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:

2016-09-19

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 (pn

Summary of Product characteristics

Trade name:
Generic name:
Applicant:
_AmoxiClav-Denk 1000/125 _
Amoxicillin 1000 mg + clavulanic acid 125 mg, powder for suspension in
sachets
DENK PHARMA GmbH & Co. KG
1/ 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AmoxiClav-Denk 1000/125
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
AmoxiClav-Denk 1000/125 are homogenous white granules with orange
flavour.
AmoxiClav-Denk 1000/125 is available in sachets containing 3 g of
powder to produce an
oral suspension.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substances are amoxicillin trihydrate and clavulanate
potassium.
One sachet contains 1148 mg amoxicillin trihydrate, equivalent to 1 g
amoxicillin and 148.9
mg clavulanate potassium, equivalent to 125 mg clavulanic acid.
One sachet contains 24.54 mg potassium and 1289.20 mg sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
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.
Trade name:
Generic name:
Applicant:
_AmoxiClav-Denk 1000/125 _
Amoxicillin 1000 mg + clavulanic acid 125 mg, powder for suspension in
sachets
DENK PHARMA GmbH & Co. KG
2/