Amoxicilline/Clavulaanzuur Devatis 400 mg/57 mg/5 ml poeder voor orale suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMOXICILLINE 3-WATER 91,8 mg/ml SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 80 mg/ml ; KALIUMCLAVULANAAT 13,6 mg/ml SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 11,4 mg/ml

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

J01CR02

INN (Algemene Internationale Benaming):

AMOXICILLINE 3-WATER 91,8 mg/ml SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 80 mg/ml ; KALIUMCLAVULANAAT 13,6 mg/ml SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 11,4 mg/ml

farmaceutische vorm:

Poeder voor orale suspensie

Samenstelling:

3-METHYL-1-BUTANOL ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; ETHYLBUTYRAAT ; GLYCEROLTRIACETAAT (E 1518) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; MIRRE ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; SINAASAPPELOLIE ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 0-WATER (E 331) ; TUTTI FRUTTI FLAVOR 051880 AP 0551 ; VANILLA FLAVOR 054286 B7P0504 ; VANILLINE ; XANTHAANGOM (E 415),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Amoxicillin and beta-lactamase inhibitor

Product samenvatting:

Hulpstoffen: BENZYLALCOHOL (E 1519); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); CROSCARMELLOSE NATRIUM (E 468); ETHYLBUTYRAAT; GLYCEROLTRIACETAAT (E 1518); MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); MALTODEXTRINE; MANNITOL (D-) (E 421); MIRRE; PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); SINAASAPPELOLIE; SUCRALOSE (E 955); TRINATRIUMCITRAAT 0-WATER (E 331); TUTTI FRUTTI FLAVOR 051880 AP 0551; VANILLA FLAVOR 054286 B7P0504; VANILLINE; XANTHAANGOM (E 415); 3-METHYL-1-BUTANOL;

Autorisatie datum:

2016-08-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLINE/CLAVULAANZUUR DEVATIS 250 MG/62,5 MG/5 ML POEDER VOOR
ORALE SUSPENSIE
AMOXICILLINE/CLAVULAANZUUR DEVATIS 400 MG/57 MG/5 ML POEDER VOOR ORALE
SUSPENSIE
Amoxicillin/clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR THEM.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine is usually prescribed for a baby or child. Do not pass
it on to others. It may harm them,
even if their signs of illness are the same as your child’s.
-
If your child gets 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 Amoxicilline/Clavulaanzuur Devatis is and what it is used for
2.
What you need to know before you give Amoxicilline/Clavulaanzuur
Devatis
3.
How to give Amoxicilline/Clavulaanzuur Devatis
4.
Possible side effects
5.
How to store Amoxicilline/Clavulaanzuur Devatis
6.
Contents of the pack and other information
1.
WHAT AMOXICILLINE/CLAVULAANZUUR DEVATIS IS AND WHAT IT IS USED FOR
Amoxicilline/Clavulaanzuur Devatis 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.
Amoxicilline/Clavulaanzuur Devatis 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 GIVE AMOXICILLINE/CLAVULAANZUUR
DEVATIS
DO NOT GIVE YOUR CHILD AMOXICILLINE/CLAVULAANZUUR DEVATIS :
-
if they are al

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicilline/Clavulaanzuur Devatis 250 mg/62,5 mg/5 ml poeder voor
orale suspensie
Amoxicilline/Clavulaanzuur Devatis 400 mg/57 mg/5 ml poeder voor orale
suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains amoxicillin trihydrate equivalent to 50
mg amoxicillin and potassium
clavulanate equivalent to 12.5 mg clavulanic acid.
5 ml of suspension contain amoxicillin trihydrate equivalent to 250 mg
amoxicillin and potassium
clavulanate equivalent to 62.5 mg clavulanic acid.
Each ml of suspension contains amoxicillin trihydrate equivalent to 80
mg amoxicillin and potassium
clavulanate equivalent to 11.4 mg clavulanic acid.
5 ml of suspension contain amoxicillin trihydrate equivalent to 400 mg
amoxicillin and potassium
clavulanate equivalent to 57 mg clavulanic acid.
Excipients with known effect
This medicinal product contains 0.4 mg benzyl alcohol per 5 ml of
suspension.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to creamy white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicilline/Clavulaanzuur Devatis 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 exacerbations 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.
2
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 Amoxicilline/Clavulaanzuur Devatis that is selec