Tro-xime 750mg powder for solution for injection/infusion powder for solution for injection/infusion

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

cefuroxime (cefuroxime sodium)

Disponible depuis:

Reyoung Pharmaceutical Co. Ltd.

Code ATC:

J01DC02

DCI (Dénomination commune internationale):

cefuroxime (cefuroxime sodium)

Dosage:

750mg

forme pharmaceutique:

powder for solution for injection/infusion

Unités en paquet:

(1) glass vial 10ml, (50) glass vials 10ml

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2020-03-17

Notice patient

CTD – MODULE 1 - ADMINISTRATIVE INFORMATION
1.3 PRODUCT INFORMATION
TRO-XIME 750 mg powder for solution for injection/infusion
(Cefuroxime)
Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany
_PACKAGE LEAFLET _
PROPOSED TEXT MATTER for the Patient Information Leaflet (PIL),
_In English_
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRO-XIME 750 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION_ _
(CEFUROXIME)
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What TRO-XIME is and what it is used for
2.
What you need to know before you are given TRO-XIME
3.
How TRO-XIME is given
4.
Possible side effects
5.
How to store TRO-XIME
6.
Contents of the pack and other information
1. WHAT TRO-XIME IS AND WHAT IT IS USED FOR
The name of this medicine is TRO-XIME 750 mg powder for solution for
injection/infusion
referred to as TRO-XIME throughout the package leaflet. TRO-XIME
contains the active
substance Cefuroxime sodium. It is an antibiotic used in adults and
children. It works by
killing
bacteria
that
cause
infections.
It
belongs
to
a
group
of
medicines
called
cephalosporins_. _
TRO-XIME is indicated for the treatment of the following infections in
adults and children,
including neonates (from birth):
The lungs or chest (Chronic bronchitis & community acquired
pneumonia), urinary tract, skin
and soft tissue, intra abdominal infections. It is also used to
prevent infections during surgery.
Your doctor may test type of bacteria causing your infection and
monitor whether bacteria are
sensitive to TRO-XIME during your treatment.
CTD – MODULE 1 - ADMINISTRATIVE INFORMATION
1.3 PRODUCT INFORMATION
TRO-XIME 750 mg powder for solution for injection/infusion
(Cefurox

Résumé des caractéristiques du produit

CTD – MODULE 1 – ADMINISTRATIVE INFORMATION AND PRESCRIBING
INFORMATION
1.3 PRESCRIBING INFORMATION
TRO-XIME 750 MG
powder for solution for injection/infusion
Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany
Page
1
of
17
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
TRO-XIME
750 MG
powder for solution for injection/infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750 mg of cefuroxime (in form of sodium salt).
The total quantity of sodium per vial is 42 mg.
_No other excipients (see section 6.1). _
3. PHARMACEUTICAL FORM
_Powder for solution for injection/infusion. _
Description: A white to faintly yellow, crystalline powder.
Color of reconstituted solution: Off-white to yellow suspension for
intramuscular use or a
clear and yellowish solution for intravenous administration.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TRO-XIME is indicated for the treatment of the infections listed below
in adults and
children, including neonates (from birth) (see sections 4.4 and 5.1).
•
Community acquired pneumonia.
•
Acute exacerbations of chronic bronchitis.
•
Complicated urinary tract infections, including pyelonephritis.
•
Soft-tissue infections: cellulitis, erysipelas and wound infections.
•
Intra-abdominal infections (see section 4.4).
•
Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic,
cardiovascular, and gynaecological surgery (including caesarean
section).
CTD – MODULE 1 – ADMINISTRATIVE INFORMATION AND PRESCRIBING
INFORMATION
1.3 PRESCRIBING INFORMATION
TRO-XIME 750 MG
powder for solution for injection/infusion
Troge Medical GmbH · Milchstrasse 19 · 20148 Hamburg · Germany
Page
2
of
17
In the treatment and prevention of infections in which it is very
likely that anaerobic
organisms
will
be
encountered,
cefuroxime
should
be
administered
with
additional
appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4