AmoxiClav-Denk 1000/125 powder for oral suspension

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Available from:

PenCef Pharma GmbH

ATC code:

J01CR02

INN (International Name):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosage:

1000mg+ 125mg

Pharmaceutical form:

powder for oral suspension

Units in package:

(8) sachets 3g, (12) sachets 3g

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-09-20

Patient Information leaflet

_AmoxiClav-Denk _
_ _
_1000/125_
Powder for oral suspension
Combination of penicillin and ß-lactamase inhibitor
Active ingredients: Amoxicillin trihydrate,
clavulanate potassium
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doc-
tor or pharmacist.
– This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. WHAT AMOXICLAV-DENK 1000/125 IS AND WHAT
IT IS USED FOR
2. BEFORE YOU TAKE AMOXICLAV-DENK 1000/125
3. HOW TO TAKE AMOXICLAV-DENK 1000/125
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE AMOXICLAV-DENK 1000/125
6. FURTHER INFORMATION
1.
What AmoxiClav-Denk 1000/125 is and
what it is used for
AmoxiClav-Denk 1000/125 is an antibiotic consisting
of the penicillin amoxicillin and the ß-lactamase inhi-
bitor clavulanic acid.
AmoxiClav-Denk 1000/125 is used in the treatment of
acute and chronic infections that are receptive to oral
therapy. Gram-positive and gram-negative microor-
ganisms are possible pathogens whose resistance to
ß-lactam antibiotics is caused by ß-lactamases, which
are however sensitive to the combination of amoxi-
cillin and clavulanic acid.
If there is a reasonable suspicion that the afore-men-
tioned pathogens could be the cause of a certain in-
fection, treatment with AmoxiClav-Denk 1000/125
can be commenced even before receiving the result
of the susceptibility test (antibiogram).
This medicine is suitable for treatment of the fol
-
lowing indications:
• infections of the upper and lower respiratory tract
including:
– middle ear infection (otitis media)
–
acute infection of the paranasal sinuses (acute
sinusitis)
– acute exacerbations of chronic bronchitis
– lung infection (pne

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AmoxiClav-Denk 1000/125
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: amoxicillin and clavulanic acid
Each sachet contains 1,000 mg amoxicillin (as trihydrate) and 125 mg
clavulanic acid (as potassium
clavulanate).
Excipients with known effect: Each sachet contains1,289.20 mg sucrose
and less than 1 mmol sodium
(23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
Sachets with white to yellowish granular powder with a characteristic
orange flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AmoxiClav-Denk 1000/125 is indicated in adults for the treatment of
acute and chronic infections that
are receptive to oral therapy. Gram-positive and gram-negative
microorganisms are possible pathogens
whose resistance to β-lactam antibiotics is caused by β-lactamases,
which are however sensitive to the
combination of amoxicillin and clavulanic acid.
If there is a reasonable suspicion that the afore-mentioned pathogens
could be the cause of a certain
infection, treatment with this combination can be commenced even
before receiving the result of the
antibiogram.
This medicine is suitable for treatment of the following indications:
-
Infections of the upper and lower respiratory tract including:
•
otitis media
•
acute sinusitis
•
acute exacerbations of chronic bronchitis
•
pneumonia
-
kidney and lower urinary tract infections
-
genital infections
Please note:
Consideration should be given to official national and international
guidelines on the appropriate use
of antimicrobial 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 amoxicillin/clavulanic acid that is selected to treat an
individual infection should take into
account:
-
the expected pathogens and their likely susceptibility to
antibacterial agen