Amoxiclav Elpen 875 mg/125 mg poeder voor orale suspensie in sachet

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

AMOXICILLINE 3-WATER 1004,3 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 875 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk

Tilgængelig fra:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave 190 09 PIKERMI ATTIKIS (GRIEKENLAND)

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLINE 3-WATER 1004,3 mg/stuk SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER 875 mg/stuk ; KALIUMCLAVULANAAT 148,9 mg/stuk SAMENSTELLING overeenkomend met ; CLAVULAANZUUR 125 mg/stuk

Lægemiddelform:

Poeder voor orale suspensie

Sammensætning:

ASPARTAAM (E 951) ; GLUCOSE, VLOEIBAAR ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; SACCHAROSE ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; SINAASAPPELSMAAKSTOF ; STIKSTOF (HEAD SPACE) (E 941) ; TOCOFEROL, DL-ALFA (E 307), ASPARTAAM (E 951) ; GLUCOSE, VLOEIBAAR ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; SACCHAROSE ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; SINAASAPPELSMAAKSTOF ; STIKSTOF (HEAD SPACE) (E 941) ; TOCOFEROL, DL-ALFA (E 307)

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Amoxicillin and beta-lactamase inhibitor

Autorisation dato:

1900-01-01

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMOXICLAV ELPEN 875 MG/125 MG POEDER VOOR ORALE SUSPENSIE IN SACHET
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 (or for your child) 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 Amoxiclav Elpen is and what it is used for
2.
What you need to know before you take Amoxiclav Elpen
3.
How to take Amoxiclav Elpen
4.
Possible side effects
5.
How to store Amoxiclav Elpen
6.
Contents of the pack and other information
1.
WHAT AMOXICLAV ELPEN IS AND WHAT IT IS USED FOR
Amoxiclav Elpen 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.
Amoxiclav Elpen 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 AMOXICLAV ELPEN
DO NOT TAKE AMOXICLAV ELPEN:
-
if you are allergic 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 reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or throat
-
if you have eve

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxiclav Elpen 875 mg/125 mg poeder voor orale suspensie in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains amoxicillin trihydrate equivalent to 875 mg
amoxicillin and potassium
clavulanate equivalent to 125 mg clavulanic acid.
Excipients with known effect:
Each sachet contains 12.5 mg aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin/clavulanic acid 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
and 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 Amoxiclav Elpen 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.
The use of alternative presentations of amoxicillin/clavulanic acid
(e.g. those that provide higher doses
of amoxicillin and/or different ratios of amoxicillin to clavulanic
acid) should be considered as
necessary (see section 4.4. and 5.1).
2
For adults and children ≥ 40 kg, this formulation of
amoxicillin/clavul