DAFRACLAV 400/57 mg FORTE

Nazione: Nigeria

Lingua: inglese

Fonte: NAFDAC (National Agency for Food and Drugs Administration and Control)

Principio attivo:

Amoxicillin + Clavulanic Acid

Commercializzato da:

Dafra Pharma GmbH

INN (Nome Internazionale):

Amoxicillin + Clavulanic Acid

Composizione:

AMOXICILLIN 400MG,CLAVULANIC ACID 57MG

Prodotto da:

BILIM PHARM CERKEZKOY ISLETMESI 59501 CERKEZKOY/TEKIRDAY,TURKEY

Indicazioni terapeutiche:

DAFRACLAV is indicated in the treatment of the following infections caused by the microorganisms indicated below. - Upper respiratory tract infections (including otitis media and sinusitis), due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. - Lower respiratory tract infections, due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. - Skin and Skin Structure infections, due to beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. - Urinary tract infections. Since DAFRACLAV contains amoxicillin, it can be used in the treatment of infections caused by bacteria susceptible to ampicillin. Additionally, if in a mixed infection a microorganisms is susceptible to ampicillin and the other which is a beta-lactamase producer is susceptible to DAFRACLAV, such an infection can be treated by the administration of DAFRACLAV alone, addition of another antibiotic is not required.

Foglio illustrativo

PATIENT INFORMATION LEAFLET
DAFRACLAV
®
400/57 FORTE
Amoxicillin + Clavulanic Acid
POWDER FOR ORAL SUSPENSION
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.
1.
WHAT IS DAFRACLAV® 400/57 AND WHAT IT IS USED FOR
Dafraclav® 400/57 contains amoxicillin and clavulanic acid (ATC code:
J01CR02). These are antibiotics, working by killing
bacteria that cause infections. Amoxicillin belongs to the group of
“penicillins”. Clavulanic acid prevents amoxicillin from being
inactivated by enzymes produced by the bacteria.
Dafraclav® 400/57 is used in the treatment of the following
infections:

respiratory tract infections (including middle ear and sinus
infections),

skin and skin structure infections (including dental infections),

urinary tract infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFRACLAV® 400/57
_DO NOT TAKE DAFRACLAV® 400/57 IF YOU _

are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other ingredients of Dafraclav® 400/57
(listed in section 6),

have ever had a severe allergic (hypersensitive) reaction to any other
antibiotic; this can include a skin rash or swelling of
the face or neck,

have ever had liver problems or jaundice (yellowing of the skin) when
taking an antibiotic.
_TAKE SPECIAL CARE WITH DAFRACLAV® 400/57 IF YOU _

have glandular fever (infectious mononucleosis),

have liver or kidney problems,

are not passing water regularly.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Dafraclav® 400/57.
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _

inflammation of the large intestine has been reported in association
with all antibiotic

Scheda tecnica

DAFRACLAV
®
400/57 MG FORTE
POWDER FOR ORAL SUSPENSION
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dafraclav® BD 400/57 mg POWDER FOR ORAL SUSPENSION contains 400 MG
AMOXICILLIN
equivalent of amoxicillin trihydrate and potassium clavulanate
equivalent to 57 MG CLAVULANIC ACID
activity per 5 ML of suspension as active ingredients.
2. PHARMACEUTICAL FORM
Each cardboard box contains 1 bottle of 70 ml. Bottle containing
enough powder mixture to give 70 ml
suspension after reconstitution with water. Supplied with a measure
spoon.
OTHER PHARMACEUTICAL FORMS AVAILABLE: Dry powder Dafraclav® BD 200/28
mg Pediatric Oral
Suspension, 70 ml; Dafraclav® 625 mg Filmcoated tablet (15 tablets);
Dafraclav® 1 g Filmcoated tablet
(10 tablets).
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS: Dafraclav® is indicated in the treatment
of the following infections caused
by the microorganisms indicated below. _UPPER RESPIRATORY TRACT
INFECTIONS (INCLUDING OTITIS MEDIA _
_AND SINUSITIS), _ due to beta-lactamase producing strains of
Haemophilus influenzae and Moraxella
catarrhalis.
_LOWER _
_RESPIRATORY _
_TRACT _
_INFECTIONS, _
due
to
beta-lactamase
producing
strains
of
Haemophilus influenzae and Moraxella catarrhalis. _SKIN AND SKIN
STRUCTURE INFECTIONS_, due to beta-
lactamase producing strains of Staphylococcus aureus, Escherichia coli
and Klebsiella spp. _URINARY _
_TRACT INFECTIONs. _Since Dafraclav® contains amoxicillin, it can be
used in the treatment of infections
caused by bacteria susceptible to ampicillin. Additionally, if in a
mixed infection a microorganisms is
susceptible to ampicillin and the other which is a beta-lactamase
producer is susceptible to Dafraclav®,
such an infection can be treated by the administration of Dafraclav®
alone, addition of another antibiotic
is not required. Since in vitro Streptococcus pneumoniae is more
susceptible to amoxicillin compared
to ampicillin and penicillin, Streptococcus pneumoniae strains that
are moderately susceptible to
penicillin and ampicillin in microbiological tes