Cefuroximaxetil 500, omhulde tabletten 500 mg

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Thành phần hoạt chất:

CEFUROXIMAXETIL SAMENSTELLING overeenkomend met ; ; CEFUROXIM

Sẵn có từ:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Mã ATC:

J01DC02

INN (Tên quốc tế):

Cefuroxime axetil COMPOSITION corresponding to ; ; CEFUROXIME

Dạng dược phẩm:

Omhulde tablet

Thành phần:

AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Tuyến hành chính:

Oraal gebruik

Khu trị liệu:

Cefuroxime

Tóm tắt sản phẩm:

Hulpstoffen: AARDAPPELZETMEEL, OPLOSBAAR; ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Ngày ủy quyền:

2004-10-04

Tờ rơi thông tin

Sandoz B.V.
Page 1/8
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
RVG 23707-8-9
1313-V7
1.3.1.3 Bijsluiter
December 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIMAXETIL 125, OMHULDE TABLETTEN 125 MG
CEFUROXIMAXETIL 250, OMHULDE TABLETTEN 250 MG
CEFUROXIMAXETIL 500, OMHULDE TABLETTEN 500 MG
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed 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_
.
[Nationally completed name] is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
[Nationally completed name] can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
[
NATIONALLY COMPLETED NAME]
DO NOT TAKE
[
NATIONALLY COMPLETED NAME]:
Sandoz B.V.
Page 2/8
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
RVG 23707-8-9
1313-V7
1.3.1.3 Bijsluiter
December 2020
-
IF YOU ARE ALLERGIC
to cefuroxime, to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of t

Đặc tính sản phẩm

Sandoz GmbH
Page 1/14
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
RVG 26707-8-9
v10
1.3.1.1 Samenvatting van de Productkenmerken
November 2022
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroximaxetil 125, omhulde tabletten 125 mg
Cefuroximaxetil 250, omhulde tabletten 250 mg
Cefuroximaxetil 500, omhulde tabletten 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 125 mg coated tablet contains 150.36 mg cefuroxime (as axetil).
Excipients with known effect
Each coated tablet contains 0.2 mg aspartame (E951).
Each 250 mg coated tablet contains 300.72 mg cefuroxime (as axetil).
Each 500 mg coated tablets contain 601.44 mg cefuroxime (as axetil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
_125 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets.
_250 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets, scored on both
sides.
_500 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
[Nationally completed 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.
Sandoz GmbH
Page 2/14
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
RVG 26707-8-9
v10
1.3.1.1 Samenvatting van de Productkenmerken
November 2022
- 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).
_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
Acut