Cefuroxim Mylan 250 mg, filmomhulde tabletten

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

CEFUROXIMAXETIL 300,7 mg/stuk SAMENSTELLING overeenkomend met ; CEFUROXIM 250 mg/stuk

から入手可能:

Mylan Ireland Limited 35/36 Grange Parade, Baldoyle Industrial Estate DUBLIN 13 (IERLAND)

ATCコード:

J01DC02

INN（国際名）:

CEFUROXIMAXETIL 300,7 mg/stuk SAMENSTELLING overeenkomend met ; CEFUROXIM 250 mg/stuk

医薬品形態:

Filmomhulde tablet

構図:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; NATRIUMLAURILSULFAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; NATRIUMLAURILSULFAAT (E 487) ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

投与経路:

Oraal gebruik

治療領域:

Cefuroxime

承認日:

1900-01-01

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIM MYLAN 250 MG, FILMOMHULDE TABLETTEN
CEFUROXIM MYLAN 500 MG, FILMOMHULDE TABLETTEN
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 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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name]
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_
.
[Invented name] is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
[Invented name] can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
Your doctor may test the type of bacteria causing your infection and
monitor whether the bacteria are
sensitive to [Invented name] during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE [INVENTED NAME]:
•
if you are allergic to cefuroxime axetil or any cephalosporin
antibiotics or any of the other
ingredients of this medicine (listed in section 6).
•
if you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
treatment with cefuroxime or any other cephalosporin antibiotics.
•
if you have ever had a severe allergic (hypers

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroxim Mylan 250 mg, filmomhulde tabletten
Cefuroxim Mylan 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg cefuroxime (as cefuroxime
axetil)
Each film-coated tablet contains 500 mg cefuroxime (as cefuroxime
axetil)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, film-coated capsule shaped tablets, (approximately
16.1 mm x 6.6 mm) with ‘A
33’ debossed on one side and plain on the other side.
White to off-white, film-coated capsule shaped tablets, (approximately
20.1 mm x 8.6 mm) with ‘A
34’ debossed on one side and plain on the other side._ _
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Invented name] is indicated for the treatment of the infections
listed below in adults and children
from the age of 3 months (see sections 4.4 and 5.1).
_ _
•
Acute streptococcal tonsillitis and pharyngitis.
•
Acute bacterial sinusitis.
•
Acute otitis media.
•
Acute exacerbations of chronic bronchitis.
•
Cystitis.
•
Pyelonephritis.
•
Uncomplicated skin and soft tissue infections.
•
Treatment of early Lyme disease.
_ _
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days). The dosage should be
clearly specified for each method/route of administration and for each
indication, as appropriate.
_ _
_Table 1. Adults and children (_≥_40 kg) _
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial
sinusitis
250 mg twice daily
Acute otitis media
500 mg twice daily
Acute exacerbations of chronic bronchitis
500 mg twice daily
Cystitis
250 mg twice daily
Pyelonephritis
250 mg twice daily
Uncomplicated skin and soft tissue infections
250 mg twice daily
Lyme disease
500 mg twice daily for 14 days (range
of 10 to 21 days)
_Table