Amoxicilline disper 1000, dispergeerbare tabletten

국가: 네덜란드

언어: 네덜란드어

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

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Download 환자 정보 전단 (PIL)
16-09-2020
Download 제품 특성 요약 (SPC)
16-09-2020

유효 성분:

AMOXICILLINE 3-WATER SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER

제공처:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC 코드:

J01CA04

INN (International Name):

AMOXICILLINE 3-WATER COMPOSITION corresponding to ; AMOXICILLIN 0-WATER

약제 형태:

Dispergeerbare tablet

구성:

ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; ERWTENZETMEEL HYDROXYPROPYL, GEPREGELATINEERD ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PERZIK-ABRIKOZENSMAAKSTOF 26 F 22, GEPOEDERD ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PERZIK-ABRIKOZENSMAAKSTOF 26 F 22, GEPOEDERD ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZETMEEL, OPLOSBAAR,

관리 경로:

Oraal gebruik

치료 영역:

Amoxicillin

제품 요약:

Hulpstoffen: ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); PERZIK-ABRIKOZENSMAAKSTOF 26 F 22, GEPOEDERD; SILICIUMDIOXIDE (E 551); SINAASAPPELSMAAKSTOF 55.301 AP 0551; TALK (E 553 B); TITAANDIOXIDE (E 171); ZETMEEL, OPLOSBAAR;

승인 날짜:

2006-07-17

환자 정보 전단

                                Sandoz B.V.
Page1/9
Amoxicilline disper 500/750/1000 mg, dispergeerbare tabletten
RVG 33897-8-9
1313-V9
1.3.1.3 Package Leaflet
Augustus 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICILLINE DISPER 500 MG, DISPERGEERBARE TABLETTEN
AMOXICILLINE DISPER 750 MG, DISPERGEERBARE TABLETTEN
AMOXICILLINE DISPER 1000 MG, DISPERGEERBARE TABLETTEN
amoxicillin
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
WHAT [NATIONALLY COMPLETED NAME] IS
[NATIONALLY COMPLETED NAME
is an antibiotic. The active ingredient is amoxicillin. This belongs
to a
group of medicines called “penicillins”.
WHAT [NATIONALLY COMPLETED NAME] IS USED FOR
[NATIONALLY COMPLETED NAME]
is used to treat infections caused by bacteria in different parts of
the
body.
[NATIONALLY COMPLETED NAME]
may also be used in combination with other medicines to treat
stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE
[
NATIONALLY COMPLETED NAME
]
:
-
If you are allergic to amoxicillin, penicillin or any of the other
ingredients of this medicine (listed
in section 6).
-
if you have ever had an allergic reaction to any antibiotic. This can
include a skin
                                
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제품 특성 요약

                                Sandoz B.V.
Page1/19
Amoxicilline disper 500/750/1000 mg, dispergeerbare
tabletten
RVG 33897-8-9
1311-V10
1.3.1.1 Summary of Product Characteristics
Augustus 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicilline disper 500 mg, dispergeerbare tabletten
Amoxicilline disper 750 mg, dispergeerbare tabletten
Amoxicilline disper 1000 mg, dispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 500 mg of amoxicillin (as
trihydrate).
Excipient with known effect
Each dispersible tablet contains 2.6 mg of aspartame (E 951), up to
0.30 mg of benzyl alcohol, up to
0.14 mg of benzyl benzoate, 0.032 mg of sorbitol (E 420) and 24 ng of
sulphur dioxide (E 220).
Each dispersible tablet contains 750 mg of amoxicillin (as
trihydrate).
Excipient with known effect
Each dispersible tablet contains 3.9 mg of aspartame (E 951), up to
0.45 mg of benzyl alcohol, up to
0.22 mg of benzyl benzoate, 0.048 mg of sorbitol (E 420) and 36 ng of
sulphur dioxide (E 220).
Each dispersible tablet contains 1000 mg of amoxicillin (as
trihydrate).
Excipient with known effect
Each dispersible tablet contains 5.2 mg of aspartame (E 951), up to
0.60 mg of benzyl alcohol, up to
0.29 mg of benzyl benzoate, 0.064 mg of sorbitol (E 420) and 48 ng of
sulphur dioxide (E 220).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablet.
_500 mg dispersible tablets: _
Oblong, biconvex, white to yellowish-white tablet, approximate size 8
x 18 mm, scored.
_750 mg dispersible tablets: _
Oblong, biconvex, white to yellowish-white tablet, approximate size 9
x 20 mm, scored.
_1000 mg dispersible tablets: _
Oblong, biconvex, white to yellowish-white tablet, approximate size 10
x 22 mm, scored.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Sandoz B.V.
Page2/19
Amoxicilline disper 500/750/1000 mg, dispergeerbare
tabletten
RVG 33897-8-9
1311-V10
1.3.1.1 Summary of Product Characteristics
Augustus 2020
4.
CLIN
                                
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