Riidor powder for solution for injection/infusion

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

cefepime (cefepime dihydrochloride monohydrate)

Tillgänglig från:

AbiPharm LLC

ATC-kod:

J01DE01 վերարտադրված դեղ

INN (International namn):

cefepime (cefepime dihydrochloride monohydrate)

Dos:

1000mg

Läkemedelsform:

powder for solution for injection/infusion

Enheter i paketet:

(1) glass vial

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2019-08-08

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIIDOR
®
(CEFEPIME HYDROCHLORIDE POWDER FOR SOLUTION FOR INJECTION OR INFUSION
1G)
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 gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET?
1.
WHAT RIIDOR
® IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RIIDOR
®
3.
HOW RIIDOR
® IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE RIIDOR
®
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT RIIDOR
® IS AND WHAT IT IS USED FOR
A fourth generation cephalosporin that binds to bacterial cell
membranes and inhibits cell
wall synthesis; Therapeutic Effect: Bactericidal.
Riidor
®
is indicated in the treatment of the following infections Cefepime
susceptible
organisms:

SEVERE AND COMPLICATED URINARY TRACT INFECTIONS (including those
associated
with pyelonephritis).
SEVERE PNEUMONIA including cases associated with concurrent bacteremia
due to
susceptible strains.

SEVERE SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus
aureus
(methicillin-susceptible strains only) or Streptococcus pyogenes.

COMPLICATED
INTRA-ABDOMINAL
INFECTIONS
(used
in
combination
with
metronidazole)
caused
by
Escherichia
coli,
viridans
group
streptococci,
Pseudomonas
aeruginosa,
Klebsiella
pneumoniae,
Enterobacter
species,
or
Bacteroides fragilis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RIIDOR
®
_ _
_YOU MUST NOT BE GIVEN RIIDOR_
®
_ IF: _
You are allergic to any ingredient in Cefepime or to another
cephalosporin antibiotic (eg,
Cephalexin)
You have had a severe allergic reaction to a penicillin antibi

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RIIDOR
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefepime Hydrochloride (equivalent to Cefepime 1.0 g)
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Riidor
®
is indicated in the treatment of the following infections cefepime
susceptible
organisms:

Severe
and
Complicated
Urinary
Tract
Infections
(including
those
associated
with
pyelonephritis).

Severe pneumonia including cases associated with concurrent bacteremia
due to
susceptible strains.

Severe
Skin
and
Skin
Structure
Infections
caused
by
Staphylococcus
aureus
(methicillin-susceptible strains only) or Streptococcus pyogenes.

Complicated Intra-abdominal Infections (used in combination with
metronidazole) caused
by Escherichia coli, viridans group streptococci, Pseudomonas
aeruginosa, Klebsiella
pneumoniae, Enterobacter species, or Bacteroides fragilis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended adult and pediatric dosages and routes of
administration are outlined in the
following table Riidor
®
should be administered intravenously over approximately 30 minutes.
Before
administration
ensure
that
the
powder
has
been
fully
dissolved
in
the
solution.
Administration duration should be within 10 days.
ADULTS
INDICATION
DOSE
FREQUENCY
Pneumonia (moderate to severe)
1-2 g, IV
Every 12h
Uncomplicated and complicated Urinary Tract Infection
Mild to moderate
Every 12h
Uncomplicated and complicated skin and skin structure
Tract infection
2 g, IV
Every 12h
Complicated Intra-abdominal Infections
2 g, IV
Every 12h
-
including cases associated with concurrent bacteremia or until
resolution of neutropenia. In
patients whose fever resolves but who remain neutropenic for more than
7 days, the need
2
for continued antimicrobial therapy should be re-evaluated frequently.
-
IM route of administration is indicated only for mild to moderate,
uncomplicated or
complicated UTIs due to E. coli when the IM rou