Amoxicilline/Clavulaanzuur Teva 500/125 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

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

Dostupno od:

Teva Nederland B.V.

ATC koda:

J01CR02

INN (International ime):

AMOXICILLINE 3-WATER COMPOSITION corresponding to ; AMOXICILLIN 0-WATER ; KALIUMCLAVULANAAT COMPOSITION corresponding to ; clavulanic acid

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CETYLALCOHOL ; ETHYLCELLULOSE (E 462) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; CETYLALCOHOL ; ETHYLCELLULOSE (E 462) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Administracija rute:

Oraal gebruik

Područje terapije:

Amoxicillin and beta-lactamase inhibitor

Proizvod sažetak:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CETYLALCOHOL; ETHYLCELLULOSE (E 462); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Datum autorizacije:

2008-08-28

Uputa o lijeku

Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017
consolidated texts IB0016 and IA0017
1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
AMOXICILLINE/CLAVULAANZUUR TEVA 500/125 MG, FILMOMHULDE TABLETTEN
amoxicillin/clavulanic acid
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 __ is and what it is used for
2.
What you need to know before you take _ _
3.
How to take __
4.
Possible side effects
5.
How to store _ _
6.
Contens of pack and other information
1.
WHAT __ IS AND WHAT IT IS USED FOR
__
is an antibiotic and works by killing bacteria that cause infections.
It contains
two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of
medicines called “penicillins” that can sometimes be stopped from
working (made inactive). The other
active component (clavulanic acid) stops this from happening.
__
is used in adults and children to treat the following infections:

middle ear and sinus infections,

respiratory tract infections,

urinary tract infections

skin and soft tissue infections including dental infections

bone and joint infections
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE __
DO NOT TAKE __

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the
other ingredients of this medicine (listed in section 6)

if you have ever had a severe allergic (hypersensitive) reaction to
a

Svojstava lijeka

Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017
consolidated texts IB0016 and IA0017
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Amoxicilline/Clavulaanzuur Teva 500/125 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 583 mg amoxicillin trihydrate
equivalent to 500 mg
amoxicillin and 149 mg potassium clavulanate equivalent to 125 mg
clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
White to slightly yellowish, oblong, film coated tablets embossed on
one side (“GG N6”).
Dimension of tablets 10 x 21 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_[PRODUCT NAME]_ is indicated for the treatment of the following
infections in adults and
children (see sections 4.2, 4.4 and 5.1):

Acute bacterial sinusitis (adequately diagnosed)

Acute otitis media,

Acute exacerbation of chronic bronchitis (adequately diagnosed)

Community acquired pneumonia.

Cystitis

Pyelonephritis

Skin and soft tissue infections in particular, cellulitis, animal
bites., severe dental
abscess with spreading cellulitis..

Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when
doses are stated in terms of an individual component.
The dose of amoxicillin/clavulanic acid that is selected to treat an
individual infection should
take into account:

The expected pathogens and their likely susceptibility to
antibacterial agents (see section
4.4)

The severity and the site of the infection

The age, weight and renal function of the patient as shown below.
Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017
consolidated texts IB0016 and IA0017
2
The use of alternative presentations of amoxicillin/clavulanic acid
(e.g. those that pro