51

INN (nemzetközi neve):

Cilastatin sodium; Imipenem monohydrate

Adagolás:

500mg ; 500mg

Gyógyszerészeti forma:

Powder for solution for infusion

Az alkalmazás módja:

Intravenous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 05010202

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIMAXIN
® IV 500MG/500MG 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 PRIMAXIN IV is and what it is used for
2.
What you need to know before you use PRIMAXIN IV
3.
How to use PRIMAXIN IV
4.
Possible side effects
5.
How to store PRIMAXIN IV
6.
Contents of the pack and other information
1.
WHAT PRIMAXIN IV IS AND WHAT IT IS USED FOR
PRIMAXIN IV 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 PRIMAXIN IV 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
PRIMAXIN IV 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.
PRIMAXIN IV 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 PRIMAXIN IV
DO NOT USE PRIMAXIN IV
-
if you are allergic to imipenem, cilastatin or any of the other
ingredients of this medicine
(listed in section 6)
-
if you are

Termékjellemzők

OBJECT 1
PRIMAXIN IV INJECTION
Summary of Product Characteristics Updated 21-Mar-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
PRIMAXIN
®
IV 500 mg/500 mg powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem
anhydrate and cilastatin
sodium equivalent to 500 mg cilastatin.
Excipient with known effect:
Each vial contains sodium bicarbonate equivalent to approximately 1.6
mEq of sodium (approximately
37.6 mg).
For a 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
PRIMAXIN 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
PRIMAXIN 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 PRIMAXIN represent the quantity of
imipenem/cilastatin to be
administered.
The daily dose of PRIMAXIN 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 ≥90
ml/min), the recommended dose
regimens are:
500 mg/500 mg every 6 hours OR
1000 mg/